- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03566459
Medications for Opioid Use Disorders (MOUD) Via Telemedicine
Making Medication Assisted Treatment Available to Veterans With Opioid Use Disorders at CBOCs Using Telemedicine (PII 18-178)
Medication Assisted Treatment (MAT) of Veterans with Opioid Use Disorder (OUD) decreases mortality and improves treatment follow-up. However, outside of large and/or urban VA medical centers, there are shortages of providers with experience treating OUD and a license to prescribe buprenorphine. This has resulted in decreased access to MAT (buprenorphine/naloxone and injectable naltrexone) at rural CBOCs and increased overdose rates in rural areas. Some individual prescribers have used clinical video teleconferencing (CVT) to overcome geographic barriers and prescribe MAT to Veterans in CBOCs. However, while locally effective, these arrangements are not standardized and are not parts of larger VISN-wide or national VHA strategies.
This proposal describes an effective program that the investigators propose to replicate and expand. The program involves increasing prescribing rates of MAT for OUD in CBOCs using telemedicine. The investigators propose to (A) develop materials and procedures for the dissemination of telemedicine delivery of MAT to Veterans at CBOCs and (B) implement telemedicine prescribing of MAT at rural CBOCs in Northern Maine that lack on-site MAT providers. MAT will be prescribed by the VISN 1 Telemental Health Hub, which already provides medication management, psychotherapy, and some MAT to sites in Northern Maine.
In later years, the program will be expanded to other VISN 1 CBOCs, and to other TMH Regional Hubs that provide services to wide catchment areas in other VISNs. By building on an existing infrastructure connecting these TMH Regional Hubs to CBOCs and collaborating with other national initiatives (e.g. SCAN ECHO, PDSI, and academic detailing), telemedicine MAT will be rapidly disseminated to Veterans at CBOCs who are at high risk for illness, overdose, and premature death from opioids.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Medication Assisted Treatment (MAT) of Veterans with Opioid Use Disorder (OUD) decreases mortality and improves treatment follow-up. However, outside of large and/or urban VA medical centers, there are shortages of providers with experience treating OUD and a license to prescribe buprenorphine. This has resulted in decreased access to MAT (buprenorphine/naloxone and injectable naltrexone) at rural CBOCs and increased overdose rates in rural areas. Some individual prescribers have used clinical video teleconferencing (CVT) to overcome geographic barriers and prescribe MAT to Veterans in CBOCs. However, while locally effective, these arrangements are not standardized and are not parts of larger VISN-wide or national VHA strategies.
This proposal describes an effective program that the investigators propose to replicate and expand. The program involves increasing prescribing rates of MAT for OUD in CBOCs using telemedicine. The investigators propose to (A) develop materials and procedures for the dissemination of telemedicine delivery of MAT to Veterans at CBOCs and (B) implement telemedicine prescribing of MAT at rural CBOCs in Northern Maine that lack on-site MAT providers. MAT will be prescribed by the VISN 1 Telemental Health Hub, which already provides medication management, psychotherapy, and some MAT to sites in Northern Maine.
In later years, the program will be expanded to other VISN 1 CBOCs, and to other TMH Regional Hubs that provide services to wide catchment areas in other VISNs. By building on an existing infrastructure connecting these TMH Regional Hubs to CBOCs and collaborating with other national initiatives (e.g. SCAN ECHO, PDSI, and academic detailing), telemedicine MAT will be rapidly disseminated to Veterans at CBOCs who are at high risk for illness, overdose, and premature death from opioids.
The "Replicating Existing Programs with Blended (External and Internal) Facilitation" approach will be the study's implementation strategy. Existing programs of telemedicine MAT---including those by VA Maine and VISN 1 TMH Regional Hub prescribers---will be replicated. External Facilitation, an approach that has been effective in increasing intervention uptake in controlled trials, will be provided to rural CBOCs in Northern Maine by expert study investigators. Internal Facilitation will be provided by VA Maine primary care and pharmacy staff, who are already supporting programs in opioid prescribing safety in the VA Maine Healthcare System. Supporting this project are consultants and collaborators with expertise in implementation science, program evaluation, pain treatment, academic detailing, and telemedicine MAT. Data collected during implementation will inform program expansion. The primary measure of program outcomes will be the SAIL SUD16 measure of MAT use for Veterans with OUD.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Connecticut
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West Haven, Connecticut, United States, 06516
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
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Maine
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Augusta, Maine, United States, 04330
- VA Maine Healthcare System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Veterans with OUD
Exclusion Criteria:
- n/a
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Veterans with opioid use disorder (OUD)
Veterans with opioid use disorder (OUD) in VA Maine Healthcare System catchment area
|
CBOC offering medications for opioid use disorder (MOUD) using telemedicine
CBOC not offering medications for opioid use disorder (MOUD) using telemedicine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Population potentially able to benefit from telemedicine MAT
Time Frame: through study completion, up to 1 year
|
Review Veterans with OUD at CBOC and compare those referred to telemedicine MAT to those not referred. Note that OUD diagnosis may increase over time with better OUD detection |
through study completion, up to 1 year
|
|
AUDIT-C
Time Frame: through study completion, up to 1 year
|
The Alcohol Use Disorders Identification Test is a ten-question test developed by a World Health Organization-sponsored collaborative project to determine if a person may be at risk for alcohol abuse problems.
|
through study completion, up to 1 year
|
|
Cost of Telemedicine MAT
Time Frame: through study completion, up to 1 year
|
cost of time provider and other staff spent in service delivery preparing for and interacting with patients (prompted by CPT-coded encounters).
Costs are calculated by multiplying time by personnel costs.
|
through study completion, up to 1 year
|
|
Cost of Training and Implementation
Time Frame: through study completion, up to 1 year
|
cost of time spent by External and Internal facilitators on training/implementation. Time-spent will be assessed by weekly questions about a list of possible training activities.
|
through study completion, up to 1 year
|
|
Veterans' subjective experience of telemedicine MAT
Time Frame: through study completion, up to 1 year
|
Interviews with treated Veterans covering the following topics (9): how came to program, other options considered; experience of intake, of induction onto MAT, of maintenance tele-prescribing visits, of other addiction treatment; good things/not-so-good things about treatment, recommended improvements, how compares to in-person treatment.
|
through study completion, up to 1 year
|
|
Providers' experience of implementing MAT
Time Frame: through study completion, up to 1 year
|
Key informant interviews after implementation with hub and spoke providers, as described earlier.
|
through study completion, up to 1 year
|
|
Negative toxicology tests
Time Frame: through study completion, up to 1 year
|
% toxicology tests that are negative for illicit opioids
|
through study completion, up to 1 year
|
|
Number of CBOCs participating in telemedicine MAT
Time Frame: through study completion, up to 1 year
|
Number of CBOCs utilizing telemedicine MAT
|
through study completion, up to 1 year
|
|
Brief Addiction Monitor-Revised (BAM-R)
Time Frame: through study completion, up to 1 year
|
Brief Addiction Monitor-Revised (BAM-R) upon intake and two months later.
|
through study completion, up to 1 year
|
|
Number of providers participating in telemedicine MAT
Time Frame: through study completion, up to 1 year
|
Number at hubs and proportions tele-prescribing MAT; number at spokes seeing Veterans as part of their MAT treatment.
|
through study completion, up to 1 year
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PIX 18-001
- PII 18-178 (Other Grant/Funding Number: QUERI)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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