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Completed

NCT Number: NCT03566459

Medications for Opioid Use Disorders (MOUD) Via Telemedicine

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

VA Connecticut Healthcare System West Haven Campus, West Haven, CT, West Haven, Connecticut, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Veterans with OUD

Exclusion criteria

  • n/a

Treatment and study plan

CBOC offering Tele-MOUD to Veterans

Other

CBOC offering medications for opioid use disorder (MOUD) using telemedicine

CBOC not offering Tele-MOUD to Veterans

Other

CBOC not offering medications for opioid use disorder (MOUD) using telemedicine

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Negative toxicology tests

    Time frame: through study completion, up to 1 year

    % toxicology tests that are negative for illicit opioids

  8. Number of CBOCs participating in telemedicine MAT

    Time frame: through study completion, up to 1 year

    Number of CBOCs utilizing telemedicine MAT

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Making Medication Assisted Treatment Available to Veterans With Opioid Use Disorders at CBOCs Using Telemedicine (PII 18-178)

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 25, 2018
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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