- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05997836
Behavioral Health Interdisciplinary Program - Collaborative Chronic Care Model (BHIP-CCM) Enhancement Project 2.0 (BHIP-CCM)
Behavioral Health Interdisciplinary Program - Collaborative Chronic Care Model (BHIP-CCM) Enhancement Project 2.0 (QUE 20-026)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This quality improvement project aims to help outpatient mental health teams, known as Behavioral Health Interdisciplinary Program (BHIP) teams, adopt more collaborative care practices (consistent with the collaborative chronic care model or CCM). The investigators therefore aim to use two different implementation strategies -- centralized technical assistance and implementation facilitation -- to align BHIP teams' care practices more closely with the principles of the CCM.
The two primary outcomes of this project are:
- BHIP team collaboration, as evidenced by improved scores in the Role Clarity and Team Primacy dimensions of the Team Development Measure (TDM)
- BHIP team clinical effectiveness, as evidenced by reduction in mental health hospitalizations among Veterans treated by the BHIP teams that have received the two types of implementation strategies described above.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arizona
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Prescott, Arizona, United States, 86313
- Northern Arizona VA Health Care System, Prescott, AZ
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Tucson, Arizona, United States, 85723-0001
- Southern Arizona VA Health Care System, Tucson, AZ
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California
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Palo Alto, California, United States, 94304-1207
- VA Palo Alto Health Care System, Palo Alto, CA
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West Los Angeles, California, United States, 90073-1003
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
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Florida
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Orlando, Florida, United States, 32827
- Orlando VA Medical Center, Orlando, FL
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Indiana
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Indianapolis, Indiana, United States, 46202-2884
- Richard L. Roudebush VA Medical Center, Indianapolis, IN
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Massachusetts
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Boston, Massachusetts, United States, 02130-4817
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
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North Carolina
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Fayetteville, North Carolina, United States, 28301-3856
- Fayetteville VA Medical Center, Fayetteville, NC
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Oklahoma
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Muskogee, Oklahoma, United States, 74401
- Jackson C. Montgomery VA Medical Center, Muskogee, OK
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Tennessee
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Memphis, Tennessee, United States, 38104-2127
- Memphis VA Medical Center, Memphis, TN
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Texas
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Big Spring, Texas, United States, 79720
- West Texas VA Health Care System, Big Spring, TX
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Dallas, Texas, United States, 75216-7167
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
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Houston, Texas, United States, 77030-4211
- Michael E. DeBakey VA Medical Center, Houston, TX
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Vermont
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White River Junction, Vermont, United States, 05001-3833
- White River Junction VA Medical Center, White River Junction, VT
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Virginia
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Salem, Virginia, United States, 24153-6404
- Salem VA Medical Center, Salem, VA
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West Virginia
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Clarksburg, West Virginia, United States, 26301-4155
- Clarksburg Louis A. Johnson VA Medical Center, Clarksburg, WV
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Huntington, West Virginia, United States, 25704-9300
- Huntington VA Medical Center, Huntington, WV
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Note that treatment assignment will be at the facility level, and given the stepped wedge design, sites in Waves 2-4 will cross over from Centralized Technical Assistance to Implementation Facilitation.
- At the provider level (for completing the TDM), the primary inclusion criterion is clinicians working on BHIP Teams at the participating medical centers.
- At the patient level (for mental health hospitalizations, costs, and all-cause mortality), the primary inclusion criterion is Veterans treated by the BHIP teams at the participating medical centers.
- Note that, for mental health hospitalizations, separate sites have been identified as comparators using a balancing algorithm.
Exclusion Criteria:
- Patients with a diagnosis of dementia in the electronic medical record.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Wave 1
Study design is a stepped wedge; Wave 1 begins by receiving Implementation Facilitation
|
Implementation Facilitation involves and External Facilitator (from outside of the participating medical center) and an Internal Facilitator (from inside the participating medical center) working together to help BHIP teams within the site adopt care practices that are more consistent with the CCM
Other Names:
|
|
Other: Wave 2
Study design is a stepped wedge; Wave 2 begins by receiving Centralized Technical Assistance before crossing over to Implementation Facilitation
|
Implementation Facilitation involves and External Facilitator (from outside of the participating medical center) and an Internal Facilitator (from inside the participating medical center) working together to help BHIP teams within the site adopt care practices that are more consistent with the CCM
Other Names:
Centralized Technical Assistance involves having external experts available for ad hoc consultation related to collaborative BHIP care practices.
Other Names:
|
|
Other: Wave 3
Study design is a stepped wedge; Wave 3 begins by receiving Centralized Technical Assistance before crossing over to Implementation Facilitation
|
Implementation Facilitation involves and External Facilitator (from outside of the participating medical center) and an Internal Facilitator (from inside the participating medical center) working together to help BHIP teams within the site adopt care practices that are more consistent with the CCM
Other Names:
Centralized Technical Assistance involves having external experts available for ad hoc consultation related to collaborative BHIP care practices.
Other Names:
|
|
Other: Wave 4
Study design is a stepped wedge; Wave 4 begins by receiving Centralized Technical Assistance before crossing over to Implementation Facilitation
|
Implementation Facilitation involves and External Facilitator (from outside of the participating medical center) and an Internal Facilitator (from inside the participating medical center) working together to help BHIP teams within the site adopt care practices that are more consistent with the CCM
Other Names:
Centralized Technical Assistance involves having external experts available for ad hoc consultation related to collaborative BHIP care practices.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Role Clarity and Team Primacy subdomains of the Team Development Measure (TDM)
Time Frame: Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).
|
The TDM is a measure of team functioning, and the two listed subdomains represent the co-primary outcome for the study.
Note that, due to the stepped wedge design, only Wave 3 and Wave 4 sites will also have a pre-centralized technical assistance administration of the TDM.
Also note that the primary time frame for this outcome, as listed above, will be post-implementation facilitation (8 months after the pre-implementation administration).
Secondary analysis will also investigate one year post-implementation facilitation (20 months after the pre-implementation administration).
|
Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).
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Mental health hospitalization rate among Veterans treated within each BHIP team.
Time Frame: Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).
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Mental health hospitalizations represent a measure of clinical effectiveness (co-primary outcome for the study).
Note that, due to the stepped wedge design, only Wave 3 and Wave 4 sites will also have a pre-centralized technical assistance calculation of the mental health hospitalization rate.
Also note that the primary time frame for this outcome, as listed above, will be post-implementation facilitation (8 months after the pre-implementation administration).
Secondary analysis will also investigate one year post-implementation facilitation (20 months after the pre-implementation administration).
|
Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Treatment cost
Time Frame: Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).
|
The investigators will calculate estimated treatment costs for Veterans treated by participating BHIP teams.
Note that the primary time frame for this outcome, as listed above, will be post-implementation facilitation (8 months after the pre-implementation administration).
Secondary analysis will also investigate one year post-implementation facilitation (20 months after the pre-implementation administration).
|
Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).
|
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All-cause mortality
Time Frame: Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).
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The investigators will calculate all-cause mortality for Veterans treated by participating BHIP teams.
Note that the primary time frame for this outcome, as listed above, will be post-implementation facilitation (8 months after the pre-implementation administration).
Secondary analysis will also investigate one year post-implementation facilitation (20 months after the pre-implementation administration).
|
Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).
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Treatment costs and hospitalization data compared to non-intervention sites
Time Frame: Post-facilitation (8 months after start of implementation facilitation) and post-sustainment (12 months after post-facilitation)
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For mental health hospitalization and treatment costs, the investigators will compare results from intervention sites to other sites that did not undergo implementation facilitation (i.e.
sites from outside the trial that are similar to intervention sites on variables like facility complexity and urban/rural location).
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Post-facilitation (8 months after start of implementation facilitation) and post-sustainment (12 months after post-facilitation)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Christopher J. Miller, PhD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
- Principal Investigator: Sara J. Landes, PhD MA BA, Central Arkansas Veterans Healthcare System , Little Rock, AR
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- QUX 23-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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