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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- RAND
- 入组人数
- 1,246
- 试验地点
- 2
- 主要终点
- Percent of Participants With Poor Mental Health Quality of Life, MCS12≤ 40
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Administrators
- •Age 18 and above
- •Work or volunteer for an enrolled program in the study and be designated as a liaison by the program
- •Age 18 and above
- •Have direct contact with patients/clients
- •Age 18 and above
- •Score 10 or greater on modified Patient Health Questionnaire (PHQ-8)
排除标准
- •grossly disorganized by screener staff assessment Not providing personal contact information
- •Administrators - Under age 18
- •Under age 18
- •Under age 18
- •Gross cognitive disorganization by screener staff assessment
- •Providing no contact information
结局指标
主要结局
Percent of Participants With Poor Mental Health Quality of Life, MCS12≤ 40
时间窗: 36 months follow-up
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).
Percent of Participants With PHQ-9 Score ≥ 10
时间窗: 6 months follow-up
Patient Health Questionnaire 9-item version (PHQ-9) at least mild depression (score ≥ 10)
Percent of Participants With PHQ-8 Score ≥ 10
时间窗: 36 months follow-up
Patient Health Questionnaire 8-item version (PHQ-8) at least mild depression (score ≥ 10)
次要结局
- Percent of Participants With Mental Wellness(6 months follow-up)
- Percent of Participants Reported Organized Life(6 months follow-up)
- Percent of Participants With Physically Active(6 months follow-up)
- Percent of Participants With Homeless or ≥ 2 Risk Factors for Homelessness(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(12 months follow-up)
- Percent of Participants With >=4 Hospital Nights for Behavioral Health in the Past 6 Months(6 months follow-up)
- Percent of Participants With >=2 Emergency Room Visits in the Past 6 Months(6 months follow-up)
- Percent of Participants With Any MHS Outpatient Visit in the Past 6 Months(12 months follow-up)
- Percent of Participants With Any PCP Visit With Depression Service in the Past 6 Months(12 months follow-up)
- Percent of Participants With >= 2 PCP Visits With Depression Services, if Any(6 months follow-up)
- Park or Community Center Visits With Depression Service if Went to Park or Community Center in Past 6 Months(6 months follow-up)
- Percent of Participants With Faith-based Program Participation 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)
- 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(6 months follow-up)
- Total Mental Health Related Outpatient Visits 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(36 months follow-up)
- Nights Hospitalized for Behavioral Health Reason in the 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(36 months follow-up)
- Survival Analysis for Time to the First Clinical Remission(from baseline to 3 years)
- Survival Analysis for Time to the First Community-Defined Remission(from baseline to 3 years)
- Percent of Participants With Clinical Remission(4 years follow-up)
- Percent of Participants With Community-Defined Remission(4 years follow-up)
