The study data are from administrators, providers, and clients; they were collected at baseline and two follow-up time points (6 and 12 months for clients; 12 and 24 months for providers and administrators). The study obtained qualitative data on implementation from meeting minutes, items within the main surveys, and other sources (see ). A summary of key constructs for client, organizational, implementation, and provider measures is found under “Community Capacity for Mental Health Planning” in . Council community leaders interest in sustainability of change at the organizational level led to a proposal to add a wave of administrator and provider surveys (changing outcome from 18 months to 12 and 24).
Framework for Partnered Design, Community Engagement Implementation and Dissemination of Evidence Based, Quality Improvement
Randomized trials designed under CPPR can enhance relevance and community ownership while maintaining scientific rigor. Over the last six years, our community-academic partnership developed the design for a randomized comparison trial, using a CPPR approach. Our partnership strove to develop the study to improve the quality of data to inform community planning about how best to improve services for depression in underserved communities and to provide data to the scientific community on the effectiveness of community engagement as an intervention strategy to promote evidence-based care for depression. We found that using a CPPR approach in the design phase (Vision) led to many changes in study design that potentially improve the fit of the study with community priorities (e.g., aligning community boundaries with existing county service planning areas), as well as enrich the study's potential scientific contributions (e.g., through expanded outcomes of community and policy relevance). Moreover, some of the changes, such as shifting the time of randomization to after the kick-off conference introducing the clinical intervention toolkits, improved internal validity by removing a potential source of bias (knowledge of intervention assignment, which could have led to differential conference attendance by intervention condition).
The strengthening of the study's overall focus on community engagement across intervention conditions, while potentially reducing the difference between intervention conditions, has improved the community support for the study. At the time of manuscript submission, we are moving from the Vision (phase 1) to the Valley (phase 2) of this CPPR initiative. To date, we have recruited 110 agency programs and sites, having randomized 74 in South Los Angeles to the two study conditions.
Overall, the changes to the design and measures in response to community input improved the external validity of the study such as including more vulnerable populations (such as people who are homeless), enhancing its relevance for underserved communities, while increasing study scope and costs. By structuring the study to respond to community input regularly, this initiative attempts to fulfill its mission as a community capacity-building and program development activity.
The CPIC design is complex, including multi-level sampling and group-level randomization. Participation in the study places a considerable demand on participating agencies without directly compensating them for services in a declining economy. Even though the scope of the randomized phase of the study in any one agency is relatively small, the economic depression in California, with a record 11.2% unemployment rate, has severely strained safety-net agencies, many of which have lost staff and infrastructure support while facing increased community needs.45,46
Yet, we have learned while both participating and non-participating agencies are concerned about the implications of participation, most agree with the importance of the study goals and appreciate the spirit of collaboration offered in the project.
The CPIC study is community-owned, in that the community is contributing time and effort and is not directly compensated. Some design features, nevertheless, make CPIC a good fit with community priorities. For example, the study supports a choice-based model, in which agencies, providers, and clients are supported in deciding which depression treatments they prefer, if any. Participants can refuse to use any intervention resources and remain in the trial. This means the study will generate findings about the effects of feasible implementation strategies, a different goal than understanding the effects of optimal treatment under a strict protocol. Because of the community's risk-taking and investment in participation, we hope that the study findings will provide important information to the community about what their collaboration achieves in terms of client and community member outcomes.
Because it takes time to obtain partnership input, studies like CPIC take time to design and revise.20-25,29-32
Despite the greater complexity of decision making, the colead CPIC committee composition and structure makes the consideration and adjustment of study protocols feasible.
Our partnership's focus has been on clinical depression, a topic that has drawn a high level of interest from all community participants, some of whom have personal concerns about depression. These distinct voices add a personal urgency to the social justice perspective of CPPR, and motivate the partnership to work hard to achieve our goals. Cashman et al.
suggested that including community partners in data analysis and interpretation can enrich insights on the findings for academic and community partners.47
Building on this theme, we hope that participation of diverse stakeholders in the CPIC initiative yields findings supporting sustainable improvements in depression outcomes in our communities.48
Box 1: CPIC Committees, Meeting Frequency, and Tasks
|Steering Council||2 × / month||Study Goals|
Project oversight and planning
|Design||2 × / month||Sampling Design|
|Operations and Recruitment||1 × / week||Day-to-day project management|
Agency, program, administrator, provider, client recruitment
Survey administration and data collection
|Implementation Evaluation||2 × / month||Training and Conference Evaluation|
CEP Workgroup Evaluation
Evaluation of agency implementation of CEP & RS Plans
|Measures||As needed||Administrator, provider, and client survey development|
|Community Engagement and Planning||1× / month||Development of CEP manual for use in CEP Workgroups|
Oversees CEP workgroups, CEP plan development and CEP trainings
|Clinical Services Intervention||As needed||Oversees PIC training and supervision for administrator and providers (cognitive behavioral therapy, medication management, care manager)|Box 1: Adaptations to Design Based on Community – Academic Partnered Solutions
|Design Component||Original Study Goal||Community Feedback||Partnered Solution|
|Study Goals||To demonstrate effectiveness of a community engagement and planning approach to disseminating evidence-based programs to improve depression care, versus technical assistance.||The win for agencies is not clear. Technical assistance suggests that study leaders are experts and not the community.||Study re-framed to offer two-way knowledge-exchange: 1) resources (academic and community) for individual agencies to improve services for depression; 2) those resources plus a mulit-agency community-academic planning process to promote sharing resources and adapting programs to the community to expand the reach of programs to all. We also emphasized the post-trial dissemination phase.|
|Sampling Design and Procedures|
|Definition of Community||Hollywood and South Los Angeles.||Base on Los Angeles County service areas but also follow clients along referral lines.||Expand to include full county service planning areas plus surrounding areas; study priorities for agency recruitment based on community knowledge of use and referral patterns;|
|Agency Sample||Primary care/community clinics, mental health clinics, Social service agencies||Expand locations to include “community trusted locations”||Expand to include churches and church health fairs, community centers and senior centres of parks and recreation, barber/beauty shops, women's gyms|
|Provider Sample||Service providers and case workers in recruited agencies||A range of leaders in the community and staff at agencies can influence clients||Expand to include faith-based leaders, community center program staff, staff at other community locations such as exercise clubs|
|Patient/Client Sample||Adults receiving services in established agencies.||Include the most vulnerable community members if possible and those not receiving services.||Agencies added that serve transitional age youth, elderly, homeless, and prison/jail release populations.|
|Randomization Procedure||Group-level (site, program, or clinical team as unit), randomized controlled (comparison) design with assignment to resources and encouragement for services (choice-based model); wait list for effective intervention at dissemination phase; randomization before kickoff conference||Choice-based model (agencies, providers, and clients are free to choose treatments or no treatment) and wait list for resources are valued types of design in the community. Acceptability of randomization in the community remains somewhat uncertain.||Provide clear explanations of this complex design (transparency).|
Involve community partners in implementing the randomization procedure.
