Clinical trial NCT01845168: Prevention of Gastric Ulcer Bleeding by Using "Computer-alert" in General Practice
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bleeding Peptic Ulcer
Keywords: Bleeding peptic ulcer
NSAID and Aspirin
Computer-alert
General practitioner
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
First posted: 2013-05-03
Enrollment: 220
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Patient outcome: The number of hospitalizations due to bleeding ulcer complication.
timeFrame: one year
Secondary outcomes:
measure: Patient outcome: The number of uncomplicated ulcer diagnosed by endoscopy.
timeFrame: one year
Other outcomes:
measure: Prescription changes: How often the GP refrains the ASA/NSAID-treatment because of the risk-information and the computer-alert
timeFrame: one year
measure: Prescription changes: The number of patients with riskfactors, who will recieve a prescription of ulcer preventive medicine
timeFrame: one year
measure: Prescription changes: general changes in the frequency of NSAID ordinations
timeFrame: one year
Locations:
city: Odense
country: Denmark
facility: Afdeling for medicinske mavetarmsygdomme - Odense Universitetshospital
state: Funen
city: Odense
country: Denmark
facility: Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital
Study officials:
affiliation: Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital.
name: Johanna Petersen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Afdeling for Medicinske mavetarmsygdomme
name: Jane M Hansen, MD, Ph.D
role: STUDY_DIRECTOR
affiliation: Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital
name: Johanna M Petersen, MD
role: PRINCIPAL_INVESTIGATOR
References: