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Improving Outcomes Among Medical/Surgical Inpatients With Alcohol Use Disorders

Improving Outcomes Among Medical/Surgical Inpatients With Alcohol Use Disorders

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03258632
Enrollment
155
Registered
2017-08-23
Start date
2018-09-01
Completion date
2022-05-31
Last updated
2024-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder

Keywords

Alcohol Use Disorder

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.

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.

Interventions

BEHAVIORALDrinking 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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time Line Follow BackAlcohol use in the past 30 days, assessed at 12-month follow-upThe 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.

Secondary

MeasureTime frameDescription
Utilization of Substance Use-related Care12 monthsThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
82
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. 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.
73
Total155

Baseline characteristics

CharacteristicInterventionTotalUsual Care
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
28 Participants63 Participants35 Participants
Age, Categorical
Between 18 and 65 years
45 Participants92 Participants47 Participants
Age, Continuous59.5 years
STANDARD_DEVIATION 12.6
59.4 years
STANDARD_DEVIATION 13.7
59.4 years
STANDARD_DEVIATION 14.7
Race (NIH/OMB)
American Indian or Alaska Native
5 Participants5 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Black or African American
6 Participants16 Participants10 Participants
Race (NIH/OMB)
More than one race
11 Participants21 Participants10 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants11 Participants9 Participants
Race (NIH/OMB)
White
49 Participants98 Participants49 Participants
Region of Enrollment
United States
73 Participants155 Participants82 Participants
Sex: Female, Male
Female
6 Participants12 Participants6 Participants
Sex: Female, Male
Male
67 Participants143 Participants76 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
5 / 823 / 73
other
Total, other adverse events
0 / 820 / 73
serious
Total, serious adverse events
19 / 8210 / 73

Outcome results

Primary

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.

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

Population: Participants who completed follow-up.

ArmMeasureValue (NUMBER)
Usual CareTime Line Follow Back48 percentage of participants abstinent
InterventionTime Line Follow Back56 percentage of participants abstinent
p-value: <0.0595% CI: [0.73, 1.9]Mixed Models Analysis
Secondary

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.

Time frame: 12 months

Population: Consented participants

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Usual CareUtilization of Substance Use-related Care21 Participants
InterventionUtilization of Substance Use-related Care6 Participants

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026