How Safe Are Our Pediatric Emergency Departments?

Completed

• Conditions: Adverse Effects; Adverse Drug Event

• Registration Number: NCT02162147
• Lead Sponsor: Children's Hospital of Eastern Ontario

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-10
• Study First Posted: 2014-06-12
• Study Start: 2014-11
• Primary Completion: 2015-11
• Study Completion: 2017-03
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-12
• Last Update Posted: 2018-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6385

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).

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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.).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
Adverse events related to care provided in the emergency department by consulting service	3 weeks
Proportion of patients experiencing a preventable adverse event	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

Trial Locations

Locations (10)

Janeway Children's Health and Rehabilitation Centre; 🇨🇦 St. John, Newfoundland and Labrador, Canada

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada

BC Children's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Alberta Children's Hospital; 🇨🇦 Calgary, Alberta, Canada

Winnipeg Children's Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

Stollery Children's Hospital; 🇨🇦 Edmonton, Alberta, Canada

Children's Hospital at London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Children's Hospital for Eastern Ontario; 🇨🇦 Ottawa, Ontario, Canada

Manitoba Institute of Child Health; 🇨🇦 Winnipeg, Manitoba, Canada

CHU Sainte-Justine; 🇨🇦 Montreal, Quebec, Canada