Behavioral Health Interdisciplinary Program - Collaborative Chronic Care Model (BHIP-CCM) Enhancement Project 2.0

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Recruiting
CT.gov ID
NCT05997836
Collaborator
US Department of Veterans Affairs Office of Mental Health and Suicide Prevention (Other)
16,000
9
4
25
1777.8
71

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Implementation Facilitation
  • Other: Centralized Technical Assistance
N/A

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:
  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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16000 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
This study will use a stepped wedge design, with participating medical centers assigned to one of four different waves. Wave 1 will begin the trial receiving implementation facilitation. Waves 2-4 will begin the trial receiving centralized technical assistance, and will then cross over to implementation facilitation.This study will use a stepped wedge design, with participating medical centers assigned to one of four different waves. Wave 1 will begin the trial receiving implementation facilitation. Waves 2-4 will begin the trial receiving centralized technical assistance, and will then cross over to implementation facilitation.
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Behavioral Health Interdisciplinary Program - Collaborative Chronic Care Model (BHIP-CCM) Enhancement Project 2.0 (QUE 20-026)
Actual Study Start Date :
Jul 14, 2023
Anticipated Primary Completion Date :
Aug 14, 2024
Anticipated Study Completion Date :
Aug 14, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: Wave 1

Study design is a stepped wedge; Wave 1 begins by receiving Implementation Facilitation

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
Other Names:
  • IF
  • Other: Wave 2

    Study design is a stepped wedge; Wave 2 begins by receiving Centralized Technical Assistance before crossing over to Implementation Facilitation

    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
    Other Names:
  • IF
  • Other: Centralized Technical Assistance
    Centralized Technical Assistance involves having external experts available for ad hoc consultation related to collaborative BHIP care practices.
    Other Names:
  • CTA
  • Other: Wave 3

    Study design is a stepped wedge; Wave 3 begins by receiving Centralized Technical Assistance before crossing over to Implementation Facilitation

    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
    Other Names:
  • IF
  • Other: Centralized Technical Assistance
    Centralized Technical Assistance involves having external experts available for ad hoc consultation related to collaborative BHIP care practices.
    Other Names:
  • CTA
  • Other: Wave 4

    Study design is a stepped wedge; Wave 4 begins by receiving Centralized Technical Assistance before crossing over to Implementation Facilitation

    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
    Other Names:
  • IF
  • Other: Centralized Technical Assistance
    Centralized Technical Assistance involves having external experts available for ad hoc consultation related to collaborative BHIP care practices.
    Other Names:
  • CTA
  • Outcome Measures

    Primary Outcome Measures

    1. Role Clarity and Team Primacy subdomains of the Team Development Measure (TDM) [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).

    2. Mental health hospitalization rate among Veterans treated within each BHIP team. [Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).]

      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).

    Secondary Outcome Measures

    1. Treatment cost [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).

    2. All-cause mortality [Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).]

      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).

    3. Treatment costs and hospitalization data compared to non-intervention sites [Post-facilitation (8 months after start of implementation facilitation) and post-sustainment (12 months after post-facilitation)]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Exclusion Criteria:
    • Patients with a diagnosis of dementia in the electronic medical record.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 VA Palo Alto Health Care System, Palo Alto, CA Palo Alto California United States 94304-1207
    2 VA Greater Los Angeles Healthcare System, West Los Angeles, CA West Los Angeles California United States 90073-1003
    3 Orlando VA Medical Center, Orlando, FL Orlando Florida United States 32827
    4 Richard L. Roudebush VA Medical Center, Indianapolis, IN Indianapolis Indiana United States 46202-2884
    5 VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Boston Massachusetts United States 02130-4817
    6 West Texas VA Health Care System, Big Spring, TX Big Spring Texas United States 79720
    7 White River Junction VA Medical Center, White River Junction, VT White River Junction Vermont United States 05001-3833
    8 Salem VA Medical Center, Salem, VA Salem Virginia United States 24153-6404
    9 Clarksburg Louis A. Johnson VA Medical Center, Clarksburg, WV Clarksburg West Virginia United States 26301-4155

    Sponsors and Collaborators

    • VA Office of Research and Development
    • US Department of Veterans Affairs Office of Mental Health and Suicide Prevention

    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 Eugene J. Towbin Healthcare Center, Little Rock, AR

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT05997836
    Other Study ID Numbers:
    • QUX 23-002
    First Posted:
    Aug 18, 2023
    Last Update Posted:
    Aug 18, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by VA Office of Research and Development

    Study Results

    No Results Posted as of Aug 18, 2023