How Safe Are Our Pediatric Emergency Departments?

How Safe Are Our Pediatric Emergency Departments? A National Prospective Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Adverse Effects; Adverse Drug Event

• Study Type: Observational
• Enrollment (Actual): 6385

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Alberta Children's Hospital
    • Edmonton, Alberta, Canada
      • Stollery Children's Hospital
  • British Columbia
    • Vancouver, British Columbia, Canada
      • BC Children's Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • Winnipeg Children's Hospital
    • Winnipeg, Manitoba, Canada
      • Manitoba Institute of Child Health
  • Newfoundland and Labrador
    • St. John, Newfoundland and Labrador, Canada
      • Janeway Children's Health and Rehabilitation Centre
  • Ontario
    • London, Ontario, Canada
      • Children's Hospital at London Health Sciences Centre
    • Ottawa, Ontario, Canada
      • Children's Hospital for Eastern Ontario
    • Toronto, Ontario, Canada
      • The Hospital for Sick Children
  • Quebec
    • Montreal, Quebec, Canada
      • CHU Sainte-Justine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects presenting to one the nine participating Canadian pediatric hospitals (BC Children's Hospital (BC), CHU Sainte-Justine (PQ), Children's Hospital of Eastern Ontario (ON), The Hospital for Sick Children (ON), Children's Hospital of Western Ontario (ON), Children's Hospital of Winnipeg (MB), Janeway Children's Health and Rehabilitation Centre (NL), Stollery Children's Hospital (AB) and Alberta Children's Hospital (AB)) Emergency Departments

Description

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.).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who experience an adverse event related to emergency department care within 3 weeks of an emergency department visit	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.	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients experiencing a preventable adverse event		3 weeks
Clinical severity of adverse events	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.	3 weeks
Types of adverse events	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	3 weeks
System response required for adverse events	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.	3 weeks
Proportion of patients for whom an adverse event is related to emergency department specific care	Versus consulting specialty service care provided in the emergency department or care provided after the child's emergency department visit	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	Including those related to in-hospital care and primary care	3 weeks

Collaborators and Investigators

• Sponsor: Children's Hospital of Eastern Ontario
• Collaborators: The Hospital for Sick Children; Ottawa Hospital Research Institute; London Health Sciences Centre; Alberta Children's Hospital; Stollery Children's Hospital; The Children's Hospital of Winnipeg; St. Justine's Hospital; Provincial Health Services Authority; Manitoba Institute of Child Health; Janeway Children's Health and Rehabilitation Centre
• Investigators: Principal Investigator: Amy Plint, MD, MSc, Children's Hospital of Eastern Ontario; Principal Investigator: Lisa Calder, MD, Ottawa Hospital Research Institute

Publications and helpful links

General Publications

• Plint AC, Newton A, Stang A, Bhatt M, Barrowman N, Calder L; Pediatric Emergency Research Canada (PERC). How safe are our paediatric emergency departments? Protocol for a national prospective cohort study. BMJ Open. 2014 Dec 4;4(12):e007064. doi: 10.1136/bmjopen-2014-007064.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: June 10, 2014
• First Submitted That Met QC Criteria: June 10, 2014
• First Posted (Estimate): June 12, 2014

Study Record Updates

• Last Update Posted (Actual): January 17, 2018
• Last Update Submitted That Met QC Criteria: January 12, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: pediatrics; patient safety; emergency medicine
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Disease Attributes; Emergencies; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: 14/70X; 312463 (Other Grant/Funding Number: CIHR)