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

NCT ID: NCT02263742

Last Updated: 2018-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-09-30

Brief Summary

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.

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.

Conditions

Mental Health Wellness 1; Mental Illnesses; Other Diagnoses, Comorbidities, and Complications | Patient

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Peer whole health

Peer whole health intervention will be compared to the treatment as usual at Wellness Center to assess healthcare choice and outcomes

Group Type: EXPERIMENTAL

Peer whole health intervention

Intervention Type: BEHAVIORAL

Provide wraparound peer support, education, and navigation to individuals

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

Group Type: ACTIVE_COMPARATOR

EBPs at Wellness Center

Intervention Type: BEHAVIORAL

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

Interventions

Peer whole health intervention

Provide wraparound peer support, education, and navigation to individuals

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chyrell Bellamy, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Kimberly D Antunes, BSW

Role: STUDY_DIRECTOR

Yale University

Locations

CT Mental Health Center

New Haven, Connecticut, United States

Yale University Program for Recovery and Community Health

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1310012851

Identifier Type: -

Identifier Source: org_study_id