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Improving Outcomes for Emergency Department Patients With Alcohol Problems

Improving Outcomes for Emergency Department Patients With Alcohol Problems

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03536546
Acronym
Project GOAL
Enrollment
206
Registered
2018-05-24
Start date
2019-06-10
Completion date
2023-06-30
Last updated
2024-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drinking, Alcohol

Keywords

Veterans Health, Intervention, Brief, Peer

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.

Interventions

BEHAVIORALAlcohol 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.

BEHAVIORALBrief 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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Drinks Per Day as Assessed by Timeline Follow-Back (TLFB)At 12-months post-randomizationAlcohol 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.
Number of Binge Drinking Days as Assessed by Timeline Follow-Back (TLFB)At 12-months post-randomizationAlcohol 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

MeasureTime frameDescription
Frequency of Healthcare Utilization as Measured by Treatment Services Review (TSR, v6)At 12-months post-randomizationThe investigators will use the Treatment Services Review (TSR, v6) to measure the 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. 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.
104
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. 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.
101
Total205

Baseline characteristics

CharacteristicTotalBrief AdviceAlcohol Peer-Mentor Intervention
Age, Continuous53.7 years
STANDARD_DEVIATION 16.2
53.9 years
STANDARD_DEVIATION 16.8
53.4 years
STANDARD_DEVIATION 15.7
Education Completion
College degree or more
54 Participants27 Participants27 Participants
Education Completion
High school or less
39 Participants19 Participants20 Participants
Education Completion
Some college
103 Participants51 Participants52 Participants
Education Completion
Technical school
9 Participants4 Participants5 Participants
Race/Ethnicity, Customized
Ethnicity: Hispanic or Latino
12 Participants6 Participants6 Participants
Race/Ethnicity, Customized
Ethnicity: Not Hispanic or Latino
193 Participants95 Participants98 Participants
Race/Ethnicity, Customized
Ethnicity: Unknown
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Race: Black or African American
19 Participants9 Participants10 Participants
Race/Ethnicity, Customized
Race: Other
18 Participants9 Participants9 Participants
Race/Ethnicity, Customized
Race: Unknown
4 Participants3 Participants1 Participants
Race/Ethnicity, Customized
Race: White
164 Participants80 Participants84 Participants
Region of Enrollment
United States
205 Participants101 Participants104 Participants
Relationship Status
Divorced/Separated
74 Participants38 Participants36 Participants
Relationship Status
Living together, not married
15 Participants5 Participants10 Participants
Relationship Status
Married
72 Participants32 Participants40 Participants
Relationship Status
Never Married
35 Participants20 Participants15 Participants
Relationship Status
Widowed
9 Participants6 Participants3 Participants
Sex/Gender, Customized
Female
23 Participants11 Participants12 Participants
Sex/Gender, Customized
Male
181 Participants89 Participants92 Participants
Sex/Gender, Customized
Unknown
1 Participants1 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1043 / 101
other
Total, other adverse events
0 / 1040 / 101
serious
Total, serious adverse events
0 / 1040 / 101

Outcome results

Primary

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).

Time frame: At 12-months post-randomization

ArmMeasureValue (LEAST_SQUARES_MEAN)
Alcohol Peer-Mentor InterventionNumber of Binge Drinking Days as Assessed by Timeline Follow-Back (TLFB)1.0 Number of Binge Drinking Days
Brief AdviceNumber of Binge Drinking Days as Assessed by Timeline Follow-Back (TLFB)3.7 Number of Binge Drinking Days
Primary

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.

Time frame: At 12-months post-randomization

ArmMeasureValue (LEAST_SQUARES_MEAN)
Alcohol Peer-Mentor InterventionNumber of Drinks Per Day as Assessed by Timeline Follow-Back (TLFB)0.91 Drinks per day
Brief AdviceNumber of Drinks Per Day as Assessed by Timeline Follow-Back (TLFB)1.62 Drinks per day
Secondary

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

The investigators will use the Treatment Services Review (TSR, v6) to measure the 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: At 12-months post-randomization

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Alcohol Peer-Mentor InterventionFrequency of Healthcare Utilization as Measured by Treatment Services Review (TSR, v6)Substance Use Disorder clinic visits3.0 number of clinic visitsStandard Deviation 16.1
Alcohol Peer-Mentor InterventionFrequency of Healthcare Utilization as Measured by Treatment Services Review (TSR, v6)Emergency Department visits1.2 number of clinic visitsStandard Deviation 1.8
Brief AdviceFrequency of Healthcare Utilization as Measured by Treatment Services Review (TSR, v6)Substance Use Disorder clinic visits1.3 number of clinic visitsStandard Deviation 5.7
Brief AdviceFrequency of Healthcare Utilization as Measured by Treatment Services Review (TSR, v6)Emergency Department visits1.2 number of clinic visitsStandard Deviation 1.5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026