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How Safe Are Our Pediatric Emergency Departments?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162147
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : January 17, 2018
Sponsor:
Collaborators:
Provincial Health Services Authority
Stollery Children's Hospital
Alberta Children's Hospital
The Children's Hospital of Winnipeg
London Health Sciences Centre
The Hospital for Sick Children
St. Justine's Hospital
Janeway Children's Health and Rehabilitation Centre
Manitoba Institute of Child Health
Ottawa Hospital Research Institute
Information provided by (Responsible Party):
Amy Plint, Children's Hospital of Eastern Ontario

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.

Condition or disease
Adverse Effects Adverse Drug Event

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Study Type : Observational
Actual Enrollment : 6385 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: How Safe Are Our Pediatric Emergency Departments? A National Prospective Cohort Study
Study Start Date : November 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162147


Locations
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Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada
Stollery Children's Hospital
Edmonton, Alberta, Canada
Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada
Canada, Manitoba
Manitoba Institute of Child Health
Winnipeg, Manitoba, Canada
Winnipeg Children's Hospital
Winnipeg, Manitoba, Canada
Canada, Newfoundland and Labrador
Janeway Children's Health and Rehabilitation Centre
St. John, Newfoundland and Labrador, Canada
Canada, Ontario
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
Canada, Quebec
CHU Sainte-Justine
Montreal, Quebec, Canada
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
Provincial Health Services Authority
Stollery Children's Hospital
Alberta Children's Hospital
The Children's Hospital of Winnipeg
London Health Sciences Centre
The Hospital for Sick Children
St. Justine's Hospital
Janeway Children's Health and Rehabilitation Centre
Manitoba Institute of Child Health
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Amy Plint, MD, MSc Children's Hospital of Eastern Ontario
Principal Investigator: Lisa Calder, MD Ottawa Hospital Research Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amy Plint, Senior Scientist, CHEO Research Institute; Physician, Division of Emergency Medicine, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT02162147    
Other Study ID Numbers: 14/70X
312463 ( Other Grant/Funding Number: CIHR )
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Keywords provided by Amy Plint, Children's Hospital of Eastern Ontario:
patient safety
pediatrics
emergency medicine
Additional relevant MeSH terms:
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Emergencies
Drug-Related Side Effects and Adverse Reactions
Disease Attributes
Pathologic Processes
Chemically-Induced Disorders