Bleeding Peptic Ulcer
Conditions
Keywords
Bleeding peptic ulcer, NSAID and Aspirin, Computer-alert, General practitioner
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.
Interventions
OTHERComputer-alert
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
DEVICEA computer alerts which pops up when the GP presribes NSAID/ASA to a patient with risk-factors
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
Sponsors
Region of Southern Denmark
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* General practitioners in the Region of Southern Denmark which are linked to Danish General Medical Database for minimum 6 months
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient outcome: The number of hospitalizations due to bleeding ulcer complication. | one year |
Secondary
| Measure | Time frame |
|---|---|
| Patient outcome: The number of uncomplicated ulcer diagnosed by endoscopy. | one year |
Other
| Measure | Time frame |
|---|---|
| Prescription changes: How often the GP refrains the ASA/NSAID-treatment because of the risk-information and the computer-alert | one year |
| Prescription changes: The number of patients with riskfactors, who will recieve a prescription of ulcer preventive medicine | one year |
| Prescription changes: general changes in the frequency of NSAID ordinations | one year |
Countries
Denmark
Contacts
Primary ContactJohanna Petersen, MD
Backup ContactJane Møller Hansen, MD, Ph.D
Outcome results
None listed