Medications for Opioid Use Disorders (MOUD) Via Telemedicine

Opioid Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03566459
• Other study ID #: PIX 18-001
• Secondary ID: PII 18-178
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: March 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Veterans with OUD

Exclusion Criteria:

• n/a

Related Conditions & MeSH terms

• Disease
• Opioid Use Disorder
• Substance-Related Disorders

Intervention

Other:
• CBOC offering Tele-MOUD to Veterans
CBOC offering medications for opioid use disorder (MOUD) using telemedicine
• CBOC not offering Tele-MOUD to Veterans
CBOC not offering medications for opioid use disorder (MOUD) using telemedicine

Locations

Country	Name	City	State
United States	VA Maine Healthcare System	Augusta	Maine
United States	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Population potentially able to benefit from telemedicine MAT	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
Primary	AUDIT-C	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
Primary	Cost of Telemedicine MAT	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
Primary	Cost of Training and Implementation	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
Primary	Veterans' subjective experience of telemedicine MAT	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
Primary	Providers' experience of implementing MAT	Key informant interviews after implementation with hub and spoke providers, as described earlier.	through study completion, up to 1 year
Primary	Negative toxicology tests	% toxicology tests that are negative for illicit opioids	through study completion, up to 1 year
Primary	Number of CBOCs participating in telemedicine MAT	Number of CBOCs utilizing telemedicine MAT	through study completion, up to 1 year
Primary	Brief Addiction Monitor-Revised (BAM-R)	Brief Addiction Monitor-Revised (BAM-R) upon intake and two months later.	through study completion, up to 1 year
Primary	Number of providers participating in telemedicine MAT	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