Medical Record Study on Adverse Events Requiring a Higher Level of Care in Flemish Hospitals

January 22, 2014 updated by: prof. dr. Neree Claes, Hasselt University
An adverse event (AE) is defined as unintended injury or complication, which results in disability, death or prolongation of hospital stay, and is caused by healthcare management (including omissions) rather than the patient's disease. Retrospective record reviews in several countries have shown that 2,9% to 16,6% of patients in acute hospitals experience one or more AEs. A patient with an AE may require a higher level of care. Although all AEs are important, preventable AEs that result in an upgraded level of patient care are of particular concern. In this study it's defined as an unplanned admission to intensive care unit (ICU) or a Mobile Emergency Team (MET) intervention. The objectives of this study are to determine the incidence of (preventable) adverse events requiring ICU admission or MET intervention and to assess the level of harm of each AE.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

878

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Limburg
      • Hasselt, Limburg, Belgium, 3500
        • Hasselt University

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

primary care clinic

Description

Inclusion Criteria:

  • All patients being transferred to a higher level of care during the study period (November 2011 - May 2012)
  • In practice, the higher level of care means
  • (1) (re)admission to the Intensive Care Unit from other care units in the hospital providing lower intensity care,
  • (2) to an intervention by a Medical Emergency Team due to an unanticipated change in the patient's clinical status

Exclusion Criteria:

-

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
Measure Description
Time Frame
Incidence of adverse events requiring a higher level of care
Time Frame: 6 months
An adverse event is an unintended injury or complication, which results in disability at discharge, death or prolongation of hospital stay, and is caused by healthcare management (including omissions) rather than the patient's disease. (Wilson, 1995)
6 months
The number of participants with preventable adverse events
Time Frame: 6 months
Assess the preventability of these adverse events using six point scale with a range of not preventable until totally preventable
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type adverse events
Time Frame: 6 months
Divide the adverse events into categories, like diagnosis, therapy, medication, surgery, non-surgery, etc.
6 months
Clinical impact of adverse events in terms of outcome
Time Frame: 6 months
Assess the impact of the adverse events in terms of disability, mortality, readmission.
6 months
Quality of the chart review
Time Frame: 6 months
The patient chart will be judge on the completeness and adequacy
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasselt University

Collaborators

Jessa Hospital
Ziekenhuis Oost-Limburg
Algemeen Ziekenhuis Vesalius
Ziekenhuis Maas en Kempen
Sint-Franciscus Ziekenhuis
Regionaal Ziekenhuis Sint-Trudo

Investigators

  • Principal Investigator: Kristel Marquet, drs, Hasselt University
  • Study Chair: Arthur Vleugels, prof. dr., KU Leuven

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

November 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

December 19, 2013

First Submitted That Met QC Criteria

January 22, 2014

First Posted (Estimate)

January 24, 2014

Study Record Updates

Last Update Posted (Estimate)

January 24, 2014

Last Update Submitted That Met QC Criteria

January 22, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11.50/intens11.01

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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