Incidence of ReadmissionsNCT02074085
Measuring the Incidence of Hospital Readmissions Based on Adverse Drug Events
An observational study of Incidence of Readmissions and ADE's Due to Anticoagulants, run by Hasselt University at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Incidence of Readmissions, ADE's Due to Anticoagulants
- How many people
- 450 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2014to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who received an anticoagulant on their last day of admission
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Martijn Droogmans, Ap. contact
Belgium1 site
Jessa Ziekenhuis
Hasselt, 3500
Kristel Marquet, drs, +3211268531, kristel.marquet@uhasselt.be
kristel Marquet, drs.
About this study
Official title: 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of readmissions within one week caused by ADE's due to anticoagulants
Measured: up to one week
incidence of readmissions within 30 days caused by ADE's due to anticoagulants
Measured: up to 1 month
incidence of preventable ADE's leading to readmission
Measured: week 1, month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incidence of ReadmissionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Principal investigator, prof. dr. Neree Claes, Hasselt University
- Investigators
- Martijn Droogmans, pharmacist, Study chair, Jessa HospitalKristel Marquet, drs, Study chair, Hasselt UniversityJanne Theuwissen, pharmacist, Study chair, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074085
- Sponsor's protocol ID
- 14.05/APO14.01
- Status last verified
- Feb 2014
- First submitted
- 25 Feb 2014
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Incidence of Hospital Readmissions, Caused by Adverse Drug Events (ADE) Due to Anticoagulants in Vzw Jessa Hospital (Belgium)
- ClinicalTrials.gov ID
- NCT02074085
- Acronym / sponsor ID
- 14.05/APO14.01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- Mar 2014
- Primary completion
- Sep 2014 (estimated)
- First posted
- 28 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who received an anticoagulant on their last day of admission
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of readmissions within one week caused by ADE's due to anticoagulants
Time frame: up to one week
incidence of readmissions within 30 days caused by ADE's due to anticoagulants
Time frame: up to 1 month
incidence of preventable ADE's leading to readmission
Time frame: week 1, month 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martijn Droogmans, Ap. contact
Martijn Droogmans, pharmacist study chair
Jessa Hospital
Kristel Marquet, drs study chair
Hasselt University
Janne Theuwissen, pharmacist study chair
Jessa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incidence of Readmissions and ADE's Due to Anticoagulants, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristel Marquet, Drs. (3211268531, kristel.marquet@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of readmissions within one week caused by ADE's due to anticoagulants (time frame: up to one week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2014.