NCT01657344

Brief 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 medical and trauma conditions; and report emergency care performance improvement measures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,019,461

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2012

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2017

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

October 21, 2019

Completed
Last Updated

October 21, 2019

Status Verified

September 1, 2019

Enrollment Period

5.6 years

First QC Date

August 2, 2012

Results QC Date

May 11, 2018

Last Update Submit

September 26, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    January 2012 - June 2016

Study Arms (1)

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.

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • All patients (0-18) who registered in the ED

You may not qualify if:

  • Greater than 18 years of age for ED patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

The Children's Hospital of Colorado

Aurora, Colorado, 80045, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Data Coordinating Center

Salt Lake City, Utah, 84158, United States

Location

Results Point of Contact

Title
Elizabeth Alpern
Organization
Lurie Children's Hospital

Study Officials

  • Elizabeth R Alpern, MD

    Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2012

First Posted

August 6, 2012

Study Start

January 1, 2012

Primary Completion

July 20, 2017

Study Completion

July 20, 2017

Last Updated

October 21, 2019

Results First Posted

October 21, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

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).

Locations