Consortium to Disseminate and Understand Implementation of Opioid Use Disorder Treatment

NCT ID: NCT04178551

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2022-09-30

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.

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.

Conditions

Opioid Medication Assisted Treatment

Keywords

Opioid Medication Assisted Treatment; Addiction, Opioid

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Implementation Facilitation

Intervention Type: 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.

The pre-implementation period served as a comparison condition

Pre-Implementation

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

Group Type: OTHER

Implementation Facilitation

Intervention Type: 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.

The pre-implementation period served as a comparison condition

Interventions

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

Intervention Type: OTHER

Other Intervention Names

Pre-implementation

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

-None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William C Becker, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, United States

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

West Los Angeles, California, United States

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, United States

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

West Haven, Connecticut, United States

Boise VA Medical Center, Boise, ID

Boise, Idaho, United States

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, United States

Maine VA Medical Center, Augusta, ME

Augusta, Maine, United States

VA Central Western Massachusetts Healthcare System, Leeds, MA

Leeds, Massachusetts, United States

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

Columbia, South Carolina, United States

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

Salt Lake City, Utah, United States

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

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PIX 19-001

Identifier Type: -

Identifier Source: org_study_id