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临床试验/NCT01060397
NCT01060397已完成不适用

A Randomized Controlled Trial of Extended Brief Interventions for Alcohol-dependent Patients in an Acute Care Setting

Southport and Ormskirk Hospital NHS Trust2 个研究点 分布在 1 个国家目标入组 267 人开始时间: 2009年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
267
试验地点
2
主要终点
Alcohol Use Disorders Identification Test (AUDIT)

研究概览

简要总结

Heavy alcohol consumption leads to various health problems and is now recognised to be an important public health problem. This is evidenced by the huge media attention recently focused on the use and misuse of alcohol, particularly by younger patients. At least 1 in 20 of the population in the UK are physically and psychologically dependent on alcohol. This not only has consequences for the physical and psychological well-being of these patients, but has adverse consequences for their family, work life and society in general. Current treatments are mostly delivered in specialist units, which are few in number meaning that few patients get access to these services. This leads to a vicious cycle which results in multiple hospital admissions, ineffective treatments and continual drinking. It is therefore vital the investigators develop alternative effective treatments for these patients which can interrupt this vicious cycle.

In patients who drink heavily, but are not yet alcohol-dependent, a treatment called brief intervention can help reduce overall alcohol consumption, and improve health and wellbeing. However, whether a similar intervention can help alcohol-dependent patients has not yet been established.

In this study, the investigators aim to identify, treat and support alcohol-dependent individuals. Using an enhanced form of BI (termed extended brief intervention, EBI) as the basis of clinical care, the investigators will undertake a randomised trial comparing EBI with usual clinical care. The investigators will use various clinical and behavioural measures to assess the effectiveness of this treatment. The investigators will also be asking patients how they felt, and what they think of their treatment and the professionals delivering that treatment. If EBI is shown to be effective and is not too costly, it could provide a national framework for treatment of alcohol-dependent patients. This could potentially improve both the opportunities to access treatment and the choice of treatments available to patients.

The investigators hypothesis is that Extended Brief Interventions (EBI) delivered to alcohol-dependent patients in a hospital setting by an Alcohol Specialist Nurse (ASN) will be effective in reducing overall alcohol consumption and improving the standard measures of alcohol dependence.

详细描述

Hypothesis Extended Brief Interventions (EBI) delivered to alcohol-dependent patients in a hospital setting by an Alcohol Specialist Nurse (ASN) will be effective when compared to usual care; in reducing overall alcohol consumption and improving on the standard measures of alcohol dependence.

Overall aim To test the clinical and cost effectiveness of extended brief interventions for individuals with alcohol dependence in an acute hospital setting.

Objectives:

  1. Determine whether brief interventions reduce overall alcohol consumption.
  2. Determine whether brief interventions are effective in the treatment of alcohol dependence.
  3. Determine whether brief interventions reduce the length of stay in hospital
  4. Determine how patients feel about being approached in an opportunistic manner for screening for alcohol-related problems and subsequently being asked to be part of a research trial (Refer to Part B of the protocol. Qualitative analysis of patient views and experience).
  5. Determine the cost effectiveness of brief interventions for alcohol dependence. (Part C. Cost effectiveness analysis) Part A. Clinical Intervention Methods Design Randomized Controlled Trial Outcome measures Primary • Severity of Alcohol dependence (SADQ)

Secondary

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Patients with a score equal to or greater than 16 on the AUDIT screening tool.

排除标准

  • Patient's known to be intravenous drug abusers.
  • Patients unable to give informed consent.
  • Patients whose medical co-morbidity requires requiring frequent or long term hospital admission. These will include patients who are/have;
  • Comatose /unconscious
  • End Stage Chronic Liver Disease
  • Congestive Cardiac Failure stage III or IV
  • Acute Pancreatitis
  • Head Injury with abnormalities on CT scan
  • Cerebral Vascular Accident (CVA)
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Other chronic conditions where an admission of 1 month or more is required.
  • Patient's presently recruited to any other research trial

结局指标

主要结局

Alcohol Use Disorders Identification Test (AUDIT)

时间窗: Baseline, twelve weeks and six months

次要结局

  • Measure of Dependence (Leeds Dependency Questionnaire)(baseline, 12 weeks and 6 months)

研究者

发起方
Southport and Ormskirk Hospital NHS Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Lynn Owens

Dr Lynn Owens

Southport and Ormskirk Hospital NHS Trust

研究点 (2)

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