Mental Health Clinical Trial
— BHIP-CCMOfficial title:
Behavioral Health Interdisciplinary Program - Collaborative Chronic Care Model (BHIP-CCM) Enhancement Project 2.0 (QUE 20-026)
Verified date | June 2024 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development | US Department of Veterans Affairs Office of Mental Health and Suicide Prevention |
United States,
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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