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

Primary Purpose

Alcohol Abuse, Alcohol Problem, AOD Misuse

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Brief Alcohol intervention
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alcohol Abuse focused on measuring Alcohol Use Disorders Identification Test, alcohol dependence, Alcohol problem

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Brief Alcohol Intervention

No intervention

Arm Description

Outcomes

Primary Outcome Measures

Rate of patients getting back to an Alcohol Use Disorders Identification Test score <7

Secondary Outcome Measures

Evolution of the Alcohol Use Disorders Identification Test score
Alcohol consumption in the month preceding the final evaluation at 1 year
Gamma-GT and CDT evolution
Frequency of normalization of gamma-GT and CDT measures
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
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
Prevalence of alcohol misuse, with or without dependence, in patients seen in pre-anaesthesia consultation
Proportion of total population presenting an increase in gamma-GT and CDT in comparison with upper limits of normal

Full Information

First Posted
July 2, 2010
Last Updated
April 30, 2014
Sponsor
Rennes University Hospital
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT01348113
Brief Title
Efficacy of a Brief Alcohol Intervention for Non Dependant Alcohol-misusing Patients Undergoing a Scheduled Surgery
Acronym
ITBCHIR
Official Title
Efficacy of a Brief Alcohol Intervention for Non Dependant Alcohol-misusing Patients Undergoing a Scheduled Surgery: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Study Start Date
July 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Alcohol Problem, AOD Misuse
Keywords
Alcohol Use Disorders Identification Test, alcohol dependence, Alcohol problem

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romain MOIRAND, MD, PhD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-Michel REYMANN, PhD
Organizational Affiliation
Rennes University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Unité d'Alcoologie et Hépatologie Générale, Département d'Anesthésie Réanimation- Hôpital de Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France

12. IPD Sharing Statement

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

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