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

N/ACompletedNCT02044718

Hasselt University878 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

878

Conditions

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

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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: \-

Outcomes

Primary Outcomes

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)

Time frame: 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

Time frame: 6 months

Secondary Outcomes

Type adverse events

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

Time frame: 6 months

Clinical impact of adverse events in terms of outcome

Assess the impact of the adverse events in terms of disability, mortality, readmission.

Time frame: 6 months

Quality of the chart review

The patient chart will be judge on the completeness and adequacy

Time frame: 6 months

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes