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Trial record 2 of 390 for:    depression NIH

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 : May 17, 2017
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Robert Wood Johnson Foundation
National Library of Medicine (NLM)
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
RAND

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Health Services Research
Conditions: Depression
Information Dissemination
Social Determinants of Health
Interventions: Other: Quality Improvement Program
Behavioral: Resources for Services Expert Team
Behavioral: Community Engagement and Planning Council

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From March 2010 to November 2010, the study screened 4,440 clients from 93 programs in 50 agencies. The ninety-three programs, included 17 primary care/public health, 18 mental health, 20 substance abuse, ten homeless services, and 28 social/other community services.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Resources for Services RS

The RS 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 (QI) Program Intervention as implemented by the RS Expert Team.

QI Program: The quality improvement program is an evidence-based toolkit from prior studies that supported team leadership, case and care management, medication management, and CBT 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.

RS Expert Team: The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a quality improvement expert, and staff support. T

Community Engagement and Planning CEP

The CEP arm supported 4 months of planning for the CEP Council consisting of representatives from all assigned programs in biweekly 2 hour meetings to fit trainings in the QI 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.

QI Program: The QI program is an evidence-based toolkit from prior studies that supported team leadership, case and care management, medication management, and CBT 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.

CEP Council: The CEP Council was supported by a workbook de


Participant Flow:   Overall Study
    Resources for Services RS   Community Engagement and Planning CEP
STARTED   606 [1]   640 [2] 
Baseline   492   488 
6-Month Follow-Up   380   379 
12-Month Follow-Up   364   369 
COMPLETED   504 [3]   514 [4] 
NOT COMPLETED   102   126 
Withdrawal by Subject                18                23 
Death                1                2 
Lost to Follow-up                83                101 
[1] 606 eligible clients enrolled and contacted by telephone for baseline or follow-up survey in RS arm
[2] 640 eligible clients enrolled and contacted by telephone for baseline or follow-up survey in CEP arm
[3] Clients in 44 programs with complete or partially complete data at baseline, 6 and 12 mo FU analyzed
[4] Clients in 46 programs with complete or partially complete data at baseline, 6 and 12 mo FU analyzed



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Resources for Services RS

RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.

QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and 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. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management.

Community Engagement and Planning CEP CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI 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 received enrolled client lists. The toolkit is the same as RS. 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.
Total Total of all reporting groups

Baseline Measures
   Resources for Services RS   Community Engagement and Planning CEP   Total 
Overall Participants Analyzed 
[Units: Participants]
 504   514   1018 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.9  (12.4)   46.6  (13.2)   45.8  (12.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      286  56.7%      309  60.1%      595  58.4% 
Male      218  43.3%      205  39.9%      423  41.6% 
Race/Ethnicity, Customized 
[Units: Participants]
     
Latino   194   215   409 
African American   239   249   488 
Non-Hispanic white   45   41   86 
Other (Asian, Native American etc)   26   9   35 
Marital status 
[Units: Participants]
     
Married or living with partner   116   115   231 
Single, widowed, divorced or separated   388   399   787 
Education [1] 
[Units: Participants]
     
Less than high school education   221   224   445 
High school or above   283   290   573 
[1] Note that the N’s may differ slightly from published papers due to multiple imputation
Health Insurance Status 
[Units: Participants]
     
No health insurance   286   259   545 
Had health insurance   218   255   473 


  Outcome Measures

1.  Primary:   Poor Mental Health Quality of Life, MCS12≤ 40   [ Time Frame: 6 months follow-up ]

2.  Primary:   Poor Mental Health Quality of Life, MCS12≤ 40   [ Time Frame: 12 months follow-up ]

3.  Primary:   PHQ-9 Score ≥ 10   [ Time Frame: 6 months follow-up ]

4.  Secondary:   Mental Wellness   [ Time Frame: 6 months follow-up ]

5.  Secondary:   Physically Active   [ Time Frame: 6 months follow-up ]

6.  Secondary:   Homeless or ≥ 2 Risk Factors for Homelessness   [ Time Frame: 6 months follow-up ]

7.  Secondary:   Hospitalization for Behavioral Health   [ Time Frame: 6 months follow-up ]

8.  Secondary:   Hospitalization for Behavioral Health   [ Time Frame: 12 months follow-up ]

9.  Secondary:   MHS Outpatient Visit   [ Time Frame: 6 months follow-up ]

10.  Secondary:   MHS Outpatient Visit   [ Time Frame: 12 months follow-up ]

11.  Secondary:   PCP Visit With Depression Service   [ Time Frame: 6 months follow-up ]

12.  Secondary:   PCP Visit With Depression Service   [ Time Frame: 12 months follow-up ]

13.  Secondary:   Faith-based Program Participation   [ Time Frame: 6 months follow-up ]

14.  Secondary:   Faith-based Program Participation   [ Time Frame: 12 months follow-up ]

15.  Secondary:   Use of Park or Community Centers   [ Time Frame: 6 months follow-up ]

16.  Secondary:   Use of Park or Community Centers   [ Time Frame: 12 months follow-up ]

17.  Secondary:   Took Antidepressant 2 Months or More in Past 6 Months   [ Time Frame: 6 months follow-up ]

18.  Secondary:   Took Antidepressant 2 Months or More in Past 6 Months   [ Time Frame: 12 months follow-up ]

19.  Secondary:   Total Outpatient Contacts for Depression   [ Time Frame: 6 months follow-up ]

20.  Secondary:   Total Outpatient Contacts for Depression   [ Time Frame: 12 months follow-up ]

21.  Secondary:   My Life is Organized   [ Time Frame: 6 months follow-up ]

22.  Secondary:   Working for Pay   [ Time Frame: 6 months follow-up ]

23.  Secondary:   Any Missed Work Day in Last 30 Days, if Working   [ Time Frame: 6 months follow-up ]

24.  Secondary:   >=4 Hospital Nights for Behavioral Health   [ Time Frame: 6 months follow-up ]

25.  Secondary:   >=2 Emergency Room Visits   [ Time Frame: 6 months follow-up ]

26.  Secondary:   >= 2 PCP Visits With Depression Services, if Any   [ Time Frame: 6 months follow-up ]

27.  Secondary:   Medication Visits Among MHS Users   [ Time Frame: 6 months follow-up ]

28.  Secondary:   Faith-based Visits With Depression Service if Faith Participation   [ Time Frame: 6 months follow-up ]

29.  Secondary:   Park or Community Center Visits With Depression Service if Went to Park or Community Center   [ Time Frame: 6 months follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Communities had history of using CPPR for depression. Response rates moderate for agencies, high for programs. Convenience samples of sites. Client retention rates lower than other QI studies. Outcomes rely on client self-report at 6-month follow-up.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kenneth B. Wells
Organization: RAND Corporation
phone: 310-794-3728
e-mail: kwells@mednet.ucla.edu


Publications of Results:

Other Publications:


Responsible Party: RAND
ClinicalTrials.gov Identifier: NCT01699789     History of Changes
Other Study ID Numbers: CPIC-2012-KW
R01MH078853 ( U.S. NIH Grant/Contract )
5G08LM011058-02 ( U.S. NIH Grant/Contract )
First Submitted: September 27, 2012
First Posted: October 4, 2012
Results First Submitted: May 6, 2014
Results First Posted: November 17, 2014
Last Update Posted: May 17, 2017