Clinical trial NCT01699789: Community Partners in Care is a Research Project Funded by the National Institutes of Health
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Information Dissemination
Social Determinants of Health
Keywords: Community Partnered Participatory Research
Community Engagement
Implementation
Community Based Participatory Research
Quality Improvement
Evidence Based Practice
Patient Centered Outcomes Research
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Robert Wood Johnson Foundation
name: National Library of Medicine (NLM)
name: Patient-Centered Outcomes Research Institute
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2012-10-04
Enrollment: 1246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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:

1. To engage two underserved communities in improving safety-net care for depression.
2. 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.
3. 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:

1. 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
2. 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
3. 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:

1. 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.
2. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of Participants With Poor Mental Health Quality of Life, MCS12≤ 40
timeFrame: 6 months follow-up
measure: Percent of Participants With PHQ-9 Score ≥ 10
timeFrame: 6 months follow-up
measure: Percent of Participants With Poor Mental Health Quality of Life, MCS12≤ 40
timeFrame: 12 months follow-up
measure: Percent of Participants With Poor Mental Health Quality of Life, MCS12≤ 40
timeFrame: 36 months follow-up
measure: Percent of Participants With PHQ-8 Score ≥ 10
timeFrame: 36 months follow-up
Secondary outcomes:
measure: Percent of Participants With Mental Wellness
timeFrame: 6 months follow-up
measure: Percent of Participants Reported Organized Life
timeFrame: 6 months follow-up
measure: Percent of Participants With Physically Active
timeFrame: 6 months follow-up
measure: Percent of Participants With Homeless or ≥ 2 Risk Factors for Homelessness
timeFrame: 6 months follow-up
measure: Percent of Participants With Working for Pay
timeFrame: 6 months follow-up
measure: Percent of Participants With Any Missed Work Day in Last 30 Days, if Working
timeFrame: 6 months follow-up
measure: Percent of Participants With Hospitalization for Behavioral Health in the Past 6 Months
timeFrame: 6 months follow-up
measure: Percent of Participants With >=4 Hospital Nights for Behavioral Health in the Past 6 Months
timeFrame: 6 months follow-up
measure: Percent of Participants With >=2 Emergency Room Visits in the Past 6 Months
timeFrame: 6 months follow-up
measure: Percent of Participants With Any MHS Outpatient Visit in the Past 6 Months
timeFrame: 6 months follow-up
measure: Percent of Participants With Any PCP Visit With Depression Service in the Past 6 Months
timeFrame: 6 months follow-up
measure: Percent of Participants With >= 2 PCP Visits With Depression Services, if Any
timeFrame: 6 months follow-up
measure: Percent of Participants With Faith-based Program Participation in the Past 6 Months
timeFrame: 6 months follow-up
measure: Percent of Participants With Any Use of Park and Recreation or Community Centers in the Past 6 Months
timeFrame: 6 months follow-up
measure: Percent of Participants With Use of an Antidepressant Medication for 2 Months or More in the Past 6 Months
timeFrame: 6 months follow-up
measure: Medication Visits Among MHS Users in the Past 6 Months
timeFrame: 6 months follow-up
measure: Faith-based Visits With Depression Service if Faith Participation in the Past 6 Months
timeFrame: 6 months follow-up
measure: Park or Community Center Visits With Depression Service if Went to Park or Community Center in Past 6 Months
timeFrame: 6 months follow-up
measure: Total Mental Health Related Outpatient Visits in the Past 6 Months
timeFrame: 6 months follow-up
measure: Percent of Participants With Hospitalization for Behavioral Health in the Past 6 Months
timeFrame: 12 months follow-up
measure: Percent of Participants With Any MHS Outpatient Visit in the Past 6 Months
timeFrame: 12 months follow-up
measure: Percent of Participants With Any PCP Visit With Depression Service in the Past 6 Months
timeFrame: 12 months follow-up
measure: Percent of Participants With Faith-based Program Participation in the Past 6 Months
timeFrame: 12 months follow-up
measure: Percent of Participants With Any Use of Park and Recreation or Community Centers in the Past 6 Months
timeFrame: 12 months follow-up
measure: Percent of Participants With Use of an Antidepressant Medication for 2 Months or More in the Past 6 Months
timeFrame: 12 months follow-up
measure: Total Mental Health Related Outpatient Visits in the Past 6 Months
timeFrame: 12 months follow-up
measure: PCS-12 Scores on 12-Item Physical Health Summary Measure, Comparison Between CEP and RS Groups
timeFrame: 36 months follow-up
measure: Nights Hospitalized for Behavioral Health Reason in the Past 6 Months
timeFrame: 36 months follow-up
measure: N of Emergency Room or Urgent Care Visits in the Past 6 Months
timeFrame: 36 months follow-up
measure: N of Visits to Primary Care in Past 6 Months
timeFrame: 36 months follow-up
measure: N of Outpatient Visits to Primary Care for Depression Services in the Past 6 Months
timeFrame: 36 months follow-up
measure: N of Outpatient Mental Health Visits in Past 6 Months
timeFrame: 36 months follow-up
measure: N of Outpatient Visits to a Substance Abuse Treatment Agency or Self Help Group in the Past 6 Months
timeFrame: 36 months follow-up
measure: N of Social Services for Depression Visits in the Past 6 Months
timeFrame: 36 months follow-up
measure: Number of Calls to Hotline for Substance Use or Mental Health Problem in the Past 6 Months
timeFrame: 36 months follow-up
measure: N of Days on Which a Self-help Visit for Mental Health Was Made in the Past 6 Months
timeFrame: 36 months follow-up
measure: Percent of Participants With Any Faith-based Services for Depression in the Past 6 Months
timeFrame: 36 months follow-up
measure: Percent of Participants With Use of Any Antidepressant in the Past 6 Months
timeFrame: 36 months follow-up
measure: Percent of Participants With Use of Any Mood Stabilizer in the Past 6 Months
timeFrame: 36 months follow-up
measure: Percent of Participants With Use of Any Antipsychotic in the Past 6 Months
timeFrame: 36 months follow-up
measure: Percent of Participants With Any Visit in Health Care Sector in the Past 6 Months
timeFrame: 36 months follow-up
measure: Percent of Participants With Any Community-sector Visit for Depression in the Past 6 Months
timeFrame: 36 months follow-up
measure: Percent of Participants With Any Depression Treatment in the Past 6 Months
timeFrame: 36 months follow-up
measure: Survival Analysis for Time to the First Clinical Remission
timeFrame: from baseline to 3 years
measure: Survival Analysis for Time to the First Community-Defined Remission
timeFrame: from baseline to 3 years
measure: Percent of Participants With Clinical Remission
timeFrame: 4 years follow-up
measure: Percent of Participants With Community-Defined Remission
timeFrame: 4 years follow-up
Other outcomes:
Locations:
city: Gardena
country: United States
facility: Krystal M Griffith
state: California
Study officials:
affiliation: RAND Corporation, UCLA Semel Institute
name: Kenneth B Wells, M.D., M.P.H
role: PRINCIPAL_INVESTIGATOR
affiliation: Harbor-UCLA Medical Center, UCLA Semel Institute
name: Bowen Chung, MD, MSHS
role: PRINCIPAL_INVESTIGATOR
affiliation: UCLA Semel Institute
name: Jeanne Miranda, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chung B, Jones L, Dixon EL, Miranda J, Wells K; Community Partners in Care Steering Council. Using a community partnered participatory research approach to implement a randomized controlled trial: planning community partners in care. J Health Care Poor Underserved. 2010 Aug;21(3):780-95. doi: 10.1353/hpu.0.0345.
citation: Khodyakov D, Mendel P, Dixon E, Jones A, Masongsong Z, Wells K. Community Partners in Care: Leveraging Community Diversity to Improve Depression Care for Underserved Populations. Int J Divers Organ Communities Nations. 2009;9(2):167-182.
citation: Dixon EL, Flaskerud JH. Community tailored responses to depression care. Issues Ment Health Nurs. 2010 Sep;31(9):611-3. doi: 10.3109/01612841003675303. No abstract available.
citation: Mango J, Cabiling E, Jones L, Lucas-Wright A, Williams P, Wells K, Pulido E, Meldrum M, Ramos A, Chung B. Community Partners in Care (CPIC): Video Summary of Rationale, Study Approach / Implementation, and Client 6-month Outcomes. CES4healthinfo. 2014 Feb 25;2014:87LWR5H2.
citation: Khodyakov D, Pulido E, Ramos A, Dixon E. Community-partnered research conference model: the experience of Community Partners in Care study. Prog Community Health Partnersh. 2014 Spring;8(1):83-97. doi: 10.1353/cpr.2014.0008.
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citation: Chung B, Ong M, Ettner SL, Jones F, Gilmore J, McCreary M, Sherbourne C, Ngo V, Koegel P, Tang L, Dixon E, Miranda J, Belin TR, Wells KB. 12-month outcomes of community engagement versus technical assistance to implement depression collaborative care: a partnered, cluster, randomized, comparative effectiveness trial. Ann Intern Med. 2014 Nov 18;161(10 Suppl):S23-34. doi: 10.7326/M13-3011.
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citation: Chung B, Ngo VK, Ong MK, Pulido E, Jones F, Gilmore J, Stoker-Mtume N, Johnson M, Tang L, Wells KB, Sherbourne C, Miranda J. Participation in Training for Depression Care Quality Improvement: A Randomized Trial of Community Engagement or Technical Support. Psychiatr Serv. 2015 Aug 1;66(8):831-9. doi: 10.1176/appi.ps.201400099. Epub 2015 May 1.
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citation: Landry CM, Jackson AP, Tang L, Miranda J, Chung B, Jones F, Ong MK, Wells K. The Effects of Collaborative Care Training on Case Managers' Perceived Depression-Related Services Delivery. Psychiatr Serv. 2017 Feb 1;68(2):123-130. doi: 10.1176/appi.ps.201500550. Epub 2016 Sep 15.
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citation: Arevian AC, Jones F, Tang L, Sherbourne CD, Jones L, Miranda J; Community Partners in Care Writing Group. Depression Remission From Community Coalitions Versus Individual Program Support for Services: Findings From Community Partners in Care, Los Angeles, California, 2010-2016. Am J Public Health. 2019 Jun;109(S3):S205-S213. doi: 10.2105/AJPH.2019.305082.
citation: Barcelo NE, Lopez A, Tang L, Aguilera Nunez MG, Jones F, Miranda J, Chung B, Arevian A, Bonds C, Izquierdo A, Dixon E, Wells K. Community Engagement and Planning versus Resources for Services for Implementing Depression Quality Improvement: Exploratory Analysis for Black and Latino Adults. Ethn Dis. 2019 Apr 18;29(2):277-286. doi: 10.18865/ed.29.2.277. eCollection 2019 Spring.
citation: Morton I, Hurley B, Castillo EG, Tang L, Gilmore J, Jones F, Watkins K, Chung B, Wells K. Outcomes of two quality improvement implementation interventions for depression services in adults with substance use problems. Am J Drug Alcohol Abuse. 2020;46(2):251-261. doi: 10.1080/00952990.2019.1708085. Epub 2020 Jan 14.