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

NCT02044718 | Completed

• 1 other identifier: 11.50/intens11.01
• Study Type: observational
• Target: 878
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

adverse events; unplanned admission intensive care; chart review

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events requiring a higher level of care

  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

  Assess the preventability of these adverse events using six point scale with a range of not preventable until totally preventable

  6 months

Secondary Outcomes (3)

• Type adverse events

  6 months

• Clinical impact of adverse events in terms of outcome

  6 months

• Quality of the chart review

  6 months

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

• 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

Sponsors & Collaborators

• Hasselt University: lead
• Jessa Hospital: collaborator
• Algemeen Ziekenhuis Vesalius: collaborator
• Sint-Franciscus Ziekenhuis: collaborator
• Regionaal Ziekenhuis Sint-Trudo: collaborator
• Ziekenhuis Maas en Kempen: collaborator
• Ziekenhuis Oost-Limburg: collaborator

Study Sites (1)

Hasselt University

Hasselt, Limburg, 3500, Belgium

Location

MeSH Terms

Conditions

Sepsis; Neoplasms; Myocardial Infarction; Heart Failure; Wounds and Injuries; Diabetes Mellitus; Lung Diseases

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Necrosis; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Respiratory Tract Diseases

Study Officials

• Kristel Marquet, drs

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Arthur Vleugels, prof. dr.

  KU Leuven

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: January 24, 2014
• Study Start: November 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 24, 2014

Record last verified: 2014-01

Locations

BE (1)