Community Partners in Care is a Research Project Funded by the National Institutes of Health

Study Overview
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Brief Summary
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CPIC is a community initiative and research study funded by the NIH. CPIC was developed and is being run by community and academic partners in Los Angeles underserved communities of color. CPIC compares two ways of supporting diverse health and social programs in under-resourced communities to improve their services to depressed clients. One approach is time-limited expert technical assistance coupled with culturally-competent community outreach to individual programs, on how to use quality improvement toolkits for depression that have already been proven to be effective or helpful in primary care settings, but adapted for this study for use in diverse community-based programs in underserved communities. The other approach brings different types of agencies and members in a community together in a 4 to 6-month planning process, to fit the same depression quality improvement programs to the needs and strengths of the community and to develop a network of programs serving the community to support clients with depression together. The study is designed to determine the added value of community engagement and planning over and above what might be offered through a community-oriented, disease management company. Both intervention models are based on the same quality improvement toolkits that support team leadership, care management, Cognitive Behavioral Therapy, medication management, and patient education and activation. Investigators hypothesized that the community engagement approach would increase agency and clinician participation in evidence-based trainings and improve client mental health-related quality of life. In addition, during the design phase, community participants prioritized adding as outcomes indicators of social determinants of mental health, including physical functioning, risk factors for homelessness and employment. Investigators hypothesized by activating community agencies that can address health and social services needs to engage depressed clients, these outcomes would also be improved more in the collaboration condition. Investigators also hypothesized that the collaboration approach would increase use of services.

Detailed Description
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Underserved communities of color in low income, largely ethnic-minority neighborhoods face an excessive burden of illness from depression due to higher prevalence of depression and lower access to quality care. Evidence-based quality improvement (QI) programs for depression in primary care settings-where many low-income and minority patients receive their only mental health care-can enhance quality of depression care and improve health outcomes. These programs are under-utilized in community-based health care settings, and have not been adapted for use across diverse agencies (social service, faith based, primary and specialty care) that could partner to support disease management for depression. Partners in Care (PIC)and WE Care are interventions designed to improve access to evidence-based depression treatments (medication management or psychotherapy) for primary care patients and, in WE Care, social service clients. PIC evaluated a services delivery intervention while WE Care was an effectiveness trial with study-provided treatments. Both studies promoted use of the same evidence-based treatments. Both PIC and WE Care programs improved use of evidence-based treatments for depression and health outcomes for African Americans and Latinos. The PIC interventions reduced health outcome disparities evident in usual care in the first follow-up year and at five-year follow-up. While these findings offer hope to underserved communities, such communities have poor resources to support implementation of these programs, and may have historical distrust in research and health care settings. There is no evidence-based approach to support agency networks in underserved communities in implementing QI programs for depression. To address this information gap, investigators created Community Partners in Care (CPIC), a group-level randomized, controlled trial, with randomization at the level of an agency site or unit. The trial is being fielded in two underserved communities, Hollywood and South Los Angeles, and conducted through a community- participatory, partnered research (CPPR) approach. The specific aims of the study are: To engage two underserved communities in improving safety-net care for depression. To examine the effects of a community-engagement approach to implementing evidence-based depression quality improvement toolkits (PIC/WE Care) through a community collaborative network across services sectors, compared to technical assistance to individual programs from the same services sectors coupled with culturally-competent outreach to implement the same toolkits. The outcomes are: a) client access to care, quality of care and health outcomes, with the primary outcome being mental-health related quality of life and additional outcomes reflecting social determinants of mental health of interest to the community (physical health, homelessness risk factors, employment); b) services utilization and costs; c) agency adoption of PIC/WE Care; d) and provider attitudes, knowledge and practice. To describe the process of implementation of the community engagement intervention. CPIC was awarded funds from the Patient Centered Outcomes Research Institute (PCORI) in 2013 to accomplish the following 3 aims: To compare the long-term (3-year) effectiveness of community engagement and planning versus agency technical assistance to implement depression QI and improve depressed clients' health status and risk for homelessness To determine how depressed clients in under-resourced communities prioritize diverse health and social outcomes and identify their preferences for services to address priority outcomes To identify capacities of providers to respond to depressed clients' priorities and to generate recommendations for building capacity to better address clients'priorities. We hypothesize that community engagement and planning will be more effective than technical assistance in improving 3-year outcomes and that clients will prioritize quality of life. We expect to find gaps in provider capacities to address client priorities that network strategies could address. Our primary outcome for the long-term follow-up is mental health related quality of life and secondary outcomes are use of healthcare and community services for depression and physical functioning and homeless risk factors. In 2014, CPIC was awarded funds from the National Institute on Minority Health and Health Disparities (NIMHD) to use existing quantitative CPIC data and collect new qualitative data to describe pathways to reducing disparities. The funding allows us to longitudinally track the implementation of the CEP model in a new county-wide initiative to develop community networks to promote healthy neighborhoods. The aims under this additional funding are: To determine pathways to reducing mental health and social disparities by conducting community-academic partnered analyses of CPIC data by 1) examining intervention effects for disparity subgroups (African Americans, Latinos, gender groups, insurance and housing status groups); 2) identifying predictors and mediators of barriers to access/services and client outcomes; 3) analyzing intervention effects on provider workforce diversity; and 4) generating explanatory models for intervention effects and their sustainability by interviewing CPIC administrators and providers, as well as prior and current clients. To explore the generalizability and replicability of the CPIC partnered model and, more broadly, to inform the process of incorporating science into policy by conducting a longitudinal case study of the CEP model implementation in a county-wide neighborhood health initiative in Los Angeles to reduce mental health and social disparities. As a result of this study, we will be able to explain how community-engaged and participatory models of intervention implementation can reduce health and social disparities and ultimately achieve public health impact. Study findings will be disseminated widely using traditional academic, community-valued, and policy-relevant dissemination channels.

