NCT03258632

Brief Summary

This project aims to help Veterans who are in medical treatment and have untreated alcohol problems. First, the investigators adapted a Decision Aid that explains alcohol-related treatment options and their risks and benefits. Then, the investigators are determining the effectiveness of an intervention called DO-MoST (for Drinking Options-Motivate, Shared Decisions, Telemonitor), whereby a Decision Coach helps Veterans make decisions about alcohol-related behaviors and treatments they prefer, and keeps in contact by phone to continue to help with drinking and treatment decisions. DO-MoST is designed to increase rates at which Veterans decide to reduce or quit drinking, and begin and remain in treatment, and to improve drinking- and medical-related outcomes over time. It may also decrease Veterans' use of expensive health services such as hospitalizations and emergency visits. Finally, the investigators will study how VA can use DO-MoST on an ongoing, more widespread basis. The project should increase patient-centered health care for Veterans with alcohol problems to benefit their recovery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
1 year until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

April 17, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

3.3 years

First QC Date

August 15, 2017

Results QC Date

February 24, 2023

Last Update Submit

April 16, 2024

Conditions

Keywords

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

  • Time Line Follow Back

    The investigators will use the Timeline Follow-Back (TLFB) to assess abstinence from alcohol use during the 30 days preceding assessment. The TLFB is a widely used, standardized, calendar-based retrospective self-report assessment to quantify daily alcohol use. The investigators will examine the primary outcome of abstinence from alcohol use at 12-month follow-up.

    Alcohol use in the past 30 days, assessed at 12-month follow-up

Secondary Outcomes (1)

  • Utilization of Substance Use-related Care

    12 months

Study Arms (2)

Usual Care

NO INTERVENTION

Under usual care, when a patient screens positive on the AUDIT-C administered at intake, a provider (social worker, nurse) provides Brief Intervention (BI), i.e., tells the patient that problems are associated with alcohol use, and about recommended drinking limits; notes the patient as ready to change drinking or not, and as agreeing to treatment or not. If the patient agrees to treatment, specialty addiction services are notified.

Intervention

EXPERIMENTAL

Patients will attend one 50-minute individual session with a Decision Coach (a trained clinical provider, e.g., MSW). Patients in DO-MoST will also attend 6 biweekly 15-minute telephone sessions from the same Decision Coach.

Behavioral: Drinking Options - Motivate, Shared Decisions, Telemonitor (DO-MoST)

Interventions

Patients will attend one 50-minute individual session with a Decision Coach (a trained clinical provider, e.g., MSW). Patients in DO-MoST will also attend 6 biweekly 15-minute telephone sessions from the same Decision Coach.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medical-surgical inpatients with alcohol use disorder at the Ann Arbor or Palo Alto VA. Specifically:
  • in a current episode of medical-surgical care,
  • meet DSM 5 criteria for an AUD
  • no specialty addiction treatment or weekly mutual-help group attendance within 60 days prior to the inpatient episode,
  • no restricted access due to infection control requirements (e.g., TB, MRSA, C. diff),
  • no significant cognitive impairment,
  • ongoing access to a cell or land line telephone,
  • at least one contact who will continue to know the patient's contact information, and (8) not having participated in an interview for Aim 1 of this project.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Related Publications (1)

  • Timko C, Lewis M, Lor MC, Aldaco-Revilla L, Blonigen D, Ilgen M. Hazardous Drinking Interventions Delivered During Medical-Surgical Care: Patient and Provider Views. J Clin Psychol Med Settings. 2024 Mar;31(1):224-235. doi: 10.1007/s10880-023-09954-4. Epub 2023 Mar 23.

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Christine Timko
Organization
Department of Veterans Affairs

Study Officials

  • Christine Timko, PhD

    VA Palo Alto Health Care System, Palo Alto, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2017

First Posted

August 23, 2017

Study Start

September 1, 2018

Primary Completion

December 26, 2021

Study Completion

May 31, 2022

Last Updated

April 17, 2024

Results First Posted

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations