Measuring the Incidence of Hospital Readmissions Based on... | NCT02074085

Studies
Measuring the Incidence of Hospital Readmissions Based on Adverse Drug Events

NCT02074085

Sponsor

Hasselt University

Status

Unknown status

Last Update Posted

Feb 28, 2014Estimated

Enrollment

450Estimated

Phase

Not provided

Conditions

Incidence of Readmissions
ADE's Due to Anticoagulants

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Sep 2014Estimated

Completion Date

Not provided

First Submitted Date

Feb 25, 2014

First Submission Date that Met QC Criteria

Feb 25, 2014

First Posted Date

Feb 28, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2014

Last Update Posted Date

Feb 28, 2014Estimated

Name	Class
Jessa Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

450Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of readmissions within one week caused by ADE's due to anticoagulants		up to one week
incidence of readmissions within 30 days caused by ADE's due to anticoagulants		up to 1 month
incidence of preventable ADE's leading to readmission		week 1, month 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients who received an anticoagulant on their last day of admission

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kristel Marquet, Drs.	Contact	3211268531		kristel.marquet@uhasselt.be
Martijn Droogmans, Ap.	Contact			martijn.droogmas@jessazh.be

Overall Officials

Name	Affiliation	Role
Martijn Droogmans, pharmacist	Jessa Hospital	Study Chair
Kristel Marquet, drs	Hasselt University	Study Chair
Janne Theuwissen, pharmacist

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jessa Ziekenhuis		Hasselt		3500	Belgium