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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01699789
Recruitment Status : Completed
First Posted : October 4, 2012
Results First Posted : November 17, 2014
Last Update Posted : June 24, 2021
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Robert Wood Johnson Foundation
National Library of Medicine (NLM)
Patient-Centered Outcomes Research Institute
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
RAND

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.

Condition or disease Intervention/treatment Phase
Depression Information Dissemination Social Determinants of Health Other: Quality Improvement Program Behavioral: Resources for Services Expert Team Behavioral: Community Engagement and Planning Council Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Study Start Date : January 2009
Actual Primary Completion Date : May 31, 2016
Actual Study Completion Date : May 31, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Percent of Participants With Poor Mental Health Quality of Life, MCS12≤ 40 [ Time Frame: 6 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).

  2. Percent of Participants With PHQ-9 Score ≥ 10 [ Time Frame: 6 months follow-up ]
    Patient Health Questionnaire 9-item version (PHQ-9) at least mild depression (score ≥ 10)

  3. Percent of Participants With Poor Mental Health Quality of Life, MCS12≤ 40 [ Time Frame: 12 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).

  4. Percent of Participants With Poor Mental Health Quality of Life, MCS12≤ 40 [ Time Frame: 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).

  5. Percent of Participants With PHQ-8 Score ≥ 10 [ Time Frame: 36 months follow-up ]
    Patient Health Questionnaire 8-item version (PHQ-8) at least mild depression (score ≥ 10)


Secondary Outcome Measures :
  1. Percent of Participants With Mental Wellness [ Time Frame: 6 months follow-up ]
    Mental wellness is defined as at least a good bit of time in the prior 4 weeks on any of three items: feeling peaceful or calm, being a happy person, having energy

  2. Percent of Participants Reported Organized Life [ Time Frame: 6 months follow-up ]
    A response of somewhat or definitely true to "my life is organized" versus unsure or somewhat false or definitely false

  3. Percent of Participants With Physically Active [ Time Frame: 6 months follow-up ]
    Physically Active is defined as at least active to "How physically active you are?"

  4. Percent of Participants With Homeless or ≥ 2 Risk Factors for Homelessness [ Time Frame: 6 months follow-up ]
    Defined as current homelessness or living in a shelter or having at least 2 risk factors (e.g., no place to stay for at least 2 nights or eviction from a primary residence, financial crisis, or food insecurity in the past 6 months)

  5. Percent of Participants With Working for Pay [ Time Frame: 6 months follow-up ]
  6. Percent of Participants With Any Missed Work Day in Last 30 Days, if Working [ Time Frame: 6 months follow-up ]
  7. Percent of Participants With Hospitalization for Behavioral Health in the Past 6 Months [ Time Frame: 6 months follow-up ]
    self-reported services use in the past 6 months for overnight hospital stays for mental health or substance abuse

  8. Percent of Participants With >=4 Hospital Nights for Behavioral Health in the Past 6 Months [ Time Frame: 6 months follow-up ]
    self-reported services use in the past 6 months with >=4 overnight hospital stays for any emotional, mental, alcohol, or drug problem, median cut point for baseline variable

  9. Percent of Participants With >=2 Emergency Room Visits in the Past 6 Months [ Time Frame: 6 months follow-up ]
    self-reported services use in the past 6 months with >=2 emergency room visits in past 6 months, median cut point for baseline variable

  10. Percent of Participants With Any MHS Outpatient Visit in the Past 6 Months [ Time Frame: 6 months follow-up ]
    self-reported mental health outpatient visit from mental health provider, including psychiatrists, psychologists, social workers, psychiatric nurses, or counselors in the past 6 months

  11. Percent of Participants With Any PCP Visit With Depression Service in the Past 6 Months [ Time Frame: 6 months follow-up ]
    self-reported services use in the past 6 months with any primary care visit for depression

  12. Percent of Participants With >= 2 PCP Visits With Depression Services, if Any [ Time Frame: 6 months follow-up ]
  13. Percent of Participants With Faith-based Program Participation in the Past 6 Months [ Time Frame: 6 months follow-up ]
    Went to any religious or spiritual places such as a church, mosque, temple, or synagogue in the past 6 months

  14. Percent of Participants With Any Use of Park and Recreation or Community Centers in the Past 6 Months [ Time Frame: 6 months follow-up ]
  15. Percent of Participants With Use of an Antidepressant Medication for 2 Months or More in the Past 6 Months [ Time Frame: 6 months follow-up ]
  16. Medication Visits Among MHS Users in the Past 6 Months [ Time Frame: 6 months follow-up ]
  17. Faith-based Visits With Depression Service if Faith Participation in the Past 6 Months [ Time Frame: 6 months follow-up ]
    For this sector, depression/mental health service is defined by client report of having assessment, counseling, education, medication discussion or referral for depression or emotional or mental health problems.

  18. Park or Community Center Visits With Depression Service if Went to Park or Community Center in Past 6 Months [ Time Frame: 6 months follow-up ]
    For this sector, depression/mental health service is defined by client report of having assessment, counseling, education, medication discussion or referral for depression or emotional or mental health problems.

  19. Total Mental Health Related Outpatient Visits in the Past 6 Months [ Time Frame: 6 months follow-up ]
    Total outpatient visits for depression, mental health or substance abuse from emergency rooms, primary care or public health, mental health, substance abuse, or social-community services sectors in the past 6 months

  20. Percent of Participants With Hospitalization for Behavioral Health in the Past 6 Months [ Time Frame: 12 months follow-up ]
    self-reported services use in the past 6 months for overnight hospital stays for mental health or substance abuse

  21. Percent of Participants With Any MHS Outpatient Visit in the Past 6 Months [ Time Frame: 12 months follow-up ]
    self-reported mental health outpatient visit from mental health provider, including psychiatrists, psychologists, social workers, psychiatric nurses, or counselors in the past 6 months

  22. Percent of Participants With Any PCP Visit With Depression Service in the Past 6 Months [ Time Frame: 12 months follow-up ]
    self-reported services use in the past 6 months with any primary care visit for depression

  23. Percent of Participants With Faith-based Program Participation in the Past 6 Months [ Time Frame: 12 months follow-up ]
    Went to any religious or spiritual places such as a church, mosque, temple, or synagogue in the past 6 months

  24. Percent of Participants With Any Use of Park and Recreation or Community Centers in the Past 6 Months [ Time Frame: 12 months follow-up ]
  25. Percent of Participants With Use of an Antidepressant Medication for 2 Months or More in the Past 6 Months [ Time Frame: 12 months follow-up ]
  26. Total Mental Health Related Outpatient Visits in the Past 6 Months [ Time Frame: 12 months follow-up ]
    Total outpatient visits for depression, mental health or substance abuse from emergency rooms, primary care or public health, mental health, substance abuse, or social-community services sectors in the past 6 months

  27. PCS-12 Scores on 12-Item Physical Health Summary Measure, Comparison Between CEP and RS Groups [ Time Frame: 36 months follow-up ]
    12-item physical composite score (PCS-12). Possible scores on range from 0 to 100, with higher scores indicating better physical health

  28. Nights Hospitalized for Behavioral Health Reason in the Past 6 Months [ Time Frame: 36 months follow-up ]
    self-reported number of overnight hospital stays for any emotional, mental, alcohol, or drug problem in past 6 months

  29. N of Emergency Room or Urgent Care Visits in the Past 6 Months [ Time Frame: 36 months follow-up ]
  30. N of Visits to Primary Care in Past 6 Months [ Time Frame: 36 months follow-up ]
  31. N of Outpatient Visits to Primary Care for Depression Services in the Past 6 Months [ Time Frame: 36 months follow-up ]
  32. N of Outpatient Mental Health Visits in Past 6 Months [ Time Frame: 36 months follow-up ]
  33. N of Outpatient Visits to a Substance Abuse Treatment Agency or Self Help Group in the Past 6 Months [ Time Frame: 36 months follow-up ]
  34. N of Social Services for Depression Visits in the Past 6 Months [ Time Frame: 36 months follow-up ]
  35. Number of Calls to Hotline for Substance Use or Mental Health Problem in the Past 6 Months [ Time Frame: 36 months follow-up ]
  36. N of Days on Which a Self-help Visit for Mental Health Was Made in the Past 6 Months [ Time Frame: 36 months follow-up ]
  37. Percent of Participants With Any Faith-based Services for Depression in the Past 6 Months [ Time Frame: 36 months follow-up ]
  38. Percent of Participants With Use of Any Antidepressant in the Past 6 Months [ Time Frame: 36 months follow-up ]
  39. Percent of Participants With Use of Any Mood Stabilizer in the Past 6 Months [ Time Frame: 36 months follow-up ]
  40. Percent of Participants With Use of Any Antipsychotic in the Past 6 Months [ Time Frame: 36 months follow-up ]
  41. Percent of Participants With Any Visit in Health Care Sector in the Past 6 Months [ Time Frame: 36 months follow-up ]
  42. Percent of Participants With Any Community-sector Visit for Depression in the Past 6 Months [ Time Frame: 36 months follow-up ]
  43. Percent of Participants With Any Depression Treatment in the Past 6 Months [ Time Frame: 36 months follow-up ]
    Antidepressant use for at least two months or at least four outpatient visits to mental health or primary care setting for depression services

  44. Survival Analysis for Time to the First Clinical Remission [ Time Frame: from baseline to 3 years ]
    clinical remission: Patient Health Questionnaire, PHQ-8 score <10. Cox Proportional Hazard model was used to examine the impact of the intervention on speed of clinical remission over the 3 years follow-up period, defined as the first assessment with clinical remission (PHQ-8<10).

  45. Survival Analysis for Time to the First Community-Defined Remission [ Time Frame: from baseline to 3 years ]
    Community-Defined Remission: PHQ-8<10 or MCS-12>40 or any mental wellness. Cox Proportional Hazard model was used to examine the impact of the intervention on speed of community-defined remission over the 3 years follow-up period, defined as the first assessment with community-defined (PHQ-8<10 or MCS-12>40 or any mental wellness)

  46. Percent of Participants With Clinical Remission [ Time Frame: 4 years follow-up ]
    Clinical remission defined as Patient Health Questionnaire-2 (PHQ-2) score < 3.

  47. Percent of Participants With Community-Defined Remission [ Time Frame: 4 years follow-up ]
    Community-Defined Remission defined as PHQ-2<3, MCS-12>40, or mental wellness



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01699789


Locations
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United States, California
Krystal M Griffith
Gardena, California, United States, 90249
Sponsors and Collaborators
RAND
National Institute of Mental Health (NIMH)
Robert Wood Johnson Foundation
National Library of Medicine (NLM)
Patient-Centered Outcomes Research Institute
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Kenneth B Wells, M.D., M.P.H RAND Corporation, UCLA Semel Institute
Principal Investigator: Bowen Chung, MD, MSHS Harbor-UCLA Medical Center, UCLA Semel Institute
Principal Investigator: Jeanne Miranda, PhD UCLA Semel Institute
  Study Documents (Full-Text)

Documents provided by RAND:
Additional Information:
Publications of Results:

Other Publications:
Goodsmith N, Zhang L, Ong M, Ngo VK, Miranda J, Hirsch S, Jones F, Wells K, Chung B. Addressing Suicidality in Research Protocols for Under-Resourced Communities: A Case Study from Community Partners in Care. Psychiatric Services Research (in press)

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Responsible Party: RAND
ClinicalTrials.gov Identifier: NCT01699789    
Other Study ID Numbers: CPIC-2012-KW
R01MH078853 ( U.S. NIH Grant/Contract )
P30MH082760 ( U.S. NIH Grant/Contract )
P30MH068639 ( U.S. NIH Grant/Contract )
PPRN-1501-26518 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute )
R01MD007721 ( U.S. NIH Grant/Contract )
G08LM011058 ( U.S. NIH Grant/Contract )
UL1TR000124 ( U.S. NIH Grant/Contract )
64244 ( Other Grant/Funding Number: Robert Wood Johnson Foundation )
First Posted: October 4, 2012    Key Record Dates
Results First Posted: November 17, 2014
Last Update Posted: June 24, 2021
Last Verified: June 2021
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:
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Depression
Behavioral Symptoms