Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Robert Wood Johnson Foundation
Patient Centered Outcome Research Institute
Information provided by (Responsible Party):
RAND
ClinicalTrials.gov Identifier:
NCT01699789
First received: September 27, 2012
Last updated: November 6, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Depression
Information Dissemination
Other: Quality Improvement Program
Behavioral: Resources for Services Expert Team
Behavioral: Community Engagement and Planning Council

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
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.

Resource links provided by NLM:


Further study details as provided by RAND:

Primary Outcome Measures:
  • Poor Mental Health Quality of Life, MCS12≤ 40 [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
    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).

  • PHQ-9 Score ≥ 10 [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
    Mild/moderate depression defined as PHQ-9 score ≥ 10.


Secondary Outcome Measures:
  • Mental Wellness [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
    Mental Wellness, % (at least good bit of time on 3 items on feeling peaceful or, calm, been a happy person, having energy), at least 1 item out of 3.

  • My Life is Organized [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
    Single item from the life chaos scale of degree to which a person feels their life is organized. My life is organized (Definitely true/Somewhat true), %

  • Physically Active [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
    Items on physical activity that are self-reported in the client survey, drawn from the SF-12 and measures of exercise and physical activity. how physically active you are (cond606>=3), 1=Quite/very/extreme active, %

  • Homeless or ≥ 2 Risk Factors for Homelessness [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
    Being homeless or having no place to stay for 2 nights or more; food insecurity; eviction from primary place of residence; or major financial crisis from items in client surveys. Homeless/shelter (pure, demo306=7) or >=2 risk factor for homelessness out of 4 items diff1 diff2 diff11 diff6)

  • Working for Pay [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
    Doing any work for pay at the present time, %

  • Any Missed Work Day in Last 30 Days if Working [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
    Any missed work days due to any reason in last 30 days,%, if working

  • Hospitalization for Behavioral Health [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
    Any hospitalization for alcohol, drug, mental health, %

  • >=4 Hospital Nights for Behavioral Health [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
    >=4 hospital nights for any emotional, mental, alcohol or drug problem

  • >2 Emergency Room Visits [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
    >2 emergency room visits, %

  • MHS Outpatient Visit [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
    Any mental health outpatient visit, %

  • PCP Visit With Depression Service [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
    Any primary care visit with depression service, %

  • >= 2 PCP Visits With Depression Service, if Any [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
    >=2 (median) primary care visits with depression service (%) if any

  • Faith-based Program Participation [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
    Any faith-based program participation, %

  • Use of Park or Community Centers [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
    Any use of parks or community centers, %

  • Took Antidepressant 2 Months or More in Past 6 Months [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
    Took antidepressant two months or more past 6 months, %

  • Medication Visits Among MHS Users [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
    # mental health specialty medication visits (mean) among users (Mean number of visits)

  • Counseling Visits From MHS or PCP [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
    # of counseling visits from mental health specialty or primary care (Mean number of visits)

  • Faith-based Visits With Depression Service if Faith Participation [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
    # faith-based visits with depression service if faith participation (Mean number of visits)

  • Park or Community Center Visits With Depression Service if Went to Park or Community Center [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
    # park or community center visits with depression service if went to park or community center (N=410)

  • Total Outpatient Contacts for Depression [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]
    Total outpatient contacts for depression, mental health or substance abuse from emergency rooms, primary care or public health, mental health, substance abuse, or social-community services sectors


Enrollment: 1246
Study Start Date: January 2009
Estimated Study Completion Date: June 2016
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Resources for Services
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
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.
Other Names:
  • Partners in Care
  • We Care
  • IMPACT
  • Mental Health Infrastructure and Training Project
Behavioral: Resources for Services Expert 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.
Other Name: Quality Improvement Team
Experimental: Community Engagement and Planning
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
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.
Other Names:
  • Partners in Care
  • We Care
  • IMPACT
  • Mental Health Infrastructure and Training Project
Behavioral: Community Engagement and Planning Council
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.
Other Name: Quality Improvement Team

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699789

Locations
United States, California
UCLA Center for Health Services & Society
Los Angeles, California, United States, 90024
Sponsors and Collaborators
RAND
Robert Wood Johnson Foundation
Patient Centered Outcome Research Institute
Investigators
Principal Investigator: Kenneth B Wells, M.D., M.P.H RAND Corporation, UCLA Geffen School of Medicine Department of Psychiatry, Center for Health Services & Society
Principal Investigator: Loretta Jones, MA Healthy African American Families II
Principal Investigator: Elizabeth Dixon, RN, PhD QueensCare Health & Faith Partnership
Principal Investigator: Jeanne Miranda, PhD UCLA Department of Psychiatry and Biobehavioral Sciences
  More Information

Additional Information:
Publications:
Responsible Party: RAND
ClinicalTrials.gov Identifier: NCT01699789     History of Changes
Other Study ID Numbers: CPIC-2012-KW, R01MH078853, 5G08LM011058-02
Study First Received: September 27, 2012
Results First Received: May 6, 2014
Last Updated: November 6, 2014
Health Authority: United States: Federal Government

Keywords provided by RAND:
Community Partnered Participatory Research
Community Engagement
Implementation
Community Based Participatory Research
Quality Improvement
Evidence Based Practice
Patient Centered Outcomes Research

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 20, 2014