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

October 28, 2013 updated by: Johanna Petersen, Odense University Hospital

Prevention of Peptic Ulcer Bleeding Related to the Use of NSAIDs and Aspirin by Using "Computer-alert" - a Randomized Study in General Practice

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jane Møller Hansen, MD, Ph.D

Study Locations

  • Denmark
      • Odense, Denmark
        • Not yet recruiting
        • Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital
        • Contact:
        • Principal Investigator:
          • Johanna Petersen
    • Funen
      • Odense, Funen, Denmark, 5000
        • Recruiting
        • Afdeling for medicinske mavetarmsygdomme - Odense Universitetshospital
        • Contact:
        • Principal Investigator:
          • Johanna Petersen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
Device: Computer-alert
NO_INTERVENTION: controlgroup, normal procedures
The control-group: GP working in normal procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient outcome: The number of hospitalizations due to bleeding ulcer complication.
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient outcome: The number of uncomplicated ulcer diagnosed by endoscopy.
Time Frame: one year
one year

Other Outcome Measures

Outcome Measure
Time Frame
Prescription changes: How often the GP refrains the ASA/NSAID-treatment because of the risk-information and the computer-alert
Time Frame: one year
one year
Prescription changes: The number of patients with riskfactors, who will recieve a prescription of ulcer preventive medicine
Time Frame: one year
one year
Prescription changes: general changes in the frequency of NSAID ordinations
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Collaborators

Region of Southern Denmark

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ANTICIPATED)

February 1, 2014

Study Completion (ANTICIPATED)

April 1, 2015

Study Registration Dates

First Submitted

March 13, 2013

First Submitted That Met QC Criteria

April 29, 2013

First Posted (ESTIMATE)

May 3, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 29, 2013

Last Update Submitted That Met QC Criteria

October 28, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-20120034

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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