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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prevention of Peptic Ulcer Bleeding Related to the Use of NSAIDs and Aspirin by Using Computer-alert - a Randomized Study in General Practice

Conditions
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Bleeding Peptic Ulcer

Intervention / Treatment
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* Other: Computer-alert
* Device: A computer alerts which pops up when the GP presribes NSAID/ASA to a patient with risk-factors
* Device: Computer-alert


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General practitioners in the Region of Southern Denmark which are linked to Danish General Medical Database for minimum 6 months Exclusion Criteria: -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Computer-alert<br>2 arm study active group: 'A computer alert which pops up when the GP prescribes NSAID/ASA to a patient with risk-factors | Other: Computer-alert<br>* A computer-alert which is activated when the physician is making a prescription for ASA or NSAID. Only for patients with riskfactors such as: Age over 60, males-gender, NSAID and ASA in kombination, Adenosine-diphosphate-inhibitor (ADP-inhibitor), blood-thinning medicine, Selective serotonin reuptake-inhibitor (SSRI) and steroids<br>Device: A computer alerts which pops up when the GP presribes NSAID/ASA to a patient with risk-factors<br>* A computer-alert which is activated when the physician is making a prescription for ASA or NSAID. Only for patients with riskfactors such as: Age over 60, males-gender, NSAID and ASA in combination, ADP-inhibitor, bloodthinning medicine, SSRI, and steroids<br>Device: Computer-alert<br> <br> |
| No Intervention: controlgroup, normal procedures<br>The control-group: GP working in normal procedures | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient outcome: The number of hospitalizations due to bleeding ulcer complication. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient outcome: The number of uncomplicated ulcer diagnosed by endoscopy. |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bleeding peptic ulcer, NSAID and Aspirin, Computer-alert, General practitioner