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

Primary Purpose

Bleeding Peptic Ulcer

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Computer-alert
A computer alerts which pops up when the GP presribes NSAID/ASA to a patient with risk-factors
Computer-alert
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bleeding Peptic Ulcer focused on measuring Bleeding peptic ulcer, NSAID and Aspirin, Computer-alert, General practitioner

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

  • Afdeling for medicinske mavetarmsygdomme - Odense UniversitetshospitalRecruiting
  • Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Computer-alert

controlgroup, normal procedures

Arm Description

2 arm study active group: 'A computer alert which pops up when the GP prescribes NSAID/ASA to a patient with risk-factors

The control-group: GP working in normal procedures

Outcomes

Primary Outcome Measures

Patient outcome: The number of hospitalizations due to bleeding ulcer complication.

Secondary Outcome Measures

Patient outcome: The number of uncomplicated ulcer diagnosed by endoscopy.

Full Information

First Posted
March 13, 2013
Last Updated
October 28, 2013
Sponsor
Odense University Hospital
Collaborators
Region of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01845168
Brief Title
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

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
Region of Southern Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding Peptic Ulcer
Keywords
Bleeding peptic ulcer, NSAID and Aspirin, Computer-alert, General practitioner

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Computer-alert
Arm Type
Active Comparator
Arm Description
2 arm study active group: 'A computer alert which pops up when the GP prescribes NSAID/ASA to a patient with risk-factors
Arm Title
controlgroup, normal procedures
Arm Type
No Intervention
Arm Description
The control-group: GP working in normal procedures
Intervention Type
Other
Intervention Name(s)
Computer-alert
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
A computer alerts which pops up when the GP presribes NSAID/ASA to a patient with risk-factors
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Computer-alert
Primary Outcome Measure Information:
Title
Patient outcome: The number of hospitalizations due to bleeding ulcer complication.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Patient outcome: The number of uncomplicated ulcer diagnosed by endoscopy.
Time Frame
one year
Other Pre-specified Outcome Measures:
Title
Prescription changes: How often the GP refrains the ASA/NSAID-treatment because of the risk-information and the computer-alert
Time Frame
one year
Title
Prescription changes: The number of patients with riskfactors, who will recieve a prescription of ulcer preventive medicine
Time Frame
one year
Title
Prescription changes: general changes in the frequency of NSAID ordinations
Time Frame
one year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johanna Petersen, MD
Email
jmpetersen@health.sdu.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Jane Møller Hansen, MD, Ph.D
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johanna Petersen, MD
Organizational Affiliation
Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jane M Hansen, MD, Ph.D
Organizational Affiliation
Afdeling for Medicinske mavetarmsygdomme
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Johanna M Petersen, MD
Organizational Affiliation
Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Afdeling for medicinske mavetarmsygdomme - Odense Universitetshospital
City
Odense
State/Province
Funen
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johanna Petersen, MD
Phone
0045 24379220
Email
jmpetersen@health.sdu.dk
First Name & Middle Initial & Last Name & Degree
Johanna Petersen, MD
Facility Name
Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital
City
Odense
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johanna Petersen
Email
jmpetersen@health.sdu.dk
First Name & Middle Initial & Last Name & Degree
Johanna Petersen

12. IPD Sharing Statement

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

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