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

Bleeding Peptic Ulcer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01845168
• Other study ID #: S-20120034
• Status: Recruiting
• Phase: N/A
• First received: March 13, 2013
• Last updated: October 28, 2013
• Start date: April 2013
• Est. completion date: April 2015

Study information

• Verified date: October 2013
• Source: Odense University Hospital
• Contact: Johanna Petersen, MD
• Email: jmpetersen[@]health.sdu.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: April 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bleeding Peptic Ulcer
• Hemorrhage
• Peptic Ulcer
• Peptic Ulcer Hemorrhage
• Ulcer

Intervention

Other:
• Computer-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

Device:
• 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 steroids
• Computer-alert

Locations

Country	Name	City	State
Denmark	Afdeling for medicinske mavetarmsygdomme - Odense Universitetshospital	Odense	Funen
Denmark	Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
Odense University Hospital	Region of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prescription changes: How often the GP refrains the ASA/NSAID-treatment because of the risk-information and the computer-alert		one year	No
Other	Prescription changes: The number of patients with riskfactors, who will recieve a prescription of ulcer preventive medicine		one year	No
Other	Prescription changes: general changes in the frequency of NSAID ordinations		one year	No
Primary	Patient outcome: The number of hospitalizations due to bleeding ulcer complication.		one year	No
Secondary	Patient outcome: The number of uncomplicated ulcer diagnosed by endoscopy.		one year	No