search
Back to results

Hybrid Collaborative Care Randomized Program Evaluation (BHIP-CCM)

Primary Purpose

Mental Health Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Replicating Effective Programs plus External Facilitation
Educational Materials
Sponsored by
VA Boston Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Health Disorders focused on measuring Quality Improvement, Organization of Services, Implementation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Chart evidence of dementia

Sites / Locations

  • VA Boston Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Implementation Facilitation

Educational Materials

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Veterans RAND-12 Physical Component Scores (VR-12 PCS)
Veterans RAND-Physical Component Score: Overall self-rated physical 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-Mental Component Score.
Satisfaction Index
Satisfaction Index: Overall patient satisfaction with mental health services. Higher is better. Minimum score is 12, maximum score is 72.
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)
Recovery-oriented quality of life score. Higher is better. Minimum score 0, maximum score 100.
Patient Assessment of Chronic Illness Care (PACIC)
Patient Assessment of Chronic Illness Care (PACIC): Veteran perception of coordination of and engagement with services. Higher is better. Minimum score is 1, maximum score is 33.
Team Development Measure (TDM)- Cohesion
Mean percentage of participant provider team members who strongly agreed or agreed with the cohesion domain within the Team Development Measure. Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100.
Team Development Measure (TDM)- Communication
Mean percentage of participant team members who strongly agreed or agreed with the communication domain within the Team Development Measure. Measure Description: Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100.
Team Development Measure (TDM)- Role Clarity
Mean percentage of participant team members who strongly agreed or agreed with the role clarity domain within the Team Development Measure. Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100. Missing: cohesion (3); communication (2); role clarity (1); team primacy (0).
Team Development Measure (TDM)- Team Primacy
Mean percentage of participant team members who strongly agreed or agreed with the team primacy domain within the Team Development Measure. Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100. Missing: cohesion (3); communication (2); role clarity (1); team primacy (0).
Mental Health Hospitalization Rates
Quarterly indicator (0 not hospitalized or 1 hospitalized) for mental health hospitalization in the prior three months.

Full Information

First Posted
September 4, 2015
Last Updated
June 22, 2020
Sponsor
VA Boston Healthcare System
Collaborators
US Department of Veterans Affairs
search

1. Study Identification

Unique Protocol Identification Number
NCT02543840
Brief Title
Hybrid Collaborative Care Randomized Program Evaluation
Acronym
BHIP-CCM
Official Title
Hybrid Controlled Trial to Implement Collaborative Care in General Mental Health
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 7, 2016 (Actual)
Primary Completion Date
April 26, 2018 (Actual)
Study Completion Date
April 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Boston Healthcare System
Collaborators
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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, the Office of Mental Health Operations (OMHO) has undertaken an effort to establish behavioral health interdisciplinary plans (BHIPs), which are intended to provide General Mental Health (GMH) care throughout the Department of Veterans Affairs (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 Veterans Affairs Medical Center (VAMC) establish at least one BHIP in the current initial phase (begun in late fiscal year 2013), 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 mental health, both within and beyond VA. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Disorders
Keywords
Quality Improvement, Organization of Services, Implementation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Implementation Facilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
Educational Materials
Arm Type
Placebo Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Replicating Effective Programs plus External Facilitation
Other Intervention Name(s)
REP-F
Intervention Description
Packaging, training and technical assistance according to the Replicating Effective Programs model plus External Facilitation
Intervention Type
Other
Intervention Name(s)
Educational Materials
Intervention Description
Dissemination of educational materials on the collaborative chronic care model for 4 or 8 months prior to cross-over to REP-F
Primary Outcome Measure Information:
Title
Veterans RAND-12 Mental Component Score (VR-12 MCS)
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Veterans RAND-12 Physical Component Scores (VR-12 PCS)
Description
Veterans RAND-Physical Component Score: Overall self-rated physical 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-Mental Component Score.
Time Frame
One year
Title
Satisfaction Index
Description
Satisfaction Index: Overall patient satisfaction with mental health services. Higher is better. Minimum score is 12, maximum score is 72.
Time Frame
One year
Title
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)
Description
Recovery-oriented quality of life score. Higher is better. Minimum score 0, maximum score 100.
Time Frame
One year
Title
Patient Assessment of Chronic Illness Care (PACIC)
Description
Patient Assessment of Chronic Illness Care (PACIC): Veteran perception of coordination of and engagement with services. Higher is better. Minimum score is 1, maximum score is 33.
Time Frame
One year
Title
Team Development Measure (TDM)- Cohesion
Description
Mean percentage of participant provider team members who strongly agreed or agreed with the cohesion domain within the Team Development Measure. Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100.
Time Frame
baseline and during stepdown (6-12 months)
Title
Team Development Measure (TDM)- Communication
Description
Mean percentage of participant team members who strongly agreed or agreed with the communication domain within the Team Development Measure. Measure Description: Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100.
Time Frame
baseline and during stepdown (6-12 months)
Title
Team Development Measure (TDM)- Role Clarity
Description
Mean percentage of participant team members who strongly agreed or agreed with the role clarity domain within the Team Development Measure. Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100. Missing: cohesion (3); communication (2); role clarity (1); team primacy (0).
Time Frame
baseline and during stepdown (6-12 months)
Title
Team Development Measure (TDM)- Team Primacy
Description
Mean percentage of participant team members who strongly agreed or agreed with the team primacy domain within the Team Development Measure. Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100. Missing: cohesion (3); communication (2); role clarity (1); team primacy (0).
Time Frame
baseline and during stepdown (6-12 months)
Title
Mental Health Hospitalization Rates
Description
Quarterly indicator (0 not hospitalized or 1 hospitalized) for mental health hospitalization in the prior three months.
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark S Bauer, MD
Organizational Affiliation
VA Boston Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Boston Healthcare System
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22772364
Citation
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.
Results Reference
background
PubMed Identifier
23938600
Citation
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.
Results Reference
background
PubMed Identifier
24129806
Citation
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.
Results Reference
background
PubMed Identifier
33762023
Citation
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.
Results Reference
derived
PubMed Identifier
32131824
Citation
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.
Results Reference
derived
PubMed Identifier
31053157
Citation
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.
Results Reference
derived
PubMed Identifier
30821830
Citation
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.
Results Reference
derived
PubMed Identifier
26912342
Citation
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.
Results Reference
derived

Learn more about this trial

Hybrid Collaborative Care Randomized Program Evaluation

We'll reach out to this number within 24 hrs