How Safe Are Our Pediatric Emergency Departments?

NCT02162147 | Completed

• 2 other identifiers: 14/70X312463
• Study Type: observational
• Target: 6,385
• Locations: 1 country
• Sites: 10

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.

Conditions

Adverse Effects; Adverse Drug Event

Keywords

patient safety; pediatrics; emergency medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Proportion of patients experiencing a preventable adverse event

  3 weeks

• Clinical severity of adverse events

  3 weeks

• Types of adverse events

  3 weeks

• System response required for adverse events

  3 weeks

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

  3 weeks

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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).

You may not qualify if:

• 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.).

Sponsors & Collaborators

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

Study Sites (10)

Alberta Children's Hospital

Calgary, Alberta, Canada

Location

Stollery Children's Hospital

Edmonton, Alberta, Canada

Location

BC Children's Hospital

Vancouver, British Columbia, Canada

Location

Manitoba Institute of Child Health

Winnipeg, Manitoba, Canada

Location

Winnipeg Children's Hospital

Winnipeg, Manitoba, Canada

Location

Janeway Children's Health and Rehabilitation Centre

St. John's, Newfoundland and Labrador, Canada

Location

Children's Hospital at London Health Sciences Centre

London, Ontario, Canada

Location

Children's Hospital for Eastern Ontario

Ottawa, Ontario, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

CHU Sainte-Justine

Montreal, Quebec, Canada

Location

Related Publications (1)

• 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.

  PMID: 25475246 DERIVED

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Amy Plint, MD, MSc

  Children's Hospital of Eastern Ontario

  PRINCIPAL INVESTIGATOR

• Lisa Calder, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist, CHEO Research Institute; Physician, Division of Emergency Medicine

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 12, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: March 1, 2017
• Last Updated: January 17, 2018

Record last verified: 2018-01

Locations

CA (10)