How Safe Are Our Pediatric Emergency Departments?

Adverse Drug Event Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02162147
• Other study ID #: 14/70X
• Secondary ID: 312463
• Status: Completed
• Phase: N/A
• First received: June 10, 2014
• Last updated: January 12, 2018
• Start date: November 2014
• Est. completion date: March 2017

Study information

• Verified date: January 2018
• Source: Children's Hospital of Eastern Ontario
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6385
• Est. completion date: March 2017
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Adverse Drug Event
• Adverse Effects
• Drug-Related Side Effects and Adverse Reactions
• Emergencies

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	Stollery Children's Hospital	Edmonton	Alberta
Canada	Children's Hospital at London Health Sciences Centre	London	Ontario
Canada	CHU Sainte-Justine	Montreal	Quebec
Canada	Children's Hospital for Eastern Ontario	Ottawa	Ontario
Canada	Janeway Children's Health and Rehabilitation Centre	St. John	Newfoundland and Labrador
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	BC Children's Hospital	Vancouver	British Columbia
Canada	Manitoba Institute of Child Health	Winnipeg	Manitoba
Canada	Winnipeg Children's Hospital	Winnipeg	Manitoba

Sponsors (11)

Lead Sponsor	Collaborator
Children's Hospital of Eastern Ontario	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, St. Justine's Hospital, Stollery Children's Hospital, The Children's Hospital of Winnipeg, The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of patients experiencing a preventable adverse event		3 weeks
Secondary	Clinical severity of adverse events	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 weeks
Secondary	Types of adverse events	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	3 weeks
Secondary	System response required for adverse events	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.	3 weeks
Secondary	Proportion of patients for whom an adverse event is related to emergency department specific care	Versus consulting specialty service care provided in the emergency department or care provided after the child's emergency department visit	3 weeks
Secondary	Adverse events related to care provided in the emergency department by consulting service		3 weeks
Secondary	Patient and system level characteristics associated with adverse events and preventable adverse events		3 weeks
Secondary	Adverse events that occur within the 3-week time frame but are not related to care received in the emergency department	Including those related to in-hospital care and primary care	3 weeks