How Safe Are Our Pediatric Emergency Departments?

NCT ID: NCT02162147

Last Updated: 2018-01-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6385 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2017-03-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.).

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Provincial Health Services Authority

OTHER

Sponsor Role: collaborator

Stollery Children's Hospital

OTHER

Sponsor Role: collaborator

Alberta Children's Hospital

OTHER

Sponsor Role: collaborator

The Children's Hospital of Winnipeg

OTHER

Sponsor Role: collaborator

London Health Sciences Centre

OTHER

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: collaborator

St. Justine's Hospital

OTHER

Sponsor Role: collaborator

Janeway Children's Health and Rehabilitation Centre

UNKNOWN

Sponsor Role: collaborator

Manitoba Institute of Child Health

INDUSTRY

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: collaborator

Children's Hospital of Eastern Ontario

OTHER

Sponsor Role: lead

Responsible Party

Amy Plint

Senior Scientist, CHEO Research Institute; Physician, Division of Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy Plint, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Eastern Ontario

Lisa Calder, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

Alberta Children's Hospital

Calgary, Alberta, Canada

Stollery Children's Hospital

Edmonton, Alberta, Canada

BC Children's Hospital

Vancouver, British Columbia, Canada

Manitoba Institute of Child Health

Winnipeg, Manitoba, Canada

Winnipeg Children's Hospital

Winnipeg, Manitoba, Canada

Janeway Children's Health and Rehabilitation Centre

St. John's, Newfoundland and Labrador, Canada

Children's Hospital at London Health Sciences Centre

London, Ontario, Canada

Children's Hospital for Eastern Ontario

Ottawa, Ontario, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

CHU Sainte-Justine

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 25475246 (View on PubMed)

Other Identifiers

312463

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

14/70X

Identifier Type: -

Identifier Source: org_study_id