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Alcohol Use DisorderNCT03258632

Improving Outcomes Among Medical/Surgical Inpatients With Alcohol Use Disorders

A study testing Drinking Options - Motivate, Shared Decisions, Telemonitor (DO-MoST) in people with Alcohol Use Disorder, run by VA Office of Research and Development at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alcohol Use Disorder
What is being tested?
Drinking Options - Motivate, Shared Decisions, Telemonitor (DO-MoST)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
155 participants
Where
2 sitesUnited States
Study dates
1 Sep 2018to 31 May 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • See inclusion criteria.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • VA Ann Arbor Healthcare System, Ann Arbor, MI

    Ann Arbor, Michigan, 48105

  • VA Palo Alto Health Care System, Palo Alto, CA

    Palo Alto, California, 94304-1290

Other trials in United States

About this study

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.

Read the 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.

Being tested
Drinking Options - Motivate, Shared Decisions, Telemonitor (DO-MoST)
Keywords
Alcohol Use Disorder
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drinking Options - Motivate, Shared Decisions, Telemonitor (DO-MoST)Behavioural

    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.

Study groups in NCT03258632
Study groupRoleWhat they receive
Usual CareNo interventionUnder 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.
InterventionExperimentalPatients 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.
Receives: Behavioral: Drinking Options - Motivate, Shared Decisions, Telemonitor (DO-MoST)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)
  1. Utilization of Substance Use-related Care

    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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2017
  2. Study start1 Sep 2018
  3. Primary completion26 Dec 2021
  4. Study completion31 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03258632
Sponsor's protocol ID
IIR 15-298
Status last verified
Apr 2024
First submitted
15 Aug 2017
Last updated
17 Apr 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36959430

Questions about this trial

What is this clinical trial studying?

A study testing Drinking Options - Motivate, Shared Decisions, Telemonitor (DO-MoST) in people with Alcohol Use Disorder, run by VA Office of Research and Development at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time Line Follow Back (time frame: Alcohol use in the past 30 days, assessed at 12-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03258632, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.

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