Project Wellness Enhancement: Increasing Health Care Choice and Outcomes for People With Mental Illness (WE)

January 12, 2018 updated by: Yale University

Increasing Health Care Choices and Improving Health Outcomes Among Persons With Serious Mental Illness

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • CT Mental Health Center
      • New Haven, Connecticut, United States, 06513
        • Yale University Program for Recovery and Community Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years or older
  • Clients receiving services from CMHC and the Wellness Center.
  • Research staff will verify with CMHC staff that the potential participant is receiving services currently at CMHC.
  • Provider research subjects will be included if they are a mental health provider at CMHC or if they are members of the staff for the Wellness Center
  • Adults with serious mental illness and physical illness

Exclusion Criteria:

  • Participant research subjects not receiving services at CMHC and the Wellness Center
  • Provider research subjects of other agencies will be excluded
  • Children and youth under 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peer whole health
Peer whole health intervention will be compared to the treatment as usual at Wellness Center to assess healthcare choice and outcomes
Behavioral: Peer whole health intervention
Provide wraparound peer support, education, and navigation to individuals
Active Comparator: EBPs at Wellness Center
EBPs at Wellness Center will be the active comparative to measure healthcare choice and outcomes with the peer whole health intervention
Behavioral: EBPs at Wellness Center
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of a Co-located Primary Health Care Center in a Local mental health center
Time Frame: up to 30 months
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
up to 30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of health care navigation in improving health outcomes for people with mental illness
Time Frame: up to 30 months
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
up to 30 months
Universal Health screening
Time Frame: up to 30 months
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
up to 30 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Chyrell Bellamy, Ph.D., Yale University
  • Study Director: Kimberly D Antunes, BSW, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

March 31, 2014

First Submitted That Met QC Criteria

October 7, 2014

First Posted (Estimate)

October 13, 2014

Study Record Updates

Last Update Posted (Actual)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 12, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1310012851

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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