Opioid Medication Assisted TreatmentCONDUITNCT04178551
Consortium to Disseminate and Understand Implementation of Opioid Use Disorder Treatment
A study testing Implementation Facilitation in people with Opioid Medication Assisted Treatment, run by VA Office of Research and Development at 11 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Opioid Medication Assisted Treatment
- What is being tested?
- Implementation Facilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 11 sitesUnited States
- Study dates
- 1 Oct 2019to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -All Veterans on prescribed opioid treatment and/or with opioid use disorder who are enrolled at participating implementation sites.
Who cannot join
- -None
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Maine VA Medical Center, Augusta, ME
Augusta, Maine, 04330
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, 35233
Boise VA Medical Center, Boise, ID
Boise, Idaho, 83702
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
Columbia, South Carolina, 29209
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, 52246-2208
VA Central Western Massachusetts Healthcare System, Leeds, MA
Leeds, Massachusetts, 01053-9764
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073
About this study
Official title: Consortium to Disseminate and Understand Implementation of Opioid Use Disorder Treatment (PII 19-321)
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.
Read the 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
- Being tested
- Implementation Facilitation
- Keywords
- Opioid Medication Assisted Treatment, Addiction, Opioid
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation FacilitationOther
Also called Pre-implementation
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Implementation Facilitation |
| Pre-Implementation | Other | The pre-implementation period was a period of needs assessment and information-gathering and served as a within-subject comparison condition. Receives: Other: Implementation Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 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.
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.
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.
Measured: 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.
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 outcome will be compared to pre-implementation.
Measured: 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.
Number of Unique Implementation Strategies Used as Measured by the Expert Recommendations for Implementing Change (ERIC) Survey
Number of unique implementation strategies.
Measured: The survey was administered 3-4 months following the start of the study as a baseline measure for comparison to follow-up.
Number of Providers With X-waiver During the Implementation Period
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.
Measured: 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.
Count of Implementation Strategies as Measured by the Expert Recommendations for Implementing Change (ERIC) Survey
Number of unique implementation strategies .
Measured: The survey was administered 12 months following a baseline measure (equivalent to 16 months following the start of the CONDUIT trial)
Secondary outcomes (3)
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. Patients experienced an overdose if we observe any recorded overdose events within the first 12 months of the phase. Overdoses are not exclusively opioid-related, but include only fatal events. Counts in the first 12 months of the implementation facilitation period are compared to counts in the 12-month pre-implementation period.
Measured: 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
Data will be extracted from patients electronic health records. Patients experienced an overdose if we observe any recorded overdose events within the first 12 months of the phase. Overdoses are not exclusively opioid-related, and include both fatal and nonfatal events. Counts in the first 12 months of the implementation facilitation period are compared to counts in the 12-month pre-implementation period.
Measured: 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
This is the count/percentage of people exposed to any sedative prescriptions as determined by patients' electronic health records.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start1 Oct 2019
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid Medication Assisted TreatmentStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- William C Becker, MD, Principal investigator, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178551
- Sponsor's protocol ID
- PIX 19-001
- Acronym
- CONDUIT
- Status last verified
- Oct 2025
- First submitted
- 21 Nov 2019
- Last updated
- 10 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consortium to Disseminate and Understand Implementation of Opioid Use Disorder Treatment (PII 19-321)
- ClinicalTrials.gov ID
- NCT04178551
- Acronym / sponsor ID
- CONDUIT / PIX 19-001
- Conditions
- Opioid Medication Assisted Treatment
- Keywords
- Opioid Medication Assisted Treatment, Addiction, Opioid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 26 Nov 2019 (actual)
- Results
- Posted 10 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Implementation Facilitation | Other | Other: Implementation FacilitationThe 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. |
| Pre-Implementation | Other | Other: Implementation FacilitationThe pre-implementation period was a period of needs assessment and information-gathering and served as a within-subject comparison condition. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -All Veterans on prescribed opioid treatment and/or with opioid use disorder who are enrolled at participating implementation sites.
Key exclusion criteria (1 listed)
- -None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation FacilitationAlso: Pre-implementationThe 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 | Other | Implementation Facilitation, Pre-Implementation |
Primary outcome
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 .
3 secondary outcomes
Percentage of Patients With OUD Who Experienced a Fatal Opioid-related or Other Drug Overdose During Implementation
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William C Becker, MD principal investigator
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation Facilitation in people with Opioid Medication Assisted Treatment, run by VA Office of Research and Development at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.