Implementation of an alcohol cessation support program reduces recurrence of acute alcoholic pancreatitis in patients with a first episode of acute alcoholic pancreatitis
ID
Bron
Verkorte titel
Aandoening
Acute alcoholic pancreatitis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Recurrent acute alcoholic pancreatitis
Achtergrond van het onderzoek
Rationale: The most important risk factor for pancreatitis recurrence and chronic pancreatitis in acute alcoholic pancreatitis is continuation of alcohol use, yet no cessation support program is applied in current practice.
Objective: To determine whether an optimally timed personalized multidisciplinary alcohol cessation support program can reduce pancreatitis recurrence in acute alcoholic pancreatitis as compared to standard practice.
Study design: Nationwide cluster randomized superiority trial. Participating centers will be randomized for the investigational management or standard practice in an equal allocation ratio and stratification according to hospital type (academic vs. non-academic).
Study population: Patients with a first episode of acute alcoholic pancreatitis (defined as an Alcohol Use Disorders Identification Test [AUDIT] score >7) without indication for referral to an addiction specialized physician (i.e. AUDIT > 15) will be included.
Intervention: The investigational management is based on the evidence-based general practice guideline on problematic alcohol use and consists of a program with six steps during hospital admission and after discharge, in which patients with acute alcoholic pancreatitis are individually supported in their alcohol cessation attempt.
Comparison: Care for acute alcoholic pancreatitis patients according to current practice.
Endpoints: The primary outcome is alcoholic pancreatitis recurrence. Secondary outcomes include cessation or reduction of alcohol use, development of chronic pancreatitis and quality of life. The follow-up period will comprise one year after admission.
Doel van het onderzoek
Implementation of an alcohol cessation support program reduces recurrence of acute alcoholic pancreatitis in patients with a first episode of acute alcoholic pancreatitis
Onderzoeksopzet
Expected start data: December 2020
Inclusion period: 2 years
Follow-up period: 1 year after inclusion
Expected end date: December 2023
Onderzoeksproduct en/of interventie
The intestigational management is based on the evidence-based general practice guideline on problematic alcohol use and consists of a program with six steps during hospital admission and after discharge, in which patients with acute alcoholic pancreatitis are individually supported in their alcohol cessation attempt
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
First episode of acute pancreatitis (according to the Revised Atlanta criteria), harmfull drinking (defined as AUDIT score>7), age of 18 or older and provided written informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Chronic pancreatitis, indication for referral to an addiction specialized phsyician (AUDIT>15), diagnosis of any etiology other than alcoholic after standard diagnostic work-up according to the IAP/APA evidence-based guidelines
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8852 |
| Ander register | Medical research Ethics Committees United (MEC-U) : W20.172 |