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

Odense University Hospital

Status: Unknown

Conditions: Bleeding Peptic Ulcer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01845168

S-20120034

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Computer-alert

Active Comparator group

Description:

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

Treatment:

Device: A computer alerts which pops up when the GP presribes NSAID/ASA to a patient with risk-factors

Device: Computer-alert

Device: Computer-alert

controlgroup, normal procedures

No Intervention group

Description:

The control-group: GP working in normal procedures