<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/NCT01677533</url>
  </required_header>
  <id_info>
    <org_study_id>EDU 08-428-2</org_study_id>
    <nct_id>NCT01677533</nct_id>
  </id_info>
  <brief_title>Program for Research on the Outcomes of VA Education</brief_title>
  <acronym>PROVE</acronym>
  <official_title>Program for Research on the Outcomes of VA Education: Controlled Study of Panel Management and Microsystem Education Interventions to Improve Outcomes in Hypertension and Smoking Cessation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA New York Harbor Healthcare System</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA New York Harbor Healthcare System</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The PROVE aims to test the efficacy of panel management support and educational intervention&#xD;
      in VA Primary Care Clinical Microsystems. The study will test three increasingly intensive&#xD;
      methods for implementing panel management strategies among health care providers in VA&#xD;
      primary care clinics: providing only panel data, providing panel management support, and&#xD;
      providing support plus clinical microsystem-enhancing education and training.It is&#xD;
      hypothesized that the group receiving panel management and educational interventions will&#xD;
      have better smoking cessation and hypertension outcomes than the group receiving only panel&#xD;
      management assistance. It is further supposed that the later will have better smoking&#xD;
      cessation and hypertension patient outcomes than the data-only group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective:&#xD;
&#xD;
      The specific aims for this study are: (1) to identify health professional educational and&#xD;
      clinical microsystem determinants of outcomes for hypertension and smoking cessation in&#xD;
      veterans. (2) to test the efficacy of three increasingly intensive methods for implementing&#xD;
      panel management strategies among health care providers in VA primary care clinics: providing&#xD;
      only panel data, providing panel management support, and providing support plus clinical&#xD;
      microsystem-enhancing education and training.&#xD;
&#xD;
      Research design:&#xD;
&#xD;
      This project will consist of two phases. Phase I (one year) is the development of the&#xD;
      necessary measurement and data infrastructure to assess health professional education,&#xD;
      microsystem function, and clinical outcomes. In Phase 2 (two years) the study team will&#xD;
      conduct a clinical demonstration project, comparing three interventions in a randomized&#xD;
      controlled trial. Primary care teams will be randomly allocated to one of three arms: 1)&#xD;
      panel management data, 2) panel management data and support, and 3) panel management data,&#xD;
      support and education. The investigators will assess the impact of the implementation of&#xD;
      panel management on primary patient outcomes in hypertension and smoking cessation (blood&#xD;
      pressure and quit rates). The investigative team will also assess the impact of the&#xD;
      implementation of panel management on secondary, intermediary, patient (patient activation,&#xD;
      adherence, behavior change), provider (knowledge and attitudes, self-efficacy, job&#xD;
      satisfaction) and microsystem outcomes (collective efficacy, teamwork, use of data, redesign&#xD;
      of patient processes and provider roles/responsibilities, use of panel management&#xD;
      strategies).&#xD;
&#xD;
      Methodology:&#xD;
&#xD;
      The study will utilize a multi-method, quasi-experimental design at VA NYHHS. Primary care is&#xD;
      delivered through two teams at the Manhattan and five teams at the Brooklyn campuses.&#xD;
      Patients, staff, nurses, and physicians are assigned to specific teams, thereby limiting&#xD;
      contamination in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2009</start_date>
  <completion_date type="Actual">August 31, 2015</completion_date>
  <primary_completion_date type="Actual">August 31, 2014</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>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Smoking Status</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>clinical outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Blood Pressure Reading</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>clinical outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in weight</measure>
    <time_frame>Baseline and most recent at 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Activation</measure>
    <time_frame>6 months and 12 months</time_frame>
    <description>The Patient Activation Measure (PAM) is used to assess patients' self-reported knowledge, skill, and confidence in self-managing of health and chronic conditions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Perceptions of Quality of Care</measure>
    <time_frame>6 months and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Provider Behavior change expertise</measure>
    <time_frame>6 months and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Provider Self-efficacy with Panel Management Tasks</measure>
    <time_frame>Baseline and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Provider Job Satisfaction</measure>
    <time_frame>Baseline and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Microsystem function and collective efficacy</measure>
    <time_frame>Baseline and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Provider's assessments of training that they received in panel management and working within a PACT team</measure>
    <time_frame>Baseline and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Proportion of panel smokers offered smoking cessation resources by study arm</measure>
    <time_frame>Baseline and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Proportion of smokers on the panel received any cessation medications</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>This information will be culled from the Vista Smoking Database</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Health care usage</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Number of primary care visits, mental health visits, emergency room/urgent care visits and the number of VA hospitalizations</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Patient-level costs</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Outpatient primary care visits, mental health visits, pharmacy and hospitalizations from the VA Decision Support System</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">5000</enrollment>
  <condition>Hypertension</condition>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>PM-Data</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Team will receive data only.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PM-Support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Team will receive data and panel management support</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PM-Education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Team will receive data, panel management support, and educational interventions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data</intervention_name>
    <description>The microsystem teams of providers, nurses, and clerks will receive monthly reports of their performance measures, which will include process and outcome data for smoking cessation and blood pressure control for veterans in their panel. The reports will provide lists of individual patients in the panel with unmet goals on VA performance measures. They will receive written informational material describing principles and practices of panel management and evidence-based guidelines for hypertension management and smoking cessation.</description>
    <arm_group_label>PM-Data</arm_group_label>
    <arm_group_label>PM-Education</arm_group_label>
    <arm_group_label>PM-Support</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Panel Management Support</intervention_name>
    <description>PMAs will meet regularly with the members of the microsystem team for one hour/week. The team will be asked to review progress on the health status of their patient panel and to plan strategies for improving their outcomes that the PMA will then implement. A PMA toolkit of panel management strategies will be established that will include guidelines for using VA databases to identify care gaps and reaching out to panel patients via phone and mail to intervene (e.g. reconnect patients to care with appointments, assess and enhance medication adherence, connect patients with VA services, motivational interviewing, and communication with the team about patient issues.</description>
    <arm_group_label>PM-Education</arm_group_label>
    <arm_group_label>PM-Support</arm_group_label>
    <other_name>Panel management assistant</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Education</intervention_name>
    <description>The educational intervention will be administered throughout the duration of the study. Our initial educational focus will be on content (concepts of population health and panel management) and process (practice change methodology). Subsequent education will be process oriented, reviewing the changing system of care and discussing its functioning. Education will cover panel management strategies, microsystem theory and skills, and specific strategies regarding the management of hypertension and smoking cessation. It will include monthly seminars, reading materials, web-based modules, and skill building workshops, and PMA-conducted monthly academic detailing using panel data and feedback. After the first three months, academic detailing will only be implemented on an as-needed basis.</description>
    <arm_group_label>PM-Education</arm_group_label>
    <other_name>Educational Intervention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  non-specialized primary care clinical microsystems&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  specialized clinical microsystems&#xD;
&#xD;
          -  pilot clinical patient-aligned care teams&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark D Schwartz</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA New York Harbor Healthcare System</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Scott Sherman, M.D., M.P.H.</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA New York Harbor Healthcare System</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Colleen Gillespie, PhD</last_name>
    <role>Study Director</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anne Dembitzer, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>VA New York Harbor Healthcare System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA NYHHS Brooklyn Campus</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA NYHHS Manhattan Campus</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>May 1, 2018</last_update_submitted>
  <last_update_submitted_qc>May 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>VA New York Harbor Healthcare System</investigator_affiliation>
    <investigator_full_name>Mark Schwartz</investigator_full_name>
    <investigator_title>Primary Care Physician</investigator_title>
  </responsible_party>
  <keyword>Panel management</keyword>
  <keyword>Clinical microsystems</keyword>
  <keyword>Hypertension management</keyword>
  <keyword>Smoking cessation</keyword>
  <keyword>Continuing medical education</keyword>
  <keyword>Quality improvement,</keyword>
  <keyword>Population health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- 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/NCT01677533
org study id: EDU 08-428-2
nct id: NCT01677533
lead sponsor: 
has dmc: Yes
The PROVE aims to test the efficacy of panel management support and educational intervention
      in VA Primary Care Clinical Microsystems. The study will test three increasingly intensive
      methods for implementing panel management strategies among health care providers in VA
      primary care clinics: providing only panel data, providing panel management support, and
      providing support plus clinical microsystem-enhancing education and training.It is
      hypothesized that the group receiving panel management and educational interventions will
      have better smoking cessation and hypertension outcomes than the group receiving only panel
      management assistance. It is further supposed that the later will have better smoking
      cessation and hypertension patient outcomes than the data-only group.
Objective:

      The specific aims for this study are: (1) to identify health professional educational and
      clinical microsystem determinants of outcomes for hypertension and smoking cessation in
      veterans. (2) to test the efficacy of three increasingly intensive methods for implementing
      panel management strategies among health care providers in VA primary care clinics: providing
      only panel data, providing panel management support, and providing support plus clinical
      microsystem-enhancing education and training.

      Research design:

      This project will consist of two phases. Phase I (one year) is the development of the
      necessary measurement and data infrastructure to assess health professional education,
      microsystem function, and clinical outcomes. In Phase 2 (two years) the study team will
      conduct a clinical demonstration project, comparing three interventions in a randomized
      controlled trial. Primary care teams will be randomly allocated to one of three arms: 1)
      panel management data, 2) panel management data and support, and 3) panel management data,
      support and education. The investigators will assess the impact of the implementation of
      panel management on primary patient outcomes in hypertension and smoking cessation (blood
      pressure and quit rates). The investigative team will also assess the impact of the
      implementation of panel management on secondary, intermediary, patient (patient activation,
      adherence, behavior change), provider (knowledge and attitudes, self-efficacy, job
      satisfaction) and microsystem outcomes (collective efficacy, teamwork, use of data, redesign
      of patient processes and provider roles/responsibilities, use of panel management
      strategies).

      Methodology:

      The study will utilize a multi-method, quasi-experimental design at VA NYHHS. Primary care is
      delivered through two teams at the Manhattan and five teams at the Brooklyn campuses.
      Patients, staff, nurses, and physicians are assigned to specific teams, thereby limiting
      contamination in this study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in Smoking Status
time frame: Baseline and 12 months
description: clinical outcome
measure: Change in Blood Pressure Reading
time frame: Baseline and 12 months
description: clinical outcome
measure: Change in weight
time frame: Baseline and most recent at 12 months
measure: Change in Patient Activation
time frame: 6 months and 12 months
description: The Patient Activation Measure (PAM) is used to assess patients' self-reported knowledge, skill, and confidence in self-managing of health and chronic conditions
measure: Change in Patient Perceptions of Quality of Care
time frame: 6 months and 12 months
measure: Change in Provider Behavior change expertise
time frame: 6 months and 12 months
measure: Change in Provider Self-efficacy with Panel Management Tasks
time frame: Baseline and 12 months
measure: Change in Provider Job Satisfaction
time frame: Baseline and 12 months
measure: Change in Microsystem function and collective efficacy
time frame: Baseline and 12 months
measure: Change in Provider's assessments of training that they received in panel management and working within a PACT team
time frame: Baseline and 12 months
measure: Change in Proportion of panel smokers offered smoking cessation resources by study arm
time frame: Baseline and 12 months
measure: Change in Proportion of smokers on the panel received any cessation medications
time frame: Baseline and 12 months
description: This information will be culled from the Vista Smoking Database
measure: Change in Health care usage
time frame: Baseline and 12 months
description: Number of primary care visits, mental health visits, emergency room/urgent care visits and the number of VA hospitalizations
measure: Change in Patient-level costs
time frame: Baseline and 12 months
description: Outpatient primary care visits, mental health visits, pharmacy and hospitalizations from the VA Decision Support System
arm group label: PM-Data
arm group type: Active Comparator
description: Team will receive data only.
arm group label: PM-Support
arm group type: Experimental
description: Team will receive data and panel management support
arm group label: PM-Education
arm group type: Experimental
description: Team will receive data, panel management support, and educational interventions.
intervention type: Other
intervention name: Data
description: The microsystem teams of providers, nurses, and clerks will receive monthly reports of their performance measures, which will include process and outcome data for smoking cessation and blood pressure control for veterans in their panel. The reports will provide lists of individual patients in the panel with unmet goals on VA performance measures. They will receive written informational material describing principles and practices of panel management and evidence-based guidelines for hypertension management and smoking cessation.
arm group label: PM-Data
arm group label: PM-Education
arm group label: PM-Support
intervention type: Other
intervention name: Panel Management Support
description: PMAs will meet regularly with the members of the microsystem team for one hour/week. The team will be asked to review progress on the health status of their patient panel and to plan strategies for improving their outcomes that the PMA will then implement. A PMA toolkit of panel management strategies will be established that will include guidelines for using VA databases to identify care gaps and reaching out to panel patients via phone and mail to intervene (e.g. reconnect patients to care with appointments, assess and enhance medication adherence, connect patients with VA services, motivational interviewing, and communication with the team about patient issues.
arm group label: PM-Education
arm group label: PM-Support
other name: Panel management assistant
intervention type: Other
intervention name: Education
description: The educational intervention will be administered throughout the duration of the study. Our initial educational focus will be on content (concepts of population health and panel management) and process (practice change methodology). Subsequent education will be process oriented, reviewing the changing system of care and discussing its functioning. Education will cover panel management strategies, microsystem theory and skills, and specific strategies regarding the management of hypertension and smoking cessation. It will include monthly seminars, reading materials, web-based modules, and skill building workshops, and PMA-conducted monthly academic detailing using panel data and feedback. After the first three months, academic detailing will only be implemented on an as-needed basis.
arm group label: PM-Education
other name: Educational Intervention
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mark D Schwartz
role: Principal Investigator
affiliation: VA New York Harbor Healthcare System
last name: Scott Sherman, M.D., M.P.H.
role: Principal Investigator
affiliation: VA New York Harbor Healthcare System
last name: Colleen Gillespie, PhD
role: Study Director
affiliation: NYU Langone Health
last name: Anne Dembitzer, M.D.
role: Study Director
affiliation: VA New York Harbor Healthcare System
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: VA New York Harbor Healthcare System
investigator full name: Mark Schwartz
investigator title: Primary Care Physician
mesh term: Hypertension