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Efficacy of a Brief Alcohol Intervention for Non Dependant Alcohol-misusing Patients Undergoing a Scheduled Surgery (ITBCHIR)

2014年4月30日 更新者:Rennes University Hospital

Efficacy of a Brief Alcohol Intervention for Non Dependant Alcohol-misusing Patients Undergoing a Scheduled Surgery: a Randomized Controlled Trial

Excessive alcohol consumption is a worldwide major public health problem. Brief interventions have shown to be an efficient treatment modality for problem drinkers, but have never been tested in scheduled surgery.

Patients will be recruited in various surgery units in 7 hospital in France. All patients attending a scheduled surgery will be screened during the visit with the anaesthesist by the Alcohol Use Disorders Identification Test (AUDIT). Patients aged 30-75 with an AUDIT between 7 and 12, corresponding to at risk or harmful use, will be proposed to enter a control study and randomized between a brief intervention by a trained nurse during the post-surgery hospitalisation and no intervention. Twelve months after the surgery, a research technician will interview by telephone patients and evaluate AUDIT and alcohol consumption of the last month.

研究概览

详细说明

Excessive alcohol consumption is a worldwide major public health problem. Persons who drink more than 2-3 drinks per day are at risk for numerous medical, psychological and social problems. Brief interventions have shown to be an efficient treatment modality for problem drinkers in settings such as primary care, emergencies or psychiatric hospitals by numerous randomized studies. Brief intervention consists typically in a brief assessment, giving patients personal feedback, dealing with resistance and ambivalence, establishing a goal of reduced alcohol use, and giving a workbook; reinforcement visits or calls are included. Brief interventions seem to be particularly effective in patients with alcohol problem without dependence.

Screening for alcohol problem is best done using standardized questionnaires, as the Alcohol Use Disorders Identification Test (AUDIT), developed by WHO and translated in many languages. The AUDIT allows distinguishing between normal alcohol use, harmful or at risk use and dependence and is easy to use.

No study on brief intervention has been conducted in scheduled surgery. This seems to be a promising situation, since there is first a visit with the anaesthetist, during which screening for alcohol problem should occur, then a hospitalisation, during which the intervention could be made. It is possible that patients are more concerned by their health when they come to hospital for a surgery.

The aim of this controlled, randomized study is to test the hypothesis that a brief intervention, consisting in a visit with a trained nurse, followed by a telephone call three months later, in patients with at risk or harmful alcohol use, undergoing a scheduled surgery, could be efficient to promote the decrease of alcohol consumption.

Patients will be screened during the visit with the anaesthetist with AUDIT. Patients with AUDIT between 7 and 12 will be proposed to enter the study, and randomised between Brief Intervention and no intervention. A research technician will interview patients 12 months after the surgery, with assessment of the AUDIT and alcohol consumption. CDT and GGT will be measured prior to surgery, then at 12 months after surgery.

研究类型

介入性

注册 (实际的)

3

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Rennes、法国、35033
        • Unité d'Alcoologie et Hépatologie Générale, Département d'Anesthésie Réanimation- Hôpital de Pontchaillou

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

30年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Man or woman
  • Aged 30 to 75 years old
  • With a scheduled surgery
  • Presenting an Alcohol Use Disorders Identification Test score between 7 and 12 (included) during the routine visit with the anaesthesist prior to hospitalisation
  • Being capable of understanding the information note
  • Who gave a written informed consent
  • Affiliated to a medical insurance

Non inclusion Criteria:

  • Surgery in relation to alcohol consumption (chronic pancreatitis, oropharyngeal cancer for example) or modifying alcohol consumption (liver transplantation for example),
  • No telephone number
  • Dependence to alcohol (Alcohol Use Disorders Identification Test score ≥ 13)
  • History of alcohol weaning complications
  • History of addiction care
  • Life expectancy less than 5 years
  • Decompensated psychiatric disease
  • Usual consumption (more than three times a week) of illicit products
  • Person deprived of freedom or under guardianship
  • Participation or intent to participate in another biomedical research

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:无干预
实验性的:Brief Alcohol Intervention
Brief intervention consists typically in a brief assessment, giving patients personal feedback, dealing with resistance and ambivalence, establishing a goal of reduced alcohol use, and giving a workbook; reinforcement visits or calls are included.
其他名称:
  • 白

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Rate of patients getting back to an Alcohol Use Disorders Identification Test score <7
大体时间:1 year
1 year

次要结果测量

结果测量
措施说明
大体时间
Evolution of the Alcohol Use Disorders Identification Test score
大体时间:1 year
1 year
Alcohol consumption in the month preceding the final evaluation at 1 year
大体时间:1 year
1 year
Gamma-GT and CDT evolution
大体时间:1 year
1 year
Frequency of normalization of gamma-GT and CDT measures
大体时间:1 year
1 year
Rate of patients in the Brief Alcohol Intervention group getting back to an Alcohol Use Disorders Identification Test score <7, with stratification on the Prochaska score
大体时间:1 year
1 year
Feeling of the patients towards the Brief Alcohol Intervention
大体时间:1 year
recollection, acceptability, relevance, recollection of the recall at 3 months, acceptability of the recall at 3 months
1 year
Prevalence of alcohol misuse, with or without dependence, in patients seen in pre-anaesthesia consultation
大体时间:6 months
6 months
Proportion of total population presenting an increase in gamma-GT and CDT in comparison with upper limits of normal
大体时间:6 months
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Romain MOIRAND, MD, PhD、Rennes University Hospital
  • 学习椅:Jean-Michel REYMANN, PhD、Rennes University Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年7月1日

初级完成 (实际的)

2012年5月1日

研究完成 (实际的)

2012年11月1日

研究注册日期

首次提交

2010年7月2日

首先提交符合 QC 标准的

2011年5月3日

首次发布 (估计)

2011年5月5日

研究记录更新

最后更新发布 (估计)

2014年5月1日

上次提交的符合 QC 标准的更新

2014年4月30日

最后验证

2014年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • RCB 2009-A00591-56
  • PHRC/09-09 (其他标识符:Rennes University Hospital)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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