Consortium to Disseminate and Understand Implementation of Opioid Use Disorder Treatment

Opioid Medication Assisted Treatment Clinical Trial

— CONDUIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04178551
• Other study ID #: PIX 19-001
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: December 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 VISN leaders in order to develop a combined effort toward increased dissemination and use of MOUD that spans 9 VISNs and 62 sites.

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 62 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4834
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-None

Related Conditions & MeSH terms

• Opioid Medication Assisted Treatment
• Opioid-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Maine VA Medical Center, Augusta, ME	Augusta	Maine
United States	Rocky Mountain Regional VA Medical Center, Aurora, CO	Aurora	Colorado
United States	Birmingham VA Medical Center, Birmingham, AL	Birmingham	Alabama
United States	Boise VA Medical Center, Boise, ID	Boise	Idaho
United States	Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC	Columbia	South Carolina
United States	Iowa City VA Health Care System, Iowa City, IA	Iowa City	Iowa
United States	VA Central Western Massachusetts Healthcare System, Leeds, MA	Leeds	Massachusetts
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	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut
United States	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with OUD initiating MOUD during the implementation period in implementation sites	Data will be extracted from patients electronic health records. The denominator for this measure is the number of patients eligible to receive MOUD at the site during the target period.	The implementation period varies by site and will likely range from 6 months to 18 months
Primary	Number of patients with OUD retained on MOUD at 90 days and 180 days during the implementation period (i.e. treatment retention)	Data will be extracted from patients electronic health records. The denominator for this measure is the number of patients 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
Primary	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 implementation period varies by site and will likely range from 6 months to 18 months
Primary	Facilitators and barriers to implementation of MOUD	Interviews with and structured data collected from facilitation teams working with each site will determine facilitators and barriers.	The outcome will be measured during pre-implementation and implementation phases. The timeframe for the measure will vary by site and will likely vary from 6 months to 2 years
Primary	Frequency and duration of implementation strategies as measured by the Expert Recommendations for Implementing Change (ERIC) survey	The survey will be administered to points-of-contact at each project site; Points-of-contact will be identified by CONDUIT personnel for each site as individuals knowledgeable about MOUD services provided.	This administration of the survey was planned for the beginning of the 3 year project period; However, initial administration of survey to capture pre-implementation period was shifted by 3-4 months due to staffing disruptions as a result of the COVID-19
Primary	Frequency and duration of Implementation Facilitation strategies as measured by facilitation tracking logs	Implementation facilitation tracking logs will be completed each month by External Facilitators, Internal Facilitators, or both for each site in implementation phase; Implementation facilitation logs will track the nature and frequency of implementation facilitation activities at each site.	Logs will be collected monthly for each site as it enters implementation phase during the course of the 3-year study
Primary	Cost of implementation	For the purpose of evaluating cost per additional Veteran initiating MOUD, using data from electronic health records and implementation logs, costs of implementation activities will be assigned and summed for each site.	Course of 3-year study
Primary	Summary of facilitators and barriers at implementation clinics	Interviews with and structured data collected from facilitation teams working with each site will determine post-implementation facilitators and barriers.	The outcome will be measured 6 months post-implementation
Primary	Elements of program maintained, including adaptations	Interviews	The post-implementation period will vary by site, and will likely range from 6 months to 1 year following conclusion of 3 year study period
Primary	Number of x-waivered providers during implementation	The outcome will be measured by electronic health records. This is a frequency count of providers.	The implementation period varies by site and will likely range from 6 months to 18 months
Primary	Frequency and duration of implementation strategies as measured by the Expert Recommendations for Implementing Change (ERIC) survey	The survey will be administered to points-of-contact at each project site; Points-of-contact will be identified by CONDUIT personnel for each site as individuals knowledgeable about MOUD services provided.	This administration of the ERIC survey will occur at approximately the end of year 1; annual timeline of survey was shifted by 3-4 months due to initial administration of survey delayed as a result of the COVID-19 pandemic
Primary	Frequency and duration of implementation strategies as measured by the Expert Recommendations for Implementing Change (ERIC) survey	The survey will be administered to points-of-contact at each project site; Points-of-contact will be identified by CONDUIT personnel for each site as individuals knowledgeable about MOUD services provided.	This administration of the ERIC survey will occur at approximately the end of year 2; annual timeline of survey was shifted by 3-4 months due to initial administration of survey delayed as a result of the COVID-19 pandemic
Primary	Frequency and duration of implementation strategies as measured by the Expert Recommendations for Implementing Change (ERIC) survey	The survey will be administered to points-of-contact at each project site; Points-of-contact will be identified by CONDUIT personnel for each site as individuals knowledgeable about MOUD services provided.	This administration of the ERIC survey will occur at approximately the end of year 3; annual timeline of survey was shifted by 3-4 months due to initial administration of survey delayed as a result of the COVID-19 pandemic
Secondary	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.	This outcome is measured for first 12 months of the implementation phase
Secondary	Percentage of patients with OUD who experienced opioid-related or other drug overdose during implementation	Data will be extracted from patients electronic health records.	This outcome is measured for first 12 months of the implementation phase
Secondary	Use of sedative prescriptions during implementation among patients with OUD	The number and type of sedative prescriptions will be extracted from patients electronic health records	The implementation period varies by site and will likely range from 6 months to 18 months
Secondary	Variation in facility-level use of implementation strategies over time	Using data from implementation facilitation tracking logs, sites (i.e., facilities) will be compared with respect to the nature and frequency of implementation strategies used over the course of the study	Course of 3-year study