Sepsis, Cancer, Heart Attack, Heart Failure, Abdominal Surgery, Trauma, Diabetes, Lung Disease, Gynaecology, Fertility, Cardiac Surgery, Clinical Trial
Official title:
Medical Record Study on Adverse Events Requiring a Higher Level of Care in Flemish Hospitals
| Verified date | January 2014 |
| Source | Hasselt University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Institutional Review Board |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 878 |
| Est. completion date | June 2013 |
| Est. primary completion date | June 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 16 Years and older |
| Eligibility |
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: |
Observational Model: Case-Only, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Hasselt University | Hasselt | Limburg |
| Lead Sponsor | Collaborator |
|---|---|
| Hasselt University | Algemeen Ziekenhuis Vesalius, Jessa Hospital, Regionaal Ziekenhuis Sint-Trudo, Sint-Franciscus Ziekenhuis, Ziekenhuis Maas en Kempen, Ziekenhuis Oost-Limburg |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Primary | 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 | Yes |
| Secondary | Type adverse events | Divide the adverse events into categories, like diagnosis, therapy, medication, surgery, non-surgery, etc. | 6 months | Yes |
| Secondary | Clinical impact of adverse events in terms of outcome | Assess the impact of the adverse events in terms of disability, mortality, readmission. | 6 months | Yes |
| Secondary | Quality of the chart review | The patient chart will be judge on the completeness and adequacy | 6 months | Yes |