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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05997836
Other study ID # QUX 23-002
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date July 14, 2023
Est. completion date September 30, 2025

Study information

Verified date June 2024
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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: 1. BHIP team collaboration, as evidenced by improved scores in the Role Clarity and Team Primacy dimensions of the Team Development Measure (TDM) 2. 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 16000
Est. completion date September 30, 2025
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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
Centralized Technical Assistance
Centralized Technical Assistance involves having external experts available for ad hoc consultation related to collaborative BHIP care practices.

Locations

Country Name City State
United States West Texas VA Health Care System, Big Spring, TX Big Spring Texas
United States VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Boston Massachusetts
United States Clarksburg Louis A. Johnson VA Medical Center, Clarksburg, WV Clarksburg West Virginia
United States VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX Dallas Texas
United States Fayetteville VA Medical Center, Fayetteville, NC Fayetteville North Carolina
United States Michael E. DeBakey VA Medical Center, Houston, TX Houston Texas
United States Huntington VA Medical Center, Huntington, WV Huntington West Virginia
United States Richard L. Roudebush VA Medical Center, Indianapolis, IN Indianapolis Indiana
United States Memphis VA Medical Center, Memphis, TN Memphis Tennessee
United States Jackson C. Montgomery VA Medical Center, Muskogee, OK Muskogee Oklahoma
United States Orlando VA Medical Center, Orlando, FL Orlando Florida
United States VA Palo Alto Health Care System, Palo Alto, CA Palo Alto California
United States Northern Arizona VA Health Care System, Prescott, AZ Prescott Arizona
United States Salem VA Medical Center, Salem, VA Salem Virginia
United States Southern Arizona VA Health Care System, Tucson, AZ Tucson Arizona
United States VA Greater Los Angeles Healthcare System, West Los Angeles, CA West Los Angeles California
United States White River Junction VA Medical Center, White River Junction, VT White River Junction Vermont

Sponsors (2)

Lead Sponsor Collaborator
VA Office of Research and Development US Department of Veterans Affairs Office of Mental Health and Suicide Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Role Clarity and Team Primacy subdomains of the Team Development Measure (TDM) 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).
Primary Mental health hospitalization rate among Veterans treated within each BHIP team. 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 Treatment cost 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).
Secondary All-cause mortality 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).
Secondary Treatment costs and hospitalization data compared to non-intervention sites 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). Post-facilitation (8 months after start of implementation facilitation) and post-sustainment (12 months after post-facilitation)
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