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

NCT ID: NCT03673852

Last Updated: 2022-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-06
• Study Completion Date: 2024-12-30

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.

Detailed Description

60 Connecticut Mental Health Center patients enrolled in BHH will be recruited for the study. The research team will begin working closely with BHH data administrators and staff to start the recruitment process. A BHH data manager will create a randomly sorted list of the current BHH roster. This list will be stratified with respect to gender, race, and ethnicity so that the research team can collect a stratified sample for this research that is representative of the population. This stratified list will be given to BHH care coordinators, who will contact patients in each strata of the population and provide a brief, scripted introduction to the study, and attempt to obtain permission to contact. A flyer will be posted at the BHH program, providing information about the study for persons interested to self-refer to the research team. The research team will not have access to names of individuals on this roster, and will only be given names and contact information of individuals who provide permission to contact or who self-refer. The research team will then contact patients, provide preliminary information about the study and assessment procedures, answer any questions, and invite patients to participate. A consent and baseline interview time and date will be scheduled, at which time more detailed explanations about the study will be provided, ability to provide informed consent will be assessed, consent forms reviewed, signatures obtained, and release of information forms for retrieval of administrative data and to allow contact with BHH coordinator, if needed. BHH coordinators will continue working down the randomly sorted list to obtain permissions to contact until 60 BHH patients have enrolled and provided consent into the study. After completion of the consent process, patients will be randomly assigned into one of three waves of WE Harambee implementation and baseline interviews will be conducted. The first wave of implementation will be standard WE Harambee intervention, as implemented in our recent pilot trial (i.e., with no modifications or adaptations to design). While Wave 1 participants are receiving the group intervention (consisting of twice a week group meetings), the research team will be analyzing the administrative data and baseline interviews obtained on all 60 participants. Following completion of the 3 months, group intervention, Wave 1 participants will complete a follow-up quantitative interview and a follow-up qualitative interview to gather additional information about specific aspects of the intervention that have worked well, areas for improvement, and questions related to feasibility and acceptability of the intervention thus far. Wave 1 participants will then be offered 1:1 peer mentorship/coaching with a peer leader of his/her choice. Individual peer mentoring will be offered for the next three months. During this time, the research team and stakeholder advisory group will be analyzing the 3-month follow-up data, graphing mean changes from baseline in the targets of the intervention, and analyzing the qualitative interviews. The stakeholder advisory group members are people that have lived experience with both mental and primary healthcare problems. The stakeholder advisory group member's experience navigating the healthcare system will guide the research, providing special attention to the challenges, barriers and facilitators that stakeholders experienced in their journey of healthcare. The data will be shared with the stakeholder advisory group and, in tandem with the research team, identify initial modifications that can be made to the WE Harambee intervention, that can be instituted in Wave 2 administration. As Wave 1 participants are nearing completion of the 12-week individual peer mentoring phase, research team will contact all 60 participants to schedule Time 2 (T2) interviews. The interviews will occur after Wave 1 participants fully complete the intervention and will mirror the baseline (T1) and post-group interview. Adaptations will be formalized for the Wave 2 implementation, which will begin in month 10 of the study. The research process will proceed in a similar manner, with all Wave 2 participants completing a post-group interview and a qualitative interview. Analyses and interpretation of data collected to date will occur while Wave 2 participants are receiving the 1:1 peer mentoring component of the WE Harambee intervention. Adaptations will again be made, this time greater attention will be paid to measures of fidelity and changes to be reflected in the intervention manual, although any changes in process, assessment, or implementation that improves the fit of the intervention will also be made. All 60 participants will complete a T3 assessment following completion of Wave 2. Final adaptations will be made to intervention and tools and in month 17, the third and final wave of 20 participants will be offered the refined intervention. As before, Wave 3 participants will complete a post-group interview and qualitative interviews following completion of the group component of the intervention. Data will be analyzed and interpreted and final adjustments will be made, in conjunction with the stakeholder advisory board, to the implementation manuals, fidelity tools, assessment protocols, and recruitment strategies, in preparation for a full-scale clinical trial. A final assessment will be completed with all 60 participants following the end of Wave 3 (T4; month 23). Recruitment and timeline will be analyzed for between and within-Wave comparisons in target engagement and outcomes. If the hypothesized targets are engaged (i.e., participants demonstrate improvement in the direction expected) and if there is some evidence of the association between target engagement and outcomes, the researchers will move forward with plans to launch full-scale clinical trial. In brief, all 60 patients enrolled in the study will participate in individual interviews in 4 different time periods of the study: T1 (before Wave 1), T2 (after Wave 1 and before Wave 2), T3 (after Wave 2 and before Wave 3), and T4 (after Wave 3). Additionally, each participant will have one additional interview following completion of the group component of the WE Harambee intervention. The post-intervention interviews will be administered to all 60 participants who have completed the group intervention. Thirty Participants will also be invited to participate in a qualitative interview (n=20 from Wave 1, n=5 from Wave 2, n=5 from Wave 3) . The wave-specific interviews are designed to provide within-group, preliminary data that can be used to inform any adaptations/modifications to subsequent waves of intervention.

Conditions

Chronic Medical Condition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Peer Wellness Enhancement (WE Harambee)

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.

Group Type: OTHER

WE Harambee

Intervention Type: 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.

Behavioral Health Home enrollment

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.

Group Type: OTHER

Behavioral Health Home Enrollment

Intervention Type: 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.

Interventions

WE Harambee

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.

Intervention Type: BEHAVIORAL

Behavioral Health Home Enrollment

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chyrell D Bellamy, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

CT Mental Health Center

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

R34MH117188-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000023089

Identifier Type: -

Identifier Source: org_study_id