Pediatric Emergency CareNCT01657344
PECARN Emergency Care Registry
An observational study of Pediatric Emergency Care, run by Children's Hospital of Philadelphia at 5 sites in United States.
Trial summary
The objectives of this study are to: develop an emergency care visit registry for pediatric patients for Quality Improvement purposes and to support future research; to use the emergency care visit registry to collect stakeholder-prioritized emergency care performance improvement measures for important pediatric… Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Emergency Care
- How many people
- 2,019,461 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2012to 20 Jul 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Study subjects are all patients (0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered to the ED.
Who may be able to join
- All patients (0-18) who registered in the ED
Who cannot join
- Greater than 18 years of age for ED patients
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The Children's Hospital of Colorado
Aurora, Colorado, 80045
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Data Coordinating Center
Salt Lake City, Utah, 84158
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Improving the Quality of Pediatric Emergency Care Using an Electronic Medical Record Registry and Clinician Feedback
The objectives of this study are to: develop an emergency care visit registry for pediatric patients for Quality Improvement purposes and to support future research; to use the emergency care visit registry to collect stakeholder-prioritized emergency care performance improvement measures for important pediatric medical and trauma conditions; and report emergency care performance improvement measures.
- Conditions
- Pediatric Emergency Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ED Patients | All patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Visits Obtained From Electronic Health Record Data From the Sites
The number of visits obtained from electronic health record data from the sites
Measured: January 2012 - June 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startJan 2012
- Primary completion20 Jul 2017
- Study completion20 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediatric Emergency CareStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,019,461 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Pediatric Emergency Care Applied Registry Network (PECARN)
- Responsible party
- Sponsor
- Investigators
- Elizabeth R Alpern, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657344
- Sponsor's protocol ID
- 12-009177
- Other IDs
- R01HS020270-01A1
- Status last verified
- Sep 2019
- First submitted
- 2 Aug 2012
- Last updated
- 21 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: When the study is completed, the data coordinating center (DCC) will prepare a distributable database in compliance with Federal requirements.This database will be de-identified sufficiently that it will not be subject to Federal regulations nor the Health Insurance Portability and Accountability Act (HIPAA).
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Quality of Pediatric Emergency Care Using an Electronic Medical Record Registry and Clinician Feedback
- ClinicalTrials.gov ID
- NCT01657344
- Acronym / sponsor ID
- 12-009177
- Conditions
- Pediatric Emergency Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,019,461 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Pediatric Emergency Care Applied Registry Network (PECARN)
- Study start
- Jan 2012 (actual)
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 20 Jul 2017 (actual)
- First posted
- 6 Aug 2012 (estimated)
- Results
- Posted 21 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to: develop an emergency care visit registry for pediatric patients for Quality Improvement purposes and to support future research; to use the emergency care visit registry to collect stakeholder-prioritized emergency care performance improvement measures for important pediatric medical and trauma conditions; and report emergency care performance improvement measures.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ED Patients | – | –All patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Study subjects are all patients (0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered to the ED.
Key inclusion criteria (1 listed)
- All patients (0-18) who registered in the ED
Key exclusion criteria (1 listed)
- Greater than 18 years of age for ED patients
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
The Number of Visits Obtained From Electronic Health Record Data From the Sites
Time frame: January 2012 - June 2016
The number of visits obtained from electronic health record data from the sites
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. When the study is completed, the data coordinating center (DCC) will prepare a distributable database in compliance with Federal requirements.This database will be de-identified sufficiently that it will not be subject to Federal regulations nor the Health Insurance Portability and Accountability Act (HIPAA).
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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.
Elizabeth R Alpern, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Emergency Care, run by Children's Hospital of Philadelphia at 5 sites in United States.
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 1 inclusion and 1 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 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
Yes. Results are posted in the registry (first posted 21 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Number of Visits Obtained From Electronic Health Record Data From the Sites (time frame: January 2012 - June 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2019.