<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03238417</url>
  </required_header>
  <id_info>
    <org_study_id>PEX 16-002</org_study_id>
    <secondary_id>PEC 16-352</secondary_id>
    <nct_id>NCT03238417</nct_id>
  </id_info>
  <brief_title>Evaluating Evidence-Based Quality Improvement of Comprehensive Women's Health Care Implementation in Low-Performing VAs</brief_title>
  <official_title>Evaluating Evidence-Based Quality Improvement of Comprehensive Women's Health Care Implementation in Low-Performing VA Facilities (PEC 16-352)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gaps in delivery of gender-sensitive comprehensive care have resulted in disparities in&#xD;
      quality and patient experience among women seen in VA. VA policy action providing guidance on&#xD;
      delivery of comprehensive healthcare services for women Veterans was disseminated nationally&#xD;
      in 2010, followed by annual assessments and site visits evaluating local VA efforts. While&#xD;
      substantial inroads have been made, policy implementation, even when leveraged by field-based&#xD;
      women's health leaders, has not been uniformly successful in achieving delivery of&#xD;
      comprehensive care by designated providers in gender-sensitive care environments that ensure&#xD;
      women's privacy, dignity and safety, all tenets of the original guidance and the updated&#xD;
      directive (2017).&#xD;
&#xD;
      Building on prior effectiveness of an evidence-based quality improvement (EBQI) approach to&#xD;
      tailoring VA's medical home model -- Patient Aligned Care Teams (PACT) -- to the needs of&#xD;
      women Veterans, VA leaders in women's health adopted EBQI to help low-performing VAs&#xD;
      systematically improve services.&#xD;
&#xD;
      The objectives of the resulting Partnered Evaluation Initiative (PEI) funded by VA's Quality&#xD;
      Enhancement Research Initiative and VA Office of Women's Health were:&#xD;
&#xD;
        1. To evaluate barriers and facilitators to achieving delivery of comprehensive women's&#xD;
           health care in the identified low-performing VAs;&#xD;
&#xD;
        2. To evaluate effectiveness of EBQI in supporting low-performing VA facilities achieve&#xD;
           improved organizational features, provider/staff attitudes, quality of care, and patient&#xD;
           experiences among women Veteran patients; and,&#xD;
&#xD;
        3. To evaluate contextual factors, local implementation processes, and organizational&#xD;
           changes in the participating facilities over time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gaps in delivery of gender-sensitive comprehensive care have resulted in disparities in&#xD;
      quality and patient experience among women seen in VA. VA policy action providing guidance on&#xD;
      delivery of comprehensive healthcare services for women Veterans was disseminated nationally&#xD;
      in 2010, followed by annual assessments and site visits evaluating local VA efforts. While&#xD;
      substantial inroads have been made, policy implementation, even when leveraged by field-based&#xD;
      women's health leaders, has not been uniformly successful in achieving delivery of&#xD;
      comprehensive care by designated providers in gender-sensitive care environments that ensure&#xD;
      women's privacy, dignity and safety, all tenets of the original guidance and the updated VA&#xD;
      directive (2017).&#xD;
&#xD;
      In collaboration with VA Women's Health Services (WHS), VA researchers developed a series of&#xD;
      studies to better understand and help improve comprehensive care implementation through the&#xD;
      Women Veterans' Healthcare CREATE Initiative. Among these, one focused on testing an&#xD;
      evidence-based quality improvement (EBQI) approach to tailoring VA's medical home model --&#xD;
      Patient Aligned Care Teams (PACT) -- to the needs of women Veterans, which has yielded&#xD;
      significant local improvements in women Veterans' care. EBQI emphasizes a multilevel&#xD;
      partnered approach to building capacity for innovation, implementation and spread of&#xD;
      evidence-based practice. With its demonstrated success in the CREATE PACT study and several&#xD;
      other EBQI trials, WHS adopted EBQI as a strategy to help low-performing VA facilities&#xD;
      systematically improve services.&#xD;
&#xD;
      The objectives of the WHS/QUERI Partnered Evaluation Initiative that this project represents&#xD;
      are:&#xD;
&#xD;
        1. To evaluate the barriers and facilitators to achieving delivery of comprehensive women's&#xD;
           health care in the identified low-performing VA facilities;&#xD;
&#xD;
        2. To evaluate the effectiveness of EBQI in supporting low-performing VA facilities achieve&#xD;
           improved:&#xD;
&#xD;
             1. Organizational features (e.g., level of comprehensive services available; care&#xD;
                coordination arrangements; PACT features implemented; environment of care&#xD;
                improvements);&#xD;
&#xD;
             2. Provider/staff attitudes (e.g., improved gender awareness; women's health knowledge&#xD;
                and practice);&#xD;
&#xD;
           d) Quality of care and patient experiences among women Veteran patients using secondary&#xD;
           data; and,&#xD;
&#xD;
        3. To evaluate contextual factors, local implementation processes, and organizational&#xD;
           changes in the participating facilities over time.&#xD;
&#xD;
      Results of the evaluation have been used to provide feedback to stakeholders, including women&#xD;
      Veterans, at the local, network and national levels, while also being used to continuously&#xD;
      refine EBQI implementation processes. The evaluation is also helping inform optimal&#xD;
      strategies for ongoing improvements in women Veterans' care in the 21 participating VA&#xD;
      facilities, other VA facilities and for other improvement initiatives in this and other&#xD;
      national program offices.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2017</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Dynamic waitlist control design with a group of 7 VA facilities was randomly allocated to Evidence-Based Quality Improvement (EBQI) in Year 1 (while 14 VA facilities serving as waitlist controls), the second group of 7 VA facilities was randomly allocated to EBQI in Year 2 (while the 7 remaining VA facilities and the first 7 EBQI sites serving as control), and the final group of 7 VA facilities was randomly allocated to EBQI in Year 3 (while the first 14 EBQI facilities subsequently serving as control). By the end of the three year study period, a total of 21 VA facilities received at least 1 year of EBQI.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gender-sensitive Care Environment</measure>
    <time_frame>12-month change in gender-sensitive care environment</time_frame>
    <description>Multi-item scale score reflecting survey items (from The Women's Assessment Tool for Comprehensive Health (WATCH)) on availability of same-gender providers, availability of same-gender staff, privacy of physical layout, availability of privacy curtains, level of implementation of local culture campaign that values and treats Women Veterans with respect. The score ranges from 0 to 7, with a higher score reflecting greater gender-sensitive care environment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gender-sensitive Care Environment</measure>
    <time_frame>24-month change in gender-sensitive care environment</time_frame>
    <description>Multi-item scale score reflecting survey items (from The Women's Assessment Tool for Comprehensive Health (WATCH)) on availability of same-gender providers, availability of same-gender staff, privacy of physical layout, availability of privacy curtains, level of implementation of local culture campaign that values and treats Women Veterans with respect. The score ranges from 0 to 7, with a higher score reflecting greater gender-sensitive care environment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gender Awareness</measure>
    <time_frame>12-month change in gender awareness among VA primary care and women's health providers and staff.</time_frame>
    <description>A 12-item score reflecting primary care and women's health providers' and staff's awareness and knowledge of women Veterans' military background and healthcare needs. The score ranges from 1 to 5 with higher scores reflecting greater gender awareness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gender Awareness</measure>
    <time_frame>24-month change in gender awareness among VA primary care and women's health providers and staff</time_frame>
    <description>A 12-item score reflecting primary care and women's health providers' and staff's awareness and knowledge of women Veterans' military roles and healthcare needs . The score ranges from 1 to 5 with higher scores reflecting greater gender awareness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality Improvement Experience</measure>
    <time_frame>12-month change</time_frame>
    <description>The count of quality improvement activities reported by providers and staff in primary care and women's health settings; including 1) training in quality improvement methods, 2) collaboration with other VA facilities to identify best practices, 3) working with Women Veteran Program Manager to identify and/or solve local problems in caring for women Veterans, 4) using of VA performance data, 5) using of VA survey data by gender, 6) working on a quality improvement project focused on women Veterans, 7) involving in small tests of change for quality improvement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality Improvement Experience</measure>
    <time_frame>24-month change</time_frame>
    <description>The count of quality improvement activities reported by provider and staff in primary care and women's health settings; including 1) training in quality improvement methods [e.g., LEAN], 2) collaboration with other VA facilities to identify best practices, 3) working with Women Veteran Program Manager to identify and/or solve local problems in caring for women Veterans, 4) using of VA performance data, 5) using of VA survey data by gender, 6) working on a quality improvement project focused on women Veterans, 7) involving in small tests of change for quality improvement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gender-specific Preventive Care Delivery</measure>
    <time_frame>12-month change</time_frame>
    <description>Rate of cervical cancer screening using the VA External Peer Review Program (EPRP) chart-based quality metrics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gender-specific Preventive Care Delivery</measure>
    <time_frame>24-month change in gender-specific preventive care delivery</time_frame>
    <description>Rate of cervical cancer screening using the VA External Peer Review Program (EPRP) chart-based quality metrics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accessibility of Care</measure>
    <time_frame>12-month change in accessibility</time_frame>
    <description>Women Veterans' ratings of accessibility based on the Survey of Healthcare Experience of Patients (SHEP) program. The mean score is the percent of female patients who responded &quot;always&quot; to validated survey items measuring accessibility, the higher percentage representing better access.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accessibility of Care</measure>
    <time_frame>24-month change in accessibility</time_frame>
    <description>Women Veterans' ratings of accessibility from the Survey of Healthcare Experience of Patients (SHEP) program. The mean score is the percent of female patients who responded &quot;always&quot; to validated survey items measuring accessibility, the higher percentage representing better access.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coordination of Care</measure>
    <time_frame>12-month change</time_frame>
    <description>Women Veterans' ratings of care coordination from the Survey of Healthcare Experience of Patients (SHEP) program. The mean score is the percent of female patients who responded &quot;always&quot; to validated survey items measuring care coordination, the higher percentage representing better coordination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coordination of Care</measure>
    <time_frame>24-month change</time_frame>
    <description>Women Veterans' ratings of care coordination from the Survey of Healthcare Experience of Patients (SHEP) program. The mean score is the percent of female patients who responded &quot;always&quot; to validated survey items measuring care coordination, the higher percentage representing better coordination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gender-neutral Guideline-concordant Preventive Care Receipt</measure>
    <time_frame>12-month change</time_frame>
    <description>Percentage of women Veterans' obtaining recommended preventive care based on eligibility for service (e.g., meet eligibility guidelines for timely eye exams for diabetes, flu vaccination, colorectal cancer screening) using VA External Peer Review Program (EPRP) chart-based quality metrics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gender-neutral Guideline-concordant Preventive Care Receipt</measure>
    <time_frame>24-month change</time_frame>
