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

Completed

• Conditions: Sepsis, Cancer, Heart Attack, Heart Failure, Abdominal Surgery, Trauma, Diabetes, Lung Disease, Gynaecology, Fertility, Cardiac Surgery,

• Registration Number: NCT02044718
• Lead Sponsor: Hasselt University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Study First Submitted: 2013-12-19
• Status Verified: 2014-01
• Study First Submitted QC: 2014-01-22
• Last Update Submitted: 2014-01-22
• Study First Posted: 2014-01-24
• Last Update Posted: 2014-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 878

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events requiring a higher level of care	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)
The number of participants with preventable adverse events	6 months	Assess the preventability of these adverse events using six point scale with a range of not preventable until totally preventable

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hasselt University; 🇧🇪 Hasselt, Limburg, Belgium