search
Back to results

Consortium to Disseminate and Understand Implementation of Opioid Use Disorder Treatment (CONDUIT)

Primary Purpose

Opioid Medication Assisted Treatment

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Implementation Facilitation
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Medication Assisted Treatment focused on measuring Opioid Medication Assisted Treatment, Addiction, Opioid

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-None

Sites / Locations

  • Birmingham VA Medical Center, Birmingham, AL
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  • Rocky Mountain Regional VA Medical Center, Aurora, CO
  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
  • Boise VA Medical Center, Boise, ID
  • Iowa City VA Health Care System, Iowa City, IA
  • Maine VA Medical Center, Augusta, ME
  • VA Central Western Massachusetts Healthcare System, Leeds, MA
  • Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
  • VA Salt Lake City Health Care System, Salt Lake City, UT
  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Implementation Facilitation

Comparison Cohort

Arm Description

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.

All other sites in VA not receiving CONDUIT implementation support or participating in other dedicated MOUD implementation activities during the same time period

Outcomes

Primary Outcome Measures

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.
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.
Number of providers (and/or clinics) providing MOUD post-implementation, stratified by type of provider, clinical setting
The number of prescribing providers will be determined by electronic health record. The denominator for this measure will be the number of providers eligible to prescribe MOUD at each site.
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.
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.
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.
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.
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.
Elements of program maintained, including adaptations
Interviews
Number of x-waivered and prescribing providers
The outcome will be measured by electronic health records. The denominator for this measure is the number of providers at each site eligible to prescribe MOUD.
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.
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.
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.

Secondary Outcome Measures

Hospitalizations and Emergency Department visits related to OUD post-implementation
Data will be extracted from patients electronic health records.
Opioid-related or other drug overdoses in patients with OUD post-implementation
Data will be extracted from patients electronic health records.
Opioid dose for patients on long-term opioid treatment post-implementation
Medication dose will be extracted from patients electronic health records
Concomitant opioid-sedative prescriptions post-implementation
The number and type of opioid-sedative prescriptions will be extracted from patients electronic health records
Number of x-waivered providers post-implementation
The outcome will be extracted from the electronic health record. The denominator for this measure will be the number of providers eligible for x-waiver.
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
Number of OUD patients receiving MOUD
This outcome will be assessed using electronic health records. The denominator for the measure will be the number of patients with OUD during the target period.

Full Information

First Posted
November 21, 2019
Last Updated
October 26, 2022
Sponsor
VA Office of Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT04178551
Brief Title
Consortium to Disseminate and Understand Implementation of Opioid Use Disorder Treatment
Acronym
CONDUIT
Official Title
Consortium to Disseminate and Understand Implementation of Opioid Use Disorder Treatment (PII 19-321)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
September 29, 2023 (Anticipated)
Study Completion Date
September 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Medication Assisted Treatment
Keywords
Opioid Medication Assisted Treatment, Addiction, Opioid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Implementation Facilitation
Arm Type
Other
Arm Description
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 Title
Comparison Cohort
Arm Type
No Intervention
Arm Description
All other sites in VA not receiving CONDUIT implementation support or participating in other dedicated MOUD implementation activities during the same time period
Intervention Type
Other
Intervention Name(s)
Implementation Facilitation
Intervention Description
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 Outcome Measure Information:
Title
Number of patients with OUD initiating MOUD during the implementation period in implementation sites
Description
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.
Time Frame
The implementation period varies by site will likely range from 6 months to 18 months
Title
Number of patients with OUD retained on MOUD at 90 days and 180 days during the implementation period (i.e. treatment retention)
Description
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.
Time Frame
The implementation period varies by site will likely range from 6 months to 18 months
Title
Number of providers (and/or clinics) providing MOUD post-implementation, stratified by type of provider, clinical setting
Description
The number of prescribing providers will be determined by electronic health record. The denominator for this measure will be the number of providers eligible to prescribe MOUD at each site.
Time Frame
The post-implementation period varies by site, and will likely range from 6 months to 1 year
Title
Facilitators and barriers to implementation of MOUD
Description
Interviews with and structured data collected from facilitation teams working with each site will determine facilitators and barriers.
Time Frame
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
Title
Frequency and duration of implementation strategies as measured by the Expert Recommendations for Implementing Change (ERIC) survey
Description
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.
Time Frame
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
Title
Frequency and duration of Implementation Facilitation strategies as measured by facilitation tracking logs
Description
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.
Time Frame
Logs will be collected monthly for each site as it enters implementation phase during the course of the 3-year study
Title
Cost of implementation
Description
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.
Time Frame
Course of 3-year study
Title
Summary of facilitators and barriers at implementation clinics
Description
Interviews with and structured data collected from facilitation teams working with each site will determine post-implementation facilitators and barriers.
Time Frame
The outcome will be measured 6 months post-implementation
Title
Elements of program maintained, including adaptations
Description
Interviews
Time Frame
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
Title
Number of x-waivered and prescribing providers
Description
The outcome will be measured by electronic health records. The denominator for this measure is the number of providers at each site eligible to prescribe MOUD.
Time Frame
As a measure of maintenance, this outcome will be measured for the 6-month period post-implementation
Title
Frequency and duration of implementation strategies as measured by the Expert Recommendations for Implementing Change (ERIC) survey
Description
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.
Time Frame
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
Title
Frequency and duration of implementation strategies as measured by the Expert Recommendations for Implementing Change (ERIC) survey
Description
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.
Time Frame
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
Title
Frequency and duration of implementation strategies as measured by the Expert Recommendations for Implementing Change (ERIC) survey
Description
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.
Time Frame
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 Measure Information:
Title
Hospitalizations and Emergency Department visits related to OUD post-implementation
Description
Data will be extracted from patients electronic health records.
Time Frame
The post-implementation period varies by site, and will likely range from 6 months to 1 year
Title
Opioid-related or other drug overdoses in patients with OUD post-implementation
Description
Data will be extracted from patients electronic health records.
Time Frame
The post-implementation period varies by site, and will likely range from 6 months to 1 year
Title
Opioid dose for patients on long-term opioid treatment post-implementation
Description
Medication dose will be extracted from patients electronic health records
Time Frame
The post-implementation period varies by site, and will likely range from 6 months to 1 year
Title
Concomitant opioid-sedative prescriptions post-implementation
Description
The number and type of opioid-sedative prescriptions will be extracted from patients electronic health records
Time Frame
The post-implementation period varies by site, and will likely range from 6 months to 1 year
Title
Number of x-waivered providers post-implementation
Description
The outcome will be extracted from the electronic health record. The denominator for this measure will be the number of providers eligible for x-waiver.
Time Frame
The post-implementation period varies by site, and will likely range from 6 months to 1 year
Title
Variation in facility-level use of implementation strategies over time
Description
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
Time Frame
Course of 3-year study
Title
Number of OUD patients receiving MOUD
Description
This outcome will be assessed using electronic health records. The denominator for the measure will be the number of patients with OUD during the target period.
Time Frame
12-24 months after implementation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William C Becker, MD
Organizational Affiliation
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Birmingham VA Medical Center, Birmingham, AL
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Rocky Mountain Regional VA Medical Center, Aurora, CO
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Facility Name
Boise VA Medical Center, Boise, ID
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Iowa City VA Health Care System, Iowa City, IA
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52246-2208
Country
United States
Facility Name
Maine VA Medical Center, Augusta, ME
City
Augusta
State/Province
Maine
ZIP/Postal Code
04330
Country
United States
Facility Name
VA Central Western Massachusetts Healthcare System, Leeds, MA
City
Leeds
State/Province
Massachusetts
ZIP/Postal Code
01053-9764
Country
United States
Facility Name
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29209
Country
United States
Facility Name
VA Salt Lake City Health Care System, Salt Lake City, UT
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Consortium to Disseminate and Understand Implementation of Opioid Use Disorder Treatment

We'll reach out to this number within 24 hrs