Peer Wellness Enhancement For Patients With Serious Mental Illness and High Medical Costs

NCT03673852 | Unknown

• 2 other identifiers: 2000023089R34MH117188-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This research addresses the important public health crisis that people with serious mental illness (SMI) are dying10-20 years younger than the average population, primarily due to chronic, untreated medical conditions. This proposal tests the feasibility, acceptability, engagement of target mechanisms, and preliminary effectiveness of a peer-led and peer-developed intervention to improve the health and wellness of people with SMI by addressing underlying social determinants of health. This research will provide key information about target mechanisms underlying peer interventions and establish the evidence needed to advance to a full scale clinical trial.

Conditions

Chronic Medical Condition

Keywords

Serious Mental Illness (SMI)

Outcome Measures

Primary Outcomes (9)

• Self-reported coping and problem solving

  Coping and problem solving will be measured by the Health Problem-Solving Scale (HPSS). The HPSS assesses effective and ineffective approaches to managing health-related problems. It has been used with diverse samples, including with samples from HIV and DM. Internal reliability coefficients were comparable in the two samples (HIV and Diabetes) and were within an acceptable psychometric range 0.63-0.88. Scale items range from 0 (not at all true for me) to 4 (extremely true of me). Higher scores indicate greater health problem solving. The total score will be represented by a mean value so the range of the total score is also 0-4.

  21 months

• Self-reported self-efficacy

  Self-efficacy will be measured by the Self-Efficacy for Chronic Illness Management scale, a 6-item measure that assesses confidence in one's ability to manage \\ symptoms, function emotionally and instrumentally, and communicate effectively with physicians. Internal consistency is reported to be .91. Scale items range from 1 (not at all confident) to 10 (totally confident). Higher scores indicate greater reported self-efficacy in managing one's chronic illness. The total score will be represented by a mean value so the range of the total score is also 0-10.

  21 months

• Self-reported hope

  Hope will be measured by the Hope Scale, a 12-item measure that assesses a) agency (goal-directed determination) and b) pathways (planning ways to meet goals). Item ratings range from 1 (definitely false) to 8 (definitely true) with higher scores indicating more hope. Subscales and total scores will be represented by means so the range is also 1 to 8.

  21 months

• Self-reported social support

  Social support will be assessed using the Interpersonal Support Evaluation List (ISEL). This 40-item instrument measures perceived availability of four types of support-tangible support, appraisal support, self-esteem support, and belonging support. Item ratings are 0 (false) or 1 (true), with higher scores indicating more social support. Subscales and total scores will be represented by means, accounting for missing data, so the range is also 0 to 1.

  21 months

• Self-reported sense of community

  Sense of community will be measured by the Community Connections Index, a 15-item measure grounded in social capital and community capacity theories organized into two dimensions of community connections - Community engagement (8 items) and Sense of community (7 items). Item ratings range from 1 (never) to 4 (often), with higher scores indicating more community connection. The total score will be represented by a mean value so the range is also 0 to 4.

  21 months

• Self-reported empowerment

  Empowerment will be measured the Empowerment Scale, which measures the construct of personal empowerment from the person's perspective. Internal consistency for the Empowerment scale as a whole has been reported, with Cronbach's alpha coefficients = 0.86 will be used to measure empowerment. Subscales include self-esteem/self-efficacy, power, community activism and autonomy, optimism and control over the future, and righteous anger. Item responses range from 1 (strongly disagree) to 4 (strongly agree), with higher scores indicating more empowerment. Subscales and total scores will be represented by a mean value, accounting for missing data, so their range is also 1-4.

  21 months

• Self-reported patient activation

  Patient activation will be assessed via the Short Form version of the Patient Activation Measure (13 items). Cronbach's alpha = -.83. Item ratings range from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating more activation. The total score will be represented by a mean value accounting for missing data, so the range is also 1-5.

