Improving Outcomes Among Medical/Surgical Inpatients With Alcohol Use Disorders

April 16, 2024 updated by: VA Office of Research and Development
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In fiscal year 2014, over 57,000 Veterans with diagnosed alcohol use disorders (AUDs) received VHA inpatient medical-surgical services. This likely underrepresents the prevalence of AUDs among Veteran inpatients, because these conditions often go undiagnosed during hospital stays. The high prevalence of AUDs among VHA medical and surgical patients is of critical concern because AUDs and medical conditions exacerbate one another, and their co-occurrence increases the use of costly health services. Yet, there are no evidence-based strategies that improve outcomes in this patient population by means of increased utilization (initiation, engagement) of AUD treatment services. The investigators have identified Drinking Options: Motivate, Shared Decisions, Telemonitor (DO-MoST) as a potential solution to the critical need for evidence-based strategies.

This project is evaluating DO-MoST as a new and innovative intervention to facilitate the transition from medical-surgical care to AUD treatment in primary and specialty care settings, thereby improving Veterans' AUD and medical outcomes. DO-MoST entails use of motivational interviewing and a decision aid during the inpatient stay to facilitate informed choices about drinking options and resources for help to change drinking, if desired, followed by telephone calls with the patient to continue to motivate and support decisions. In addition to determining the effectiveness of DO-MoST, this project includes a process evaluation - that is, will gather information from providers and patients on DO-MoST's implementation at the two project sites - to inform VA's potential widespread implementation of DO-MoST with medical-surgical patients with AUDs.

Using an effectiveness/implementation Hybrid Type 1 design, incorporating a randomized controlled trial (RCT) and process evaluation to facilitate future implementation, this project has three Specific Aims.

Aim 1: Adapt a decision aid being implemented with AUD patients in non-VA primary care settings to be appropriate for Veterans with AUDs in medical-surgical treatment settings. With this prototype, the investigators will conduct alpha testing with patients and providers, and adapt and pilot the decision aid to finalize it for use in the RCT.

Aim 2: Conduct DO-MoST at two VA facilities (Ann Arbor and Palo Alto) and evaluate its effectiveness.

The primary hypotheses are: Patients in DO-MoST, compared to patients in usual care (UC), will be more likely to (1) utilize AUD help (initiate, engage), (2) have better AUD (fewer heavy drinking days) and medical (physical status) outcomes, and (3) have fewer and more delayed acute care episodes (Emergency Department visits, rehospitalizations). Patients will be assessed at baseline, and 3, 6, and 12 months post-baseline, for outcomes and non-VA health care; VA health care will be assessed with VA databases. GLMM analyses will be conducted to compare the UC and DO-MoST groups on course of outcomes.

Aim 3: Conduct a qualitative process evaluation to inform the wider implementation of DO-MoST, using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. The purpose is to provide guidance for VA facilities' broader adoption of DO-MoST in the future, including its possible adaptation for diverse subpopulations of Veterans, such as patients with mental health diagnoses (e.g., PTSD).

In summary, this project will develop a decision aid and comprehensively examine DO-MoST as a novel and groundbreaking approach to providing a bridge between medical-surgical treatment and AUD treatment. Decision Aids have been used successfully in a number of contexts, but never with medical-AUD patients. The investigator's operations partners from VHA Office of Mental Health and Suicide Prevention, and Medical Service, are committed to directly addressing the dangerous, costly pattern of Veterans obtaining medical-surgical services but not receiving the AUD treatment they need. The project is focused on priorities in the VA Blueprint for Excellence, of HSR&D Service, and of the PIs' HSR&D Centers of Innovation.

Study Type

Interventional

Enrollment (Actual)

155

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 Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304-1290
        • VA Palo Alto Health Care System, Palo Alto, CA
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • VA Ann Arbor Healthcare System, Ann Arbor, MI

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

See inclusion criteria.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
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.
Experimental: Intervention
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Line Follow Back
Time Frame: Alcohol use in the past 30 days, assessed at 12-month follow-up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Utilization of Substance Use-related Care
Time Frame: 12 months
The investigators used a TLFB approach to assess utilization of substance use-related care (any receipt of outpatient and/or residential treatment for alcohol and/or drug problems, yes or no) between baseline and the 12-month follow-up.
12 months

Collaborators and Investigators

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

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Christine Timko, PhD, VA Palo Alto Health Care System, Palo Alto, CA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 1, 2018

Primary Completion (Actual)

December 26, 2021

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

August 15, 2017

First Submitted That Met QC Criteria

August 21, 2017

First Posted (Actual)

August 23, 2017

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 15-298

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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