Trial Outcomes & Findings for Improving Outcomes for Emergency Department Patients With Alcohol Problems (NCT NCT03536546)

Last Updated: 2024-08-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

206 participants

Primary outcome timeframe

At 12-months post-randomization

Results posted on

2024-08-30

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	104	101
Overall Study COMPLETED	90	92
Overall Study NOT COMPLETED	14	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Outcomes for Emergency Department Patients With Alcohol Problems

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alcohol Peer-Mentor Intervention n=104 Participants 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.	Brief Advice n=101 Participants 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.	Total n=205 Participants Total of all reporting groups
Age, Continuous	53.4 years STANDARD_DEVIATION 15.7 • n=5 Participants	53.9 years STANDARD_DEVIATION 16.8 • n=7 Participants	53.7 years STANDARD_DEVIATION 16.2 • n=5 Participants
Sex/Gender, Customized Male	92 Participants n=5 Participants	89 Participants n=7 Participants	181 Participants n=5 Participants
Sex/Gender, Customized Female	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Sex/Gender, Customized Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race: Unknown	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race: Black or African American	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Race: White	84 Participants n=5 Participants	80 Participants n=7 Participants	164 Participants n=5 Participants
Race/Ethnicity, Customized Race: Other	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity: Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity: Not Hispanic or Latino	98 Participants n=5 Participants	95 Participants n=7 Participants	193 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity: Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	104 Participants n=5 Participants	101 Participants n=7 Participants	205 Participants n=5 Participants
Education Completion High school or less	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Education Completion Technical school	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Education Completion Some college	52 Participants n=5 Participants	51 Participants n=7 Participants	103 Participants n=5 Participants
Education Completion College degree or more	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Relationship Status Married	40 Participants n=5 Participants	32 Participants n=7 Participants	72 Participants n=5 Participants
Relationship Status Divorced/Separated	36 Participants n=5 Participants	38 Participants n=7 Participants	74 Participants n=5 Participants
Relationship Status Widowed	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Relationship Status Living together, not married	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Relationship Status Never Married	15 Participants n=5 Participants	20 Participants n=7 Participants	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 12-months post-randomization

Outcome measures

Outcome measures
Measure	Alcohol Peer-Mentor Intervention n=104 Participants 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.	Brief Advice n=101 Participants 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.
Number of Drinks Per Day as Assessed by Timeline Follow-Back (TLFB)	0.91 Drinks per day Interval 0.66 to 1.14	1.62 Drinks per day Interval 1.18 to 2.02

PRIMARY outcome

Timeframe: At 12-months post-randomization

Outcome measures

Outcome measures
Measure	Alcohol Peer-Mentor Intervention n=104 Participants 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.	Brief Advice n=101 Participants 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.
Number of Binge Drinking Days as Assessed by Timeline Follow-Back (TLFB)	1.0 Number of Binge Drinking Days Interval 0.2 to 1.8	3.7 Number of Binge Drinking Days Interval 2.3 to 5.1

SECONDARY outcome

Timeframe: At 12-months post-randomization

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.

Outcome measures

Outcome measures
Measure	Alcohol Peer-Mentor Intervention n=104 Participants 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.	Brief Advice n=101 Participants 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.
Frequency of Healthcare Utilization as Measured by Treatment Services Review (TSR, v6) Substance Use Disorder clinic visits	3.0 number of clinic visits Standard Deviation 16.1	1.3 number of clinic visits Standard Deviation 5.7
Frequency of Healthcare Utilization as Measured by Treatment Services Review (TSR, v6) Emergency Department visits	1.2 number of clinic visits Standard Deviation 1.8	1.2 number of clinic visits Standard Deviation 1.5

Adverse Events

Alcohol Peer-Mentor Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Brief Advice

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paul N Pfeiffer, MD MS

Department of Veterans Affairs

Phone: (734) 769-1000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place