Efficacy of a Brief Alcohol Intervention for Non Dependant Alcohol-misusing Patients Undergoing a Scheduled Surgery (ITBCHIR)
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
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Rennes、法国、35033
- Unité d'Alcoologie et Hépatologie Générale, Département d'Anesthésie Réanimation- Hôpital de Pontchaillou
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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 |
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无干预:无干预
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实验性的:Brief Alcohol Intervention
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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:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Rate of patients getting back to an Alcohol Use Disorders Identification Test score <7
大体时间:1 year
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1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evolution of the Alcohol Use Disorders Identification Test score
大体时间:1 year
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1 year
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Alcohol consumption in the month preceding the final evaluation at 1 year
大体时间:1 year
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1 year
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Gamma-GT and CDT evolution
大体时间:1 year
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1 year
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Frequency of normalization of gamma-GT and CDT measures
大体时间:1 year
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1 year
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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
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1 year
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Feeling of the patients towards the Brief Alcohol Intervention
大体时间:1 year
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recollection, acceptability, relevance, recollection of the recall at 3 months, acceptability of the recall at 3 months
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1 year
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Prevalence of alcohol misuse, with or without dependence, in patients seen in pre-anaesthesia consultation
大体时间:6 months
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6 months
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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
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6 months
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合作者和调查者
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
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
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)
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