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Clinical Trials/NCT04178551
NCT04178551CompletedNot Applicable

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

VA Office of Research and Development22 sites in 1 country63 target enrollmentStarted: October 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
63
Locations
22
Primary Endpoint
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.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

Pre-Implementation

Other

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

Intervention: Implementation Facilitation (Other)

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.

Intervention: Implementation Facilitation (Other)

Outcomes

Primary Outcomes

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.

Time Frame: 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.

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.

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.

Time Frame: 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.

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.

Number of Providers Prescribing MOUD During Implementation

Time Frame: 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.

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.

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

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

Number of unique implementation strategies.

Number of Providers With X-waiver During the Implementation Period

Time Frame: 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.

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.

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

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

Number of unique implementation strategies .

Secondary Outcomes

  • 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.)

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (22)

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