NCT05997836

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
81,424

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

17 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2023

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 1, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

November 6, 2024

Status Verified

November 1, 2024

Enrollment Period

1.3 years

First QC Date

August 1, 2023

Last Update Submit

November 4, 2024

Conditions

Keywords

collaborative care

Outcome Measures

Primary Outcomes (2)

  • 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).

  • 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 Outcomes (3)

  • Treatment cost

    Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).

  • All-cause mortality

    Primary comparison will be between pre-implementation facilitation and post-implementation facilitation (8 months after the pre-implementation administration).

  • 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)

Study Arms (4)

Wave 1

OTHER

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

Other: Implementation Facilitation

Wave 2

OTHER

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

Other: Implementation FacilitationOther: Centralized Technical Assistance

Wave 3

OTHER

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

Other: Implementation FacilitationOther: Centralized Technical Assistance

Wave 4

OTHER

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

Other: Implementation FacilitationOther: Centralized Technical Assistance

Interventions

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

Also known as: IF
Wave 1Wave 2Wave 3Wave 4

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

Also known as: CTA
Wave 2Wave 3Wave 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Note that, for mental health hospitalizations, separate sites have been identified as comparators using a balancing algorithm.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Northern Arizona VA Health Care System, Prescott, AZ

Prescott, Arizona, 86313, United States

Location

Southern Arizona VA Health Care System, Tucson, AZ

Tucson, Arizona, 85723-0001, United States

Location

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073-1003, United States

Location

Orlando VA Medical Center, Orlando, FL

Orlando, Florida, 32827, United States

Location

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

Location

Fayetteville VA Medical Center, Fayetteville, NC

Fayetteville, North Carolina, 28301-3856, United States

Location

Jackson C. Montgomery VA Medical Center, Muskogee, OK

Muskogee, Oklahoma, 74401, United States

Location

Memphis VA Medical Center, Memphis, TN

Memphis, Tennessee, 38104-2127, United States

Location

West Texas VA Health Care System, Big Spring, TX

Big Spring, Texas, 79720, United States

Location

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, 75216-7167, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

Location

White River Junction VA Medical Center, White River Junction, VT

White River Junction, Vermont, 05001-3833, United States

Location

Salem VA Medical Center, Salem, VA

Salem, Virginia, 24153-6404, United States

Location

Clarksburg Louis A. Johnson VA Medical Center, Clarksburg, WV

Clarksburg, West Virginia, 26301-4155, United States

Location

Huntington VA Medical Center, Huntington, WV

Huntington, West Virginia, 25704-9300, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2023

First Posted

August 18, 2023

Study Start

July 14, 2023

Primary Completion

October 30, 2024

Study Completion

October 30, 2025

Last Updated

November 6, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations