Hybrid Collaborative Care Randomized Program Evaluation

NCT02543840 | Completed Results

• 2 other identifiers: 15-289QUE-15-289
• Study Type: interventional
• Target: 1,112
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mental Health Disorders

Keywords

Quality Improvement; Organization of Services; Implementation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• 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)

Study Arms (2)

Implementation Facilitation

EXPERIMENTAL

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

Educational Materials

PLACEBO COMPARATOR

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

Interventions

Replicating Effective Programs plus External Facilitation OTHER

Packaging, training and technical assistance according to the Replicating Effective Programs model plus External Facilitation

Also known as: REP-F

Implementation Facilitation

Educational Materials OTHER

Dissemination of educational materials on the collaborative chronic care model for 4 or 8 months prior to cross-over to REP-F

Educational Materials

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Chart evidence of dementia

Sponsors & Collaborators

• VA Boston Healthcare System: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

VA Boston Healthcare System

Boston, Massachusetts, 02131, United States

Location

Related Publications (8)

• 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.

  PMID: 22772364 BACKGROUND

• 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.

  PMID: 23938600 BACKGROUND

• 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.

  PMID: 24129806 BACKGROUND

• 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.

  PMID: 33762023 DERIVED

• 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.

  PMID: 32131824 DERIVED

• 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.

  PMID: 31053157 DERIVED

• 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.

  PMID: 30821830 DERIVED

• 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.

  PMID: 26912342 DERIVED

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Mark S. Bauer, MD
• Organization: VA Boston Healthcare System- Center for Healthcare Organization and Implementation Research

mark.bauer@va.gov

857-364-6380

Study Officials

• Mark S Bauer, MD

  VA Boston Healthcare System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, Center for Healthcare Organization and Implementation Research

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: September 7, 2015
• Study Start: March 7, 2016
• Primary Completion: April 26, 2018
• Study Completion: April 26, 2018
• Last Updated: June 23, 2020
• Results First Posted: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)