Improving Outcomes for Emergency Department Patients With Alcohol Problems

NCT03536546 | Completed Results

• 1 other identifier: IIR 16-235
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct a study to examine the impact of an alcohol peer-mentor intervention starting in the emergency department (ED) combined with 6 peer booster sessions to reduce hazardous drinking and facilitate primary/specialty care use compared to enhanced usual care. Approximately 450 Veterans with hazardous drinking behaviors will be randomized to one of these two conditions. Follow-up assessments will occur at 3-, 6-, and 12-month post-randomization.

Conditions

Drinking, Alcohol

Keywords

Veterans Health; Intervention, Brief; Peer

Outcome Measures

Primary Outcomes (2)

• Number of Drinks Per Day as Assessed by Timeline Follow-Back (TLFB)

  Alcohol consumption is measured by Timeline Follow-Back (TLFB). The investigators will administer a 30-day TLFB for finer grained data on participant's self-reported drinking behaviors. The investigators will collect participant self-report data on number of drinks per day on days of drinking.

  At 12-months post-randomization

• Number of Binge Drinking Days as Assessed by Timeline Follow-Back (TLFB)

  Alcohol consumption is measured by Timeline Follow-Back (TLFB). The investigators will administer a 30-day TLFB for finer grained data on participant's self-reported drinking behaviors. The investigators will collect participant self-report data on number of days when the participant demonstrates binge drinking (5+ drinks per day for men; 4+ drinks per day for women).

  At 12-months post-randomization

Secondary Outcomes (1)

• Frequency of Healthcare Utilization as Measured by Treatment Services Review (TSR, v6)

  At 12-months post-randomization

Study Arms (2)

Alcohol Peer-Mentor Intervention

EXPERIMENTAL

A Veteran Peer research assistant will have contact with a study participant once in person in the emergency department at enrollment, and up to 6 times after enrollment over the course of 2 months. Participants will receive brief advice from a peer. Brief advice content will be based on strengths-based discussions with participants regarding their drinking and personal goals and preferences. Participants will also receive a resource pamphlet on alcohol and other health issues. Follow-up contact will be made by phone. The content of the follow-up peer intervention will be based on the manual developed by the study team to address strengths-based intervention topics.

Behavioral: Alcohol Peer Mentor Intervention

Brief Advice

ACTIVE COMPARATOR

Participants will receive brief substance use advice from a non-peer research staff member in the emergency department. Brief advice content will mirror standard care practices currently provided in VHA when a patient endorses hazardous drinking behaviors. Participants will also receive a resource pamphlet on alcohol and other health issues.

Behavioral: Brief Advice

Interventions

Alcohol Peer Mentor Intervention BEHAVIORAL

A Veteran Peer research assistant will have contact with a study participant once in person in the emergency department at enrollment, and up to 6 times after enrollment over the course of 2 months. Participants will receive brief advice from a peer. Brief advice content will be based on strengths-based discussions with participants regarding their drinking and personal goals and preferences. Participants will also receive a resource pamphlet on alcohol and other health issues. Follow-up contact will be made by phone. The content of the follow-up peer intervention will be based on the manual developed by the study team to address strengths-based intervention topics.

Also known as: APM

Alcohol Peer-Mentor Intervention

Brief Advice BEHAVIORAL

Participants will receive brief substance use advice from a non-peer research staff member in the emergency department. Brief advice content will mirror standard care practices currently provided in VHA when a patient endorses hazardous drinking behaviors. Participants will also receive a resource pamphlet on alcohol and other health issues.

Also known as: BA

Brief Advice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Screening:
• Presenting for care in the Ann Arbor Veterans Health Administration (VHA) ED
• Medically stable
• Able to provide informed consent
• Enrollment:
• Have an AUDIT-C score of 4 or more for men and 3 or more for women in the prior 3 months, indicating that they meet criteria for hazardous use (NIAAA 2005; World Health Organization)
• Have a telephone and/or the ability to provide information about individuals who can help contact the participant

You may not qualify if:

• Screening:
• Do not understand English
• Patients in or having received substance abuse treatment in the past 3-months, per medical record
• Patients in or having received peer services in the past 3-months, per medical record
• Pregnant women
• Patients deemed unable to provide informed consent
• Profound psychotic symptoms and/or cognitive deficits that would prevent patients from understanding the content of the intervention and/or assessments
• Enrollment:
• Patients currently active in or having received alcohol or other substance abuse treatment in the past 3-months, per self-report screening.
• Patients currently active in or having received peer services in the past 3-months, per self-report screening.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Ethanol; Crisis Intervention

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Paul N Pfeiffer, MD MS
• Organization: Department of Veterans Affairs

Paul.Pfeiffer@va.gov

(734) 769-1000

Study Officials

• Paul N Pfeiffer, MD MS

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Veteran peer research assistants will deliver alcohol brief advice in the ED and will initiate conversations with the participant for at least 6-sessions over 2 months post-ED visit. Strengths-based discussions will include a combination of scripted and open-ended content to best facilitate reductions in drinking and engagement across severity.

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: May 24, 2018
• Study Start: June 10, 2019
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 30, 2024
• Results First Posted: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)