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

Primary Purpose

Substance Use, Substance Use Disorders, Substance Dependence

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

VetReach

About this trial

This is an interventional treatment trial for Substance Use focused on measuring Telehealth, Motivational Interviewing, Cognitive Behavioral Therapy, Rural Health

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

VA Ann Arbor Healthcare System, Ann Arbor, MIRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MI-CBT Teletx

Arm Description

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).

Outcomes

Primary Outcome Measures

Feasibility of the intervention (engagement)

Percent (%) of participants engaging in the intervention (at least 3 completed sessions)

Acceptability of the telehealth intervention

Study-specific acceptability rating completed by participants (% with a positive rating, higher % is better)

Secondary Outcome Measures

Full Information

NCT ID

NCT05348317

First Posted

April 21, 2022

Last Updated

September 27, 2023

Sponsor

VA Office of Research and Development

Collaborators

VA Ann Arbor Healthcare System

1. Study Identification

Unique Protocol Identification Number

NCT05348317

Brief Title

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

Acronym

VetReach

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 19, 2022 (Actual)

Primary Completion Date

September 30, 2026 (Anticipated)

Study Completion Date

September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

Collaborators

VA Ann Arbor Healthcare System

4. Oversight

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.

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Substance Use, Substance Use Disorders, Substance Dependence, Veterans

Keywords

Telehealth, Motivational Interviewing, Cognitive Behavioral Therapy, Rural Health

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MI-CBT Teletx

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

VetReach

Intervention Description

Telehealth-delivered MI-CBT substance use disorder care model

Primary Outcome Measure Information:

Title

Feasibility of the intervention (engagement)

Description

Percent (%) of participants engaging in the intervention (at least 3 completed sessions)

Time Frame

8 weeks

Title

Acceptability of the telehealth intervention

Description

Study-specific acceptability rating completed by participants (% with a positive rating, higher % is better)

Time Frame

2 months

Other Pre-specified Outcome Measures:

Title

Change in substance consumption

Description

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.

Time Frame

baseline, 8 weeks post-baseline

Title

Change in frequency of substance use as reported on the Timeline Follow-Back (TLFB)

Description

Based on frequency and quantity, higher scores indicate worse outcome.

Time Frame

baseline, 8 weeks post-baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Deborah A Manderachia, MSW

Phone

(734) 222-7424

deborah.manderachia@va.gov

First Name & Middle Initial & Last Name or Official Title & Degree

Carly Brin, MSW

Phone

(734) 769-7100

brinca@med.umich.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lewei Lin, MD

Organizational Affiliation

VA Ann Arbor Healthcare System, Ann Arbor, MI

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Ann Arbor Healthcare System, Ann Arbor, MI

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48105-2303

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Deborah A Manderachia, MSW

Phone

734-222-7424

deborah.manderachia@va.gov

First Name & Middle Initial & Last Name & Degree

Carly Brin, MSW

Phone

(734) 769-7100

brinca@med.umich.edu

First Name & Middle Initial & Last Name & Degree

Lewei Lin, MD

First Name & Middle Initial & Last Name & Degree

Mark A. Ilgen, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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