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Improving Outcomes Among Medical/Surgical Inpatients With Alcohol Use Disorders

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ClinicalTrials.gov Identifier: NCT03258632
Recruitment Status : Not yet recruiting
First Posted : August 23, 2017
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
This project aims to help Veterans who are in the hospital and have untreated alcohol problems. First, the investigators will adapt a Decision Aid that explains alcohol-related treatment options and their risks and benefits. Then, the investigators will determine 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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Behavioral: Drinking Options - Motivate, Shared Decisions, Telemonitor (DO-MoST) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 292 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Improving Outcomes Among Medical/Surgical Inpatients With Alcohol Use Disorders
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

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 during their inpatient stay 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 during their inpatient stay 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Medical-surgical inpatients with alcohol use disorder at the Ann Arbor or Palo Alto VA. Specifically:

  • in a current episode of inpatient medical-surgical care,
  • meet DSM 5 criteria for an AUD (moderate or severe),
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258632


Contacts
Contact: Christine Timko, PhD (650) 493-5000 ext 23336 Christine.Timko@va.gov
Contact: Daniel M Blonigen, PhD MA (650) 493-5000 ext 27828 Daniel.Blonigen@va.gov

Locations
United States, California
VA Palo Alto Health Care System, Palo Alto, CA Not yet recruiting
Palo Alto, California, United States, 94304-1290
Contact: Kristin B Frazier    650-493-5000 ext 67593    Kristin.Frazier@va.gov   
Contact: Anastasia M Villafranca    (650) 493-5000 ext 66853    Anastasia.Villafranca@va.gov   
Principal Investigator: Christine Timko, PhD         
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI Not yet recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Mark A Ilgen, PhD    734-845-5046    mark.ilgen@va.gov   
Contact: Emily Yaegley, MPH    (734) 456-7890    eyeagley@umich.med.edu   
Sub-Investigator: Mark A. Ilgen, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Christine Timko, PhD VA Palo Alto Health Care System, Palo Alto, CA

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03258632     History of Changes
Other Study ID Numbers: IIR 15-298
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by VA Office of Research and Development:
Alcohol Use Disorder

Additional relevant MeSH terms:
Disease
Alcohol Drinking
Pathologic Processes
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs