Clinical Trial: Prevention of Gastric Ulcer Bleeding by Using "Computer-alert" in General Practice
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Prevention of Peptic Ulcer Bleeding Related to the Use of NSAIDs and Aspirin by Using "Computer-alert" - a Randomized Study in General Practice
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 Summary:
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.
Sponsor: Odense University Hospital
Current Primary Outcome: Patient outcome: The number of hospitalizations due to bleeding ulcer complication. [ Time Frame: one year ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Patient outcome: The number of uncomplicated ulcer diagnosed by endoscopy. [ Time Frame: one year ]
Original Secondary Outcome: Same as current
Information By: Odense University Hospital
Dates:
Date Received: March 13, 2013
Date Started: April 2013
Date Completion: April 2015
Last Updated: October 28, 2013
Last Verified: October 2013
