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NCT Number: NCT02044718

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

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.

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Key information

Conditions

Sepsis, Cancer, Heart Attack, Heart Failure, Abdominal Surgery, Trauma, Diabetes, Lung Disease, Gynaecology, Fertility, Cardiac Surgery, Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Heart Failure Infarction Infections Inflammation Ischemia Lung Diseases Metabolic Diseases Myocardial Infarction Myocardial Ischemia Necrosis Neoplasms Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Sepsis Systemic Inflammatory Response Syndrome Vascular Diseases Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hasselt University

Hasselt, Limburg, 3500, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. Type adverse events

    Time frame: 6 months

    Divide the adverse events into categories, like diagnosis, therapy, medication, surgery, non-surgery, etc.

  2. 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.

  3. Quality of the chart review

    Time frame: 6 months

    The patient chart will be judge on the completeness and adequacy

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

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

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 24, 2014
Registry last updated
Jan 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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