NCT02543840|CompletedResults
Hybrid Collaborative Care Randomized Program Evaluation
BHIP-CCM
Hybrid Controlled Trial to Implement Collaborative Care in General Mental Health
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Sponsor study identifier
Secondary identifiers
OTHER · U.S. Department of Veterans Affairs
interventional
1,112
1 country
1
Study Start
March 7, 2016
Actual (reported)Primary Completion
April 26, 2018
Actual (reported)Study Completion
April 26, 2018
Actual (reported)This randomized program evaluation is undertaken in conjunction with the Department of Veterans Affairs (VA) Office of Mental Health Operations (OMHO) and the Quality Enhancement Research Initiative. It is designed to answer two related questions: (1) Can an evidence-based implementation strategy using the Center for Disease Control (CDC)'s Replicating Effective Programs plus External Facilitation (REP-F) enhance the adoption of team-based care in VA General Mental Health (GMH) 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 26, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 4, 2015
Actual (reported)September 7, 2015
Actual (reported)March 7, 2016
Actual (reported)April 26, 2018
Actual (reported)April 26, 2018
Actual (reported)June 23, 2020
Actual (reported)Veterans RAND-12 Mental Component Score (VR-12 MCS)
Veterans RAND-Mental Component Score: Overall self-rated mental health status over past two weeks among Veteran participants. Possible scores of minimum 0 and maximum 50. Higher is better. Administered with items for Veterans RAND-Physical Component Score.
one year
Veterans RAND-12 Physical Component Scores (VR-12 PCS)
One year
Satisfaction Index
One year
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)
One year
Patient Assessment of Chronic Illness Care (PACIC)
One year
Team Development Measure (TDM)- Cohesion
baseline and during stepdown (6-12 months)
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.
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.
Packaging, training and technical assistance according to the Replicating Effective Programs model plus External Facilitation
Dissemination of educational materials on the collaborative chronic care model for 4 or 8 months prior to cross-over to REP-F
VA Boston Healthcare System
Boston, Massachusetts, 02131, United States
Woltmann E, Grogan-Kaylor A, Perron B, Georges H, Kilbourne AM, Bauer MS. Comparative effectiveness of collaborative chronic care models for mental health conditions across primary, specialty, and behavioral health care settings: systematic review and meta-analysis. Am J Psychiatry. 2012 Aug;169(8):790-804. doi: 10.1176/appi.ajp.2012.11111616.
Miller CJ, Grogan-Kaylor A, Perron BE, Kilbourne AM, Woltmann E, Bauer MS. Collaborative chronic care models for mental health conditions: cumulative meta-analysis and metaregression to guide future research and implementation. Med Care. 2013 Oct;51(10):922-30. doi: 10.1097/MLR.0b013e3182a3e4c4.
All facilities received implementation support, randomized as to start time. There was thus no independent parallel control group. However, several validity checks were conducted to establish internal validity of positive findings.
Mark S Bauer, MD
VA Boston Healthcare System
1,112 participants (actual enrollment reported by the registry).
First Submitted
September 4, 2015
First Posted
September 7, 2015
Study Start
March 7, 2016
Actual (reported)Introduction Seminar About Patient Participation and Treatment Options Decisional Preferences
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Waxmonsky J, Kilbourne AM, Goodrich DE, Nord KM, Lai Z, Laird C, Clogston J, Kim HM, Miller C, Bauer MS. Enhanced fidelity to treatment for bipolar disorder: results from a randomized controlled implementation trial. Psychiatr Serv. 2014 Jan 1;65(1):81-90. doi: 10.1176/appi.ps.201300039.
Sullivan JL, Kim B, Miller CJ, Elwy AR, Drummond KL, Connolly SL, Riendeau RP, Bauer MS. Collaborative chronic care model implementation within outpatient behavioral health care teams: qualitative results from a multisite trial using implementation facilitation. Implement Sci Commun. 2021 Mar 24;2(1):33. doi: 10.1186/s43058-021-00133-w.
Connolly SL, Sullivan JL, Ritchie MJ, Kim B, Miller CJ, Bauer MS. External facilitators' perceptions of internal facilitation skills during implementation of collaborative care for mental health teams: a qualitative analysis informed by the i-PARIHS framework. BMC Health Serv Res. 2020 Mar 4;20(1):165. doi: 10.1186/s12913-020-5011-3.
Lew RA, Miller CJ, Kim B, Wu H, Stolzmann K, Bauer MS. A method to reduce imbalance for site-level randomized stepped wedge implementation trial designs. Implement Sci. 2019 May 3;14(1):46. doi: 10.1186/s13012-019-0893-3.
Bauer MS, Miller CJ, Kim B, Lew R, Stolzmann K, Sullivan J, Riendeau R, Pitcock J, Williamson A, Connolly S, Elwy AR, Weaver K. Effectiveness of Implementing a Collaborative Chronic Care Model for Clinician Teams on Patient Outcomes and Health Status in Mental Health: A Randomized Clinical Trial. JAMA Netw Open. 2019 Mar 1;2(3):e190230. doi: 10.1001/jamanetworkopen.2019.0230.
Bauer MS, Miller C, Kim B, Lew R, Weaver K, Coldwell C, Henderson K, Holmes S, Seibert MN, Stolzmann K, Elwy AR, Kirchner J. Partnering with health system operations leadership to develop a controlled implementation trial. Implement Sci. 2016 Feb 24;11:22. doi: 10.1186/s13012-016-0385-7.
Primary Completion
April 26, 2018
Actual (reported)Study Completion
April 26, 2018
Actual (reported)Last Updated
June 23, 2020
Results First Posted
June 23, 2020
Record last verified: 2020-06
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