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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Odense University Hospital
Sponsor:
Collaborators:
Quality improvement Committee for General Practice in The Region of Southern Denmark
Region Southern Denmark
Information provided by (Responsible Party):
Johanna Petersen, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01845168
First received: March 13, 2013
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Patient outcome: The number of hospitalizations due to bleeding ulcer complication. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient outcome: The number of uncomplicated ulcer diagnosed by endoscopy. [ Time Frame: one year ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Prescription changes: How often the GP refrains the ASA/NSAID-treatment because of the risk-information and the computer-alert [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Prescription changes: The number of patients with riskfactors, who will recieve a prescription of ulcer preventive medicine [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Prescription changes: general changes in the frequency of NSAID ordinations [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01845168

Contacts
Contact: Johanna Petersen, MD jmpetersen@health.sdu.dk
Contact: Jane Møller Hansen, MD, Ph.D

Locations
Denmark
Afdeling for medicinske mavetarmsygdomme - Odense Universitetshospital Recruiting
Odense, Funen, Denmark, 5000
Contact: Johanna Petersen, MD    0045 24379220    jmpetersen@health.sdu.dk   
Principal Investigator: Johanna Petersen, MD         
Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital Not yet recruiting
Odense, Denmark
Contact: Johanna Petersen       jmpetersen@health.sdu.dk   
Principal Investigator: Johanna Petersen         
Sponsors and Collaborators
Odense University Hospital
Quality improvement Committee for General Practice in The Region of Southern Denmark
Region 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
  More Information

No publications provided

Responsible Party: Johanna Petersen, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01845168     History of Changes
Other Study ID Numbers: S-20120034
Study First Received: March 13, 2013
Last Updated: October 28, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Odense University Hospital:
Bleeding peptic ulcer
NSAID and Aspirin
Computer-alert
General practitioner

Additional relevant MeSH terms:
Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Ulcer
Digestive System Diseases
Duodenal Diseases
Gastrointestinal Diseases
Gastrointestinal Hemorrhage
Intestinal Diseases
Pathologic Processes
Stomach Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014