跳至主要内容
临床试验/NCT03536546
NCT03536546已完成不适用

Improving Outcomes for Emergency Department Patients With Alcohol Problems

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2019年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
206
试验地点
2
主要终点
Number of Drinks Per Day as Assessed by Timeline Follow-Back (TLFB)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Number of Drinks Per Day as Assessed by Timeline Follow-Back (TLFB)

时间窗: 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)

时间窗: 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).

次要结局

  • Frequency of Healthcare Utilization as Measured by Treatment Services Review (TSR, v6)(At 12-months post-randomization)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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