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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02044718

Enrollment

878

Registered

2014-01-24

Start date

2011-11-30

Completion date

2013-06-30

Last updated

2014-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Type adverse events	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	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

Countries

Belgium

Outcome results