VetReach: Developing a Telehealth Model to Improve Treatment Access for Rural Veterans With Substance Use Disorders

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Recruiting

CT.gov ID

NCT05348317

Collaborator

VA Ann Arbor Healthcare System (U.S. Fed)

100

Enrollment

Location

Arm

52.4

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This project will pilot-test and obtain stakeholder input on a telehealth-delivered substance use disorder (SUD) care model (with initial engagement and ongoing MI-CBT treatment) with the goal of increasing treatment utilization and improving outcomes for rural and non-rural Veterans with SUDs.

Condition or Disease	Intervention/Treatment	Phase
Substance Use Substance Use Disorders Substance Dependence Veterans	Behavioral: VetReach	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Using Telehealth to Expand Treatment Access for Veterans With Opioid Use Disorder (CDA 18-008)

Actual Study Start Date :

May 19, 2022

Anticipated Primary Completion Date :

Sep 30, 2026

Anticipated Study Completion Date :

Sep 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MI-CBT Teletx The intervention consists of an initial 30-60 min phone-delivered Engagement session that focuses on MI to help participants build self-efficacy and motivation to engage and to empower them to plan change and use Elicit-Provide-Elicit (EPE) to address treatment barriers (e.g., stigma, appeal, accessibility). Participants will then complete up to 8 ~50 minute Teletx weekly sessions via videoconference (or phone if needed). The intervention is highly patient-centered, by meeting and assessing patients where they are including in their unique context (i.e. rural community), helping them identify reasons and motivations for change, and centered around their goals (e.g. substance use reduction or abstinence).	Behavioral: VetReach Telehealth-delivered MI-CBT substance use disorder care model

Arm

Intervention/Treatment

Experimental: MI-CBT Teletx

The intervention consists of an initial 30-60 min phone-delivered Engagement session that focuses on MI to help participants build self-efficacy and motivation to engage and to empower them to plan change and use Elicit-Provide-Elicit (EPE) to address treatment barriers (e.g., stigma, appeal, accessibility). Participants will then complete up to 8 ~50 minute Teletx weekly sessions via videoconference (or phone if needed). The intervention is highly patient-centered, by meeting and assessing patients where they are including in their unique context (i.e. rural community), helping them identify reasons and motivations for change, and centered around their goals (e.g. substance use reduction or abstinence).

Behavioral: VetReach

Telehealth-delivered MI-CBT substance use disorder care model

Outcome Measures

Primary Outcome Measures

Feasibility of the intervention (engagement) [8 weeks]
Percent (%) of participants engaging in the intervention (at least 3 completed sessions)
Acceptability of the telehealth intervention [2 months]
Study-specific acceptability rating completed by participants (% with a positive rating, higher % is better)

Other Outcome Measures

Change in substance consumption [baseline, 8 weeks post-baseline]
Substance use/consumption will be assessed using the 30-day Timeline Follow-Back (TLFB). The TLFB will capture information on the frequency and quantity of substance use, with total consumption calculated.
Change in frequency of substance use as reported on the Timeline Follow-Back (TLFB) [baseline, 8 weeks post-baseline]
Based on frequency and quantity, higher scores indicate worse outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Veteran patients at the Ann Arbor VA Healthcare System
Diagnostic and Statistical Manual of Mental Disorders (DSM-5) SUD diagnosis and/or substance use on average of 2 days a week over the past month
Telephone access
Able to provide informed consent

Exclusion Criteria:

Receiving SUD psychotherapy
Inability to speak or understand English
Substantial mental health instability or conditions that preclude informed consent (e.g., acute psychosis, cognitive deficits) or understanding of assessment or program content
Prior alcohol withdrawal seizures or delirium tremens

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan	United States	48105

Sponsors and Collaborators

VA Office of Research and Development
VA Ann Arbor Healthcare System

Investigators

Principal Investigator: Lewei Lin, MD, VA Ann Arbor Healthcare System, Ann Arbor, MI

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT05348317

Other Study ID Numbers:

CDX 22-007
PROJ-03672

First Posted:

Apr 27, 2022

Last Update Posted:

May 27, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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.:

Keywords provided by VA Office of Research and Development

Telehealth

Motivational Interviewing

Cognitive Behavioral Therapy

Rural Health

Additional relevant MeSH terms:

Substance-Related Disorders

Study Results

No Results Posted as of May 27, 2022