Adverse Drug Event, Adverse Effects
Conditions
Keywords
patient safety, pediatrics, emergency medicine
Brief summary
Patient safety is an internationally recognized health care priority. Canadian data suggests that about 8% of adults admitted to hospital experience unintended harm (or 'adverse events') from the health care provided during their hospital stay. On a national level, this represents almost 25,000 preventable deaths among hospitalized adults each year. The emergency department is recognized as a high-risk environment for adverse events but most patient safety research is not specific to the emergency department. As well, the vast majority of people treated in the emergency department are sent home after their visit; yet safety research focuses primarily on people who are admitted to hospital. Finally, although children have also been identified as particularly high risk for suffering adverse events, very little research has been done on how often these events occur among children who visit the emergency department. Our study will address this gap in our knowledge about patient safety and provide important information on the frequency, severity and preventability of adverse events occurring among children in the emergency department. This information will help us to improve the safety of emergency department care for all Canadian children.
Interventions
None listed
Sponsors
Provincial Health Services Authority British Columbia
Stollery Children's Hospital
Alberta Children's Hospital
The Children's Hospital of Winnipeg
London Health Sciences Centre
The Hospital for Sick Children
St. Justine's Hospital
Janeway Children's Health and Rehabilitation Centre
Manitoba Institute of Child Health
Ottawa Hospital Research Institute
Children's Hospital of Eastern Ontario
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age less than 18 years * Patients from all pediatric Canadian Triage Acuity Scale categories (pedsCTAS; 1:resuscitation; 2:emergent, 3:urgent, 4:semi-urgent, 5:non-urgent).
Exclusion criteria
* Insurmountable language barrier that prevents informed consent and follow-up by telephone. * Children and families that will be unavailable for telephone follow-up in the three weeks after their emergency department visit (e.g., no telephone in the home, travelling out of the country, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who experience an adverse event related to emergency department care within 3 weeks of an emergency department visit | 3 weeks | An adverse event will be defined as an event that results in unintended harm to the patient, and is related to the health care and/or services provided to the patient rather than to the patient's underlying medical condition. Emergency department care will be defined as any care provided in the emergency department and will explicitly include care provided by emergency department specific staff (i.e., staff physicians, nurses, and allied health care providers) and care provided by consultants in the emergency department. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical severity of adverse events | 3 weeks | For all patients, we will report the clinical severity as: (a) an abnormality on laboratory testing, (b) ≤1 day of symptoms, (c) \>1 day of symptoms, (d) nonpermanent disability (e) permanent disability, or (f) death. For admitted patients, we will also report clinical severity according to The Institute for Health Care Improvement trigger tool categories: (a) temporary harm to the patient requiring intervention, (b) temporary harm to the patient requiring initial or prolonged hospitalization, (c) permanent patient harm, (d) intervention required to sustain life, or (e) death. |
| Types of adverse events | 3 weeks | Adverse Events will be classified as (a) diagnostic issue, (b) management issue, (c) unsafe disposition decision, (d) suboptimal follow-up, (e) medication adverse effect, (f) procedural complication, and (g) nosocomial infection |
| System response required for adverse events | 3 weeks | The response will be classified as: (a) no treatment (symptoms only), (b) required medical/surgical intervention, (c) visit to MD office, (d) Emergency Department visit, (e) admission to hospital. These previously published broad categories were chosen in order to address the effect of the Adverse Events at both the patient and health care system level.These categories are not exclusive. |
| Proportion of patients experiencing a preventable adverse event | 3 weeks | — |
| Adverse events related to care provided in the emergency department by consulting service | 3 weeks | — |
| Patient and system level characteristics associated with adverse events and preventable adverse events | 3 weeks | — |
| Adverse events that occur within the 3-week time frame but are not related to care received in the emergency department | 3 weeks | Including those related to in-hospital care and primary care |
| Proportion of patients for whom an adverse event is related to emergency department specific care | 3 weeks | Versus consulting specialty service care provided in the emergency department or care provided after the child's emergency department visit |
Countries
Canada
Outcome results
None listed