This trial is active, not recruiting.

Conditions depression, information dissemination
Treatments quality improvement program, resources for services expert team, community engagement and planning council
Sponsor RAND
Collaborator National Institute of Mental Health (NIMH)
Start date January 2009
End date February 2012
Trial size 1782 participants
Trial identifier NCT01699789, 5G08LM011058-02, CPIC-2012-KW, R01MH078853


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose health services research
(Active Comparator)
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.
quality improvement program Partners in Care
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.
resources for services expert team Quality Improvement Team
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.
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.
quality improvement program Partners in Care
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.
community engagement and planning council Quality Improvement Team
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.

Primary Outcomes

agency and provider participation in evidence-based depression trainings.
time frame: 18 months
Client mental health-related quality of life
time frame: 6 month follow-up

Secondary Outcomes

physical functioning
time frame: baseline, 6 months, and 12 months
Risk factors for homelessness
time frame: Baseline, 6 and 12 month follow-up
employment status and days missed from work
time frame: baseline, 6 and 12 month follow-up
Mental Wellness
time frame: baseline, 6 and 12 month outcomes
perception that life is organized
time frame: baseline, 6 and 12 month follow-up
Overall poor mental health
time frame: baseline,6 and 12 month follow-up
Administrator and program adoption of quality improvement programs for depression and attitudes and knowledge of depression treatments and programs
time frame: baseline and 12 months
Program provider or staff use of quality improvement for depression and depression services use, attitudes and knowledge
time frame: baseline and 12 months
Services access and utilization
time frame: Baseline, 6 and 12 month follow-up

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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.
Principal investigator Kenneth B Wells, M.D., M.P.H
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by RAND.