Official Title
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CPIC is a Community Partnered Participatory Research (CPPR) Project of Community and Academic Partners Working Together to Learn the Best Way to Reduce Depression in Our Communities.

Conditions
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Depression, Information Dissemination, Social Determinants of Health

Intervention / Treatment
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* Other: Quality Improvement Program
* Behavioral: Resources for Services Expert Team
* Behavioral: Community Engagement and Planning Council


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Administrators Age 18 and above Work or volunteer for an enrolled program in the study and be designated as a liaison by the program Providers Age 18 and above Have direct contact with patients/clients Clients Age 18 and above Score 10 or greater on modified Patient Health Questionnaire (PHQ-8) Exclusion Criteria: grossly disorganized by screener staff assessment Not providing personal contact information Administrators - Under age 18 Providers - Under age 18 Clients Under age 18 Gross cognitive disorganization by screener staff assessment Providing no contact information

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Resources for Services<br>The Resources for Services condition offers time-limited technical assistance to individual agencies, coupled with outreach from a community engagement specialty, to participate in structured reviews of components of the Quality Improvement Program Intervention as implemented by the Resources for Services Expert Team. | Other: Quality Improvement Program<br>* The quality improvement program is an evidence-based toolkit from prior studies (see Names above) that supported team leadership, case and care management, medication management, and Cognitive Behavioral Therapy for Depression. The Case management manual supported depression screening and monitoring/tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual.<br>* Other names: Mental Health Infrastructure and Training Project;Behavioral: Resources for Services Expert Team<br>* The expert team consisted for RS consisted of 3 psychiatrists, a psychologist expert in Cognitive Behavioral Therapy, a nurse care manager, a community engagement specialist, a quality improvement expert, and staff support. They team offered 12 web-based seminars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management.<br>* Other names: Quality Improvement Team;|
| Experimental: Community Engagement and Planning<br>The Community Engagement and Planning arm supported 4 months of planning for the Community Engagement and Planning Council consisting representatives of all assigned programs in biweekly 2 hour meetings to fit trainings in the Quality Improvement Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites were provided with enrolled client lists. | Other: Quality Improvement Program<br>* The quality improvement program is an evidence-based toolkit from prior studies (see Names above) that supported team leadership, case and care management, medication management, and Cognitive Behavioral Therapy for Depression. The Case management manual supported depression screening and monitoring/tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual.<br>* Other names: Mental Health Infrastructure and Training Project;Behavioral: Community Engagement and Planning Council<br>* The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.<br>* Other names: Quality Improvement Team;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Participants With Poor Mental Health Quality of Life, MCS12≤ 40 | From the Short Form, 12-item quality of life measure, mental health-related quality of life is the primary client outcome. Poor mental health related quality of life is defined as MCS12≤ 40 (one standard deviation below population mean). | 6 months follow-up | 
| Percent of Participants With PHQ-9 Score ≥ 10 | Patient Health Questionnaire 9-item version (PHQ-9) at least mild depression (score ≥ 10) | 6 months follow-up | 
| Percent of Participants With Poor Mental Health Quality of Life, MCS12≤ 40 | From the Short Form, 12-item quality of life measure, mental health-related quality of life is the primary client outcome. Poor mental health related quality of life is defined as MCS12≤ 40 (one standard deviation below population mean). | 12 months follow-up | 
| Percent of Participants With Poor Mental Health Quality of Life, MCS12≤ 40 | From the Short Form, 12-item quality of life measure, mental health-related quality of life is the primary client outcome. Poor mental health related quality of life is defined as MCS12≤ 40 (one standard deviation below population mean). | 36 months follow-up | 
