跳至主要内容
临床试验/NCT00261859
NCT00261859已完成2 期

Enhancing EP-Performed Alcohol Interventions in the ED

Yale University1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2005年10月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
900
试验地点
1
主要终点
efficacy of brief intervention

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of an enhanced emergency practitioner (EP) performed brief intervention (BI), namely, the Enhanced Brief Negotiation Interview (E-BNI). This includes a basic BNI performed in the ED with referral to a primary care provider, followed by a telephone booster intervention performed by trained nurses 1-month post ED visit. The E-BNI will be compared to the basic BNI (without booster), and standard care with assessments (SC-A) and without (SC-NA). In a randomized, controlled clinical trial 900 hazardous and harmful (HH) drinkers will be randomly assigned to one of the 4 conditions. We, the researchers at Yale University, will conduct cost benefit analysis of the interventions. Follow-up assessments, at 6 and 12-months, will be obtained via interactive voice response (IVR).

详细描述

A critical need exists to refine and test brief interventions (BI) for Emergency Department (ED) populations with hazardous and harmful (HH) drinking that can be translated into real-world settings; and to enhance the effects of these BIs so they can be maintained over time. The ED is an ideal setting for BIs, as many ED patients who exceed low-risk recommendations do not have contact with either alcohol treatment specialists or visit primary care medical practitioners. This includes a large segment of young adults ages 18-30 whose only contact with the health care system is often an ED visit. The purpose of this study is to evaluate the effectiveness of an enhanced Emergency Practitioner (EP) performed BI, namely, the Enhanced Brief Negotiation Interview (E-BNI). This includes a basic BNI performed in the ED with referral to a primary care provider, followed by a telephone booster intervention performed by trained nurses 1-month post ED visit. The E-BNI will be compared to the basic BNI (without booster), and standard care with assessments (SC-A) and without (SC-NA). In a randomized, controlled clinical trial 900 HH drinkers will be randomly assigned to one of the 4 conditions. We will conduct cost benefit analysis of the interventions. Follow-up assessments, at 6 and 12-months, will be obtained via interactive voice response (IVR).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
盲法
Triple (Participant, Care Provider, Investigator)

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

  • •Patients, 18 years or older, who present to the adult ED at Yale-New Haven Hospital will be screened for exceeding the NIAAA criteria for low-risk drinking
  • •Patients may be hazardous "at-risk" drinkers who screen over the limits, but do not currently exhibit medical, social or legal problems as a result of their drinking, or they may be harmful drinkers, presenting with an alcohol associated injury or illness.

排除标准

  • •Patients will be excluded for the following reasons:
  • •Non-English speaking;
  • •Alcohol dependence;
  • •Current enrollment in a substance abuse treatment program;
  • •Current ED visit for acute psychiatric complaint;
  • •Condition that precludes interview i.e., life threatening injury/illness;
  • •In police custody; or
  • •Inability to provide two contact numbers for follow-up.

研究组 & 干预措施

SCA

No Intervention

Standard Care with Assessment

SCNA

No Intervention

Standard Care No Assessment

BNI

Experimental

Brief Negotiated Interview

干预措施: BNI (Behavioral)

EBNI

Experimental

Enhanced Brief Negotiated Interview

干预措施: BNI (Behavioral)

结局指标

主要结局

efficacy of brief intervention

时间窗: 12 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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