Drinking, AlcoholProject GOALNCT03536546
Improving Outcomes for Emergency Department Patients With Alcohol Problems
A study testing Alcohol Peer Mentor Intervention and Brief Advice in people with Drinking, Alcohol, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drinking, Alcohol
- What is being tested?
- Alcohol Peer Mentor Intervention and Brief Advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2019to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
About this study
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.
Read the 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.
- Conditions
- Drinking, Alcohol
- Being tested
- Alcohol Peer Mentor Intervention, Brief Advice
- Keywords
- Veterans Health, Intervention, Brief, Peer
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol Peer Mentor InterventionBehavioural
Also called APM
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 AdviceBehavioural
Also called BA
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Brief Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: At 12-months post-randomization
Secondary outcomes (1)
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.
Measured: At 12-months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start10 Jun 2019
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Drinking, AlcoholStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Paul N Pfeiffer, MD MS, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536546
- Sponsor's protocol ID
- IIR 16-235
- Acronym
- Project GOAL
- Status last verified
- Aug 2024
- First submitted
- 14 May 2018
- Last updated
- 30 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes for Emergency Department Patients With Alcohol Problems
- ClinicalTrials.gov ID
- NCT03536546
- Acronym / sponsor ID
- Project GOAL / IIR 16-235
- Conditions
- Drinking, Alcohol
- Keywords
- Veterans Health, Intervention, Brief, Peer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 24 May 2018 (actual)
- Results
- Posted 30 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Alcohol Peer-Mentor Intervention | Experimental | Behavioral: Alcohol Peer Mentor InterventionA 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 | Active comparator | Behavioral: Brief AdviceParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Presenting for care in the Ann Arbor Veterans Health Administration (VHA) ED
- Medically stable
- Able to provide informed consent
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol Peer Mentor InterventionAlso: APMA 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. | Behavioural | Alcohol Peer-Mentor Intervention |
| Brief AdviceAlso: BAParticipants 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. | Behavioural | Brief Advice |
Primary outcome
Number of Drinks Per Day as Assessed by Timeline Follow-Back (TLFB)
Time frame: At 12-months post-randomization
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.
Number of Binge Drinking Days as Assessed by Timeline Follow-Back (TLFB)
Time frame: At 12-months post-randomization
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).
1 secondary outcome
Frequency of Healthcare Utilization as Measured by Treatment Services Review (TSR, v6)
Time frame: At 12-months post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul N Pfeiffer, MD MS principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol Peer Mentor Intervention and Brief Advice in people with Drinking, Alcohol, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Drinks Per Day as Assessed by Timeline Follow-Back (TLFB) (time frame: At 12-months post-randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.