Clinical trial NCT02162147: How Safe Are Our Pediatric Emergency Departments?
Official title: How Safe Are Our Pediatric Emergency Departments? A National Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adverse Effects
Adverse Drug Event
Keywords: patient safety
pediatrics
emergency medicine
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
Collaborators: name: Provincial Health Services Authority
name: Stollery Children's Hospital
name: Alberta Children's Hospital
name: The Children's Hospital of Winnipeg
name: London Health Sciences Centre
name: The Hospital for Sick Children
name: St. Justine's Hospital
name: Janeway Children's Health and Rehabilitation Centre
name: Manitoba Institute of Child Health
name: Ottawa Hospital Research Institute
First posted: 2014-06-12
Enrollment: 6385
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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.).

Primary outcomes:
measure: Proportion of patients who experience an adverse event related to emergency department care within 3 weeks of an emergency department visit
timeFrame: 3 weeks
Secondary outcomes:
measure: Proportion of patients experiencing a preventable adverse event
timeFrame: 3 weeks
measure: Clinical severity of adverse events
timeFrame: 3 weeks
measure: Types of adverse events
timeFrame: 3 weeks
measure: System response required for adverse events
timeFrame: 3 weeks
measure: Proportion of patients for whom an adverse event is related to emergency department specific care
timeFrame: 3 weeks
measure: Adverse events related to care provided in the emergency department by consulting service
timeFrame: 3 weeks
measure: Patient and system level characteristics associated with adverse events and preventable adverse events
timeFrame: 3 weeks
measure: Adverse events that occur within the 3-week time frame but are not related to care received in the emergency department
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Manitoba Institute of Child Health
state: Manitoba
city: Winnipeg
country: Canada
facility: Winnipeg Children's Hospital
state: Manitoba
city: St. John
country: Canada
facility: Janeway Children's Health and Rehabilitation Centre
state: Newfoundland and Labrador
city: London
country: Canada
facility: Children's Hospital at London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital for Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
affiliation: Children's Hospital of Eastern Ontario
name: Amy Plint, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Hospital Research Institute
name: Lisa Calder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.