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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:
Sponsor: Hasselt University

Current Primary Outcome:

• 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)
• 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

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Type adverse events [ Time Frame: 6 months ]
  Divide the adverse events into categories, like diagnosis, therapy, medication, surgery, non-surgery, etc.
• 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.
• Quality of the chart review [ Time Frame: 6 months ]
  The patient chart will be judge on the completeness and adequacy

Original Secondary Outcome: Same as current

Information By: Hasselt University

Dates:
Date Received: December 19, 2013
Date Started: November 2011
Date Completion:
Last Updated: January 22, 2014
Last Verified: January 2014