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Hybrid Collaborative Care Randomized Program Evaluation (BHIP-CCM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by VA Boston Healthcare System
Sponsor:
Collaborator:
VA Office of Research and Development
Information provided by (Responsible Party):
Mark Bauer, VA Boston Healthcare System
ClinicalTrials.gov Identifier:
NCT02543840
First received: September 4, 2015
Last updated: April 5, 2017
Last verified: April 2017
  Purpose

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.


Condition Intervention
Mental Health Disorders
Other: Replicating Effective Programs plus External Facilitation
Other: Educational Materials

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Hybrid Controlled Trial to Implement Collaborative Care in General Mental Health

Resource links provided by NLM:


Further study details as provided by VA Boston Healthcare System:

Primary Outcome Measures:
  • VR-12 Mental and Physical Component Scores [ Time Frame: One year ]
    Overall self-rated mental and physical health status


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 675
Study Start Date: January 2016
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Chart evidence of dementia

  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: NCT02543840

Contacts
Contact: Mark S Bauer, MD 857-364-6380 mark.bauer@va.gov
Contact: Rachel P Riendeau, BA 857-364-6104 Rachel.Riendeau@va.gov

Locations
United States, Massachusetts
VA Boston Healthcare System Recruiting
Boston, Massachusetts, United States, 02131
Contact: Mark Bauer, MD       Mark.Bauer@va.gov   
Sponsors and Collaborators
VA Boston Healthcare System
VA Office of Research and Development
Investigators
Principal Investigator: Mark S Bauer, MD VA Boston Healthcare System
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mark Bauer, Associate Director, Center for Healthcare Organization and Implementation Research, VA Boston Healthcare System
ClinicalTrials.gov Identifier: NCT02543840     History of Changes
Other Study ID Numbers: 15-289
QUE-15-289 ( Other Identifier: U.S. Department of Veterans Affairs )
Study First Received: September 4, 2015
Last Updated: April 5, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by VA Boston Healthcare System:
Quality Improvement
Organization of Services
Implementation

Additional relevant MeSH terms:
Mental Disorders

ClinicalTrials.gov processed this record on April 24, 2017