Clinical trial NCT03536546: Improving Outcomes for Emergency Department Patients With Alcohol Problems
Official title: Improving Outcomes for Emergency Department Patients With Alcohol Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drinking, Alcohol
Keywords: Veterans Health
Intervention, Brief
Peer
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-05-24
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Drinks Per Day as Assessed by Timeline Follow-Back (TLFB)
timeFrame: At 12-months post-randomization
measure: Number of Binge Drinking Days as Assessed by Timeline Follow-Back (TLFB)
timeFrame: At 12-months post-randomization
Secondary outcomes:
measure: Frequency of Healthcare Utilization as Measured by Treatment Services Review (TSR, v6)
timeFrame: At 12-months post-randomization
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Paul N Pfeiffer, MD MS
role: PRINCIPAL_INVESTIGATOR
References: