<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/NCT02991534</url>
  </required_header>
  <id_info>
    <org_study_id>QUX 16-007</org_study_id>
    <nct_id>NCT02991534</nct_id>
  </id_info>
  <brief_title>Cardiovascular Risk Screening and Risk Reduction in Women Vets</brief_title>
  <official_title>Facilitating Cardiovascular Risk Screening and Risk Reduction in Women Veterans (QUE 15-272)</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>
      Background: Women Veterans are the fastest growing segment of Veterans Health Administration&#xD;
      (VHA) users. This dramatic growth has created challenges for VHA. Gender disparities persist&#xD;
      in cardiovascular (CV) and diabetes risk factor control, and rates of depression, anxiety,&#xD;
      and mental health comorbidity are disproportionately high among women Veterans. Furthermore,&#xD;
      a high rate of women Veterans' attrition from VA care, along with organizational barriers to&#xD;
      care, substantiate that organizational changes are needed in order to engage and retain women&#xD;
      Veteran VHA users in evidence-based, patient-centered care.&#xD;
&#xD;
      Objectives: The Enhancing Mental and Physical health of Women through Engagement and&#xD;
      Retention (EMPOWER) QUERI addresses VHA Blueprint for Excellence Strategy 6, by advancing&#xD;
      &quot;personalized, proactive, patient-centered&quot; care models, and Transformational Strategy 7.2.g&#xD;
      by implementation of innovative care models in women Veterans' health care.&quot; The EMPOWER&#xD;
      QUERI Program is designed to improve women Veterans' engagement and retention in&#xD;
      evidence-based care for three high priority health conditions, i.e., prediabetes,&#xD;
      cardiovascular, and mental health. To achieve this impact goal, we propose a cohesive&#xD;
      portfolio of projects with the following aims: (1) To use an evidence-based implementation&#xD;
      strategy that emphasizes local tailoring of care models, multilevel stakeholder engagement,&#xD;
      and systematic evaluation of complex implementation processes in order to enrich&#xD;
      organizational capacity for innovations in women Veterans' VHA health care; (2) To implement&#xD;
      personalized, proactive, patient-centered innovations in VHA women's health that are&#xD;
      acceptable, feasible, satisfactory, relevant, and effective for both providers and patients,&#xD;
      thereby encouraging women Veterans' engagement and retention and sustainability of the&#xD;
      innovations; and, (3) To generate implementation &quot;playbooks&quot; for our partners that are&#xD;
      scalable and serve as guidance for future implementation of a broader array of evidence-based&#xD;
      women's health programs and policy.&#xD;
&#xD;
      Methods: Three projects will be conducted by an experienced multidisciplinary team.&#xD;
      &quot;Tailoring VA's Diabetes Prevention Program to Women Veterans' Needs&quot; is a one-year QI&#xD;
      project to be conducted in VA Greater Los Angeles women's health clinics. Women Veterans with&#xD;
      prediabetes will select an in-person, peer-led or online gender-specific, evidence-based&#xD;
      diabetes prevention program to address their risk behaviors and health conditions.&#xD;
      &quot;Facilitating Cardiovascular Risk Screening and Risk Reduction in Women Veterans&quot; will&#xD;
      increase identification of CV risk among women Veterans, enhance patient/provider&#xD;
      communication and shared decision-making about CV risk, and provide a supportive, coordinated&#xD;
      health coaching intervention to facilitate women Veterans' engagement and retention in&#xD;
      appropriate health services. &quot;Implementation of Tailored Collaborative Care for Women&#xD;
      Veterans&quot; will evaluate implementation of an evidence-based collaborative care model tailored&#xD;
      to enhance provider- and system-level capabilities to address women Veterans' anxiety and&#xD;
      depression treatment needs, thereby improving organizational primary care-mental health&#xD;
      integration (PC-MHI) effectiveness and women Veterans' engagement and retention in PC-MHI.&#xD;
      Both implementation research studies will use a modified stepped wedge design and will apply&#xD;
      the evidence-based Replicating Effective Programs (REP) implementation strategy. Mixed&#xD;
      methods implementation evaluations will focus on investigating primary implementation&#xD;
      outcomes of adoption, acceptability, feasibility, and reach. Multilevel stakeholder&#xD;
