search
Back to results

Improving Outcomes for Emergency Department Patients With Alcohol Problems (Project GOAL)

Primary Purpose

Drinking, Alcohol

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alcohol Peer Mentor Intervention
Brief Advice
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drinking, Alcohol focused on measuring Veterans Health, Intervention, Brief, Peer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Alcohol Peer-Mentor Intervention

Brief Advice

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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 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 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).

Secondary Outcome Measures

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.

Full Information

First Posted
May 14, 2018
Last Updated
August 2, 2023
Sponsor
VA Office of Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT03536546
Brief Title
Improving Outcomes for Emergency Department Patients With Alcohol Problems
Acronym
Project GOAL
Official Title
Improving Outcomes for Emergency Department Patients With Alcohol Problems
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 10, 2019 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drinking, Alcohol
Keywords
Veterans Health, Intervention, Brief, Peer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alcohol Peer-Mentor Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Brief Advice
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Alcohol Peer Mentor Intervention
Other Intervention Name(s)
APM
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief Advice
Other Intervention Name(s)
BA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Number of Drinking Days as Assessed by Timeline Follow-Back (TLFB)
Description
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.
Time Frame
Change over time from Baseline to 12-months post-randomization
Title
Change in Number of Drinks per Day as Assessed by Timeline Follow-Back (TLFB)
Description
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.
Time Frame
Change over time from Baseline to 12-months post-randomization
Title
Change in Number of Binge Drinking Days as Assessed by Timeline Follow-Back (TLFB)
Description
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).
Time Frame
Change over time from Baseline to 12-months post-randomization
Secondary Outcome Measure Information:
Title
Change in Frequency of Healthcare Utilization as Measured by Treatment Services Review (TSR, v6)
Description
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.
Time Frame
Change over time from Baseline to 12-months post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul N Pfeiffer, MD MS
Organizational Affiliation
VA Ann Arbor Healthcare System, Ann Arbor, MI
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105-2303
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Improving Outcomes for Emergency Department Patients With Alcohol Problems

We'll reach out to this number within 24 hrs