Consortium to Disseminate and Understand Implementation of Opioid Use Disorder Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Opioid Medication Assisted Treatment

Intervention / Treatment
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* Other: Implementation Facilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -All Veterans on prescribed opioid treatment and/or with opioid use disorder who are enrolled at participating implementation sites. Exclusion Criteria: -None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Implementation Facilitation<br>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<br>* 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.<br>|
| No Intervention: Comparison Cohort<br>All other sites in VA not receiving CONDUIT implementation support or participating in other dedicated MOUD implementation activities during the same time period | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 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. | This outcome is measured for first 12 months of the implementation phase | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid Medication Assisted Treatment, Addiction, Opioid