Consortium to Disseminate and Understand Implementation of Opioid Use Disorder Treatment (CONDUIT)

Consortium to Disseminate and Understand Implementation of Opioid Use Disorder Treatment (PII 19-321)

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.

Study Overview

• Status: Completed
• Conditions: Opioid Medication Assisted Treatment
• Intervention / Treatment: Other: Implementation Facilitation

Detailed Description

Opioid use disorder (OUD) is a major cause of morbidity and mortality among Veterans and a high-priority target for quality improvement in the Veterans Health Administration (VHA). Effective medications for OUD (MOUD) are available but uptake of them has been highly variable across VHA. Additionally, VHA has been at the forefront in the U.S. in promoting alternative therapies for pain, but these are not consistently available to Veterans in great need of them: those with chronic pain and harmful opioid use. VHA, through its Office of Mental Health and Suicide Prevention, has made access to MOUD for all Veterans who need it a system-wide priority. However, successful implementation of complex care processes that face myriad barriers requires intentional, structured, evidence-based implementation efforts carried out by expert teams in close partnership with local leadership.

As such, the overarching goal of this project - the Consortium to Disseminate and Understand Implementation of Opioid Use Disorder Treatment (CONDUIT) -- is to unite six inter-related VISN/QUERI pilot Partnered Implementation Initiative projects in a concerted effort to improve access to MOUD among Veterans with OUD and access to alternative therapies for pain in 63 VHA sites spanning nine VISNs. CONDUIT will span four critical care settings in the OUD continuum of care: Primary Care; Specialty Care; Acute Care (inpatient and Emergency Department); and Telehealth. These efforts will be connected by Veteran Engagement, Implementation, and Quantitative/Economic Cores that will help CONDUIT teams harmonize on metrics, processes and outcomes. There will also be a Strategic Advisory Group composed of Operations leaders and Veterans that will help CONDUIT remain maximally aligned with VHA and Veteran priorities. CONDUIT will also offer sites the opportunity to implement new evidence-based practices (i.e. ones that were not part of initial launch) in the latter half of the project period.

The methods deployed by each of the CONDUIT teams will be similar: expert "external facilitation" teams will lead partnered "internal facilitation" teams at local sites in a process called "Implementation Facilitation (IF)" - a multi-component suite of tools aimed to help the sites effectively adopt evidence-based practices. The six projects piloted and systematically modified IF strategies in Phase 1 and now propose to disseminate those sharpened strategies on a national scale over the next three years, including new VISNs and dozens of additional sites. In terms of evaluation, CONDUIT will use well-established formative evaluation methods to assess the effectiveness of and to drive refinements to the IF strategies. Additionally, CONDUIT will use cutting edge quantitative methods to assess the impact the work on important clinical targets and to assess the value of the work in terms of costs vs. benefits. Throughout the project period, teams will develop and refine products such as patient and provider educational materials, prescribing and communication guides, and clinic operations manuals. These evaluation and product development efforts will prime successful scale-up and dissemination efforts throughout VHA.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Birmingham VA Medical Center, Birmingham, AL
  • California
    • West Los Angeles, California, United States, 90073
      • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Rocky Mountain Regional VA Medical Center, Aurora, CO
  • Connecticut
    • West Haven, Connecticut, United States, 06516-2770
      • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
  • Idaho
    • Boise, Idaho, United States, 83702
      • Boise VA Medical Center, Boise, ID
  • Iowa
    • Iowa City, Iowa, United States, 52246-2208
      • Iowa City VA Health Care System, Iowa City, IA
  • Maine
    • Augusta, Maine, United States, 04330
      • Maine VA Medical Center, Augusta, ME
  • Massachusetts
    • Leeds, Massachusetts, United States, 01053-9764
      • VA Central Western Massachusetts Healthcare System, Leeds, MA
  • South Carolina
    • Columbia, South Carolina, United States, 29209
      • Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
  • Utah
    • Salt Lake City, Utah, United States, 84148
      • VA Salt Lake City Health Care System, Salt Lake City, UT
  • Washington
    • Seattle, Washington, United States, 98108
      • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

-None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Implementation Facilitation; 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; 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; Other Names: Pre-implementation
Other: Pre-Implementation; The pre-implementation period was a period of needs assessment and information-gathering and served as a within-subject comparison condition.	Other: Implementation Facilitation; 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; Other Names: Pre-implementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With OUD Who Experienced a Fatal Opioid-related or Other Drug Overdose During Implementation	Data will be extracted from patients electronic health records. Patients experienced an overdose if we observe any recorded overdose events within the first 12 months of the phase. Overdoses are not exclusively opioid-related, but include only fatal events. Counts in the first 12 months of the implementation facilitation period are compared to counts in the 12-month pre-implementation period.	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	Data will be extracted from patients electronic health records. Patients experienced an overdose if we observe any recorded overdose events within the first 12 months of the phase. Overdoses are not exclusively opioid-related, and include both fatal and nonfatal events. Counts in the first 12 months of the implementation facilitation period are compared to counts in the 12-month pre-implementation period.	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	This is the count/percentage of people exposed to any sedative prescriptions as determined by patients' electronic health records.	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.

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: William C Becker, MD, VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Estimated): November 7, 2025
• Last Update Submitted That Met QC Criteria: October 23, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Opioid Medication Assisted Treatment; Addiction, Opioid
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders
• Other Study ID Numbers: PIX 19-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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