Prevention of Gastric Ulcer Bleeding by Using "Computer-alert" in General Practice

Not Applicable

• Conditions: Bleeding Peptic Ulcer
• Interventions: Device: A computer alerts which pops up when the GP presribes NSAID/ASA to a patient with risk-factors; Device: Computer-alert

• Registration Number: NCT01845168
• Lead Sponsor: Odense University Hospital

Brief Summary

The purpose of this study is to investigate if a computerised decision-support tool used in general practice, can reduce the frequency of peptic ulcer bleeding related to the use of NSAIDs (Non-Steroidal-antiinflammatory-drug) and ASA( Acetylsalicylic acid) .

On the basis of "The Danish general medical database" it is possible to develope a computerised decision-support tool, which enables the general practitioner (GP) in a "pop-up" window to get information on each patients risk-factors, when prescribing NSAID and aspirin to a patient at risk. This will give the general practitioner the oppurtunity to choose a different type of preparation or prescribe ulcer-preventive medicine at the same time.

The decision-support tool will be tested in a randomized trial among general practitioners. The aim is to reduce the occurence of peptic ulcer bleeding. The expected outcome is a reduction in half of the total numbers of peptic ulcers.

Detailed Description

The background of the study is that NSAIDs and Aspirins increase the risk of peptic ulcer bleeding. On average 1-2% of patients using NSAID and Aspirin will develope gastric ulcer bleeding. But for patients with one or more risk-factors, the risk increases to 9% per 6 months. The mortality in this case is 10-15%. Approximately 3200 patients are admitted to the hospital with bleeding ulcer annually in Denmark.

Danish investigations have shown that 80% of all peptic ulcer bleedings admitted to hospital are related to the use of NSAID or Aspirin.

The consumption of NSAID and Aspirin is large. A third of people over 60 are treated within a year with these preparations. The risk of developing gastric ulcer related to NSAID and Aspirin can be reduced by concomitant therapy with antacids. Several studies have shown that only 20-30% of patients with risk-factors receive ulcer preventive medicine.

Study Timeline

• Study First Submitted: 2013-03-13
• Study Start: 2013-04
• Study First Submitted QC: 2013-04-29
• Study First Posted: 2013-05-03
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-28
• Last Update Posted: 2013-10-29
• Primary Completion: 2014-02
• Study Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• General practitioners in the Region of Southern Denmark which are linked to Danish General Medical Database for minimum 6 months

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computer-alert	A computer alerts which pops up when the GP presribes NSAID/ASA to a patient with risk-factors	2 arm study active group: 'A computer alert which pops up when the GP prescribes NSAID/ASA to a patient with risk-factors
Computer-alert	Computer-alert	2 arm study active group: 'A computer alert which pops up when the GP prescribes NSAID/ASA to a patient with risk-factors

Primary Outcome Measures

Name	Time	Method
Patient outcome: The number of hospitalizations due to bleeding ulcer complication.	one year

Secondary Outcome Measures

Name	Time	Method
Patient outcome: The number of uncomplicated ulcer diagnosed by endoscopy.	one year

Trial Locations

Locations (2)

Afdeling for medicinske mavetarmsygdomme - Odense Universitetshospital; 🇩🇰 Odense, Funen, Denmark

Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital; 🇩🇰 Odense, Denmark