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临床试验/NCT01370226
NCT01370226已完成不适用

Optimizing Alcohol Brief Interventions in the ED: Computer vs. Clinician Delivery

University of Michigan2 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
750
试验地点
2
主要终点
Alcohol use - number of drinks per day

研究概览

简要总结

The aims of the study are to develop and refine tailored motivational brief interventions that are parallel in structure but have varied delivery modalities (computer vs. therapist) for patients with at-risk or problematic alcohol use, and to conduct a randomized controlled trial comparing the efficacy of these BI approaches (CBI, TBI, control) on subsequent alcohol consumption and alcohol consequences, including alcohol-related injury, mental and physical-health functioning, and HIV risk behaviors at 3-, 6-, and 12-months post-ED visit.

详细描述

Although a high proportion of patients seen in Emergency Departments (EDs) have at-risk or problem alcohol use, few are screened and receive services such as brief interventions (BI) designed to help them cut-back or stop drinking. EDs do not routinely provide BIs, perhaps due to feasibility challenges such as training of staff, monitoring fidelity, and maintaining a system to ensure longer-term implementation. Alcohol BIs have been found to be efficacious and effective in a variety of health care settings. However, the evidence for their use in the ED has been mixed. There is a pressing need to develop efficacious strategies to screen and optimally deliver alcohol BIs in this fast-paced and widely-used setting. Existing clinician-delivered BI strategies need to be modified so that they can be standardized and administered with high fidelity and minimal demands on ED staff time and resources. Computer-delivered BIs are one method to address the challenges inherent in delivering interventions in this and other healthcare settings. The proposed study will use computerized screening via touch-screen computer tablets with audio to recruit inner-city ED patients screening positive for at-risk or problem alcohol use. Participants age 21-65 will be randomized to one of three conditions: 1) Computer-delivered brief intervention (CBI); 2) Therapist-delivered brief intervention (TBI); or 3) Enhanced usual care (EUC). All participants will receive written information regarding community resources; individuals who meet alcohol abuse/dependence criteria will also receive alcohol treatment referrals. Stratified random assignment [by gender; meeting criteria for an alcohol use disorder] will take place at baseline for all conditions. The rigorous examination of the efficacy of therapist- vs. computer-delivered BIs, including potential moderators and mediators, will address the key limitations raised by previous trials and will determine the optimal modality for wide implementation of brief alcohol interventions in this venue. Because the ED is such an important portal for entry into the medical care system, particularly for inner-city patients, the delivery of efficacious alcohol BIs that emphasize key motivational interviewing components and minimize staff resources could have a major public health impact.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients age 21-65 years presenting to the ED for medical care (except exclusions as noted below)
  • ability to provide informed consent
  • Additional criteria for intervention: past 3-month at-risk alcohol use

排除标准

  • patients who do not understand English
  • prisoners
  • patients classified by medical staff as "Level 1 trauma" (e.g., unconscious, intubated on respirators, in need of immediate lifesaving procedures such as surgery)
  • patients deemed unable to provide informed consent as stated above (e.g., intoxication, mental incompetence)
  • patients treated in the ED for suicide attempts or sexual assault

结局指标

主要结局

Alcohol use - number of drinks per day

时间窗: change over time (3, 6 and 12-months post baseline)

Alcohol use - number of binge drinking days

时间窗: change over time (3, 6 and 12-months post baseline)

Alcohol use

时间窗: change over time (3, 6 and 12-months post baseline)

Alcohol Use Disorders Identification Test (AUDIT-C)

Alcohol use - number of drinking days

时间窗: change over time (3, 6 and 12-months post baseline)

Alcohol related consequences

时间窗: change over time (3, 6 and 12-months post baseline)

Consequences are measured using the modified Short Inventory of Problems (SIP).

次要结局

  • Consequences of Alcohol Use - injury(change over time (3, 6 and 12-months post baseline))
  • Consequences of Alcohol Use - health functioning - depression(change over time (3, 6 and 12-months post baseline))
  • Consequences of Alcohol Use - HIV-risk behaviors(change over time (3, 6 and 12-months post baseline))
  • Consequences of Alcohol Use - health functioning(change over time (3, 6 and 12-months post baseline))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Frederic C. Blow

Principal Investigator

University of Michigan

研究点 (2)

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