All respondents are free to participate or not as they choose. Those who do not want services or choose the treatments can remain in the study.
Randomization will take place after kick-off conference.
|Theory Basis of Intervention Implementation Evaluation||Diffusion of Innovation Theory, Quality improvement frameworks, Organizational Learning, Communities of Practice||Use community knowledge of services, practice, and populations; select theories that reflect the group or community values||Expand theory to include Collective Efficacy. Expand community input into concepts based on the principles of Community-Partnered Participatory Research.|
|Resources for Services||Standard components of collaborative care for depression: Resources for primary care providers, nurse care managers, psychotherapists and counselors, patient education and activation, tracking and coordination, and team management/quality review||Resources are limited, especially primary care clinician time for training and services; few community clinics have available nurse or other trained staff for care manager roles||Train-the-trainers approach to training; identify potential community leaders for training early on. Simplify and clarify care manager materials for a range of staff levels|
|Community Engagement and Planning||Manual to guide use of action plans to review resources and adapt for agencies, plan trainings, and develop a collaboration plan||Communities of color may be reluctant to engage in more traditional or Western treatment models Many value alternative therapies Community-trusted locations such as parks do not have staff with clinical backgrounds; develop outreach.||Collaborate with community agencies to identify cultural competence resources Identify outreach models for mental health and supplement with locally-developed materials for diverse cultural groups|
|Outcome Measures (Clients)||See ||Relevance of economic stress and strain with job losses|
Other outcomes of interest such as housing stability
|Expand to include employment status/workforce participation outcomes; and housing, recent victimization, and other common sources of stress in the community|
|Survey payments||Checks||Many community members do not use banks, and check cashing locations charge fees.||Cash or gift cards instead of checks.|Box 2: Timeline of Intervention Planning and Training Activities
|CPIC Kick-Off Conference (participants)||Timeframe||Activities||Resources|
|RS CEP||One day||Overview of CPIC materials||Introductory Materials: Improving Depression Outcomes in Primary Care: A User's Guide to Implementing the Partners in Care Approach (PIC); Training Materials: Training Agendas and Materials for Expert Leaders, Depression Nurse Specialists, and Psychotherapists, Videotape of Nurse Specialist Assessment; Materials for Primary Care Physicians & Care Managers: Clinician Guide to Depression Assessment & Management (PIC), Physician Pocket Reminder Cards, Guidelines/Resources for Depression Nurse Specialist (PIC); Psychotherapy Materials: Guidelines for the Study Therapist Group and Individual CBT Therapy Manuals for clinicians and clients (PIC, WE Care), Modified manuals for nurses, substance abuse counselors, and lay coaches; Materials for Patients: Patient Education Brochure in English and Spanish), Patient and Family Education Videotape (English and Spanish) including relapse prevention plan. All PIC / We Care materials have been culturally and linguistically adapted for African American and Latinos.|
|Resources for Services (participants)|
|RS||same timeframe as CEP Intervention (18 months)||Training resources from CPIC Kick-Off Conference and technical assistance follow-up phone calls on medication management, cognitive behavioral therapy, care management|
|Community Engagement and Planning Orientation (Participants)|
|CEP||Two hours||Introduction to goals and resources of intervention condition||CEP Manual, Sample Action Plans, CPIC Organizational Plans|
|Community Engagement and Planning Workgroups (Participants)|
|CEP||Two meetings per month for Four to Five months||Workgroups will develop a written plan for coordinated delivery for depression for implementation in the pilot phase.||In addition to the materials in CEP orientation, the workgroups will receive administrative support and small pilot funds to develop plans.|
|Community Engagement and Planning Training (Participants)|
|CEP||One day – to be modified by the CEP workgroups||Training based on CEP workgroup planning and adaptation of materials from PIC / WE Care||Community Plan and Adapted materials from Initial CPIC Kick-off Conference|
|Pilot Implementation (Participants)|
|CEP||One year||Refine Interventions based on feedback from agency administrators, providers, community leaders, community members, and patients.||Outcome measures of successful implementation (providing supervision of therapy models such as cognitive behavioral therapy, new outreach roles, adjustments to collaboration agreements)|
|One day||CPIC Council and Policy Advisory Board||Comparisons of CEP and RS interventions; Discussions of findings; Recommendations for community-wide plan for reducing impact of depression in the community; Sharing of testimonials from leadership of interventions conditions.|
|CPIC Council and intervention working groups||CPIC plan for dissemination of study findings and resources.|