Adverse EffectsNCT02162147
How Safe Are Our Pediatric Emergency Departments?
An observational study of Adverse Effects and Adverse Drug Event, run by Children's Hospital of Eastern Ontario at 10 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Adverse Effects, Adverse Drug Event
- How many people
- 6,385 participants
- Where
- 10 sitesCanada
- Study dates
- Nov 2014to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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).
Who cannot join
- 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.).
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Canada10 sites
Alberta Children's Hospital
Calgary, Alberta
Stollery Children's Hospital
Edmonton, Alberta
Children's Hospital at London Health Sciences Centre
London, Ontario
CHU Sainte-Justine
Montreal, Quebec
Children's Hospital for Eastern Ontario
Ottawa, Ontario
Janeway Children's Health and Rehabilitation Centre
St. John's, Newfoundland and Labrador
The Hospital for Sick Children
Toronto, Ontario
BC Children's Hospital
Vancouver, British Columbia
Manitoba Institute of Child Health
Winnipeg, Manitoba
Winnipeg Children's Hospital
Winnipeg, Manitoba
About this study
Official title: 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.
- Conditions
- Adverse Effects, Adverse Drug Event
- Keywords
- patient safety, pediatrics, emergency medicine
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (8)
Proportion of patients experiencing a preventable adverse event
Measured: 3 weeks
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.
Measured: 3 weeks
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
Measured: 3 weeks
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.
Measured: 3 weeks
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
Measured: 3 weeks
Adverse events related to care provided in the emergency department by consulting service
Measured: 3 weeks
Patient and system level characteristics associated with adverse events and preventable adverse events
Measured: 3 weeks
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
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2015
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adverse EffectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- Provincial Health Services Authority British Columbia, 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
- Responsible party
- Principal investigator, Amy Plint, Children's Hospital of Eastern Ontario
- Investigators
- Amy Plint, MD, MSc, Principal investigator, Children's Hospital of Eastern OntarioLisa Calder, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162147
- Sponsor's protocol ID
- 14/70X
- Other IDs
- 312463
- Status last verified
- Jan 2018
- First submitted
- 10 Jun 2014
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25475246
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Safe Are Our Pediatric Emergency Departments? A National Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02162147
- Acronym / sponsor ID
- 14/70X
- Conditions
- Adverse Effects, Adverse Drug Event
- Keywords
- patient safety, pediatrics, emergency medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,385 participants (actual)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Collaborators
- Provincial Health Services Authority British Columbia, 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
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 12 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
Proportion of patients experiencing a preventable adverse event
Time frame: 3 weeks
Clinical severity of adverse events
Time frame: 3 weeks
Types of adverse events
Time frame: 3 weeks
System response required for adverse events
Time frame: 3 weeks
Proportion of patients for whom an adverse event is related to emergency department specific care
Time frame: 3 weeks
Adverse events related to care provided in the emergency department by consulting service
Time frame: 3 weeks
Patient and system level characteristics associated with adverse events and preventable adverse events
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Derived from this study: PubMed 25475246Plint 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Plint, MD, MSc principal investigator
Children's Hospital of Eastern Ontario
Lisa Calder, MD principal investigator
Ottawa Hospital Research Institute
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Effects and Adverse Drug Event, run by Children's Hospital of Eastern Ontario at 10 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02162147, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.