Clinical trial NCT03673852: Peer Wellness Enhancement For Patients With Serious Mental Illness and High Medical Costs
Official title: Peer Wellness Enhancement For Patients With Serious Mental Illness and High Medical Costs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Medical Condition
Keywords: Serious Mental Illness (SMI)
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-09-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Self-reported coping and problem solving
timeFrame: 21 months
measure: Self-reported self-efficacy
timeFrame: 21 months
measure: Self-reported hope
timeFrame: 21 months
measure: Self-reported social support
timeFrame: 21 months
measure: Self-reported sense of community
timeFrame: 21 months
measure: Self-reported empowerment
timeFrame: 21 months
measure: Self-reported patient activation
timeFrame: 21 months
measure: Self-reported health literacy
timeFrame: 21 months
measure: Self-reported barriers and facilitators to healthcare
timeFrame: 21 months
Secondary outcomes:
measure: Self-reported illness self management
timeFrame: 21 months
measure: Self-reported engagement in healthcare
timeFrame: 21 months
measure: Number of preventive care/screenings conducted
timeFrame: 21 months
measure: Number of outpatient visits
timeFrame: 21 months
measure: Diastolic blood pressure level
timeFrame: 21 months
measure: Systolic blood pressure level
timeFrame: 21 months
measure: hgA1c level
timeFrame: 21 months
measure: Triglyceride level
timeFrame: 21 months
measure: High-density lipoprotein (HDL) level
timeFrame: 21 months
measure: Low-density lipoprotein (LDL) levels
timeFrame: 21 months
measure: Body mass index (BMI) level
timeFrame: 21 months
measure: Self-reported psychiatric symptoms
timeFrame: 21 months
measure: Self-reported substance use
timeFrame: 21 months
measure: Self-reported quality of functioning
timeFrame: 21 months
measure: Self-reported overall wellness
timeFrame: 21 months
measure: Number of Emergency Department visits
timeFrame: 21 months
measure: Number of Hospitalizations
timeFrame: 21 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: CT Mental Health Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Chyrell D Bellamy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: