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

September 27, 2023 updated by: VA Office of Research and Development

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

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.

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Michigan
      • Ann Arbor, Michigan, United States, 48105-2303
        • Recruiting
        • VA Ann Arbor Healthcare System, Ann Arbor, MI
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lewei Lin, MD
        • Sub-Investigator:
          • Mark A. Ilgen, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).
Telehealth-delivered MI-CBT substance use disorder care model

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in substance consumption
Time Frame: 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.
baseline, 8 weeks post-baseline
Change in frequency of substance use as reported on the Timeline Follow-Back (TLFB)
Time Frame: baseline, 8 weeks post-baseline
Based on frequency and quantity, higher scores indicate worse outcome.
baseline, 8 weeks post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2022

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

April 21, 2022

First Submitted That Met QC Criteria

April 21, 2022

First Posted (Actual)

April 27, 2022

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CDX 22-007
  • PROJ-03672 (Other Identifier: VA Ann Arbor Healthcare System)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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