<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/NCT02263742</url>
  </required_header>
  <id_info>
    <org_study_id>1310012851</org_study_id>
    <nct_id>NCT02263742</nct_id>
  </id_info>
  <brief_title>Project Wellness Enhancement: Increasing Health Care Choice and Outcomes for People With Mental Illness</brief_title>
  <acronym>WE</acronym>
  <official_title>Increasing Health Care Choices and Improving Health Outcomes Among Persons With Serious Mental Illness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project aims to study health outcomes of individuals with mental illness attending a&#xD;
      co-located primary health care center in a mental health center. This study uses mixed&#xD;
      methods to collect a range of information about who chooses to use what Wellness Center&#xD;
      services and in what combinations, with what short and longer-term effects and with what&#xD;
      outcomes.&#xD;
&#xD;
      Based on participant interviews, identify barriers to and facilitators of access, service,&#xD;
      and improvements in person-centered outcomes and elicit suggestions for enhancing health care&#xD;
      outcomes and choice.&#xD;
&#xD;
      Collaborate with persons in recovery in using the data collected through Aims 1 and 2 to&#xD;
      develop and pilot the effectiveness of a new peer-led community based intervention in&#xD;
      enhancing access and choice and improving person-centered health outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Americans with serious mental illnesses (SMI) die an average of 25 years earlier&#xD;
      due to modifiable risk factors, medical conditions, and lack of access to quality,&#xD;
      coordinated care. Strategies for addressing this disparity have amassed evidence. What&#xD;
      remains to be determined is who will choose to use these evidence-based practices (EBPs) when&#xD;
      implemented in routine practice, in what combinations, with what short term effects and&#xD;
      health outcomes, and what else might be needed for persons for whom these strategies are not&#xD;
      effective.&#xD;
&#xD;
      Objectives: The proposed research builds upon the investigators receipt of a SAMHSA grant&#xD;
      that established an integrated Wellness Center (WC) within the local mental health center&#xD;
      that provides four EBPs: a) on-site primary care; b) screening of clients for modifiable risk&#xD;
      factors and medical conditions; c) care coordination; and d) peer health navigation. Through&#xD;
      PCORI, the investigators propose to add a comparative effectiveness dimension and a focus on&#xD;
      patient-centered outcomes. The investigators specific aims are:&#xD;
&#xD;
        1. to assess patient preferences and use of services, short-term effects, and longer term&#xD;
           outcomes associated with various practices for the population and subpopulations;&#xD;
&#xD;
        2. to identify barriers to and facilitators of access, service use, and improvements in&#xD;
           traditional and patient-centered health outcomes; and&#xD;
&#xD;
        3. to develop and pilot a peer-led, community-based intervention in enhancing access and&#xD;
           choice, and improving patient-centered health outcomes, among 40 treatment-refractory&#xD;
           clients of the WC.&#xD;
&#xD;
      The investigators long-term objectives are to: a) identify which practices work for which&#xD;
      persons with SMI in improving health and patient-centered outcomes, and b) provide&#xD;
      stakeholders around the nation with the knowledge and tools to replicate this model&#xD;
      efficiently, effectively, and broadly.&#xD;
&#xD;
      Methods: The sample includes 360 poor, urban adults with SMI who are at risk for or have&#xD;
      co-morbid medical conditions. Using participatory and mixed methodology, the investigators&#xD;
      will assess Specific Aims 1 &amp; 2 by collecting health and patient-centered outcome data on&#xD;
      patients entering the WC and at 6 month follow-up intervals and analyze the data using Linear&#xD;
      Mixed Models and logistic regression. Outcome data from the pilot intervention (Aim 3; N=40)&#xD;
      will be compared to outcomes of a propensity matched sample of WC patients. Qualitative data&#xD;
      will be collected each year through focus groups (N=48 agency stakeholders, year 1) and&#xD;
      individual interviews (50 WC patients, years 2 &amp; 3).&#xD;
&#xD;
      Projected Patient Outcomes: Outcomes include both traditional medical/clinical outcomes&#xD;
      (e.g., blood pressure, BMI, fasting plasma glucose, HbGA1c, cholesterol, triglycerides,&#xD;
      alcohol and drug use, psychiatric symptoms) and a range of patient-centered outcomes to be&#xD;
      identified by key stakeholders in the initial phase of research. The investigators previous&#xD;
      research suggests that these outcomes are likely to include self-efficacy, quality of life,&#xD;
      employment, citizenship, and social connectedness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effectiveness of a Co-located Primary Health Care Center in a Local mental health center</measure>
    <time_frame>up to 30 months</time_frame>
    <description>Use mixed methods to collect a rage of information about who chooses to use Using quantitative and qualitative measures by looking at the number of participants, follow up rates, improvement in health indices</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effectiveness of health care navigation in improving health outcomes for people with mental illness</measure>
    <time_frame>up to 30 months</time_frame>
    <description>Use mixed methods to collect a rage of information about who chooses to use Using quantitative and qualitative measures by looking at the number of participants, follow up rates, improvement in health indices, including some patient centered measures, and also the number of times they meet with their health care navigators</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Universal Health screening</measure>
    <time_frame>up to 30 months</time_frame>
    <description>Look at whether clients of the Wellness Center have improvement in their overall health by looking at their health measurements and lab works from each of their 6 month appointments</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Collaborate with persons in recovery in using data collected to develop and pilot a new peer led, community based intervention in enhancing access and choice</measure>
    <time_frame>up to 30 months</time_frame>
    <description>48 participants will be in a pilot intervention run by peers on whole health, measures will be both qualitative and quantitative to look for overall health improvement and choices</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">204</enrollment>
  <condition>Mental Health Wellness 1</condition>
  <condition>Mental Illnesses</condition>
  <condition>Other Diagnoses, Comorbidities, and Complications | Patient</condition>
  <arm_group>
    <arm_group_label>Peer whole health</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Peer whole health intervention will be compared to the treatment as usual at Wellness Center to assess healthcare choice and outcomes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EBPs at Wellness Center</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>EBPs at Wellness Center will be the active comparative to measure healthcare choice and outcomes with the peer whole health intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Peer whole health intervention</intervention_name>
    <description>Provide wraparound peer support, education, and navigation to individuals</description>
    <arm_group_label>Peer whole health</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>EBPs at Wellness Center</intervention_name>
    <description>four EBPs: a) on-site primary care; b) screening of clients for modifiable risk factors and medical conditions; c) care coordination; and d) peer health navigation</description>
    <arm_group_label>EBPs at Wellness Center</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Clients receiving services from CMHC and the Wellness Center.&#xD;
&#xD;
          -  Research staff will verify with CMHC staff that the potential participant is receiving&#xD;
             services currently at CMHC.&#xD;
&#xD;
          -  Provider research subjects will be included if they are a mental health provider at&#xD;
             CMHC or if they are members of the staff for the Wellness Center&#xD;
&#xD;
          -  Adults with serious mental illness and physical illness&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant research subjects not receiving services at CMHC and the Wellness Center&#xD;
&#xD;
          -  Provider research subjects of other agencies will be excluded&#xD;
&#xD;
          -  Children and youth under 18 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chyrell Bellamy, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kimberly D Antunes, BSW</last_name>
    <role>Study Director</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CT Mental Health Center</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University Program for Recovery and Community Health</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06513</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>March 31, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>January 12, 2018</last_update_submitted>
  <last_update_submitted_qc>January 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthcare choice and outcomes</keyword>
  <keyword>Peer-led whole health</keyword>
  <keyword>Mental Illness</keyword>
  <keyword>Peer Health Navigation</keyword>
  <keyword>Health care Coordination</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</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/NCT02263742
org study id: 1310012851
nct id: NCT02263742
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project aims to study health outcomes of individuals with mental illness attending a
      co-located primary health care center in a mental health center. This study uses mixed
      methods to collect a range of information about who chooses to use what Wellness Center
      services and in what combinations, with what short and longer-term effects and with what
      outcomes.

      Based on participant interviews, identify barriers to and facilitators of access, service,
      and improvements in person-centered outcomes and elicit suggestions for enhancing health care
      outcomes and choice.

      Collaborate with persons in recovery in using the data collected through Aims 1 and 2 to
      develop and pilot the effectiveness of a new peer-led community based intervention in
      enhancing access and choice and improving person-centered health outcomes.
Background: Americans with serious mental illnesses (SMI) die an average of 25 years earlier
      due to modifiable risk factors, medical conditions, and lack of access to quality,
      coordinated care. Strategies for addressing this disparity have amassed evidence. What
      remains to be determined is who will choose to use these evidence-based practices (EBPs) when
      implemented in routine practice, in what combinations, with what short term effects and
      health outcomes, and what else might be needed for persons for whom these strategies are not
      effective.

      Objectives: The proposed research builds upon the investigators receipt of a SAMHSA grant
      that established an integrated Wellness Center (WC) within the local mental health center
      that provides four EBPs: a) on-site primary care; b) screening of clients for modifiable risk
      factors and medical conditions; c) care coordination; and d) peer health navigation. Through
      PCORI, the investigators propose to add a comparative effectiveness dimension and a focus on
      patient-centered outcomes. The investigators specific aims are:

        1. to assess patient preferences and use of services, short-term effects, and longer term
           outcomes associated with various practices for the population and subpopulations;

        2. to identify barriers to and facilitators of access, service use, and improvements in
           traditional and patient-centered health outcomes; and

        3. to develop and pilot a peer-led, community-based intervention in enhancing access and
           choice, and improving patient-centered health outcomes, among 40 treatment-refractory
           clients of the WC.

      The investigators long-term objectives are to: a) identify which practices work for which
      persons with SMI in improving health and patient-centered outcomes, and b) provide
      stakeholders around the nation with the knowledge and tools to replicate this model
      efficiently, effectively, and broadly.

      Methods: The sample includes 360 poor, urban adults with SMI who are at risk for or have
      co-morbid medical conditions. Using participatory and mixed methodology, the investigators
      will assess Specific Aims 1 & 2 by collecting health and patient-centered outcome data on
      patients entering the WC and at 6 month follow-up intervals and analyze the data using Linear
      Mixed Models and logistic regression. Outcome data from the pilot intervention (Aim 3; N=40)
      will be compared to outcomes of a propensity matched sample of WC patients. Qualitative data
      will be collected each year through focus groups (N=48 agency stakeholders, year 1) and
      individual interviews (50 WC patients, years 2 & 3).

      Projected Patient Outcomes: Outcomes include both traditional medical/clinical outcomes
      (e.g., blood pressure, BMI, fasting plasma glucose, HbGA1c, cholesterol, triglycerides,
      alcohol and drug use, psychiatric symptoms) and a range of patient-centered outcomes to be
      identified by key stakeholders in the initial phase of research. The investigators previous
      research suggests that these outcomes are likely to include self-efficacy, quality of life,
      employment, citizenship, and social connectedness.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Effectiveness of a Co-located Primary Health Care Center in a Local mental health center
time frame: up to 30 months
description: Use mixed methods to collect a rage of information about who chooses to use Using quantitative and qualitative measures by looking at the number of participants, follow up rates, improvement in health indices
measure: Effectiveness of health care navigation in improving health outcomes for people with mental illness
time frame: up to 30 months
description: Use mixed methods to collect a rage of information about who chooses to use Using quantitative and qualitative measures by looking at the number of participants, follow up rates, improvement in health indices, including some patient centered measures, and also the number of times they meet with their health care navigators
measure: Universal Health screening
time frame: up to 30 months
description: Look at whether clients of the Wellness Center have improvement in their overall health by looking at their health measurements and lab works from each of their 6 month appointments
measure: Collaborate with persons in recovery in using data collected to develop and pilot a new peer led, community based intervention in enhancing access and choice
time frame: up to 30 months
description: 48 participants will be in a pilot intervention run by peers on whole health, measures will be both qualitative and quantitative to look for overall health improvement and choices
arm group label: Peer whole health
arm group type: Experimental
description: Peer whole health intervention will be compared to the treatment as usual at Wellness Center to assess healthcare choice and outcomes
arm group label: EBPs at Wellness Center
arm group type: Active Comparator
description: EBPs at Wellness Center will be the active comparative to measure healthcare choice and outcomes with the peer whole health intervention
intervention type: Behavioral
intervention name: Peer whole health intervention
description: Provide wraparound peer support, education, and navigation to individuals
arm group label: Peer whole health
intervention type: Behavioral
intervention name: EBPs at Wellness Center
description: four EBPs: a) on-site primary care; b) screening of clients for modifiable risk factors and medical conditions; c) care coordination; and d) peer health navigation
arm group label: EBPs at Wellness Center
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Chyrell Bellamy, Ph.D.
role: Principal Investigator
affiliation: Yale University
last name: Kimberly D Antunes, BSW
role: Study Director
affiliation: Yale University
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Mental Disorders