| Percent of Participants With PHQ-8 Score ≥ 10 | Patient Health Questionnaire 8-item version (PHQ-8) at least mild depression (score ≥ 10) | 36 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Participants With Mental Wellness | Mental wellness is defined as at least a good bit of time in the prior 4 weeks on any of three items: feeling peaceful or calm, being a happy person, having energy | 6 months follow-up | 
| Percent of Participants Reported Organized Life | A response of somewhat or definitely true to my life is organized versus unsure or somewhat false or definitely false | 6 months follow-up | 
| Percent of Participants With Physically Active | Physically Active is defined as at least active to How physically active you are? | 6 months follow-up | 
| Percent of Participants With Homeless or ≥ 2 Risk Factors for Homelessness | Defined as current homelessness or living in a shelter or having at least 2 risk factors (e.g., no place to stay for at least 2 nights or eviction from a primary residence, financial crisis, or food insecurity in the past 6 months) | 6 months follow-up | 
| Percent of Participants With Working for Pay |  | 6 months follow-up | 
| Percent of Participants With Any Missed Work Day in Last 30 Days, if Working |  | 6 months follow-up | 
| Percent of Participants With Hospitalization for Behavioral Health in the Past 6 Months | self-reported services use in the past 6 months for overnight hospital stays for mental health or substance abuse | 6 months follow-up | 
| Percent of Participants With >=4 Hospital Nights for Behavioral Health in the Past 6 Months | self-reported services use in the past 6 months with >=4 overnight hospital stays for any emotional, mental, alcohol, or drug problem, median cut point for baseline variable | 6 months follow-up | 
| Percent of Participants With >=2 Emergency Room Visits in the Past 6 Months | self-reported services use in the past 6 months with >=2 emergency room visits in past 6 months, median cut point for baseline variable | 6 months follow-up | 
| Percent of Participants With Any MHS Outpatient Visit in the Past 6 Months | self-reported mental health outpatient visit from mental health provider, including psychiatrists, psychologists, social workers, psychiatric nurses, or counselors in the past 6 months | 6 months follow-up | 
| Percent of Participants With Any PCP Visit With Depression Service in the Past 6 Months | self-reported services use in the past 6 months with any primary care visit for depression | 6 months follow-up | 
| Percent of Participants With >= 2 PCP Visits With Depression Services, if Any |  | 6 months follow-up | 
| Percent of Participants With Faith-based Program Participation in the Past 6 Months | Went to any religious or spiritual places such as a church, mosque, temple, or synagogue in the past 6 months | 6 months follow-up | 
| Percent of Participants With Any Use of Park and Recreation or Community Centers in the Past 6 Months |  | 6 months follow-up | 
| Percent of Participants With Use of an Antidepressant Medication for 2 Months or More in the Past 6 Months |  | 6 months follow-up | 
| Medication Visits Among MHS Users in the Past 6 Months |  | 6 months follow-up | 
| Faith-based Visits With Depression Service if Faith Participation in the Past 6 Months | For this sector, depression/mental health service is defined by client report of having assessment, counseling, education, medication discussion or referral for depression or emotional or mental health problems. | 6 months follow-up | 
| Park or Community Center Visits With Depression Service if Went to Park or Community Center in Past 6 Months | For this sector, depression/mental health service is defined by client report of having assessment, counseling, education, medication discussion or referral for depression or emotional or mental health problems. | 6 months follow-up | 
| Total Mental Health Related Outpatient Visits in the Past 6 Months | Total outpatient visits for depression, mental health or substance abuse from emergency rooms, primary care or public health, mental health, substance abuse, or social-community services sectors in the past 6 months | 6 months follow-up | 
| Percent of Participants With Hospitalization for Behavioral Health in the Past 6 Months | self-reported services use in the past 6 months for overnight hospital stays for mental health or substance abuse | 12 months follow-up | 
| Percent of Participants With Any MHS Outpatient Visit in the Past 6 Months | self-reported mental health outpatient visit from mental health provider, including psychiatrists, psychologists, social workers, psychiatric nurses, or counselors in the past 6 months | 12 months follow-up | 
| Percent of Participants With Any PCP Visit With Depression Service in the Past 6 Months | self-reported services use in the past 6 months with any primary care visit for depression | 12 months follow-up | 
| Percent of Participants With Faith-based Program Participation in the Past 6 Months | Went to any religious or spiritual places such as a church, mosque, temple, or synagogue in the past 6 months | 12 months follow-up | 
| Percent of Participants With Any Use of Park and Recreation or Community Centers in the Past 6 Months |  | 12 months follow-up | 
| Percent of Participants With Use of an Antidepressant Medication for 2 Months or More in the Past 6 Months |  | 12 months follow-up | 
| Total Mental Health Related Outpatient Visits in the Past 6 Months | Total outpatient visits for depression, mental health or substance abuse from emergency rooms, primary care or public health, mental health, substance abuse, or social-community services sectors in the past 6 months | 12 months follow-up | 
| PCS-12 Scores on 12-Item Physical Health Summary Measure, Comparison Between CEP and RS Groups | 12-item physical composite score (PCS-12). Possible scores on range from 0 to 100, with higher scores indicating better physical health | 36 months follow-up | 
| Nights Hospitalized for Behavioral Health Reason in the Past 6 Months | self-reported number of overnight hospital stays for any emotional, mental, alcohol, or drug problem in past 6 months | 36 months follow-up | 
| N of Emergency Room or Urgent Care Visits in the Past 6 Months |  | 36 months follow-up | 
| N of Visits to Primary Care in Past 6 Months |  | 36 months follow-up | 
| N of Outpatient Visits to Primary Care for Depression Services in the Past 6 Months |  | 36 months follow-up | 
| N of Outpatient Mental Health Visits in Past 6 Months |  | 36 months follow-up | 
| N of Outpatient Visits to a Substance Abuse Treatment Agency or Self Help Group in the Past 6 Months |  | 36 months follow-up | 
| N of Social Services for Depression Visits in the Past 6 Months |  | 36 months follow-up | 
| Number of Calls to Hotline for Substance Use or Mental Health Problem in the Past 6 Months |  | 36 months follow-up | 
| N of Days on Which a Self-help Visit for Mental Health Was Made in the Past 6 Months |  | 36 months follow-up | 
| Percent of Participants With Any Faith-based Services for Depression in the Past 6 Months |  | 36 months follow-up | 
| Percent of Participants With Use of Any Antidepressant in the Past 6 Months |  | 36 months follow-up | 
| Percent of Participants With Use of Any Mood Stabilizer in the Past 6 Months |  | 36 months follow-up | 
| Percent of Participants With Use of Any Antipsychotic in the Past 6 Months |  | 36 months follow-up | 
| Percent of Participants With Any Visit in Health Care Sector in the Past 6 Months |  | 36 months follow-up | 
| Percent of Participants With Any Community-sector Visit for Depression in the Past 6 Months |  | 36 months follow-up | 
| Percent of Participants With Any Depression Treatment in the Past 6 Months | Antidepressant use for at least two months or at least four outpatient visits to mental health or primary care setting for depression services | 36 months follow-up | 
| Survival Analysis for Time to the First Clinical Remission | clinical remission: Patient Health Questionnaire, PHQ-8 score <10. Cox Proportional Hazard model was used to examine the impact of the intervention on speed of clinical remission over the 3 years follow-up period, defined as the first assessment with clinical remission (PHQ-8<10). | from baseline to 3 years | 
| Survival Analysis for Time to the First Community-Defined Remission | Community-Defined Remission: PHQ-8<10 or MCS-12>40 or any mental wellness. Cox Proportional Hazard model was used to examine the impact of the intervention on speed of community-defined remission over the 3 years follow-up period, defined as the first assessment with community-defined (PHQ-8<10 or MCS-12>40 or any mental wellness) | from baseline to 3 years | 
| Percent of Participants With Clinical Remission | Clinical remission defined as Patient Health Questionnaire-2 (PHQ-2) score < 3. | 4 years follow-up | 
| Percent of Participants With Community-Defined Remission | Community-Defined Remission defined as PHQ-2<3, MCS-12>40, or mental wellness | 4 years follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Community Partnered Participatory Research, Community Engagement, Implementation, Community Based Participatory Research, Quality Improvement, Evidence Based Practice, Patient Centered Outcomes Research