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

NCT01845168 | Unknown DMC

• 1 other identifier: S-20120034
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

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.

Conditions

Bleeding Peptic Ulcer

Keywords

Bleeding peptic ulcer; NSAID and Aspirin; Computer-alert; General practitioner

Outcome Measures

Primary Outcomes (1)

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

  one year

Secondary Outcomes (1)

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

  one year

Other Outcomes (3)

• Prescription changes: How often the GP refrains the ASA/NSAID-treatment because of the risk-information and the computer-alert

  one year

• Prescription changes: The number of patients with riskfactors, who will recieve a prescription of ulcer preventive medicine

  one year

• Prescription changes: general changes in the frequency of NSAID ordinations

  one year

Study Arms (2)

Computer-alert

ACTIVE COMPARATOR

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; Device: A computer alerts which pops up when the GP presribes NSAID/ASA to a patient with risk-factors; Device: Computer-alert

controlgroup, normal procedures

NO INTERVENTION

The control-group: GP working in normal procedures

Interventions

Computer-alert OTHER

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

Computer-alert

A computer alerts which pops up when the GP presribes NSAID/ASA to a patient with risk-factors DEVICE

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Odense University Hospital: lead
• Region of Southern Denmark: collaborator

Study Sites (2)

Afdeling for medicinske mavetarmsygdomme - Odense Universitetshospital

Odense, Funen, 5000, Denmark

RECRUITING

Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital

Odense, Denmark

NOT YET RECRUITING

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage

Interventions

Risk Factors

Condition Hierarchy (Ancestors)

Gastrointestinal Hemorrhage; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Risk; Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Causality; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Johanna Petersen, MD

  Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital.

  PRINCIPAL INVESTIGATOR

• Jane M Hansen, MD, Ph.D

  Afdeling for Medicinske mavetarmsygdomme

  STUDY DIRECTOR

• Johanna M Petersen, MD

  Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johanna Petersen, MD

CONTACT

jmpetersen@health.sdu.dk

Jane Møller Hansen, MD, Ph.D

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: May 3, 2013
• Study Start: April 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: April 1, 2015
• Last Updated: October 29, 2013

Record last verified: 2013-10

Locations

DK (2)