Improving Outcomes for Emergency Department Patients With Alcohol Problems

Drinking, Alcohol Clinical Trial

— Project GOAL  

Official title:

Improving Outcomes for Emergency Department Patients With Alcohol Problems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03536546
• Other study ID #: IIR 16-235
• Status: Completed
• Phase: N/A
• Start date: June 10, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The objective of the study is to conduct a randomized controlled trial to determine the efficacy of an alcohol peer-mentor intervention starting in the ED, combined with a continuing 6-session program of post-ED strengths-based peer mentorship to facilitate reduction in hazardous drinking, and linkage and engagement in primary and/or specialty alcohol treatment services and mental health care, if needed. Project Methods: The study will screen Veterans Affairs (VA) ED patients for hazardous drinking. Those screening positive and who enroll in the study will be randomized to one of two conditions: 1) Alcohol Peer-Mentor (APM) intervention (n=225), or 2) Brief Advice (BA) comparison condition (n=225). Stratified random assignment to conditions will be by sex and presence of AUD (yes/no) defined as a score of 14 for men and 10 for women on the AUDIT. Randomization will proceed in blocks of 10. All participants will also receive written community resource information. Participants randomized to the APM condition will receive peer support to reduce hazardous drinking, and those who meet alcohol use disorder criteria will be coached by the peer and will assist in a warm handoff linkage to addiction treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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 Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol-Related Disorders
• Drinking, Alcohol
• Emergencies

Intervention

Behavioral:
• Alcohol Peer Mentor Intervention
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.
• Brief Advice
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.

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Number of 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. Using a calendar, the TLFB is a drinking assessment of retrospective drinking estimates. The investigators will collect participant self-report data on number of drinking days in the past month.	Change over time from Baseline to 12-months post-randomization
Primary	Change in 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.	Change over time from Baseline to 12-months post-randomization
Primary	Change in 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).	Change over time from Baseline to 12-months post-randomization
Secondary	Change in Frequency of Healthcare Utilization as Measured by Treatment Services Review (TSR, v6)	The investigators will use the Treatment Services Review (TSR, v6) to measure change in total number of healthcare visits across medical, mental health, and substance use care. The TSR, v6 is a semi-structured interview that gathers specific healthcare utilization information with adequate reliability and validity.	Change over time from Baseline to 12-months post-randomization