Clinical trial NCT04178551: Consortium to Disseminate and Understand Implementation of Opioid Use Disorder Treatment
Official title: Consortium to Disseminate and Understand Implementation of Opioid Use Disorder Treatment (PII 19-321)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Medication Assisted Treatment
Keywords: Opioid Medication Assisted Treatment
Addiction, Opioid
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-11-26
Enrollment: 4834
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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 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: 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.

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

Primary outcomes:
measure: Number of patients with OUD initiating MOUD during the implementation period in implementation sites
timeFrame: The implementation period varies by site and will likely range from 6 months to 18 months
measure: Number of patients with OUD retained on MOUD at 90 days and 180 days during the implementation period (i.e. treatment retention)
timeFrame: The implementation period varies by site and will likely range from 6 months to 18 months
measure: Number of providers prescribing MOUD during implementation
timeFrame: The implementation period varies by site and will likely range from 6 months to 18 months
measure: Facilitators and barriers to implementation of MOUD
timeFrame: 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
measure: Frequency and duration of implementation strategies as measured by the Expert Recommendations for Implementing Change (ERIC) survey
timeFrame: 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
measure: Frequency and duration of Implementation Facilitation strategies as measured by facilitation tracking logs
timeFrame: Logs will be collected monthly for each site as it enters implementation phase during the course of the 3-year study
measure: Cost of implementation
timeFrame: Course of 3-year study
measure: Summary of facilitators and barriers at implementation clinics
timeFrame: The outcome will be measured 6 months post-implementation
measure: Elements of program maintained, including adaptations
timeFrame: 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
measure: Number of x-waivered providers during implementation
timeFrame: The implementation period varies by site and will likely range from 6 months to 18 months
measure: Frequency and duration of implementation strategies as measured by the Expert Recommendations for Implementing Change (ERIC) survey
timeFrame: 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
measure: Frequency and duration of implementation strategies as measured by the Expert Recommendations for Implementing Change (ERIC) survey
timeFrame: 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
measure: Frequency and duration of implementation strategies as measured by the Expert Recommendations for Implementing Change (ERIC) survey
timeFrame: 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 outcomes:
measure: Percentage of patients with OUD who experienced a fatal opioid-related or other drug overdose during implementation
timeFrame: This outcome is measured for first 12 months of the implementation phase
measure: Percentage of patients with OUD who experienced opioid-related or other drug overdose during implementation
timeFrame: This outcome is measured for first 12 months of the implementation phase
measure: Use of sedative prescriptions during implementation among patients with OUD
timeFrame: The implementation period varies by site and will likely range from 6 months to 18 months
measure: Variation in facility-level use of implementation strategies over time
timeFrame: Course of 3-year study
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham VA Medical Center, Birmingham, AL
state: Alabama
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
city: Boise
country: United States
facility: Boise VA Medical Center, Boise, ID
state: Idaho
city: Iowa City
country: United States
facility: Iowa City VA Health Care System, Iowa City, IA
state: Iowa
city: Augusta
country: United States
facility: Maine VA Medical Center, Augusta, ME
state: Maine
city: Leeds
country: United States
facility: VA Central Western Massachusetts Healthcare System, Leeds, MA
state: Massachusetts
city: Columbia
country: United States
facility: Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
state: South Carolina
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System, Salt Lake City, UT
state: Utah
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
name: William C Becker, MD
role: PRINCIPAL_INVESTIGATOR
References: