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

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ClinicalTrials.gov Identifier: NCT03536546
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Drinking, Alcohol Behavioral: Alcohol Peer Mentor Intervention Behavioral: Brief Advice Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Outcomes for Emergency Department Patients With Alcohol Problems
Actual Study Start Date : June 10, 2019
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : May 31, 2022

Arm Intervention/treatment
Experimental: 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.
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.
Other Name: APM

Active Comparator: 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.
Behavioral: 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.
Other Name: BA




Primary Outcome Measures :
  1. Change in Number of Drinking Days as Assessed by Timeline Follow-Back (TLFB) [ Time Frame: Change over time from Baseline to 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. 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.

  2. Change in Number of Drinks per Day as Assessed by Timeline Follow-Back (TLFB) [ Time Frame: Change over time from Baseline to 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.

  3. Change in Number of Binge Drinking Days as Assessed by Timeline Follow-Back (TLFB) [ Time Frame: Change over time from Baseline to 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).


Secondary Outcome Measures :
  1. Change in Frequency of Healthcare Utilization as Measured by Treatment Services Review (TSR, v6) [ Time Frame: Change over time from Baseline to 12-months post-randomization ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536546


Contacts
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Contact: Deborah A Manderachia, MSW (734) 222-7424 deborah.manderachia@va.gov
Contact: Frederic C Blow, PhD MA (734) 845-3657 fred.blow@va.gov

Locations
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United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Deborah A Manderachia, MSW    (734) 222-7424    deborah.manderachia@va.gov   
Contact: Frederic C Blow, PhD MA    (734) 845-3657    fred.blow@va.gov   
Sub-Investigator: Amy S Bohnert, PhD MHS BA         
Principal Investigator: Frederic C. Blow, PhD MA         
Sub-Investigator: Paul N Pfeiffer, MD MS         
Sub-Investigator: Rebecca Kaufman Sripada, PhD MS         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Frederic C. Blow, PhD MA VA Ann Arbor Healthcare System, Ann Arbor, MI

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03536546     History of Changes
Other Study ID Numbers: IIR 16-235
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
Veterans Health
Intervention, Brief
Peer
Additional relevant MeSH terms:
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Emergencies
Alcohol Drinking
Disease Attributes
Pathologic Processes
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs