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| ID | Type | Description | Link |
|---|---|---|---|
| R01HS020270-01A1 | U.S. AHRQ Grant/Contract | View source |
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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
| Pediatric Emergency Care Applied Registry Network (PECARN) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth R Alpern, MD | Ann & Robert H Lurie Children's Hospital of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Colorado | Aurora | Colorado | 80045 | United States | ||
| Children's National Medical Center |
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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All participating sites' IRBs have granted a waiver of informed consent and assent for this study. In addition, all participating sites' IRBs have a granted a waiver of written authorization for HIPAA. Patients will not be approached for recruitment.
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| ID | Title | Description |
|---|---|---|
| FG000 | CHOP Base Emergency Department (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 in the calendar year of 2011 through 2021. |
| FG001 | Cincinnati Children's Hospital Medical Center (CCHMC) Base ED | All patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED in the calendar year of 2011 through 2021. |
| FG002 | CCHMC Satellite ED | All patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED in the calendar year of 2011 through 2021. |
| FG003 | Children's National Medical Center (CNMC) Base ED | All patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED in the calendar year of 2011 through 2021. |
| FG004 | CNMC Satellite ED | All patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED in the calendar year of 2011 through 2021. |
| FG005 | The Children's Hospital Colorado Base ED | All patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED in the calendar year of 2011 through 2021. |
| FG006 | The Children's Hospital Colorado Satellite ED | All patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED in the calendar year of 2011 through 2021. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Visits to the Emergency Department | There are no arms for this study. We are collecting all electronic patient data for all patients that present to the Emergency Department. Quality performance measures are constructed directly from the data in the registry. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median Age | Number Analyzed corresponds to the number of ED visits at each ED. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | number of visits | January 2012 - June 2016 |
|
January 2012- June 2016
The study is without direct patient contact and utilizes only existing electronic health record data. The primary potential risk to subjects is improper disclosure of medical information.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Alpern | Lurie Children's Hospital | 312-227-6080 | ealpern@luriechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 9, 2016 | May 9, 2018 | Prot_SAP_000.pdf |
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| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Data Coordinating Center | Salt Lake City | Utah | 84158 | United States |
| Median |
| Inter-Quartile Range |
| years |
|
| Sex/Gender, Customized | The number of participants analyzed is equal to the number of ED visits for the hospital ED named for the row, not the overall study. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | The number analyzed in the rows corresponds to each hospital's emergency department, rather than the overall participants. | Count of Participants | Participants |
|
| OG002 | CCHMC Satellite ED | All ED visits from patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED. |
| OG003 | Children's National Medical Center (CNMC) Base ED | All ED visits from patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED. |
| OG004 | CNMC Satellite ED | All ED visits from patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED. |
| OG005 | The Children's Hospital Colorado Base ED | All ED visits from patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED. |
| OG006 | The Children's Hospital Colorado Satellite ED | All ED visits from patients (age 0-18 regardless of race, ethnicity, or gender and of diagnosis or chronic health condition) who are registered in the ED. |
|
|
| 0 |
| 2,019,461 |
| 0 |
| 2,019,461 |
| 0 |
| 2,019,461 |
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