跳至主要内容
临床试验/NCT00280488
NCT00280488Unknown3 期

Enhanced MI With Alcohol Positive Trauma Patients

Brown University2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2005年5月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
入组人数
300
试验地点
2
主要终点
Alcohol-related problems (e.g., drinking and driving)

研究概览

简要总结

The primary goal of this study is to test the efficacy of a brief intervention that includes the patient and a significant other, relative to an intervention including the patient only, for reducing alcohol use and alcohol-related problems among trauma patients.

详细描述

Alcohol-positive trauma patients are more likely to be readmitted to a trauma center or subsequently die from an injury than are alcohol-negative patients. Empirically supported treatments to reduce alcohol use and alcohol-related problems (e.g., injuries, drinking and driving) in this high-risk population are needed, but few exist. This randomized controlled clinical trial assesses the efficacy of a brief intervention that includes the patient and a significant other, relative to an intervention including the patient only, for reducing alcohol use and alcohol-related problems among trauma patients.

Motivational Interviewing (MI), a brief, directive, non-confrontational intervention, has demonstrated some promise in this setting. Further, inclusion of a significant other (SO) in prolonged, intensive alcohol treatment appears to improve treatment retention and efficacy. Although inclusion of an SO in MI has been suggested, there are few data to support this endorsement.

Accordingly, this study will address whether motivational interviewing including both the trauma patient and an SO can more effectively decrease and maintain reductions in alcohol use and alcohol-related problems 6 and 12 months following discharge from the trauma unit than MI with the individual patient or an assessment-only condition.

The 2 MI groups will each receive 2 intervention sessions timed to occur in the hospital, and 1 booster session, occurring 1 month following discharge.

In the assessment-only condition, patients will receive only assessment of their drinking at baseline. This proposal will allow us to address the next phase of our program of research designed to develop easily disseminable treatments for these high-risk populations in medical settings. This study will also address potential mediators (motivation to change alcohol use, self-efficacy, alcohol treatment attendance, and social support for abstinence) and moderators of MI effects. The cost-effectiveness of the intervention will also be addressed.

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
否

入选标准

  • •admitted to trauma unit
  • •greater than 18 years old
  • •had a blood alcohol concentration (BAC) greater than .01% according to a biochemical test OR self-reported drinking alcohol in the 6 hours prior to the event that caused their hospital visit OR scored 8 or higher on the Alcohol Use Disorders Identification Test (AUDIT)
  • •identify at least one eligible significant other

排除标准

  • •not English-speaking
  • •had a self-inflicted injury
  • •in police custody
  • •did not pass a mental status exam

研究组 & 干预措施

2) MI with patient only

Active Comparator

Motivational Interviewing (MI), a brief, directive, non-confrontational intervention, with the individual patient

干预措施: Motivational Interview (Behavioral)

1) MI with SO

Active Comparator

Motivational Interviewing (MI), a brief, directive, non-confrontational intervention, with inclusion of a significant other (SO) in prolonged, intensive alcohol treatment.

干预措施: Motivational Interview (Behavioral)

3) Assessment only

Active Comparator

In the assessment-only condition, patients will receive only assessment of their drinking at baseline.

干预措施: Assessment (Behavioral)

结局指标

主要结局

Alcohol-related problems (e.g., drinking and driving)

时间窗: 12 months

Alcohol Consumption

时间窗: 12 months

次要结局

  • Cost-effectiveness of intervention(12 months)

研究者

申办方类型
Other

研究点 (2)

Loading locations...

相似试验