Prevention of Gastric Ulcer Bleeding by Using "Computer-alert" in General Practice
|ClinicalTrials.gov Identifier: NCT01845168|
Recruitment Status : Unknown
Verified October 2013 by Johanna Petersen, Odense University Hospital.
Recruitment status was: Recruiting
First Posted : May 3, 2013
Last Update Posted : October 29, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Bleeding Peptic Ulcer||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||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||February 2014|
|Estimated Study Completion Date :||April 2015|
Active Comparator: Computer-alert
2 arm study active group: 'A computer alert which pops up when the GP prescribes 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 kombination, Adenosine-diphosphate-inhibitor (ADP-inhibitor), blood-thinning medicine, Selective serotonin reuptake-inhibitor (SSRI) and steroidsDevice: A 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 steroidsDevice: Computer-alert
No Intervention: controlgroup, normal procedures
The control-group: GP working in normal procedures
- Patient outcome: The number of hospitalizations due to bleeding ulcer complication. [ Time Frame: one year ]
- Patient outcome: The number of uncomplicated ulcer diagnosed by endoscopy. [ Time Frame: one year ]
- Prescription changes: How often the GP refrains the ASA/NSAID-treatment because of the risk-information and the computer-alert [ Time Frame: one year ]
- Prescription changes: The number of patients with riskfactors, who will recieve a prescription of ulcer preventive medicine [ Time Frame: one year ]
- Prescription changes: general changes in the frequency of NSAID ordinations [ Time Frame: one year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01845168
|Contact: Johanna Petersen, MDfirstname.lastname@example.org|
|Contact: Jane Møller Hansen, MD, Ph.D|
|Afdeling for medicinske mavetarmsygdomme - Odense Universitetshospital||Recruiting|
|Odense, Funen, Denmark, 5000|
|Contact: Johanna Petersen, MD 0045 24379220 email@example.com|
|Principal Investigator: Johanna Petersen, MD|
|Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital||Not yet recruiting|
|Contact: Johanna Petersen firstname.lastname@example.org|
|Principal Investigator: Johanna Petersen|
|Principal Investigator:||Johanna Petersen, MD||Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital.|
|Study Director:||Jane M Hansen, MD , Ph.D||Afdeling for Medicinske mavetarmsygdomme|
|Principal Investigator:||Johanna M Petersen, MD||Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital|