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

NCT ID: NCT01845168

Last Updated: 2013-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bleeding Peptic Ulcer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Bleeding peptic ulcer NSAID and Aspirin Computer-alert General practitioner

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Computer-alert

Intervention Type 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

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

Intervention Type 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

Intervention Type DEVICE

controlgroup, normal procedures

The control-group: GP working in normal procedures

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

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

Intervention Type DEVICE

Computer-alert

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Region of Southern Denmark

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Johanna Petersen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Johanna Petersen, MD

Role: PRINCIPAL_INVESTIGATOR

Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital.

Jane M Hansen, MD, Ph.D

Role: STUDY_DIRECTOR

Afdeling for Medicinske mavetarmsygdomme

Johanna M Petersen, MD

Role: PRINCIPAL_INVESTIGATOR

Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Afdeling for medicinske mavetarmsygdomme - Odense Universitetshospital

Odense, Funen, Denmark

Site Status RECRUITING

Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital

Odense, , Denmark

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Johanna Petersen, MD

Role: CONTACT

Email: [email protected]

Jane Møller Hansen, MD, Ph.D

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Johanna Petersen, MD

Role: primary

Johanna Petersen

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

S-20120034

Identifier Type: -

Identifier Source: org_study_id