Trial Outcomes & Findings for Consortium to Disseminate and Understand Implementation of Opioid Use Disorder Treatment (NCT NCT04178551)
NCT ID: NCT04178551
Last Updated: 2025-11-10
Results Overview
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.
COMPLETED
NA
63 participants
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.
2025-11-10
Participant Flow
Individual projects within CONDUIT conducted outreach to VA sites that might benefit from implementation facilitation strategies to support medications for opioid use disorder. Sites opted in/out to receive implementation facilitation. VA Facility Sites were enrolled in the study; patients and providers were not considered enrolled.
In this study, the intervention occurred at the site level. Site was the level of analysis. Sites advanced from the pre-implementation to implementation phase upon agreement by internal and external facilitation teams.
Unit of analysis: VA Facility Sites
Participant milestones
| Measure |
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.
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.
|
|---|---|
|
Pre-Implementation (12 Months)
STARTED
|
0 63
|
|
Pre-Implementation (12 Months)
COMPLETED
|
0 46
|
|
Pre-Implementation (12 Months)
NOT COMPLETED
|
0 17
|
|
Implementation Facilitation (6-18 Mos)
STARTED
|
0 46
|
|
Implementation Facilitation (6-18 Mos)
COMPLETED
|
0 46
|
|
Implementation Facilitation (6-18 Mos)
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Consortium to Disseminate and Understand Implementation of Opioid Use Disorder Treatment
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Implementation Facilitation Period
n=5127 Participants
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.
The start date of the implementation facilitation period for each site was reported by the study PI.
|
Pre-Implementation Period
n=3261 Participants
Pre-implementation period defined as the 12 months prior to the implementation start date for each site.
|
|---|---|---|
|
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.
|
2116 patients within participating sites
|
974 patients within participating sites
|
PRIMARY outcome
Timeframe: 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.Population: Among Veterans/patients with MOUD initiation, we assessed continued MOUD use, identified as prescription fills for 90 days with no lapses \> 30 days. Patients identified as initiating MOUD treatment in a Substance Use Disorder (SUD) clinic were excluded. Patients are counted as retained if they have at least 90 days between first and last SUD visit within phase, without a break \> 30 days.
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.
Outcome measures
| Measure |
Implementation Facilitation Period
n=1846 Participants
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.
The start date of the implementation facilitation period for each site was reported by the study PI.
|
Pre-Implementation Period
n=727 Participants
Pre-implementation period defined as the 12 months prior to the implementation start date for each site.
|
|---|---|---|
|
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.
|
1017 patients within participating sites
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357 patients within participating sites
|
PRIMARY outcome
Timeframe: 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.Population: Prescribers are considered active and having an X-waiver in phase if they held an x-waiver any time from the first day of the month the phase started to the last day of the month the phase ended and had prescribed buprenorphine any time in the 6 months prior. Prescribers are considered having an X-waiver (i.e., eligible to prescribe buprenorphine) in phase if they held an x-waiver any time from the first day of the month the phase started to the last day of the month the phase ended.
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.
Outcome measures
| Measure |
Implementation Facilitation Period
n=1554 Participants
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.
The start date of the implementation facilitation period for each site was reported by the study PI.
|
Pre-Implementation Period
n=1128 Participants
Pre-implementation period defined as the 12 months prior to the implementation start date for each site.
|
|---|---|---|
|
Number of Providers Prescribing MOUD During Implementation
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474 prescribers in participating sites
|
258 prescribers in participating sites
|
PRIMARY outcome
Timeframe: The survey was administered 3-4 months following the start of the study as a baseline measure for comparison to follow-up.Population: Respondents to ERIC survey
Number of unique implementation strategies.
Outcome measures
| Measure |
Implementation Facilitation Period
n=24 Participants
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.
The start date of the implementation facilitation period for each site was reported by the study PI.
|
Pre-Implementation Period
Pre-implementation period defined as the 12 months prior to the implementation start date for each site.
|
|---|---|---|
|
Number of Unique Implementation Strategies Used as Measured by the Expert Recommendations for Implementing Change (ERIC) Survey
|
6 Number implementation strategies
|
—
|
PRIMARY outcome
Timeframe: 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.Population: Prescriber data comes from a custom extract similar to the X-Waiver/buprenorphine prescriber report, which details providers holding a Drug Enforcement Administration (DEA) X-waiver on a monthly level.
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.
Outcome measures
| Measure |
Implementation Facilitation Period
n=1554 Participants
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.
The start date of the implementation facilitation period for each site was reported by the study PI.
|
Pre-Implementation Period
n=1128 Participants
Pre-implementation period defined as the 12 months prior to the implementation start date for each site.
|
|---|---|---|
|
Number of Providers With X-waiver During the Implementation Period
|
1554 count of prescribers
|
1128 count of prescribers
|
PRIMARY outcome
Timeframe: The survey was administered 12 months following a baseline measure (equivalent to 16 months following the start of the CONDUIT trial)Population: Respondents to ERIC survey
Number of unique implementation strategies .
Outcome measures
| Measure |
Implementation Facilitation Period
n=41 Participants
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.
The start date of the implementation facilitation period for each site was reported by the study PI.
|
Pre-Implementation Period
Pre-implementation period defined as the 12 months prior to the implementation start date for each site.
|
|---|---|---|
|
Count of Implementation Strategies as Measured by the Expert Recommendations for Implementing Change (ERIC) Survey
|
10 Number implementation strategies
|
—
|
SECONDARY outcome
Timeframe: This outcome is measured for first 12 months of the implementation phase and compared to the measure for the pre-implementation period.Population: We used the suicide navigator data from PERC to identify fatal and non-fatal overdose events. Cohort is defined as veterans who had a visit with an associated OUD diagnosis during the relevant phases. Patients must be observed in phase for at least 30 days. Overdose - Veterans experienced an overdose if we find any recorded overdose events within the first 12 months of the phase. Overdoses are not exclusively opioid-related, and include only fatal events.
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.
Outcome measures
| Measure |
Implementation Facilitation Period
n=6289 Participants
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.
The start date of the implementation facilitation period for each site was reported by the study PI.
|
Pre-Implementation Period
n=5325 Participants
Pre-implementation period defined as the 12 months prior to the implementation start date for each site.
|
|---|---|---|
|
Percentage of Patients With OUD Who Experienced a Fatal Opioid-related or Other Drug Overdose During Implementation
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: This outcome is measured for first 12 months of the implementation phase and is compared to the 12-month pre-implementation period.Population: We used the suicide navigator data from PERC to identify fatal and non-fatal overdose events. Cohort is defined as veterans who had a visit with an associated OUD diagnosis during the relevant phases. Patients must be observed in phase for at least 30 days. Overdose - Veterans experienced an overdose if we find any recorded overdose events within the first 12 months of the phase. Overdoses are not exclusively opioid-related, and include both fatal and non-fatal events.
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.
Outcome measures
| Measure |
Implementation Facilitation Period
n=6289 Participants
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.
The start date of the implementation facilitation period for each site was reported by the study PI.
|
Pre-Implementation Period
n=5325 Participants
Pre-implementation period defined as the 12 months prior to the implementation start date for each site.
|
|---|---|---|
|
Percentage of Patients With OUD Who Experienced Opioid-related or Other Drug Overdose During Implementation
|
272 Participants
|
188 Participants
|
SECONDARY outcome
Timeframe: 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.Population: Patients were counted as having a prescription for benzodiazepines if they were dispensed at least 1 prescription of benzodiazepines at any time during the phase. Patients were included in the numerator if they had a qualifying prescription during the phase. They were included in the denominator for each phase in which they had a qualifying opioid use disorder diagnosis.
This is the count/percentage of people exposed to any sedative prescriptions as determined by patients' electronic health records.
Outcome measures
| Measure |
Implementation Facilitation Period
n=4872 Participants
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.
The start date of the implementation facilitation period for each site was reported by the study PI.
|
Pre-Implementation Period
n=3037 Participants
Pre-implementation period defined as the 12 months prior to the implementation start date for each site.
|
|---|---|---|
|
Use of Sedative Prescriptions During Implementation Among Patients With OUD
|
1538 Participants
|
888 Participants
|
Adverse Events
Implementation Facilitation
Comparison Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place