      engagement will be prioritized. Program-wide organizational-, provider-, and patient-level&#xD;
      measures and tools will be utilized to enhance synergy, productivity, and impact. As a&#xD;
      coherent program of women's health implementation research and quality improvement, the&#xD;
      proposed EMPOWER QUERI will constitute a major milestone in achieving BPE strategies and&#xD;
      realizing women Veterans' engagement and, ultimately, empowerment in our VHA system.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 15, 2016</start_date>
  <completion_date type="Actual">September 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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Referrals to Health Promotion and Disease Prevention Services</measure>
    <time_frame>6 months</time_frame>
    <description>Examples include smoking cessation, dietitian, MOVE program or other weight loss/physical activity programs, pharmacy services, facilitated groups, Health Coaching services, specialty services, and other programs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Altarum Consumer Engagement (ACE)</measure>
    <time_frame>6 months</time_frame>
    <description>Brief measure of patient engagement in care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Global Health</measure>
    <time_frame>6 months</time_frame>
    <description>Brief measure of global health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>6 months</time_frame>
    <description>Global rating of patient satisfaction/quality of care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Anxiety Severity and Impairment Scale (OASIS)</measure>
    <time_frame>6 months</time_frame>
    <description>Brief measure of anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression screen (PHQ-4)</measure>
    <time_frame>6 months</time_frame>
    <description>Brief measure of depression symptoms</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">254</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Hypertension</condition>
  <condition>Hyperlipidemias</condition>
  <condition>Dyslipidemias</condition>
  <condition>Obesity</condition>
  <condition>Diabetes Mellitus</condition>
  <condition>Tobacco Use Disorder</condition>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The investigators will use a nonrandomized stepped wedge design to evaluate the implementation in four VA Women's Practice Based Research Network (PBRN) sites. In this nonrandomized stepped wedge design, the intervention is &quot;turned on&quot; when a primary care provider (PCP) uses a CV screening template which maps to the patient CV self-screener. This design relies on sequential roll-out to participating sites over time, while using other sites as controls until they begin implementation. The investigators will use nonrandomized stepped wedges (rather than randomized) given their suitability for studying implementation. The design explicitly considers the timing of implementation spread and addresses the statistical issues introduced by lack of randomization in implementation starts and processes. The investigators will analytically compensate for the design by collecting patient-, provider-, and site-level data that may be associated with timing of the adoption of each intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CV Toolkit Components</intervention_name>
    <description>Patient completes a CV self screener.&#xD;
Patient discusses CV risks factors with primary care providers and CV risks are documented and discussed for action steps and referrals.&#xD;
Patient will be recommended to attend a gender tailored facilitated workgroup - Gateways to Healthy Living to make specific SMART goals and commit to patient preferred services or program</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For Patient Activities: Women VA patients with any cardiovascular risk factors&#xD;
&#xD;
          -  For Key Stakeholder Activities: VA staff affiliated with the Women's Health Clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  For Patient Activities: Men &amp; Patients with cognitive impairment precluding informed&#xD;
             consent&#xD;
&#xD;
          -  For Key Stakeholder Activities: non- VA staff&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bevanne A Bean-Mayberry, MD MHS</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Greater Los Angeles Healthcare System, West Los Angeles, CA</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Melissa M Farmer Coste, PhD MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Greater Los Angeles Healthcare System, Sepulveda, CA</affiliation>
  </overall_official>
  <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 Greater Los Angeles Healthcare System, West Los Angeles, CA</name>
      <address>
        <city>West Los Angeles</city>
        <state>California</state>
        <zip>90073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Connecticut Healthcare System West Haven Campus, West Haven, CT</name>
      <address>
        <city>West Haven</city>
        <state>Connecticut</state>
        <zip>06516</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_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.queri.research.va.gov/programs/womens_health.cfm</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>October 6, 2020</last_update_submitted>
  <last_update_submitted_qc>October 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Patient Participation [N05.300.150.600.620]</keyword>
  <keyword>Health Behavior [F01.145.488]</keyword>
  <keyword>Women [M01.975]</keyword>
  <keyword>Patient Satisfaction [N05.715.360.600]</keyword>
  <keyword>Physicians, Primary Care [M01.526.485.810.800]</keyword>
  <keyword>Physicians, Women [M01.526.485.810.820]</keyword>
  <keyword>Health Educators [M01.526.485.410]</keyword>
  <keyword>Cardiovascular Diseases [C14]</keyword>
  <keyword>Hypertension [C14.907.489]</keyword>
  <keyword>Hyperlipidemias [C18.452.584.500.500]</keyword>
  <keyword>Dyslipidemias [C18.452.584.500]</keyword>
  <keyword>Obesity [C18.654.726.500]</keyword>
  <keyword>Diabetes Mellitus [C18.452.394.750]</keyword>
  <keyword>Tobacco Use Disorder [C25.775.912]</keyword>
  <keyword>Overweight [C23.888.144.699]</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Dyslipidemias</mesh_term>
    <mesh_term>Hyperlipidemias</mesh_term>
    <mesh_term>Hyperlipoproteinemias</mesh_term>
    <mesh_term>Tobacco Use Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 16, 2022</submitted>
    <returned>July 19, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02991534
org study id: QUX 16-007
nct id: NCT02991534
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Background: Women Veterans are the fastest growing segment of Veterans Health Administration
      (VHA) users. This dramatic growth has created challenges for VHA. Gender disparities persist
      in cardiovascular (CV) and diabetes risk factor control, and rates of depression, anxiety,
      and mental health comorbidity are disproportionately high among women Veterans. Furthermore,
      a high rate of women Veterans' attrition from VA care, along with organizational barriers to
      care, substantiate that organizational changes are needed in order to engage and retain women
      Veteran VHA users in evidence-based, patient-centered care.

      Objectives: The Enhancing Mental and Physical health of Women through Engagement and
      Retention (EMPOWER) QUERI addresses VHA Blueprint for Excellence Strategy 6, by advancing
      "personalized, proactive, patient-centered" care models, and Transformational Strategy 7.2.g
      by implementation of innovative care models in women Veterans' health care." The EMPOWER
      QUERI Program is designed to improve women Veterans' engagement and retention in
      evidence-based care for three high priority health conditions, i.e., prediabetes,
      cardiovascular, and mental health. To achieve this impact goal, we propose a cohesive
      portfolio of projects with the following aims: (1) To use an evidence-based implementation
      strategy that emphasizes local tailoring of care models, multilevel stakeholder engagement,
      and systematic evaluation of complex implementation processes in order to enrich
      organizational capacity for innovations in women Veterans' VHA health care; (2) To implement
      personalized, proactive, patient-centered innovations in VHA women's health that are
      acceptable, feasible, satisfactory, relevant, and effective for both providers and patients,
      thereby encouraging women Veterans' engagement and retention and sustainability of the
      innovations; and, (3) To generate implementation "playbooks" for our partners that are
      scalable and serve as guidance for future implementation of a broader array of evidence-based
      women's health programs and policy.

      Methods: Three projects will be conducted by an experienced multidisciplinary team.
      "Tailoring VA's Diabetes Prevention Program to Women Veterans' Needs" is a one-year QI
      project to be conducted in VA Greater Los Angeles women's health clinics. Women Veterans with
      prediabetes will select an in-person, peer-led or online gender-specific, evidence-based
      diabetes prevention program to address their risk behaviors and health conditions.
      "Facilitating Cardiovascular Risk Screening and Risk Reduction in Women Veterans" will
      increase identification of CV risk among women Veterans, enhance patient/provider
      communication and shared decision-making about CV risk, and provide a supportive, coordinated
      health coaching intervention to facilitate women Veterans' engagement and retention in
      appropriate health services. "Implementation of Tailored Collaborative Care for Women
      Veterans" will evaluate implementation of an evidence-based collaborative care model tailored
      to enhance provider- and system-level capabilities to address women Veterans' anxiety and
      depression treatment needs, thereby improving organizational primary care-mental health
      integration (PC-MHI) effectiveness and women Veterans' engagement and retention in PC-MHI.
      Both implementation research studies will use a modified stepped wedge design and will apply
      the evidence-based Replicating Effective Programs (REP) implementation strategy. Mixed
      methods implementation evaluations will focus on investigating primary implementation
      outcomes of adoption, acceptability, feasibility, and reach. Multilevel stakeholder
      engagement will be prioritized. Program-wide organizational-, provider-, and patient-level
      measures and tools will be utilized to enhance synergy, productivity, and impact. As a
      coherent program of women's health implementation research and quality improvement, the
      proposed EMPOWER QUERI will constitute a major milestone in achieving BPE strategies and
      realizing women Veterans' engagement and, ultimately, empowerment in our VHA system.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Referrals to Health Promotion and Disease Prevention Services
time frame: 6 months
description: Examples include smoking cessation, dietitian, MOVE program or other weight loss/physical activity programs, pharmacy services, facilitated groups, Health Coaching services, specialty services, and other programs.
measure: Altarum Consumer Engagement (ACE)
time frame: 6 months
description: Brief measure of patient engagement in care
measure: PROMIS Global Health
time frame: 6 months
description: Brief measure of global health
measure: Patient Satisfaction
time frame: 6 months
description: Global rating of patient satisfaction/quality of care
measure: Overall Anxiety Severity and Impairment Scale (OASIS)
time frame: 6 months
description: Brief measure of anxiety
measure: Depression screen (PHQ-4)
time frame: 6 months
description: Brief measure of depression symptoms
arm group label: Arm 1
arm group type: Other
description: The investigators will use a nonrandomized stepped wedge design to evaluate the implementation in four VA Women's Practice Based Research Network (PBRN) sites. In this nonrandomized stepped wedge design, the intervention is "turned on" when a primary care provider (PCP) uses a CV screening template which maps to the patient CV self-screener. This design relies on sequential roll-out to participating sites over time, while using other sites as controls until they begin implementation. The investigators will use nonrandomized stepped wedges (rather than randomized) given their suitability for studying implementation. The design explicitly considers the timing of implementation spread and addresses the statistical issues introduced by lack of randomization in implementation starts and processes. The investigators will analytically compensate for the design by collecting patient-, provider-, and site-level data that may be associated with timing of the adoption of each intervention.
intervention type: Behavioral
intervention name: CV Toolkit Components
description: Patient completes a CV self screener.
Patient discusses CV risks factors with primary care providers and CV risks are documented and discussed for action steps and referrals.
Patient will be recommended to attend a gender tailored facilitated workgroup - Gateways to Healthy Living to make specific SMART goals and commit to patient preferred services or program
arm group label: Arm 1
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bevanne A Bean-Mayberry, MD MHS
role: Principal Investigator
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
last name: Melissa M Farmer Coste, PhD MS
role: Principal Investigator
affiliation: VA Greater Los Angeles Healthcare System, Sepulveda, CA
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.queri.research.va.gov/programs/womens_health.cfm
description: Related Info
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Cardiovascular Diseases
mesh term: Diabetes Mellitus
mesh term: Overweight
mesh term: Dyslipidemias
mesh term: Hyperlipidemias
mesh term: Hyperlipoproteinemias
mesh term: Tobacco Use Disorder
sharing ipd: No
submitted: August 16, 2022
returned: July 19, 2023