  21 months

• Self-reported health literacy

  Health Literacy will be measured by the reading comprehension section of the Short-Test of Functional Health Literacy (S-TOFHLA), which was designed to measure the ability to read and understand things patients commonly encounter in the healthcare setting. The reading comprehension section asks respondents to read two passages about medical care and answer 20 questions in which they choose the correct missing word(s) from the sentences. Total scores range from 0-100, with 5 points given for each question correctly answered. Scores from 0-50 indicate inadequate health literacy, scores from 51-65 indicate marginal health literacy, and scores from 66-100 indicate adequate health literacy.

  21 months

• Self-reported barriers and facilitators to healthcare

  Barriers and Facilitators of Healthcare will be assessed via the Peer Health Navigator Toolbox Barriers and Facilitators Measure. Internal consistency is estimated at .69. Scores range from 2 (major barrier) to 0 (not at all a barrier); 2 (helps a lot) to 0 (does not help), with higher scores indicating greater barrier or facilitator. Individual barriers and facilitators will be analyzed separately. Also, separate scores will be calculated for total barriers and total facilitators as mean scores, accounting for missing data, and will range from 0 to 2.

  21 months

Secondary Outcomes (17)

• Self-reported illness self management

  21 months

• Self-reported engagement in healthcare

  21 months

• Number of preventive care/screenings conducted

  21 months

• Number of outpatient visits

  21 months

• Diastolic blood pressure level

  21 months

Study Arms (2)

Peer Wellness Enhancement (WE Harambee)

OTHER

This project employs a pragmatic, stepped wedge experimental design in which 60 BHH participants are randomly assigned to one of 3 waves of WE Harambee implementation (20 in each wave) during the 2 year study. Participants in this arm receive the WE Harambee Wellness Enhancement and are enrolled in a Behavioral Health Home. WE Harambee is a 6-month peer-delivered whole health intervention intended to address the 8 dimensions of wellness and the social determinants of health.

Behavioral: WE Harambee

Behavioral Health Home enrollment

OTHER

In the stepped wedge experimental design, 40 participants at any time during the 2 year study are receiving only the Behavioral Health Home (BHH) intervention. The 2010 Patient Protection and Affordable Care Act (ACA) established a "health home" option under Medicaid that serves enrollees with chronic conditions including serious mental illness and chronic physical illness.

Behavioral: Behavioral Health Home Enrollment

Interventions

WE Harambee BEHAVIORAL

WE Harambee is a 6-month intervention, comprised of twice a week group meetings for 12 weeks, followed by a second 12 weeks of individual peer coaching/navigation. WE Harambee aims to enhance access to and engagement in primary care and behavioral health services, as well as improve overall health and well-being, including the 8 dimensions of wellness and social determinants of health.

Peer Wellness Enhancement (WE Harambee)

Behavioral Health Home Enrollment BEHAVIORAL

A BHH is a Center for Medicaid Services program supporting Medicaid beneficiaries with complex needs, typically multiple chronic conditions impacting both physical and behavioral health. Utilizing a team-based clinical approach that includes the patient, his/her providers, and possibly family members, BHH programs target service fragmentation by linking community supports and resources as well as by enhancing the integration of primary and behavioral health care. Care Coordinators oversee and facilitate access to all services an individual needs to stay as healthy as possible, aiming to promote continuous health management not mere resolution of repeated acute episodes.

Behavioral Health Home enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be CMHC enrolled patients in the Behavioral Health Homes Program over the age of 18 years old

You may not qualify if:

• Participants who are not CMHC enrolled patients in the Behavioral Health Homes Program and under the age of 18 years old

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

CT Mental Health Center

New Haven, Connecticut, 06511, United States

Location

Study Officials

• Chyrell D Bellamy, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: September 17, 2018
• Study Start: December 6, 2018
• Primary Completion: May 30, 2021
• Study Completion: December 30, 2024
• Last Updated: February 17, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will become available at the completion of data analysis and final report indefinitely.
• Access Criteria: The research generated will be freely distributed to qualified academic investigators for non-commercial research. Materials generated will be disseminated in accordance with University/Participating institutional and NIH policies. Interested parties my also contact the Principal Investigator for information.

Locations

US (1)