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

30. april 2014 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

3

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

30 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Ingen inngrep
Eksperimentell: 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 navn:
  • BAI

Hva måler studien?

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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2010

Primær fullføring (Faktiske)

1. mai 2012

Studiet fullført (Faktiske)

1. november 2012

Datoer for studieregistrering

Først innsendt

2. juli 2010

Først innsendt som oppfylte QC-kriteriene

3. mai 2011

Først lagt ut (Anslag)

5. mai 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

1. mai 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. april 2014

Sist bekreftet

1. april 2014

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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