- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02074085
Measuring the Incidence of Hospital Readmissions Based on Adverse Drug Events
February 25, 2014 updated by: prof. dr. Neree Claes, Hasselt University
Measuring the Incidence of Hospital Readmissions, Caused by Adverse Drug Events (ADE) Due to Anticoagulants in Vzw Jessa Hospital (Belgium)
An ADE is defined as harm caused by a drug or the inappropriate use of a drug.
Retrospective record reviews in several countries have shown that anticoagulants frequently lead to hospital readmissions.
In this study a hospital readmission is defined as an admission to the emergency department of the Jessa hospital.
The objective of this study is to determine the incidence of one week and 30-day readmissions caused by (preventable) ADE's due to anticoagulants.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
450
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
- Name: Kristel Marquet, Drs.
- Phone Number: 3211268531
- Email: kristel.marquet@uhasselt.be
Study Contact Backup
- Name: Martijn Droogmans, Ap.
- Email: martijn.droogmas@jessazh.be
Study Locations
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-
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Hasselt, Belgium, 3500
- Jessa Ziekenhuis
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Contact:
- Kristel Marquet, drs
- Phone Number: +3211268531
- Email: kristel.marquet@uhasselt.be
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Sub-Investigator:
- kristel Marquet, drs.
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-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients who received an anticoagulant on their last day of admission
Description
Inclusion Criteria:
- Patients who received an anticoagulant on their last day of admission
- Patients who were readmitted within 30 days
- Patients who were diagnosed using the pathology registration of the emergency department of the Jessa hospital
Exclusion Criteria:
- Patients who didn't receive an anticoagulant on their last day of admission
- Patients who were not readmitted within 30 days
- Patients who were not diagnosed using the pathology registration of the emergency department of the Jessa hospital
- Patients with missing data
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
incidence of readmissions within one week caused by ADE's due to anticoagulants
Time Frame: up to one week
|
up to one week
|
incidence of readmissions within 30 days caused by ADE's due to anticoagulants
Time Frame: up to 1 month
|
up to 1 month
|
incidence of preventable ADE's leading to readmission
Time Frame: week 1, month 1
|
week 1, month 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Martijn Droogmans, pharmacist, Jessa hospital
- Study Chair: Kristel Marquet, drs, Hasselt University
- Study Chair: Janne Theuwissen, pharmacist, Jessa hospital
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
March 1, 2014
Primary Completion (Anticipated)
September 1, 2014
Study Registration Dates
First Submitted
February 25, 2014
First Submitted That Met QC Criteria
February 25, 2014
First Posted (Estimate)
February 28, 2014
Study Record Updates
Last Update Posted (Estimate)
February 28, 2014
Last Update Submitted That Met QC Criteria
February 25, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14.05/APO14.01
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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