    <description>Percentage of women Veterans' obtaining recommended preventive care based on eligibility for service (e.g., meet eligibility guidelines for timely eye exams for diabetes, flu vaccination, colorectal cancer screening) using VA External Peer Review Program (EPRP) chart-based quality metrics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assignment to a Designated Women's Health Provider or a Women's Health Primary Care Teams, Using Patient Aligned Care Teams Compass</measure>
    <time_frame>12-month change</time_frame>
    <description>Percentage of women Veterans assigned to a designated women's health provider in a general primary care and/or women's health primary care setting.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assignment to a Designated Women's Health Provider or a Women's Health Primary Care Teams, Using Patient Aligned Care Teams Compass</measure>
    <time_frame>24-month change</time_frame>
    <description>Percentage of women Veterans assigned to a designated women's health provider in a general primary care and/or women's health primary care setting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Provider Rating</measure>
    <time_frame>12 month change</time_frame>
    <description>Percent of women patients who rated 9 or 10 on a scale of 0 to 10 for the provider rating question on the Survey of Healthcare Experiences of Patients (SHEP). Higher scores are better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Provider Rating</measure>
    <time_frame>24-month change</time_frame>
    <description>Percent of women patients who rated 9 or 10 on a scale of 0 to 10 for the provider rating question from the Survey of Healthcare Experiences of Patients (SHEP). Higher scores are better.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Comprehensive Care</condition>
  <arm_group>
    <arm_group_label>Evidence-Based Quality Improvement (EBQI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist Controls</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Evidence-Based Quality Improvement</intervention_name>
    <description>Multilevel research-clinical partnership approach to supporting local strategic planning, priority setting, skill building and engagement in addressing targeted healthcare delivery problems. Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI education/training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines.</description>
    <arm_group_label>Evidence-Based Quality Improvement (EBQI)</arm_group_label>
    <other_name>EBQI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unit of randomization: VA healthcare facilities (VA medical center or community-based&#xD;
             outpatient clinic)&#xD;
&#xD;
          -  Subset of VA healthcare facilities identified as low-performing on the basis of&#xD;
             composites of access/wait times, gender disparities in quality, e.g.:&#xD;
&#xD;
               -  depression screening&#xD;
&#xD;
               -  diabetic blood sugar control&#xD;
&#xD;
          -  Presence/absence of VA-required structural facets of care, e.g.:&#xD;
&#xD;
               -  designated women's health providers&#xD;
&#xD;
               -  mammography coordinator&#xD;
&#xD;
               -  gynecology access&#xD;
&#xD;
               -  Women Veteran Program Manager (WVPM)&#xD;
&#xD;
               -  3:1 staffing ratio for PACT teamlets&#xD;
&#xD;
        Key Stakeholder Inclusion Criteria (qualitative interviews):&#xD;
&#xD;
          -  Veteran Integrated Service Network (VISN) level leader (Director or Chief Medical&#xD;
             Officer)&#xD;
&#xD;
          -  VISN level WVPM Lead, VISN level primary care director, VISN level QI/system redesign&#xD;
             lead)&#xD;
&#xD;
          -  VA facility leader (Director or other member of senior leadership)&#xD;
&#xD;
          -  Chief of Staff&#xD;
&#xD;
          -  primary care director&#xD;
&#xD;
          -  women's health medical director&#xD;
&#xD;
          -  WVPM&#xD;
&#xD;
          -  local EBQI champion&#xD;
&#xD;
          -  other key personnel&#xD;
&#xD;
        Provider/Staff Survey Inclusion Criteria:&#xD;
&#xD;
          -  Primary care providers (medical doctor [MD], doctor of osteopathy [DO], nurse&#xD;
             practitioner [NP], physician assistant [PA]) delivering primary care in general&#xD;
             primary care and/or women's health clinics&#xD;
&#xD;
          -  PACT teamlet members (registered nurse [RN] care managers, licensed vocational&#xD;
             nurse/licensed practical nurse [LVN/LPN]/health technicians, and clerks)&#xD;
&#xD;
          -  larger PACT team members, e.g.:&#xD;
&#xD;
               -  social workers&#xD;
&#xD;
               -  dieticians&#xD;
&#xD;
               -  health coaches&#xD;
&#xD;
               -  integrated mental health&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Facility-level exclusion: Facilities not identified in the initial sample of VA&#xD;
             facilities (sample not renewed over time).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth M Yano, PhD MSPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Greater Los Angeles Healthcare System, Sepulveda, CA</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alison B Hamilton, PhD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Greater Los Angeles Healthcare System, West Los Angeles, CA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Central Alabama Veterans Health Care System West Campus, Montgomery, AL</name>
      <address>
        <city>Montgomery</city>
        <state>Alabama</state>
        <zip>36109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern Arizona VA Health Care System, Prescott, AZ</name>
      <address>
        <city>Prescott</city>
        <state>Arizona</state>
        <zip>86313</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Northern California Health Care System, Mather, CA</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Greater Los Angeles Healthcare System, Sepulveda, CA</name>
      <address>
        <city>Sepulveda</city>
        <state>California</state>
        <zip>91343</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Eastern Colorado Health Care System, Denver, CO</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Florida/South Georgia Veterans Health System, Gainesville, FL</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami VA Healthcare System, Miami, FL</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta VA Medical and Rehab Center, Decatur, GA</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carl Vinson VA Medical Center, Dublin, GA</name>
      <address>
        <city>Dublin</city>
        <state>Georgia</state>
        <zip>31021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marion VA Medical Center, Marion, IL</name>
      <address>
        <city>Marion</city>
        <state>Illinois</state>
        <zip>62959</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Robert J. Dole Department of Veterans Affairs Medical and Regional Office Center, Wichita, KS</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Overton Brooks VA Medical Center, Shreveport, LA</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rehabilitation R&amp;D Service, Baltimore, MD</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Battle Creek VA Medical Center, Battle Creek, MI</name>
      <address>
        <city>Battle Creek</city>
        <state>Michigan</state>
        <zip>49037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harry S. Truman Memorial, Columbia, MO</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65201-5297</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Southern Nevada Healthcare System, North Las Vegas, NV</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bath VA Medical Center, Bath, NY</name>
      <address>
        <city>Bath</city>
        <state>New York</state>
        <zip>14810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC</name>
      <address>
        <city>Salisbury</city>
        <state>North Carolina</state>
        <zip>28144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chalmers P. Wylie Ambulatory Care Center, Columbus, OH</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43203-1278</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Black Hills Health Care System Fort Meade Campus, Fort Meade, SD</name>
      <address>
        <city>Fort Meade</city>
        <state>South Dakota</state>
        <zip>57741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Valley Healthcare System Nashville Campus, Nashville, TN</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212-2637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Texas Health Care System, San Antonio, TX</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Texas Veterans Health Care System, Temple, TX</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hampton VA Medical Center, Hampton, VA</name>
      <address>
        <city>Hampton</city>
        <state>Virginia</state>
        <zip>23667</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jonathan M. Wainwright Memorial VA Medical Center, Walla Walla, WA</name>
      <address>
        <city>Walla Walla</city>
        <state>Washington</state>
        <zip>99362</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <results_first_submitted>April 5, 2021</results_first_submitted>
  <results_first_submitted_qc>July 9, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 3, 2021</results_first_posted>
  <last_update_submitted>July 19, 2023</last_update_submitted>
  <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>women's health</keyword>
  <keyword>primary health care</keyword>
  <keyword>mental health</keyword>
  <keyword>Veterans</keyword>
  <keyword>quality improvement</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT03238417/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Cross-sectional surveys were sent to primary care providers and staff at 21 VA Medical Centers at baseline, 12 months, and 24 months.</recruitment_details>
      <pre_assignment_details>Twenty one VA facilities were randomized to receive evidence-based quality improvement (EBQI) in a dynamic waitlist control design in which seven facilities received EBQI per year while the remaining 14 facilities were assigned as control.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Evidence-Based Quality Improvement (EBQI)</title>
          <description>EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level quality improvement (QI) team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.&#xD;
Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines.</description>
        </group>
        <group group_id="P2">
          <title>Waitlist Controls</title>
          <description>Waitlist controls will continue naturalistic routine care implementation of VA directives and other guidance related to comprehensive women's health care.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1330"/>
                <participants group_id="P2" count="2632"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="327"/>
                <participants group_id="P2" count="644"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1003"/>
                <participants group_id="P2" count="1988"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>non-response</title>
              <participants_list>
                <participants group_id="P1" count="955"/>
                <participants group_id="P2" count="1920"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>partial completion</title>
              <participants_list>
                <participants group_id="P1" count="48"/>
                <participants group_id="P2" count="68"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Baseline</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="513"/>
                <participants group_id="P2" count="934"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="124"/>
                <participants group_id="P2" count="217"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="389"/>
                <participants group_id="P2" count="717"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Partial completion</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="48"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>non-response</title>
              <participants_list>
                <participants group_id="P1" count="372"/>
                <participants group_id="P2" count="669"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>12-month</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="400"/>
                <participants group_id="P2" count="911"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="81"/>
                <participants group_id="P2" count="205"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="319"/>
                <participants group_id="P2" count="706"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>non-response</title>
              <participants_list>
                <participants group_id="P1" count="296"/>
                <participants group_id="P2" count="669"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>partial completion</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>24-month</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="417"/>
                <participants group_id="P2" count="847"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="122"/>
                <participants group_id="P2" count="222"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="295"/>
                <participants group_id="P2" count="625"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>non-response</title>
              <participants_list>
                <participants group_id="P1" count="287"/>
                <participants group_id="P2" count="594"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>partial completion</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>primary care providers and staff</population>
      <group_list>
        <group group_id="B1">
          <title>Evidence-Based Quality Improvement (EBQI)</title>
          <description>EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.&#xD;
Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines.</description>
        </group>
        <group group_id="B2">
          <title>Waitlist Controls</title>
          <description>Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="124"/>
            <count group_id="B2" value="217"/>
            <count group_id="B3" value="341"/>
          </count_list>
        </analyzed>
        <analyzed>
          <units>VA Medical Centers</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="7"/>
            <count group_id="B2" value="14"/>
            <count group_id="B3" value="21"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="124"/>
                <count group_id="B2" value="217"/>
                <count group_id="B3" value="341"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>VA Medical Centers</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="7"/>
                <count group_id="B2" value="14"/>
                <count group_id="B3" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>age</title>
              <category_list>
                <category>
                  <title>20-29</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>30-39</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>40-49</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="76"/>
                  </measurement_list>
                </category>
                <category>
                  <title>50-59</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="115"/>
                  </measurement_list>
                </category>
                <category>
                  <title>60+</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="124"/>
                <count group_id="B2" value="217"/>
                <count group_id="B3" value="341"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>VA Medical Centers</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="7"/>
                <count group_id="B2" value="14"/>
                <count group_id="B3" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Gender</title>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                    <measurement group_id="B2" value="163"/>
                    <measurement group_id="B3" value="254"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="0"/>
                <count group_id="B2" value="0"/>
                <count group_id="B3" value="0"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>VA Medical Centers</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="7"/>
                <count group_id="B2" value="14"/>
                <count group_id="B3" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Primary care provider and staff</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="124"/>
                <count group_id="B2" value="217"/>
                <count group_id="B3" value="341"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>VA Medical Centers</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="7"/>
                <count group_id="B2" value="14"/>
                <count group_id="B3" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Primary care providers</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>staff</title>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="167"/>
                    <measurement group_id="B3" value="268"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Years worked in VA</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="124"/>
                <count group_id="B2" value="217"/>
                <count group_id="B3" value="341"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>VA Medical Centers</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="7"/>
                <count group_id="B2" value="14"/>
                <count group_id="B3" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.85" spread="8.40"/>
                    <measurement group_id="B2" value="6.96" spread="7.24"/>
                    <measurement group_id="B3" value="8.01" spread="7.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Gender-sensitive Care Environment</title>
        <description>Multi-item scale score reflecting survey items (from The Women's Assessment Tool for Comprehensive Health (WATCH)) on availability of same-gender providers, availability of same-gender staff, privacy of physical layout, availability of privacy curtains, level of implementation of local culture campaign that values and treats Women Veterans with respect. The score ranges from 0 to 7, with a higher score reflecting greater gender-sensitive care environment.</description>
        <time_frame>12-month change in gender-sensitive care environment</time_frame>
        <population>One Women Veteran Program Manger per VA Medical Center responded to the survey about the site's Women's Health Program on WATCH.</population>
        <group_list>
          <group group_id="O1">
            <title>Evidence-Based Quality Improvement (EBQI)</title>
            <description>EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.&#xD;
Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines.</description>
          </group>
          <group group_id="O2">
            <title>Waitlist Controls</title>
            <description>Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.</description>
          </group>
        </group_list>
        <measure>
          <title>Gender-sensitive Care Environment</title>
          <description>Multi-item scale score reflecting survey items (from The Women's Assessment Tool for Comprehensive Health (WATCH)) on availability of same-gender providers, availability of same-gender staff, privacy of physical layout, availability of privacy curtains, level of implementation of local culture campaign that values and treats Women Veterans with respect. The score ranges from 0 to 7, with a higher score reflecting greater gender-sensitive care environment.</description>
          <population>One Women Veteran Program Manger per VA Medical Center responded to the survey about the site's Women's Health Program on WATCH.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>VA Medical Centers.</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>VA Medical Centers.</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="2.3"/>
                    <measurement group_id="O2" value="3.3" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="1.9"/>
                    <measurement group_id="O2" value="1.4" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Analysis of Variance comparing change in outcome between EBQI and control from baseline to 12 month.</non_inferiority_desc>
            <p_value>0.623</p_value>
            <p_value_desc>P-value is from the interaction term between EBQI and time.</p_value_desc>
            <method>ANOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.65</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.32</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.3</ci_lower_limit>
            <ci_upper_limit>2.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Gender-sensitive Care Environment</title>
        <description>Multi-item scale score reflecting survey items (from The Women's Assessment Tool for Comprehensive Health (WATCH)) on availability of same-gender providers, availability of same-gender staff, privacy of physical layout, availability of privacy curtains, level of implementation of local culture campaign that values and treats Women Veterans with respect. The score ranges from 0 to 7, with a higher score reflecting greater gender-sensitive care environment.</description>
        <time_frame>24-month change in gender-sensitive care environment</time_frame>
        <population>One Women Veteran Program Manger per VA Medical Center responded to the survey about the site's Women's Health Program on WATCH.</population>
        <group_list>
          <group group_id="O1">
            <title>Evidence-Based Quality Improvement (EBQI)</title>
            <description>EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.&#xD;
Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines.</description>
          </group>
          <group group_id="O2">
            <title>Waitlist Controls</title>
            <description>Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.</description>
          </group>
        </group_list>
        <measure>
          <title>Gender-sensitive Care Environment</title>
          <description>Multi-item scale score reflecting survey items (from The Women's Assessment Tool for Comprehensive Health (WATCH)) on availability of same-gender providers, availability of same-gender staff, privacy of physical layout, availability of privacy curtains, level of implementation of local culture campaign that values and treats Women Veterans with respect. The score ranges from 0 to 7, with a higher score reflecting greater gender-sensitive care environment.</description>
          <population>One Women Veteran Program Manger per VA Medical Center responded to the survey about the site's Women's Health Program on WATCH.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>VA Medical Center</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>VA Medical Center</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="2.3"/>
                    <measurement group_id="O2" value="3.3" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="0.8"/>
                    <measurement group_id="O2" value="2.8" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Analysis of Variance testing for change in outcome between EBQI and control from baseline to 24 months.</non_inferiority_desc>
            <p_value>0.678</p_value>
            <p_value_desc>P-value is from the interaction term of EBQI and time.</p_value_desc>
            <method>ANOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.48</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.1</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.8</ci_lower_limit>
            <ci_upper_limit>1.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Gender Awareness</title>
        <description>A 12-item score reflecting primary care and women's health providers' and staff's awareness and knowledge of women Veterans' military background and healthcare needs. The score ranges from 1 to 5 with higher scores reflecting greater gender awareness.</description>
        <time_frame>12-month change in gender awareness among VA primary care and women's health providers and staff.</time_frame>
        <population>Primary care and women's health providers and staff. The analysis was based on cases with non-missing outcome data. There are 19 missing cases in the EBQI arm and 39 missing in the control arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Evidence-Based Quality Improvement (EBQI)</title>
            <description>EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.&#xD;
Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines.</description>
          </group>
          <group group_id="O2">
            <title>Waitlist Controls</title>
            <description>Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.</description>
          </group>
        </group_list>
        <measure>
          <title>Gender Awareness</title>
          <description>A 12-item score reflecting primary care and women's health providers' and staff's awareness and knowledge of women Veterans' military background and healthcare needs. The score ranges from 1 to 5 with higher scores reflecting greater gender awareness.</description>
          <population>Primary care and women's health providers and staff. The analysis was based on cases with non-missing outcome data. There are 19 missing cases in the EBQI arm and 39 missing in the control arm.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>VA Medical Centers</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="205"/>
                <count group_id="O2" value="422"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>VA Medical Centers</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.66" spread="0.53"/>
                    <measurement group_id="O2" value="3.63" spread="0.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12- month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.67" spread="0.61"/>
                    <measurement group_id="O2" value="3.62" spread="0.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change in gender awareness score between EBQI and control from baseline to 12-month</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Difference-in-differences analysis using linear regression, adjusted for age, how often they saw women patients in the past year, location of practice in primary care or women's health clinic, and having had any type of quality improvement training. We adjusted our analysis with non-response weights.</non_inferiority_desc>
            <p_value>0.364</p_value>
            <p_value_desc>P-value is from the interaction term between EBQI and time, adjusted for non-response weights and characteristics described in the statistical analysis overview.</p_value_desc>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.09</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.13</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.17</ci_lower_limit>
            <ci_upper_limit>0.35</ci_upper_limit>
            <estimate_desc>The estimated value reported here is the predicted mean change from baseline to 12-month, adjusting for characteristics described in the statistical analysis overview.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Gender Awareness</title>
        <description>A 12-item score reflecting primary care and women's health providers' and staff's awareness and knowledge of women Veterans' military roles and healthcare needs . The score ranges from 1 to 5 with higher scores reflecting greater gender awareness.</description>
        <time_frame>24-month change in gender awareness among VA primary care and women's health providers and staff</time_frame>
        <population>Primary care and women's health providers and staff. The analysis was based on cases with non-missing outcome data. There are 22 missing cases in the EBQI arm and 32 in the control arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Evidence-Based Quality Improvement (EBQI)</title>
            <description>EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.&#xD;
Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines.</description>
          </group>
          <group group_id="O2">
            <title>Waitlist Controls</title>
            <description>Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.</description>
          </group>
        </group_list>
        <measure>
          <title>Gender Awareness</title>
          <description>A 12-item score reflecting primary care and women's health providers' and staff's awareness and knowledge of women Veterans' military roles and healthcare needs . The score ranges from 1 to 5 with higher scores reflecting greater gender awareness.</description>
          <population>Primary care and women's health providers and staff. The analysis was based on cases with non-missing outcome data. There are 22 missing cases in the EBQI arm and 32 in the control arm.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>VA Medical Centers</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="246"/>
                <count group_id="O2" value="439"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>VA Medical Centers</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="217"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>VA Medical Centers</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.66" spread="0.53"/>
                    <measurement group_id="O2" value="3.63" spread="0.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="122"/>
                    <count group_id="O2" value="222"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>VA Medical Centers</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.64" spread="0.51"/>
                    <measurement group_id="O2" value="3.74" spread="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change in gender awareness score between EBQI and control from baseline to 24-month</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Difference-in-differences analysis using linear regression, adjusted for age, how often they saw women patients in the past year, location of practice in primary care or women's health clinic, and having had any type of quality improvement training. We adjusted our analysis with non-response weights.</non_inferiority_desc>
            <p_value>0.29</p_value>
            <p_value_desc>P-value reflects the interaction term between EBQI and time, adjusted for non-response weights and characteristics described in the statistical analysis overview.</p_value_desc>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.11</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.10</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.33</ci_lower_limit>
            <ci_upper_limit>0.10</ci_upper_limit>
            <estimate_desc>The estimated value reported here is the predicted mean change from baseline to 24-month, adjusting for characteristics described in the statistical analysis overview.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Quality Improvement Experience</title>
        <description>The count of quality improvement activities reported by providers and staff in primary care and women's health settings; including 1) training in quality improvement methods, 2) collaboration with other VA facilities to identify best practices, 3) working with Women Veteran Program Manager to identify and/or solve local problems in caring for women Veterans, 4) using of VA performance data, 5) using of VA survey data by gender, 6) working on a quality improvement project focused on women Veterans, 7) involving in small tests of change for quality improvement.</description>
        <time_frame>12-month change</time_frame>
        <population>Primary care and women's health providers and staff at 21 VA Medical Centers. The analysis was based on cases with non-missing outcome data. There were 31 missing in the EBQI arm and 43 missing in the control arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Evidence-Based Quality Improvement (EBQI)</title>
            <description>EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.&#xD;
Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines.</description>
          </group>
          <group group_id="O2">
            <title>Waitlist Controls</title>
            <description>Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality Improvement Experience</title>
          <description>The count of quality improvement activities reported by providers and staff in primary care and women's health settings; including 1) training in quality improvement methods, 2) collaboration with other VA facilities to identify best practices, 3) working with Women Veteran Program Manager to identify and/or solve local problems in caring for women Veterans, 4) using of VA performance data, 5) using of VA survey data by gender, 6) working on a quality improvement project focused on women Veterans, 7) involving in small tests of change for quality improvement.</description>
          <population>Primary care and women's health providers and staff at 21 VA Medical Centers. The analysis was based on cases with non-missing outcome data. There were 31 missing in the EBQI arm and 43 missing in the control arm.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="205"/>
                <count group_id="O2" value="422"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="217"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>0 activity</title>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="70"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 activity</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4 activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5 activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>6 activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>7 activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="205"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>0 activity</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 activity</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4 activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5 activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>6 activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>7 activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Difference-in-differences analysis using logistic regression. The number of activities were recoded into 0 vs 1+ activities. The model was adjusted for age, how often they saw women patients in the past year, location of practice in primary care or women's health clinic, and having had any type of quality improvement training. We also adjusted for non-response weights.</non_inferiority_desc>
            <p_value>0.10</p_value>
            <p_value_desc>P-value is from the interaction term between EBQI and time, adjusted for non-response weights and characteristics described in the statistical analysis overview.</p_value_desc>
            <method>Difference-in-Differences analysis</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>-0.69</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.42</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.52</ci_lower_limit>
            <ci_upper_limit>0.13</ci_upper_limit>
            <estimate_desc>The estimated value is predicted change in the odds of involving in one or more quality improvement activities, adjusting for characteristics described in the statistical analysis overview.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Quality Improvement Experience</title>
        <description>The count of quality improvement activities reported by provider and staff in primary care and women's health settings; including 1) training in quality improvement methods [e.g., LEAN], 2) collaboration with other VA facilities to identify best practices, 3) working with Women Veteran Program Manager to identify and/or solve local problems in caring for women Veterans, 4) using of VA performance data, 5) using of VA survey data by gender, 6) working on a quality improvement project focused on women Veterans, 7) involving in small tests of change for quality improvement.</description>
        <time_frame>24-month change</time_frame>
        <population>Primary care and women's health providers and staff at 21 VA Medical Centers. The analysis was based on cases with non-missing outcome data. There were 27 missing in the EBQI arm and 32 missing in the control arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Evidence-Based Quality Improvement (EBQI)</title>
            <description>EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.&#xD;
Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines.</description>
          </group>
          <group group_id="O2">
            <title>Waitlist Controls</title>
            <description>Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality Improvement Experience</title>
          <description>The count of quality improvement activities reported by provider and staff in primary care and women's health settings; including 1) training in quality improvement methods [e.g., LEAN], 2) collaboration with other VA facilities to identify best practices, 3) working with Women Veteran Program Manager to identify and/or solve local problems in caring for women Veterans, 4) using of VA performance data, 5) using of VA survey data by gender, 6) working on a quality improvement project focused on women Veterans, 7) involving in small tests of change for quality improvement.</description>
          <population>Primary care and women's health providers and staff at 21 VA Medical Centers. The analysis was based on cases with non-missing outcome data. There were 27 missing in the EBQI arm and 32 missing in the control arm.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="246"/>
                <count group_id="O2" value="439"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="217"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>0 activity</title>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="70"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 activity</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4 activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5 activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>6 activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>7 activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="122"/>
                    <count group_id="O2" value="222"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>0 activity</title>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 activity</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4 activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5 activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>6 activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>7 activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Difference-in-differences analysis using logistic regression. The number of activities were recoded into 0 vs 1+ activities. The model was adjusted for age, how often they saw women patients in the past year, location of practice in primary care or women's health clinic, and having had any type of quality improvement training. We also adjusted for non-response weights.</non_inferiority_desc>
            <p_value>0.22</p_value>
            <p_value_desc>P-value is from the interaction term between EBQI and time, adjusted for non-response weights and characteristics described in the statistical analysis overview.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>-0.48</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.39</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.25</ci_lower_limit>
            <ci_upper_limit>0.29</ci_upper_limit>
            <estimate_desc>The estimated value is predicted change in the odds of involving in one or more quality improvement activities, adjusting for characteristics described in the statistical analysis overview.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Gender-specific Preventive Care Delivery</title>
        <description>Rate of cervical cancer screening using the VA External Peer Review Program (EPRP) chart-based quality metrics.</description>
        <time_frame>12-month change</time_frame>
        <population>The analysis population size was extracted from EPRP reported denominators. EPRP randomly selected women patients aged 21-64and reviewed their charts for cervical cancer screening with a Pap test in the past three years.</population>
        <group_list>
          <group group_id="O1">
            <title>Evidence-Based Quality Improvement (EBQI)</title>
            <description>EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.&#xD;
Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines.</description>
          </group>
          <group group_id="O2">
            <title>Waitlist Controls</title>
            <description>Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.</description>
          </group>
        </group_list>
        <measure>
          <title>Gender-specific Preventive Care Delivery</title>
          <description>Rate of cervical cancer screening using the VA External Peer Review Program (EPRP) chart-based quality metrics.</description>
          <population>The analysis population size was extracted from EPRP reported denominators. EPRP randomly selected women patients aged 21-64and reviewed their charts for cervical cancer screening with a Pap test in the past three years.</population>
          <units>percentage of women patients</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>VA Medical Centers</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4077"/>
                <count group_id="O2" value="7057"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>VA Medical Centers</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1975"/>
                    <count group_id="O2" value="3666"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>VA Medical Centers</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.5" spread="4.1"/>
                    <measurement group_id="O2" value="87.2" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2102"/>
                    <count group_id="O2" value="3391"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>VA Medical Centers</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.5" spread="3.9"/>
                    <measurement group_id="O2" value="88.1" spread="6.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Analysis of Variance testing the differences in outcome between EBQI and control groups over 12 month period.</non_inferiority_desc>
            <p_value>0.788</p_value>
            <p_value_desc>The p-value reflects the interaction term between EBQI and time</p_value_desc>
            <method>ANOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.08</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.1</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.1</ci_lower_limit>
            <ci_upper_limit>5.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Gender-specific Preventive Care Delivery</title>
        <description>Rate of cervical cancer screening using the VA External Peer Review Program (EPRP) chart-based quality metrics.</description>
        <time_frame>24-month change in gender-specific preventive care delivery</time_frame>
        <population>The analysis population size is extracted from EPRP reported denominators. EPRP randomly selected women patients aged 21-64and reviewed their charts for cervical cancer screening with a Pap test in the past three years.</population>
        <group_list>
          <group group_id="O1">
            <title>Evidence-Based Quality Improvement (EBQI)</title>
            <description>EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.&#xD;
Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines.</description>
          </group>
          <group group_id="O2">
            <title>Waitlist Controls</title>
            <description>Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.</description>
          </group>
        </group_list>
        <measure>
          <title>Gender-specific Preventive Care Delivery</title>
          <description>Rate of cervical cancer screening using the VA External Peer Review Program (EPRP) chart-based quality metrics.</description>
          <population>The analysis population size is extracted from EPRP reported denominators. EPRP randomly selected women patients aged 21-64and reviewed their charts for cervical cancer screening with a Pap test in the past three years.</population>
          <units>percentage of women patients</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>VA Medical Centers</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3549"/>
                <count group_id="O2" value="7733"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>VA Medical Centers</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1975"/>
                    <count group_id="O2" value="3666"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>VA Medical Centers</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.5" spread="4.12"/>
                    <measurement group_id="O2" value="87.2" spread="4.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1574"/>
                    <count group_id="O2" value="4067"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>VA Medical Centers</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.6" spread="3.98"/>
                    <measurement group_id="O2" value="85.8" spread="4.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Analysis of Variance testing for differences in outcomes between EBQI and control arms from baseline to 24 months.</non_inferiority_desc>
            <p_value>0.61</p_value>
            <p_value_desc>The p-value reflects the interaction terms between EBQI and control arms.</p_value_desc>
            <method>ANOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.89</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.35</ci_lower_limit>
            <ci_upper_limit>4.35</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Accessibility of Care</title>
        <description>Women Veterans' ratings of accessibility based on the Survey of Healthcare Experience of Patients (SHEP) program. The mean score is the percent of female patients who responded &quot;always&quot; to validated survey items measuring accessibility, the higher percentage representing better access.</description>
        <time_frame>12-month change in accessibility</time_frame>
        <population>The analysis population size is extracted from SHEP, which randomly selected eligible patients who were invited to respond to the SHEP surveys by mail or online.</population>
        <group_list>
          <group group_id="O1">
            <title>Evidence-Based Quality Improvement (EBQI)</title>
            <description>EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.&#xD;
Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines.</description>
          </group>
          <group group_id="O2">
            <title>Waitlist Controls</title>
            <description>Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.</description>
          </group>
        </group_list>
        <measure>
          <title>Accessibility of Care</title>
          <description>Women Veterans' ratings of accessibility based on the Survey of Healthcare Experience of Patients (SHEP) program. The mean score is the percent of female patients who responded &quot;always&quot; to validated survey items measuring accessibility, the higher percentage representing better access.</description>
          <population>The analysis population size is extracted from SHEP, which randomly selected eligible patients who were invited to respond to the SHEP surveys by mail or online.</population>
          <units>percent always</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>VA Medical Centers</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="495"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>VA Medical Centers</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="262"/>
                    <count group_id="O2" value="309"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>VA Medical Centers</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.6" spread="12.2"/>
                    <measurement group_id="O2" value="44.4" spread="18.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                    <count group_id="O2" value="186"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>VA Medical Centers</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.1" spread="24.5"/>
                    <measurement group_id="O2" value="37.1" spread="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>ANOVA comparing changes in outcome over time between EBQI and control arms</non_inferiority_desc>
            <p_value>0.987</p_value>
            <p_value_desc>The p-value reflects the interaction term between EBQI and time</p_value_desc>
            <method>ANOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.17</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>10.5</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-21.45</ci_lower_limit>
            <ci_upper_limit>21.11</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Accessibility of Care</title>
        <description>Women Veterans' ratings of accessibility from the Survey of Healthcare Experience of Patients (SHEP) program. The mean score is the percent of female patients who responded &quot;always&quot; to validated survey items measuring accessibility, the higher percentage representing better access.</description>
        <time_frame>24-month change in accessibility</time_frame>
        <population>The analysis population size is extracted from SHEP, which randomly selected eligible patients who were invited to respond to the SHEP surveys by mail or online.</population>
        <group_list>
          <group group_id="O1">
            <title>Evidence-Based Quality Improvement (EBQI)</title>
            <description>EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.&#xD;
Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines.</description>
          </group>
          <group group_id="O2">
            <title>Waitlist Controls</title>
            <description>Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.</description>
          </group>
        </group_list>
        <measure>
          <title>Accessibility of Care</title>
          <description>Women Veterans' ratings of accessibility from the Survey of Healthcare Experience of Patients (SHEP) program. The mean score is the percent of female patients who responded &quot;always&quot; to validated survey items measuring accessibility, the higher percentage representing better access.</description>
          <population>The analysis population size is extracted from SHEP, which randomly selected eligible patients who were invited to respond to the SHEP surveys by mail or online.</population>
          <units>Percent always</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>VA Medical Centers</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="340"/>
                <count group_id="O2" value="466"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>VA Medical Centers</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="262"/>
                    <count group_id="O2" value="309"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>VA Medical Centers</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.7" spread="9.3"/>
                    <measurement group_id="O2" value="43.0" spread="17.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="157"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>VA Medical Centers</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.7" spread="13.7"/>
                    <measurement group_id="O2" value="42.3" spread="14.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>ANOVA comparing changes in outcome over time between EBQI and control groups</non_inferiority_desc>
            <p_value>0.708</p_value>
            <p_value_desc>The p-value reflects the interaction terms between EBQI and time</p_value_desc>
            <method>ANOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-3.91</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>10.35</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-24.89</ci_lower_limit>
            <ci_upper_limit>17.08</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Coordination of Care</title>
        <description>Women Veterans' ratings of care coordination from the Survey of Healthcare Experience of Patients (SHEP) program. The mean score is the percent of female patients who responded &quot;always&quot; to validated survey items measuring care coordination, the higher percentage representing better coordination.</description>
        <time_frame>12-month change</time_frame>
        <population>The analysis population size is unknown and reported at the level of the VA Medical Centers. SHEP randomly selected eligible patients who were invited to respond to the SHEP surveys by mail or online.</population>
        <group_list>
          <group group_id="O1">
            <title>Evidence-Based Quality Improvement (EBQI)</title>
            <description>EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.&#xD;
Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines.</description>
          </group>
          <group group_id="O2">
            <title>Waitlist Controls</title>
            <description>Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.</description>
          </group>
        </group_list>
        <measure>
          <title>Coordination of Care</title>
          <description>Women Veterans' ratings of care coordination from the Survey of Healthcare Experience of Patients (SHEP) program. The mean score is the percent of female patients who responded &quot;always&quot; to validated survey items measuring care coordination, the higher percentage representing better coordination.</description>
          <population>The analysis population size is unknown and reported at the level of the VA Medical Centers. SHEP randomly selected eligible patients who were invited to respond to the SHEP surveys by mail or online.</population>
          <units>percent always</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>VA Medical Centers</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="510"/>
                <count group_id="O2" value="790"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>VA Medical Centers</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="422"/>
                    <count group_id="O2" value="486"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>VA Medical Centers</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.60" spread="12.43"/>
                    <measurement group_id="O2" value="55.78" spread="14.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="304"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>VA Medical Centers</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.95" spread="19.30"/>
                    <measurement group_id="O2" value="58.65" spread="9.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>ANOVA comparing changes in outcome over time between EBQI and control groups</non_inferiority_desc>
            <p_value>0.613</p_value>
            <p_value_desc>The p-value reflects the interaction term between EBQI and time</p_value_desc>
            <method>ANOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-4.51</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>8.85</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-22.43</ci_lower_limit>
            <ci_upper_limit>13.40</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Coordination of Care</title>
        <description>Women Veterans' ratings of care coordination from the Survey of Healthcare Experience of Patients (SHEP) program. The mean score is the percent of female patients who responded &quot;always&quot; to validated survey items measuring care coordination, the higher percentage representing better coordination.</description>
        <time_frame>24-month change</time_frame>
        <population>The analysis population size is extracted SHEP, which randomly selected eligible patients who were invited to respond to the SHEP surveys by mail or online.</population>
        <group_list>
          <group group_id="O1">
            <title>Evidence-Based Quality Improvement (EBQI)</title>
            <description>EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.&#xD;
Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines.</description>
          </group>
          <group group_id="O2">
            <title>Waitlist Controls</title>
            <description>Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.</description>
          </group>
        </group_list>
        <measure>
          <title>Coordination of Care</title>
          <description>Women Veterans' ratings of care coordination from the Survey of Healthcare Experience of Patients (SHEP) program. The mean score is the percent of female patients who responded &quot;always&quot; to validated survey items measuring care coordination, the higher percentage representing better coordination.</description>
          <population>The analysis population size is extracted SHEP, which randomly selected eligible patients who were invited to respond to the SHEP surveys by mail or online.</population>
          <units>percent always</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>VA Medical Centers</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="541"/>
                <count group_id="O2" value="750"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>VA Medical Centers</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="422"/>
                    <count group_id="O2" value="486"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>VA Medical Centers</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.0" spread="9.3"/>
                    <measurement group_id="O2" value="54.7" spread="13.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="119"/>
                    <count group_id="O2" value="264"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>VA Medical Centers</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.4" spread="13.7"/>
                    <measurement group_id="O2" value="51.2" spread="15.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>ANOVA comparing changes in outcome over time between EBQI and control groups</non_inferiority_desc>
            <p_value>0.922</p_value>
            <p_value_desc>The p-value reflects the interaction term between EBQI and time.</p_value_desc>
            <method>ANOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.94</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>9.48</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.26</ci_lower_limit>
            <ci_upper_limit>20.13</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Gender-neutral Guideline-concordant Preventive Care Receipt</title>
        <description>Percentage of women Veterans' obtaining recommended preventive care based on eligibility for service (e.g., meet eligibility guidelines for timely eye exams for diabetes, flu vaccination, colorectal cancer screening) using VA External Peer Review Program (EPRP) chart-based quality metrics.</description>
        <time_frame>12-month change</time_frame>
        <population>The analysis population is extracted from EPRP, which randomly selected VA women patients aged 18-75 whose charts were reviewed for preventive care measures.</population>
        <group_list>
          <group group_id="O1">
            <title>Evidence-Based Quality Improvement (EBQI)</title>
            <description>EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.&#xD;
Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines.</description>
          </group>
          <group group_id="O2">
            <title>Waitlist Controls</title>
            <description>Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.</description>
          </group>
        </group_list>
        <measure>
          <title>Gender-neutral Guideline-concordant Preventive Care Receipt</title>
          <description>Percentage of women Veterans' obtaining recommended preventive care based on eligibility for service (e.g., meet eligibility guidelines for timely eye exams for diabetes, flu vaccination, colorectal cancer screening) using VA External Peer Review Program (EPRP) chart-based quality metrics.</description>
          <population>The analysis population is extracted from EPRP, which randomly selected VA women patients aged 18-75 whose charts were reviewed for preventive care measures.</population>
          <units>percentage of female patients</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>VA Medical Centers</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43587"/>
                <count group_id="O2" value="73735"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>VA Medical Centers</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21684"/>
                    <count group_id="O2" value="31334"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>VA Medical Centers</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.8" spread="2.2"/>
                    <measurement group_id="O2" value="78.6" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21907"/>
                    <count group_id="O2" value="42401"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>VA Medical Centers</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.9" spread="4.7"/>
                    <measurement group_id="O2" value="75.1" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>two-way ANOVA testing change in a composite score of gender-neutral preventive care between EBQI and control arms over time</non_inferiority_desc>
            <p_value>0.789</p_value>
            <p_value_desc>The p-value represents the interaction term between EBQI and control.</p_value_desc>
            <method>ANOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.58</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.13</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.74</ci_lower_limit>
            <ci_upper_limit>4.89</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Gender-neutral Guideline-concordant Preventive Care Receipt</title>
        <description>Percentage of women Veterans' obtaining recommended preventive care based on eligibility for service (e.g., meet eligibility guidelines for timely eye exams for diabetes, flu vaccination, colorectal cancer screening) using VA External Peer Review Program (EPRP) chart-based quality metrics</description>
        <time_frame>24-month change</time_frame>
        <population>The analysis population is extracted from EPRP, which randomly selected women patients aged 18-75 whose charts were reviewed for preventive care metrics.</population>
        <group_list>
          <group group_id="O1">
            <title>Evidence-Based Quality Improvement (EBQI)</title>
            <description>EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.&#xD;
Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines.</description>
          </group>
          <group group_id="O2">
            <title>Waitlist Controls</title>
            <description>Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.</description>
          </group>
        </group_list>
        <measure>
          <title>Gender-neutral Guideline-concordant Preventive Care Receipt</title>
          <description>Percentage of women Veterans' obtaining recommended preventive care based on eligibility for service (e.g., meet eligibility guidelines for timely eye exams for diabetes, flu vaccination, colorectal cancer screening) using VA External Peer Review Program (EPRP) chart-based quality metrics</description>
          <population>The analysis population is extracted from EPRP, which randomly selected women patients aged 18-75 whose charts were reviewed for preventive care metrics.</population>
          <units>percentage of female patients</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>VA Medical Centers</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39271"/>
                <count group_id="O2" value="73819"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>VA Medical Centers</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21684"/>
                    <count group_id="O2" value="31334"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>VA Medical Centers</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.8" spread="2.23"/>
                    <measurement group_id="O2" value="78.6" spread="2.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17587"/>
                    <count group_id="O2" value="45485"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>VA Medical Centers</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.9" spread="4.7"/>
                    <measurement group_id="O2" value="75.0" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>ANOVA comparing changes in outcomes over time between EBQI and control groups</non_inferiority_desc>
            <p_value>0.51</p_value>
            <p_value_desc>The p-value reflects the interaction between EBQI and time.</p_value_desc>
            <method>ANOVA</method>
            <method_desc>The analysis is adjusted for EBQI and time.</method_desc>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.63</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.45</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.60</ci_lower_limit>
            <ci_upper_limit>3.33</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assignment to a Designated Women's Health Provider or a Women's Health Primary Care Teams, Using Patient Aligned Care Teams Compass</title>
        <description>Percentage of women Veterans assigned to a designated women's health provider in a general primary care and/or women's health primary care setting.</description>
        <time_frame>12-month change</time_frame>
        <population>The analysis population was extracted from the Patient Aligned Care Teams (PACT) Compass, developed to meet the needs for VA PACT implementation.</population>
        <group_list>
          <group group_id="O1">
            <title>Evidence-Based Quality Improvement (EBQI)</title>
            <description>EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.&#xD;
Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines.</description>
          </group>
          <group group_id="O2">
            <title>Waitlist Controls</title>
            <description>Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.</description>
          </group>
        </group_list>
        <measure>
          <title>Assignment to a Designated Women's Health Provider or a Women's Health Primary Care Teams, Using Patient Aligned Care Teams Compass</title>
          <description>Percentage of women Veterans assigned to a designated women's health provider in a general primary care and/or women's health primary care setting.</description>
          <population>The analysis population was extracted from the Patient Aligned Care Teams (PACT) Compass, developed to meet the needs for VA PACT implementation.</population>
          <units>percentage of female patients</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>VA Medical Centers</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82328"/>
                <count group_id="O2" value="127153"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>VA Medical Centers</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39664"/>
                    <count group_id="O2" value="61513"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>VA Medical Centers</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.8" spread="17.2"/>
                    <measurement group_id="O2" value="65.8" spread="17.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42664"/>
                    <count group_id="O2" value="65640"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>VA Medical Centers</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.0" spread="6.3"/>
                    <measurement group_id="O2" value="73.8" spread="13.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>ANOVA testing for change in outcome over time between EBQI and control arms</non_inferiority_desc>
            <p_value>0.711</p_value>
            <p_value_desc>The p-value reflects the interaction between EBQI and time</p_value_desc>
            <method>ANOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>3.11</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>8.3</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.7</ci_lower_limit>
            <ci_upper_limit>19.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assignment to a Designated Women's Health Provider or a Women's Health Primary Care Teams, Using Patient Aligned Care Teams Compass</title>
        <description>Percentage of women Veterans assigned to a designated women's health provider in a general primary care and/or women's health primary care setting</description>
        <time_frame>24-month change</time_frame>
        <population>The analysis population was extracted from the Patient Aligned Care Teams (PACT) Compass, developed to meet the needs for VA PACT implementation.</population>
        <group_list>
          <group group_id="O1">
            <title>Evidence-Based Quality Improvement (EBQI)</title>
            <description>EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.&#xD;
Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines.</description>
          </group>
          <group group_id="O2">
            <title>Waitlist Controls</title>
            <description>Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.</description>
          </group>
        </group_list>
        <measure>
          <title>Assignment to a Designated Women's Health Provider or a Women's Health Primary Care Teams, Using Patient Aligned Care Teams Compass</title>
          <description>Percentage of women Veterans assigned to a designated women's health provider in a general primary care and/or women's health primary care setting</description>
          <population>The analysis population was extracted from the Patient Aligned Care Teams (PACT) Compass, developed to meet the needs for VA PACT implementation.</population>
          <units>percentage of female patients</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>VA Medical Centers</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64461"/>
                <count group_id="O2" value="151493"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>VA Medical Centers</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39664"/>
                    <count group_id="O2" value="61513"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>VA Medical Centers</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.8" spread="17.2"/>
                    <measurement group_id="O2" value="68.7" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24797"/>
                    <count group_id="O2" value="89980"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>VA Medical Centers</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.6" spread="11.3"/>
                    <measurement group_id="O2" value="73.1" spread="13.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>ANOVA comparing changes in outcome over time between EBQI and control arms</non_inferiority_desc>
            <p_value>0.335</p_value>
            <p_value_desc>The p-value reflects the interaction term between EBQI and time.</p_value_desc>
            <method>ANOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>8.49</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>8.7</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.1</ci_lower_limit>
            <ci_upper_limit>26.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Provider Rating</title>
        <description>Percent of women patients who rated 9 or 10 on a scale of 0 to 10 for the provider rating question on the Survey of Healthcare Experiences of Patients (SHEP). Higher scores are better.</description>
        <time_frame>12 month change</time_frame>
        <population>Analysis population size was extracted SHEP, which randomly selected eligible patients who were invited to respond to the SHEP surveys by mail or online.</population>
        <group_list>
          <group group_id="O1">
            <title>Evidence-Based Quality Improvement (EBQI)</title>
            <description>EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.&#xD;
Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines.</description>
          </group>
          <group group_id="O2">
            <title>Waitlist Controls</title>
            <description>Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.</description>
          </group>
        </group_list>
        <measure>
          <title>Provider Rating</title>
          <description>Percent of women patients who rated 9 or 10 on a scale of 0 to 10 for the provider rating question on the Survey of Healthcare Experiences of Patients (SHEP). Higher scores are better.</description>
          <population>Analysis population size was extracted SHEP, which randomly selected eligible patients who were invited to respond to the SHEP surveys by mail or online.</population>
          <units>percentage of women patients</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>VA Medical Centers</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="535"/>
                <count group_id="O2" value="832"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>VA Medical Centers</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="443"/>
                    <count group_id="O2" value="513"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>VA Medical Centers</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.9" spread="13.5"/>
                    <measurement group_id="O2" value="63.6" spread="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="319"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>VA Medical Centers</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.9" spread="32.5"/>
                    <measurement group_id="O2" value="71.3" spread="13.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Analysis of Variance testing for change in outcome between EBQI and control groups from baseline to 12 months.</non_inferiority_desc>
            <p_value>0.268</p_value>
            <p_value_desc>P-value is from the interaction term between EBQI and time.</p_value_desc>
            <method>ANOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-13.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>12.3</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-38.7</ci_lower_limit>
            <ci_upper_limit>11.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Provider Rating</title>
        <description>Percent of women patients who rated 9 or 10 on a scale of 0 to 10 for the provider rating question from the Survey of Healthcare Experiences of Patients (SHEP). Higher scores are better.</description>
        <time_frame>24-month change</time_frame>
        <population>The analysis population size is extracted SHEP, which randomly selected eligible patients who were invited to respond to the SHEP surveys by mail or online.</population>
        <group_list>
          <group group_id="O1">
            <title>Evidence-Based Quality Improvement (EBQI)</title>
            <description>EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.&#xD;
Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines.</description>
          </group>
          <group group_id="O2">
            <title>Waitlist Controls</title>
            <description>Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.</description>
          </group>
        </group_list>
        <measure>
          <title>Provider Rating</title>
          <description>Percent of women patients who rated 9 or 10 on a scale of 0 to 10 for the provider rating question from the Survey of Healthcare Experiences of Patients (SHEP). Higher scores are better.</description>
          <population>The analysis population size is extracted SHEP, which randomly selected eligible patients who were invited to respond to the SHEP surveys by mail or online.</population>
          <units>percentage of women patients</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>VA Medical Centers</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="571"/>
                <count group_id="O2" value="786"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>VA Medical Centers</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="443"/>
                    <count group_id="O2" value="513"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>VA Medical Centers</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.9" spread="13.5"/>
                    <measurement group_id="O2" value="63.6" spread="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="273"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>VA Medical Centers</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.7" spread="14.2"/>
                    <measurement group_id="O2" value="57.5" spread="14.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Analysis of Variance testing the differences between EBQI and control from baseline and 24 months</non_inferiority_desc>
            <p_value>0.991</p_value>
            <p_value_desc>P-value is from the interaction between EBQI and time.</p_value_desc>
            <method>ANOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.14</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>12.6</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-25.6</ci_lower_limit>
            <ci_upper_limit>25.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Study time frame was over three years (fiscal years 2017, 2018, 2019).</time_frame>
      <desc>Adverse events (all-cause mortality, serious adverse events, other adverse events) were not monitored/assessed for this study as the target of EBQI was the VA facility and the providers and staff therein. Data collection focused on surveys about their attitudes (e.g., gender sensitivity) and experiences with and perspectives on quality improvement for comprehensive women's health care.</desc>
      <group_list>
        <group group_id="E1">
          <title>Evidence-Based Quality Improvement (EBQI)</title>
          <description>EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.&#xD;
Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines.</description>
        </group>
        <group group_id="E2">
          <title>Waitlist Controls</title>
          <description>Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Elizabeth M. Yano, PhD, MSPH</name_or_title>
      <organization>VA Greater Los Angeles Healthcare System</organization>
      <phone>818-891-7711 ext 36031</phone>
      <email>elizabeth.yano@va.gov</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03238417
org study id: PEX 16-002
secondary id: PEC 16-352
nct id: NCT03238417
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Gaps in delivery of gender-sensitive comprehensive care have resulted in disparities in
      quality and patient experience among women seen in VA. VA policy action providing guidance on
      delivery of comprehensive healthcare services for women Veterans was disseminated nationally
      in 2010, followed by annual assessments and site visits evaluating local VA efforts. While
      substantial inroads have been made, policy implementation, even when leveraged by field-based
      women's health leaders, has not been uniformly successful in achieving delivery of
      comprehensive care by designated providers in gender-sensitive care environments that ensure
      women's privacy, dignity and safety, all tenets of the original guidance and the updated
      directive (2017).

      Building on prior effectiveness of an evidence-based quality improvement (EBQI) approach to
      tailoring VA's medical home model -- Patient Aligned Care Teams (PACT) -- to the needs of
      women Veterans, VA leaders in women's health adopted EBQI to help low-performing VAs
      systematically improve services.

      The objectives of the resulting Partnered Evaluation Initiative (PEI) funded by VA's Quality
      Enhancement Research Initiative and VA Office of Women's Health were:

        1. To evaluate barriers and facilitators to achieving delivery of comprehensive women's
           health care in the identified low-performing VAs;

        2. To evaluate effectiveness of EBQI in supporting low-performing VA facilities achieve
           improved organizational features, provider/staff attitudes, quality of care, and patient
           experiences among women Veteran patients; and,

        3. To evaluate contextual factors, local implementation processes, and organizational
           changes in the participating facilities over time.
Gaps in delivery of gender-sensitive comprehensive care have resulted in disparities in
      quality and patient experience among women seen in VA. VA policy action providing guidance on
      delivery of comprehensive healthcare services for women Veterans was disseminated nationally
      in 2010, followed by annual assessments and site visits evaluating local VA efforts. While
      substantial inroads have been made, policy implementation, even when leveraged by field-based
      women's health leaders, has not been uniformly successful in achieving delivery of
      comprehensive care by designated providers in gender-sensitive care environments that ensure
      women's privacy, dignity and safety, all tenets of the original guidance and the updated VA
      directive (2017).

      In collaboration with VA Women's Health Services (WHS), VA researchers developed a series of
      studies to better understand and help improve comprehensive care implementation through the
      Women Veterans' Healthcare CREATE Initiative. Among these, one focused on testing an
      evidence-based quality improvement (EBQI) approach to tailoring VA's medical home model --
      Patient Aligned Care Teams (PACT) -- to the needs of women Veterans, which has yielded
      significant local improvements in women Veterans' care. EBQI emphasizes a multilevel
      partnered approach to building capacity for innovation, implementation and spread of
      evidence-based practice. With its demonstrated success in the CREATE PACT study and several
      other EBQI trials, WHS adopted EBQI as a strategy to help low-performing VA facilities
      systematically improve services.

      The objectives of the WHS/QUERI Partnered Evaluation Initiative that this project represents
      are:

        1. To evaluate the barriers and facilitators to achieving delivery of comprehensive women's
           health care in the identified low-performing VA facilities;

        2. To evaluate the effectiveness of EBQI in supporting low-performing VA facilities achieve
           improved:

             1. Organizational features (e.g., level of comprehensive services available; care
                coordination arrangements; PACT features implemented; environment of care
                improvements);

             2. Provider/staff attitudes (e.g., improved gender awareness; women's health knowledge
                and practice);

           d) Quality of care and patient experiences among women Veteran patients using secondary
           data; and,

        3. To evaluate contextual factors, local implementation processes, and organizational
           changes in the participating facilities over time.

      Results of the evaluation have been used to provide feedback to stakeholders, including women
      Veterans, at the local, network and national levels, while also being used to continuously
      refine EBQI implementation processes. The evaluation is also helping inform optimal
      strategies for ongoing improvements in women Veterans' care in the 21 participating VA
      facilities, other VA facilities and for other improvement initiatives in this and other
      national program offices.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Dynamic waitlist control design with a group of 7 VA facilities was randomly allocated to Evidence-Based Quality Improvement (EBQI) in Year 1 (while 14 VA facilities serving as waitlist controls), the second group of 7 VA facilities was randomly allocated to EBQI in Year 2 (while the 7 remaining VA facilities and the first 7 EBQI sites serving as control), and the final group of 7 VA facilities was randomly allocated to EBQI in Year 3 (while the first 14 EBQI facilities subsequently serving as control). By the end of the three year study period, a total of 21 VA facilities received at least 1 year of EBQI.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Gender-sensitive Care Environment
time frame: 12-month change in gender-sensitive care environment
description: Multi-item scale score reflecting survey items (from The Women's Assessment Tool for Comprehensive Health (WATCH)) on availability of same-gender providers, availability of same-gender staff, privacy of physical layout, availability of privacy curtains, level of implementation of local culture campaign that values and treats Women Veterans with respect. The score ranges from 0 to 7, with a higher score reflecting greater gender-sensitive care environment.
measure: Gender-sensitive Care Environment
time frame: 24-month change in gender-sensitive care environment
description: Multi-item scale score reflecting survey items (from The Women's Assessment Tool for Comprehensive Health (WATCH)) on availability of same-gender providers, availability of same-gender staff, privacy of physical layout, availability of privacy curtains, level of implementation of local culture campaign that values and treats Women Veterans with respect. The score ranges from 0 to 7, with a higher score reflecting greater gender-sensitive care environment.
measure: Gender Awareness
time frame: 12-month change in gender awareness among VA primary care and women's health providers and staff.
description: A 12-item score reflecting primary care and women's health providers' and staff's awareness and knowledge of women Veterans' military background and healthcare needs. The score ranges from 1 to 5 with higher scores reflecting greater gender awareness.
measure: Gender Awareness
time frame: 24-month change in gender awareness among VA primary care and women's health providers and staff
description: A 12-item score reflecting primary care and women's health providers' and staff's awareness and knowledge of women Veterans' military roles and healthcare needs . The score ranges from 1 to 5 with higher scores reflecting greater gender awareness.
measure: Quality Improvement Experience
time frame: 12-month change
description: The count of quality improvement activities reported by providers and staff in primary care and women's health settings; including 1) training in quality improvement methods, 2) collaboration with other VA facilities to identify best practices, 3) working with Women Veteran Program Manager to identify and/or solve local problems in caring for women Veterans, 4) using of VA performance data, 5) using of VA survey data by gender, 6) working on a quality improvement project focused on women Veterans, 7) involving in small tests of change for quality improvement.
measure: Quality Improvement Experience
time frame: 24-month change
description: The count of quality improvement activities reported by provider and staff in primary care and women's health settings; including 1) training in quality improvement methods [e.g., LEAN], 2) collaboration with other VA facilities to identify best practices, 3) working with Women Veteran Program Manager to identify and/or solve local problems in caring for women Veterans, 4) using of VA performance data, 5) using of VA survey data by gender, 6) working on a quality improvement project focused on women Veterans, 7) involving in small tests of change for quality improvement.
measure: Gender-specific Preventive Care Delivery
time frame: 12-month change
description: Rate of cervical cancer screening using the VA External Peer Review Program (EPRP) chart-based quality metrics.
measure: Gender-specific Preventive Care Delivery
time frame: 24-month change in gender-specific preventive care delivery
description: Rate of cervical cancer screening using the VA External Peer Review Program (EPRP) chart-based quality metrics.
measure: Accessibility of Care
time frame: 12-month change in accessibility
description: Women Veterans' ratings of accessibility based on the Survey of Healthcare Experience of Patients (SHEP) program. The mean score is the percent of female patients who responded "always" to validated survey items measuring accessibility, the higher percentage representing better access.
measure: Accessibility of Care
time frame: 24-month change in accessibility
description: Women Veterans' ratings of accessibility from the Survey of Healthcare Experience of Patients (SHEP) program. The mean score is the percent of female patients who responded "always" to validated survey items measuring accessibility, the higher percentage representing better access.
measure: Coordination of Care
time frame: 12-month change
description: Women Veterans' ratings of care coordination from the Survey of Healthcare Experience of Patients (SHEP) program. The mean score is the percent of female patients who responded "always" to validated survey items measuring care coordination, the higher percentage representing better coordination.
measure: Coordination of Care
time frame: 24-month change
description: Women Veterans' ratings of care coordination from the Survey of Healthcare Experience of Patients (SHEP) program. The mean score is the percent of female patients who responded "always" to validated survey items measuring care coordination, the higher percentage representing better coordination.
measure: Gender-neutral Guideline-concordant Preventive Care Receipt
time frame: 12-month change
description: Percentage of women Veterans' obtaining recommended preventive care based on eligibility for service (e.g., meet eligibility guidelines for timely eye exams for diabetes, flu vaccination, colorectal cancer screening) using VA External Peer Review Program (EPRP) chart-based quality metrics.
measure: Gender-neutral Guideline-concordant Preventive Care Receipt
time frame: 24-month change
description: Percentage of women Veterans' obtaining recommended preventive care based on eligibility for service (e.g., meet eligibility guidelines for timely eye exams for diabetes, flu vaccination, colorectal cancer screening) using VA External Peer Review Program (EPRP) chart-based quality metrics
measure: Assignment to a Designated Women's Health Provider or a Women's Health Primary Care Teams, Using Patient Aligned Care Teams Compass
time frame: 12-month change
description: Percentage of women Veterans assigned to a designated women's health provider in a general primary care and/or women's health primary care setting.
measure: Assignment to a Designated Women's Health Provider or a Women's Health Primary Care Teams, Using Patient Aligned Care Teams Compass
time frame: 24-month change
description: Percentage of women Veterans assigned to a designated women's health provider in a general primary care and/or women's health primary care setting
measure: Provider Rating
time frame: 12 month change
description: Percent of women patients who rated 9 or 10 on a scale of 0 to 10 for the provider rating question on the Survey of Healthcare Experiences of Patients (SHEP). Higher scores are better.
measure: Provider Rating
time frame: 24-month change
description: Percent of women patients who rated 9 or 10 on a scale of 0 to 10 for the provider rating question from the Survey of Healthcare Experiences of Patients (SHEP). Higher scores are better.
arm group label: Evidence-Based Quality Improvement (EBQI)
arm group type: Experimental
description: EBQI represents a multilevel stakeholder engaged top-down/bottom-up research-clinical partnership approach to systematically improving the design and implementation of local innovations adapted to local contexts. The EBQI contractor will (1) convene facility-level stakeholder meetings, (2) facilitate local facility-level QI team design meetings, (3) provide external practice facilitation through within and across facility QI collaboration calls, (4) provide formative QI data feedback and (5) provide QI training/education to local teams.
arm group label: Waitlist Controls
arm group type: No Intervention
description: Waitlist controls will continue naturalistic routine care implementation of VHA directives and other guidance related to comprehensive women's health care.
intervention type: Other
intervention name: Evidence-Based Quality Improvement
description: Multilevel research-clinical partnership approach to supporting local strategic planning, priority setting, skill building and engagement in addressing targeted healthcare delivery problems. Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI education/training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines.
arm group label: Evidence-Based Quality Improvement (EBQI)
other name: EBQI
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elizabeth M Yano, PhD MSPH
role: Principal Investigator
affiliation: VA Greater Los Angeles Healthcare System, Sepulveda, CA
last name: Alison B Hamilton, PhD MPH
role: Principal Investigator
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
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country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
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reported events: 
certain agreements: 
point of contact: 