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| Name | Class |
|---|---|
| Region of Southern Denmark | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computer-alert | Active Comparator | 2 arm study active group: 'A computer alert which pops up when the GP prescribes NSAID/ASA to a patient with risk-factors |
|
| controlgroup, normal procedures | No Intervention | The control-group: GP working in normal procedures |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computer-alert | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient outcome: The number of hospitalizations due to bleeding ulcer complication. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Patient outcome: The number of uncomplicated ulcer diagnosed by endoscopy. | one year |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johanna Petersen, MD | Contact | jmpetersen@health.sdu.dk | ||
| Jane Møller Hansen, MD, Ph.D | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Johanna Petersen, MD | Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital. | Principal Investigator |
| Jane M Hansen, MD, Ph.D | Afdeling for Medicinske mavetarmsygdomme | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Afdeling for medicinske mavetarmsygdomme - Odense Universitetshospital | Recruiting | Odense | Funen | 5000 | Denmark |
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| ID | Term |
|---|---|
| D010438 | Peptic Ulcer Hemorrhage |
| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
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| ID | Term |
|---|---|
| D012307 | Risk Factors |
| ID | Term |
|---|---|
| D012306 | Risk |
| D011336 | Probability |
| D013223 | Statistics as Topic |
| D004812 | Epidemiologic Methods |
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|
| A computer alerts which pops up when the GP presribes NSAID/ASA to a patient with risk-factors | Device | 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 |
|
| Computer-alert | Device |
|
| one year |
| Prescription changes: general changes in the frequency of NSAID ordinations | one year |
| Johanna M Petersen, MD | Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital | Principal Investigator |
| Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital | Not yet recruiting | Odense | Denmark |
|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008919 |
| Investigative Techniques |
| D015984 | Causality |
| D015981 | Epidemiologic Factors |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |