NCT04178551

Brief Summary

Opioid use disorder (OUD) is a major cause of illness and death among Veterans for which effective treatment is a major priority of the Veterans Health Administration (VHA). Expanding access to alternatives to opioid medications for chronic pain management is also a leading priority. Effective medications for OUD (MOUD) are available, but their availability and use among Veterans varies across VHA. The aims of this study are to pull together the efforts of six individual pilot projects into a single project. The purpose of combining the projects is to maximize the value of the individual projects to VHA and to provide information to guide strategies to increase access and use of MOUD and alternative therapies for pain in VHA nationally. The researchers leading the individual projects will make use of their partnerships with Veterans Integrated Service Network (VISN) leaders in order to develop a combined effort toward increased dissemination and use of MOUD that spans 9 VISNs and 63 sites.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

11 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

November 10, 2025

Completed
Last Updated

November 10, 2025

Status Verified

October 1, 2025

Enrollment Period

3 years

First QC Date

November 21, 2019

Results QC Date

September 18, 2024

Last Update Submit

October 23, 2025

Conditions

Keywords

Opioid Medication Assisted TreatmentAddiction, Opioid

Outcome Measures

Primary Outcomes (6)

  • Number of Patients Within Participating Sites With OUD Initiating MOUD During the Implementation Facilitation Period in Implementation Sites. This Will be Compared to Pre-implementation.

    Data will be extracted from patients electronic health records and reported at the site level. The denominator for this measure is the number of patients within participating sites eligible to receive MOUD at the site during the target period. This outcome will be compared to pre-implementation.

    The implementation period varies by site and will likely range from 6 months to 18 months. The pre-implementation is the 12-month period before implementation.

  • Number of Patients Within Participating Sites With OUD Retained on MOUD at 90 Days During the Implementation Period (i.e. Treatment Retention). This Will be Compared to Pre-implementation.

    Data will be extracted from patients electronic health records. The denominator for this measure is the number of patients within participating sites receiving MOUD at the time of the site-specific implementation periods.

    The implementation period varies by site and will likely range from 6 months to 18 months. The pre-implementation is the 12-month period before implementation.

  • Number of Providers Prescribing MOUD During Implementation

    The number of prescribing providers will be determined by electronic health record. This is a frequency count. The outcome will be compared to pre-implementation.

    The implementation period varies by site and will likely range from 6 months to 18 months. The pre-implementation is the 12-month period before implementation.

  • Number of Unique Implementation Strategies Used as Measured by the Expert Recommendations for Implementing Change (ERIC) Survey

    Number of unique implementation strategies.

    The survey was administered 3-4 months following the start of the study as a baseline measure for comparison to follow-up.

  • Number of Providers With X-waiver During the Implementation Period

    The outcome will be measured by electronic health records. This is a frequency count of providers with X-waivers (for eligibility to prescribe buprenorphine) during the implementation phase. It will be compared to pre-implementation.

    The implementation period varies by site and will likely range from 6 months to 18 months. Pre-implementation is the 12 months prior to implementation.

  • Count of Implementation Strategies as Measured by the Expert Recommendations for Implementing Change (ERIC) Survey

    Number of unique implementation strategies .

    The survey was administered 12 months following a baseline measure (equivalent to 16 months following the start of the CONDUIT trial)

Secondary Outcomes (3)

  • Percentage of Patients With OUD Who Experienced a Fatal Opioid-related or Other Drug Overdose During Implementation

    This outcome is measured for first 12 months of the implementation phase and compared to the measure for the pre-implementation period.

  • Percentage of Patients With OUD Who Experienced Opioid-related or Other Drug Overdose During Implementation

    This outcome is measured for first 12 months of the implementation phase and is compared to the 12-month pre-implementation period.

  • Use of Sedative Prescriptions During Implementation Among Patients With OUD

    The implementation period varies by site and will likely range from 6 months to 18 months. This outcome is compared to 12-month the pre-implementation period.

Study Arms (2)

Implementation Facilitation

OTHER

The foundation of CONDUIT's implementation activities are the structured interactions between external facilitation teams and internal facilitation teams. A core set of internal facilitation activities will be used across all facilitation teams, and external facilitation teams will use additional activities based on the needs of their sites or clinical settings.

Other: Implementation Facilitation

Pre-Implementation

OTHER

The pre-implementation period was a period of needs assessment and information-gathering and served as a within-subject comparison condition.

Other: Implementation Facilitation

Interventions

The foundation of CONDUIT's implementation activities are the structured interactions between external facilitation teams and internal facilitation teams. A core set of internal facilitation activities will be used across all facilitation teams, and external facilitation teams will use additional activities based on the needs of their sites or clinical settings. The pre-implementation period served as a comparison condition

Also known as: Pre-implementation
Implementation FacilitationPre-Implementation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All Veterans on prescribed opioid treatment and/or with opioid use disorder who are enrolled at participating implementation sites.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, 35233, United States

Location

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

West Los Angeles, California, 90073, United States

Location

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045, United States

Location

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516-2770, United States

Location

Boise VA Medical Center, Boise, ID

Boise, Idaho, 83702, United States

Location

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, 52246-2208, United States

Location

Maine VA Medical Center, Augusta, ME

Augusta, Maine, 04330, United States

Location

VA Central Western Massachusetts Healthcare System, Leeds, MA

Leeds, Massachusetts, 01053-9764, United States

Location

Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC

Columbia, South Carolina, 29209, United States

Location

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148, United States

Location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
William C. Becker, MD
Organization
VA Connecticut Healthcare System

Study Officials

  • William C Becker, MD

    VA Connecticut Healthcare System West Haven Campus, West Haven, CT

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The VHA Consortium to Disseminate and Understand Implementation of Opioid Use Disorder Treatment (CONDUIT) will improve access to evidence-based MOUD and advance the science of implementation by providing an integrated, multidisciplinary approach to implementation of evidence-based MOUD across the continuum of care in VHA. CONDUIT implementation teams incorporate expertise from addiction medicine and addiction psychiatry, primary care and hospital medicine, implementation science and health economics. The foundation of CONDUIT's implementation activities are the structured interactions between external facilitation teams and internal facilitation teams. A core set of internal facilitation activities will be used across all facilitation teams, and external facilitation teams will use additional activities based on the needs of their sites or clinical settings.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2019

First Posted

November 26, 2019

Study Start

October 1, 2019

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

November 10, 2025

Results First Posted

November 10, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations