Clinical trial NCT02263742: Project Wellness Enhancement: Increasing Health Care Choice and Outcomes for People With Mental Illness
Official title: Increasing Health Care Choices and Improving Health Outcomes Among Persons With Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Mental Illnesses
Other Diagnoses, Comorbidities, and Complications | Patient
Keywords: Healthcare choice and outcomes
Peer-led whole health
Mental Illness
Peer Health Navigation
Health care Coordination
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-10-13
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Effectiveness of a Co-located Primary Health Care Center in a Local mental health center
timeFrame: up to 30 months
Secondary outcomes:
measure: Effectiveness of health care navigation in improving health outcomes for people with mental illness
timeFrame: up to 30 months
measure: Universal Health screening
timeFrame: up to 30 months
Other outcomes:
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
timeFrame: up to 30 months
Locations:
city: New Haven
country: United States
facility: CT Mental Health Center
state: Connecticut
city: New Haven
country: United States
facility: Yale University Program for Recovery and Community Health
state: Connecticut
Study officials:
affiliation: Yale University
name: Chyrell Bellamy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Kimberly D Antunes, BSW
role: STUDY_DIRECTOR
References: