Skip to main content
OpenTrials
Completed

NCT Number: NCT02162147

How Safe Are Our Pediatric Emergency Departments?

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adverse Effects Adverse Drug Event Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Alberta Children's Hospital, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Primary outcomes

  1. 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

    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 outcomes

  1. Proportion of patients experiencing a preventable adverse event

    Time frame: 3 weeks

  2. Clinical severity of adverse events

    Time frame: 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.

  3. Types of adverse events

    Time frame: 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

  4. System response required for adverse events

    Time frame: 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.

  5. Proportion of patients for whom an adverse event is related to emergency department specific care

    Time frame: 3 weeks

    Versus consulting specialty service care provided in the emergency department or care provided after the child's emergency department visit

  6. Adverse events related to care provided in the emergency department by consulting service

    Time frame: 3 weeks

  7. Patient and system level characteristics associated with adverse events and preventable adverse events

    Time frame: 3 weeks

  8. 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

    Including those related to in-hospital care and primary care

Sponsors and collaborators

Lead sponsor

Children's Hospital of Eastern Ontario

Other

Collaborators

  • Alberta Children's Hospital
  • Janeway Children's Health and Rehabilitation Centre
  • London Health Sciences Centre
  • Manitoba Institute of Child Health
  • Ottawa Hospital Research Institute
  • Provincial Health Services Authority British Columbia
  • St. Justine's Hospital
  • Stollery Children's Hospital
  • The Children's Hospital of Winnipeg
  • The Hospital for Sick Children

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Jun 12, 2014
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.