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Trial record 10 of 200 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

Hybrid Collaborative Care Randomized Program Evaluation (BHIP-CCM)

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ClinicalTrials.gov Identifier: NCT02543840
Recruitment Status : Recruiting
First Posted : September 7, 2015
Last Update Posted : April 7, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

September 4, 2015
September 7, 2015
April 7, 2017
January 2016
September 2018   (Final data collection date for primary outcome measure)
VR-12 Mental and Physical Component Scores [ Time Frame: One year ]
Overall self-rated mental and physical health status
Same as current
Complete list of historical versions of study NCT02543840 on ClinicalTrials.gov Archive Site
  • Patient Assessment of Chronic Illness Care (PACIC) [ Time Frame: One year ]
    Veteran perception of coordination of and engagement with services
  • Satisfaction Index [ Time Frame: One year ]
    Overall satisfaction with mental health services
  • Provider perceptions of collaborative care [ Time Frame: One year ]
    Qualitative interview-based analysis of perceptions of collaborative care among providers on the BHIP teams
  • Administrative measures of care model fidelity [ Time Frame: One year ]
    Administrative measures of fidelity to the care model.
  • Patient Assessment of Chronic Illness Care (PACIC) [ Time Frame: One year ]
    Veteran perception of coordination of and engagement with services
  • Satisfaction Index [ Time Frame: One year ]
    Overall satisfaction with mental health services
  • Provider perceptions of collaborative care [ Time Frame: 1 year ]
    Qualitative interview-based analysis of perceptions of collaborative care among providers on the BHIP teams
Not Provided
Not Provided
 
Hybrid Collaborative Care Randomized Program Evaluation
Hybrid Controlled Trial to Implement Collaborative Care in General Mental Health

This randomized program evaluation is undertaken in conjunction with the Department of Veterans Affairs Office of Mental Health Operations and the Quality Enhancement Research Initiative. It is designed to answer two related questions: (1) Can an evidence-based implementation strategy using the CDC's Replicating Effective Programs plus External Facilitation (REP-F)enhance the adoption of team-based care in VA General Mental Health Clinics, and (2) Does the establishment of such teams via implementation enhance Veterans' health status, satisfaction, and perceptions of care? The model for team-based care is the evidence-based Collaborative Chronic Care Model (CCM).

In conjunction with a nation-wide roll-out of the VA's Behavioral Health Interdisciplinary Program team (BHIP) initiative, the investigators have structured a randomized, controlled program evaluation to answer these questions. Specifically, using a stepped wedge design the investigators will randomize 9 VAMCs that have requested support in establishing a BHIP to 1 of 3 waves of REP-F support: immediate implementation support vs. 4-month vs. 8-month wait with dissemination of CCM materials (3 sites per wave). Fidelity and health outcome measures will be collected in a repeated measures design at 6-month intervals, and analyzed with general linear modeling.

Based on an internal system-wide review of mental health services and the Mental Health Action Plan submitted to Congress in November, 2011, OMHO has undertaken an effort to establish BHIPs, which are intended to provide GMH care throughout VA. The BHIP goal is to build effective interdisciplinary teams, which will provide the majority of care for Veterans in GMH. It is now expected that every VAMC establish at least one BHIP in the current initial phase (begun in late FY2013), and that the effort scale-up subsequently. Not surprisingly, progress has been uneven.

In 2015 OMHO incorporated the Collaborative Chronic Care Model (CCM) as an evidence-based model by which to structure BHIPs. Consistent with BHIP goals, CCMs were developed to provide anticipatory, continuous, collaborative, evidence-based care. CCMs consist of 6 elements: delivery system redesign, use of clinical information systems, provider decision support, patient self-management support, linkage to community resources, and healthcare organization support. Replicating Effective Programs with External Facilitation (REP-F) has been shown to be effective in implementing complex care models, including CCMs for MH, both within and beyond VHA.

Thus in conjunction with OMHO, the investigators propose this project with the Specific Aim of evaluating the impact of REP-F in implementing CCM-based BHIPs and their effect on Veteran health status. The investigators propose a Hybrid Type III implementation-effectiveness stepped wedge controlled trial, specifically hypothesizing that:

H1: REP-F-based implementation to establish CCM-based BHIPs, compared to existing centralized technical assistance will result in: (H1a) increased Veteran perceptions of CCM-based care, (H1b) higher rates of achieving national BHIP clinical fidelity measures (implementation outcomes), and (H1c) higher provider ratings of the presence of CCM elements.

H2: CCM-based BHIPs, supported by REP-F implementation, will result in improved Veteran health outcomes compared to BHIPs supported by dissemination material alone (intervention outcomes).

The investigators will utilize the national BHIP rollout as a vehicle for this project. Using a stepped wedge design the investigators will randomize 9 VAMCs that have requested support in establishing a BHIP to 1 of 3 waves of REP-F support: immediate implementation support vs. 4-month vs. 8-month wait with dissemination of CCM materials (3 sites per wave). Fidelity and health outcome measures will be collected in a repeated measures design at 6-month intervals, and analyzed with general linear modeling.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Mental Health Disorders
  • Other: Replicating Effective Programs plus External Facilitation
    Packaging, training and technical assistance according to the Replicating Effective Programs model plus External Facilitation
    Other Name: REP-F
  • Other: Educational Materials
    Dissemination of educational materials on the collaborative chronic care model for 4 or 8 months prior to cross-over to REP-F
  • Experimental: Implementation Facilitation
    Implementation Facilitation consists of the Center for Disease Control's Replicating Effective Programs, plus External Facilitation. The intervention lasts 6 months followed by a 6-month step-down period.
    Intervention: Other: Replicating Effective Programs plus External Facilitation
  • Placebo Comparator: Educational Materials
    Dissemination of available materials explaining the Collaborative Chronic Care Model and implementation tools. Sites randomized to delay initiation of facilitation will have these materials plus technical assistance for 4 or 8 months prior to full implementation facilitation.
    Intervention: Other: Educational Materials

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
675
September 2018
September 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

At least three visits to the General Mental Health Clinic's BHIP team in prior year

Exclusion Criteria:

Chart evidence of dementia

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Mark S Bauer, MD 857-364-6380 mark.bauer@va.gov
Contact: Rachel P Riendeau, BA 857-364-6104 Rachel.Riendeau@va.gov
United States
 
 
NCT02543840
15-289
QUE-15-289 ( Other Identifier: U.S. Department of Veterans Affairs )
No
Not Provided
Plan to Share IPD: No
Mark Bauer, VA Boston Healthcare System
VA Boston Healthcare System
VA Office of Research and Development
Principal Investigator: Mark S Bauer, MD VA Boston Healthcare System
VA Boston Healthcare System
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP