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临床试验/NCT02236494
NCT02236494已完成不适用

Pilot Trial of Emergency Department Intervention and Referral for Alcohol Misuse in Older Adults

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2014年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
222
试验地点
2
主要终点
Subgroup analysis of patients who met hazardous alcohol use criteria based on time-line follow back method of assessing alcohol consumption

研究概览

简要总结

This is a randomized trial to assess the value of an emergency department-based intervention to reduce hazardous alcohol use among older adults. We hypothesize that the intervention will result in a 25% reduction in the prevalence of hazardous alcohol use while the control group will only have a 5% reduction.

详细描述

The goal of this project is to perform a pilot, randomized, controlled trial of a brief intervention and referral for treatment among older adults in the emergency department (ED) with alcohol misuse. The pilot data would then be used to design a larger study. The intervention for this trial will consist of a Brief Negotiation Interview (BNI) with a stratified referral for further treatment, compared with usual care. The BNI is a standardized, well-described intervention that has been implemented in a broad range of clinical settings but has not been specifically tested in older adults in the ED. Following the BNI, we will provide a referral for further care for the patient that is stratified by severity of alcohol misuse. Patients with hazardous or harmful alcohol use will follow-up with a primary care physician; patients with alcohol abuse or dependence will follow-up with an outpatient alcohol and substance abuse program; those at risk for complicated withdrawal will be recommended for inpatient treatment. In all cases we will contact the referral physician to help transition the patient's care, and ensure the patient receives a consistent message regarding their alcohol use across the different care settings.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Age 65 and older
  • Receiving care in the emergency department
  • Hazardous alcohol use, defined as reporting drinking more than 7 drinks per week on an average week during the three months prior to the visit, and whether they have consumed more than three drinks on any given occasion.

排除标准

  • psychosis or psychiatric hold
  • nursing home
  • life-threatening condition
  • current hospice care

研究组 & 干预措施

General Health Information Pamphlet

Active Comparator

This group will not receive a brief intervention in the ED. They will receive a pamphlet with general health information for older adults, as well as contact information for an outpatient alcohol treatment center where they have the option to follow-up for alcohol treatment at their discretion. The patient's readiness to change their alcohol habits will be measured using a 1-10 scale with a visual cue.

干预措施: General Health Information (Behavioral)

Brief Negotiated Interview

Experimental

The BNI will follow standard steps (7, 63): 1. The research assistant (RA) will ask permission to discuss the patient's alcohol use with them. 2. They will provide feedback regarding the patient's alcohol use, and will review guidelines drinking in older adults. Where relevant, the RA will discuss how the patient's current visit may relate to their alcohol use. 3. The RA will assess the patient's readiness to change using a 1-10 scale, and will enhance motivation. 4. The RA will negotiate a goal for the patient's drinking and give advice. The patient will be asked to sign a drinking agreement.

干预措施: Brief Negotiated Interview (Behavioral)

结局指标

主要结局

Subgroup analysis of patients who met hazardous alcohol use criteria based on time-line follow back method of assessing alcohol consumption

时间窗: 6 months

Analysis of rate of hazardous alcohol use in the control and intervention arms within the subgroup of patients who met hazardous drinking criteria of \>7 drinks in the past 7 days, or \>3 drinks per occasion within the last 28 days using the time-line follow back method.

Alcohol misuse

时间窗: 6 months

Self-reported alcohol misuse is defined as patient self-report of either drinking \>7 drinks per week or \>3 drinks per occasion in the past month.

次要结局

  • Alcohol misuse(3 months, 12 months)
  • Function(6,12 months)
  • Alcohol consumption(3,6,12 months)
  • Alcohol abuse(3,6,12 months)
  • General Health(3,6,12 months)
  • Risk-taking behavior(6,12 months)
  • Trauma(6,12 months)
  • Healthcare Utilization(6,12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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