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

Alcohol Abuse Clinical Trial

— ITBCHIR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01348113
• Other study ID #: RCB 2009-A00591-56
• Secondary ID: PHRC/09-09
• Status: Terminated
• Phase: Phase 3
• First received: July 2, 2010
• Last updated: April 30, 2014
• Start date: July 2010
• Est. completion date: November 2012

Study information

• Verified date: April 2014
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: November 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Problem
• AOD Misuse

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Unité d'Alcoologie et Hépatologie Générale, Département d'Anesthésie Réanimation- Hôpital de Pontchaillou	Rennes

Sponsors (2)

Lead Sponsor	Collaborator
Rennes University Hospital	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients getting back to an Alcohol Use Disorders Identification Test score <7		1 year	No
Secondary	Evolution of the Alcohol Use Disorders Identification Test score		1 year	No
Secondary	Alcohol consumption in the month preceding the final evaluation at 1 year		1 year	No
Secondary	Gamma-GT and CDT evolution		1 year	No
Secondary	Frequency of normalization of gamma-GT and CDT measures		1 year	No
Secondary	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		1 year	No
Secondary	Feeling of the patients towards the Brief Alcohol Intervention	recollection, acceptability, relevance, recollection of the recall at 3 months, acceptability of the recall at 3 months	1 year	No
Secondary	Prevalence of alcohol misuse, with or without dependence, in patients seen in pre-anaesthesia consultation		6 months	No
Secondary	Proportion of total population presenting an increase in gamma-GT and CDT in comparison with upper limits of normal		6 months	No