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

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ClinicalTrials.gov Identifier: NCT03673852
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Chyrell Bellamy, Yale University

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.

Condition or disease Intervention/treatment Phase
Chronic Medical Condition Behavioral: WE Harambee Behavioral: Behavioral Health Home Enrollment Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Peer Wellness Enhancement For Patients With Serious Mental Illness and High Medical Costs
Actual Study Start Date : December 6, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

Arm Intervention/treatment
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.
Behavioral: 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.

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.
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.




Primary Outcome Measures :
  1. Self-reported coping and problem solving [ Time Frame: 21 months ]
    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.

  2. Self-reported self-efficacy [ Time Frame: 21 months ]
    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.

  3. Self-reported hope [ Time Frame: 21 months ]
    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.

  4. Self-reported social support [ Time Frame: 21 months ]
    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.

  5. Self-reported sense of community [ Time Frame: 21 months ]
    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.

  6. Self-reported empowerment [ Time Frame: 21 months ]
    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.

  7. Self-reported patient activation [ Time Frame: 21 months ]
    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.

  8. Self-reported health literacy [ Time Frame: 21 months ]
    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.

  9. Self-reported barriers and facilitators to healthcare [ Time Frame: 21 months ]
    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.


Secondary Outcome Measures :
  1. Self-reported illness self management [ Time Frame: 21 months ]
    Illness self-management will be assessed using the Coping and Stress Reduction subscales of the Strategies Used by People to Promote Health (SUPPH-29). The scale was designed specifically for people with chronic conditions, and has been used with cancer patients, patients with end stage renal disease, stroke survivors, and women with AIDS. The measure asks about how confident a person is in using different techniques to reduce stress and cope with their illness. Item ratings range from 1 (very little confidence) to 5 (quite a lot of confidence), with higher scores indicating more confidence. Subscale scores and total scores will be represented by mean scores, accounting for missing data, and will also range from 1 to 5.

  2. Self-reported engagement in healthcare [ Time Frame: 21 months ]
    Engagement in healthcare will be assessed via the Patient Health Engagement Measure. Items ask about how emotionally overwhelmed patients get when dealing with their illness. Item ratings range from 1 (very upset/discouraged) or 4 (very positive/optimistic) with higher scores indicating more positive feelings. Total scores will be represented by a mean score and will also range from 1 to 4.

  3. Number of preventive care/screenings conducted [ Time Frame: 21 months ]
    Number of preventive care/screenings conducted will be collected via electronic health records.

  4. Number of outpatient visits [ Time Frame: 21 months ]
    Number of outpatient visits will be collected via electronic health records.

  5. Diastolic blood pressure level [ Time Frame: 21 months ]
    Diastolic blood pressure will be measured in mmHg (millimeters of mercury) and collected from the participant's electronic medical record.

  6. Systolic blood pressure level [ Time Frame: 21 months ]
    Systolic blood pressure will be measured in mmHg (millimeters of mercury) and collected from the participant's electronic medical record.

  7. hgA1c level [ Time Frame: 21 months ]
    Glycated haemoglobin (hgA1c) levels will be measured in mmol/mol units and collected from the participant's electronic medical record.

  8. Triglyceride level [ Time Frame: 21 months ]
    Triglyceride levels will be measured in milligrams per deciliter (mg/dL) and collected from the participant's electronic medical record.

  9. High-density lipoprotein (HDL) level [ Time Frame: 21 months ]
    HDL levels will be measured in milligrams per deciliter (mg/dL) and obtained from the participant's electronic medical record.

  10. Low-density lipoprotein (LDL) levels [ Time Frame: 21 months ]
    LDL levels will be measured in milligrams per deciliter (mg/dL) and obtained from the participant's electronic medical record.

  11. Body mass index (BMI) level [ Time Frame: 21 months ]
    BMI levels will be measured in kilograms per square meter (kg/m2) and collected from the participant's electronic medical record.

  12. Self-reported psychiatric symptoms [ Time Frame: 21 months ]
    Psychiatric symptoms will be assessed through multiple subscales of the Symptom Checklist-90-Revised. We will collect subscales related to the symptoms we expect will be affected by Harambee: Anxiety, Depression, Psychoticism, Paranoia, Somatization, Hostility, Interpersonal sensitivity, and Obsessive-compulsiveness. Internal consistency of the subscales is high (range .77-.90). Item scores range from 1 (not at all) to 5 (extremely).

  13. Self-reported substance use [ Time Frame: 21 months ]
    Substance use will be assessed using the Addiction Severity Index. The ASI is a structured interview for evaluating the degree of potential treatment barriers across domains typically affected by alcohol and drug use disorders, including psychiatric and social considerations. For the purposes of this investigation, we will limit administration to the alcohol and drug use subscales. The alcohol and drug subscales concern the frequency and severity of use in the past 30 days. The ASI has been rigorously assessed within similar client populations and shown to demonstrate high reliability for assessing alcohol and drug use and its consequences, Cronbach alpha = 0.65-0.89. Item ratings range from 0 (not at all) to 4 (extremely).

  14. Self-reported quality of functioning [ Time Frame: 21 months ]
    Functional status will be assessed by the Quality of Well-being scale (QWB-SA), a common health related quality of life measuring health utilities. Most scores are coded 0 (no) or 1 (yes). Overall, the QWB-SA includes five parts assessing physical and mental health symptoms (chronic and acute), self-care, mobility, physical functioning, and social activities. In all, the domain scores are combined into a single index score ranging from 0.09 (lowest possible health state) to 1 for perfect health.

  15. Self-reported overall wellness [ Time Frame: 21 months ]
    Overall Wellness will be measured by the 8 Dimensions of Wellness Measure. This measure assesses the extent to which respondents engage in behaviors that promote physical, intellectual, environmental, spiritual, emotional, financial, social, and occupational wellness. Item ratings range from 4 (always true) to 1 (never true), with higher scores indicating greater wellness. Subscale and total scores are represented by mean scores, accounting for missing data, and have the same range of 1 to 4.

  16. Number of Emergency Department visits [ Time Frame: 21 months ]
    Number of Emergency Department visits will be collected via electronic health records.

  17. Number of Hospitalizations [ Time Frame: 21 months ]
    Number of Hospitalizations will be collected via electronic health records.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03673852


Contacts
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Contact: Chyrell D Bellamy, Ph.D. 203-764-8694 chyrell.bellamy@yale.edu
Contact: Kimberly D Antunes, BSW 203-764-8694 kimberly.antunes@yale.edu

Locations
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United States, Connecticut
CT Mental Health Center Recruiting
New Haven, Connecticut, United States, 06511
Contact: Robert Cole       robert.cole@yale.edu   
Sponsors and Collaborators
Yale University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Chyrell D Bellamy, Ph.D. Yale University

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Responsible Party: Chyrell Bellamy, ASSOCIATE PROFESSOR, Yale University
ClinicalTrials.gov Identifier: NCT03673852     History of Changes
Other Study ID Numbers: 2000023089
R34MH117188-01 ( U.S. NIH Grant/Contract )
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Research Resources 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. Depending on such policies, materials may be transferred to others under the terms of a material transfer agreement. Access to databases and associated software tools generated under the project will be available for educational, research and non-profit purposes. Such access will be provided using web-based applications, as appropriate, to avoid or minimize associated costs.

Research data which documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. All data obtained from participants will also be shared via the NDCT related to Mental Illness. In enrolling participants, necessary information will be obtained to generate a GUID.

Supporting Materials: Study Protocol
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chyrell Bellamy, Yale University:
Serious Mental Illness (SMI)
Additional relevant MeSH terms:
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Mental Disorders