Medications for Opioid Use Disorders (MOUD) Via Telemedicine

• ClinicalTrials.gov Identifier: NCT03566459
• Recruitment Status: Completed
• First Posted: June 25, 2018
• Last Update Posted: March 24, 2020
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Opioid Use Disorder	Other: CBOC offering Tele-MOUD to Veterans; Other: CBOC not offering Tele-MOUD to Veterans

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 Design

• Study Type: Observational
• Actual Enrollment: 12 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Making Medication Assisted Treatment Available to Veterans With Opioid Use Disorders at CBOCs Using Telemedicine (PII 18-178)
• Actual Study Start Date: April 1, 2018
• Actual Primary Completion Date: March 31, 2019
• Actual Study Completion Date: March 31, 2019

Groups and Cohorts

Group/Cohort	Intervention/treatment
Veterans with opioid use disorder (OUD); Veterans with opioid use disorder (OUD) in VA Maine Healthcare System catchment area	Other: CBOC offering Tele-MOUD to Veterans; CBOC offering medications for opioid use disorder (MOUD) using telemedicine; Other: CBOC not offering Tele-MOUD to Veterans; CBOC not offering medications for opioid use disorder (MOUD) using telemedicine

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Veterans with OUD

Criteria

Inclusion Criteria:

• Veterans with OUD

Exclusion Criteria:

• n/a

Contacts and Locations

Locations

United States, Connecticut

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

West Haven, Connecticut, United States, 06516

United States, Maine

VA Maine Healthcare System

Augusta, Maine, United States, 04330

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: Marc I. Rosen, MD; VA Connecticut Healthcare System West Haven Campus, West Haven, CT

More Information

Publications of Results:

Brunet N, Moore DT, Lendvai Wischik D, Mattocks KM, Rosen MI. Increasing buprenorphine access for veterans with opioid use disorder in rural clinics using telemedicine. Subst Abus. 2020 Feb 20:1-8. doi: 10.1080/08897077.2020.1728466. [Epub ahead of print]

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT03566459
• Other Study ID Numbers: PIX 18-001; PII 18-178 ( Other Grant/Funding Number: QUERI )
• First Posted: June 25, 2018
• Last Update Posted: March 24, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by VA Office of Research and Development:

Opioid Use Disorder (OUD); Medication Assisted Treatment (MAT); Telemedicine; Veteran

Additional relevant MeSH terms:

Disease; Opioid-Related Disorders; Substance-Related Disorders; Pathologic Processes; Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders