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

30. april 2014 opdateret af: Rennes University Hospital

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.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

3

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Rennes, Frankrig, 35033
        • Unité d'Alcoologie et Hépatologie Générale, Département d'Anesthésie Réanimation- Hôpital de Pontchaillou

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

30 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Ingen indgriben
Eksperimentel: 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.
Andre navne:
  • BAI

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Rate of patients getting back to an Alcohol Use Disorders Identification Test score <7
Tidsramme: 1 year
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evolution of the Alcohol Use Disorders Identification Test score
Tidsramme: 1 year
1 year
Alcohol consumption in the month preceding the final evaluation at 1 year
Tidsramme: 1 year
1 year
Gamma-GT and CDT evolution
Tidsramme: 1 year
1 year
Frequency of normalization of gamma-GT and CDT measures
Tidsramme: 1 year
1 year
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
Tidsramme: 1 year
1 year
Feeling of the patients towards the Brief Alcohol Intervention
Tidsramme: 1 year
recollection, acceptability, relevance, recollection of the recall at 3 months, acceptability of the recall at 3 months
1 year
Prevalence of alcohol misuse, with or without dependence, in patients seen in pre-anaesthesia consultation
Tidsramme: 6 months
6 months
Proportion of total population presenting an increase in gamma-GT and CDT in comparison with upper limits of normal
Tidsramme: 6 months
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Romain MOIRAND, MD, PhD, Rennes University Hospital
  • Studiestol: Jean-Michel REYMANN, PhD, Rennes University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2010

Primær færdiggørelse (Faktiske)

1. maj 2012

Studieafslutning (Faktiske)

1. november 2012

Datoer for studieregistrering

Først indsendt

2. juli 2010

Først indsendt, der opfyldte QC-kriterier

3. maj 2011

Først opslået (Skøn)

5. maj 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. maj 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. april 2014

Sidst verificeret

1. april 2014

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • RCB 2009-A00591-56
  • PHRC/09-09 (Anden identifikator: Rennes University Hospital)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Brief Alcohol intervention

3
Abonner