This trial is active, not recruiting.

Conditions adverse effects, adverse drug event
Sponsor Children's Hospital of Eastern Ontario
Collaborator Provincial Health Services Authority
Start date November 2014
End date November 2015
Trial size 6385 participants
Trial identifier NCT02162147, 14/70X, 312463


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Proportion of patients who experience an adverse event related to emergency department care within 3 weeks of an emergency department visit
time frame: 3 weeks

Secondary Outcomes

Proportion of patients experiencing a preventable adverse event
time frame: 3 weeks
Clinical severity of adverse events
time frame: 3 weeks
Types of adverse events
time frame: 3 weeks
System response required for adverse events
time frame: 3 weeks
Proportion of patients for whom an adverse event is related to emergency department specific care
time frame: 3 weeks
Adverse events related to care provided in the emergency department by consulting service
time frame: 3 weeks
Patient and system level characteristics associated with adverse events and preventable adverse events
time frame: 3 weeks
Adverse events that occur within the 3-week time frame but are not related to care received in the emergency department
time frame: 3 weeks

Eligibility Criteria

Male or female participants up to 18 years old.

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.).

Additional Information

Official title How Safe Are Our Pediatric Emergency Departments? A National Prospective Cohort Study
Principal investigator Amy Plint, MD, MSc
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Children's Hospital of Eastern Ontario.