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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Rennes、フランス、35033
- Unité d'Alcoologie et Hépatologie Générale, Département d'Anesthésie Réanimation- Hôpital de Pontchaillou
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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介入なし：介入なし
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実験的：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Rate of patients getting back to an Alcohol Use Disorders Identification Test score <7
時間枠：1 year
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1 year
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Evolution of the Alcohol Use Disorders Identification Test score
時間枠：1 year
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1 year
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Alcohol consumption in the month preceding the final evaluation at 1 year
時間枠：1 year
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1 year
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Gamma-GT and CDT evolution
時間枠：1 year
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1 year
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Frequency of normalization of gamma-GT and CDT measures
時間枠：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
時間枠：1 year
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1 year
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Feeling of the patients towards the Brief Alcohol Intervention
時間枠：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
時間枠：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
時間枠：6 months
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6 months
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協力者と研究者
捜査官
- 主任研究者：Romain MOIRAND, MD, PhD、Rennes University Hospital
- スタディチェア：Jean-Michel REYMANN, PhD、Rennes University Hospital
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- RCB 2009-A00591-56
- PHRC/09-09 (その他の識別子：Rennes University Hospital)
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