Improving Outcomes Among Medical/Surgical Inpatients With Alcohol Use Disorders

• ClinicalTrials.gov Identifier: NCT03258632
• Recruitment Status: Completed
• First Posted: August 23, 2017
• Results First Posted: April 17, 2024
• Last Update Posted: April 17, 2024
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Tracking Information

• First Submitted Date: August 15, 2017
• First Posted Date: August 23, 2017
• Results First Submitted Date: February 24, 2023
• Results First Posted Date: April 17, 2024
• Last Update Posted Date: April 17, 2024
• Actual Study Start Date: September 1, 2018
• Actual Primary Completion Date: December 26, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 16, 2024)

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.

Original Primary Outcome Measures (submitted: August 21, 2017)

Time Line Follow Back [ Time Frame: 90 days ]

The investigators will use the Timeline Follow-Back (TLFB) to assess alcohol use during the 90 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 percent of drinking days.

Current Secondary Outcome Measures (submitted: April 16, 2024)

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.

Original Secondary Outcome Measures (submitted: August 21, 2017)

TLFB [ Time Frame: 90 days ]

The investigators will use the TLFB to assess percent of heavy drinking days (i.e., 4 or more standard drinks for women, 5 or more standard drinks for men, per day) during the past 90 days.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Improving Outcomes Among Medical/Surgical Inpatients With Alcohol Use Disorders
• Official Title: Improving Outcomes Among Medical/Surgical Inpatients With Alcohol Use Disorders
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Health Services Research
• Condition: Alcohol Use Disorder

Intervention

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.

Study Arms

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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 16, 2024): 155
• Original Estimated Enrollment (submitted: August 21, 2017): 292
• Actual Study Completion Date: May 31, 2022
• Actual Primary Completion Date: December 26, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03258632
• Other Study ID Numbers: IIR 15-298
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: VA Office of Research and Development
• Original Responsible Party: Same as current
• Current Study Sponsor: VA Office of Research and Development
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: VA Office of Research and Development
• Verification Date: April 2024