How Safe Are Our Pediatric Emergency Departments?

January 12, 2018 updated by: Amy Plint, Children's Hospital of Eastern Ontario

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6385

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 day to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of patients experiencing a preventable adverse event
Time Frame: 3 weeks
3 weeks
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 weeks
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
3 weeks
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.
3 weeks
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
3 weeks
Adverse events related to care provided in the emergency department by consulting service
Time Frame: 3 weeks
3 weeks
Patient and system level characteristics associated with adverse events and preventable adverse events
Time Frame: 3 weeks
3 weeks
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
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Eastern Ontario

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Hospital for Sick Children
Ottawa Hospital Research Institute
London Health Sciences Centre
Alberta Children's Hospital
Stollery Children's Hospital
The Children's Hospital of Winnipeg
St. Justine's Hospital
Provincial Health Services Authority
Manitoba Institute of Child Health
Janeway Children's Health and Rehabilitation Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amy Plint, MD, MSc, Children's Hospital of Eastern Ontario
  • Principal Investigator: Lisa Calder, MD, Ottawa Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14/70X
  • 312463 (Other Grant/Funding Number: CIHR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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