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

This study has been terminated.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01348113
First received: July 2, 2010
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Alcohol Abuse
Alcohol Problem
AOD Misuse
Other: Brief Alcohol intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Efficacy of a Brief Alcohol Intervention for Non Dependant Alcohol-misusing Patients Undergoing a Scheduled Surgery: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Rate of patients getting back to an Alcohol Use Disorders Identification Test score <7 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evolution of the Alcohol Use Disorders Identification Test score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Alcohol consumption in the month preceding the final evaluation at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Gamma-GT and CDT evolution [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Frequency of normalization of gamma-GT and CDT measures [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Feeling of the patients towards the Brief Alcohol Intervention [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Proportion of total population presenting an increase in gamma-GT and CDT in comparison with upper limits of normal [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: July 2010
Study Completion Date: November 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brief Alcohol 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.
Other Name: BAI
No Intervention: No intervention

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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01348113

Locations
France
Unité d'Alcoologie et Hépatologie Générale, Département d'Anesthésie Réanimation- Hôpital de Pontchaillou
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Ministry of Health, France
Investigators
Principal Investigator: Romain MOIRAND, MD, PhD Rennes University Hospital
Study Chair: Jean-Michel REYMANN, PhD Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01348113     History of Changes
Other Study ID Numbers: RCB 2009-A00591-56, PHRC/09-09
Study First Received: July 2, 2010
Last Updated: April 30, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
Alcohol Use Disorders Identification Test
alcohol dependence
Alcohol problem

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 28, 2014