Brief Summary
The purpose of this initiative is to improve care and outcomes for infants with HLHS by expanding the NPC-QIC national registry to gather clinical care process, outcome, and developmental data on infants with HLHS between diagnosis and 12 months of age, by improving the use of standards into everyday practice across pediatric cardiology centers, and by engaging parents as partners in the process.
Brief Title
National Collaborative to Improve Care of Children With Complex Congenital Heart Disease
Detailed Description
The purpose of this initiative is to improve care and outcomes for infants with HLHS by: 1) expanding the established NPC-QIC national registry to gather clinical care process, outcome, and developmental data on infants with HLHS between diagnosis and 12 months of age, 2) improving implementation of consensus standards, tested by teams, into everyday practice across pediatric cardiology centers, and 3) engaging parents as partners in improving care and outcomes.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Email
mark.timbers@cchmc.org
Completion Date
Completion Date Type
Estimated
Conditions
Hypoplastic Left Heart Syndrome (HLHS)
Eligibility Criteria
Inclusion Criteria:
* Fetuses or newborns diagnosed with HLHS or other univentricular condition
* Intended to undergo Norwood procedure
Exclusion Criteria:
* None
* Fetuses or newborns diagnosed with HLHS or other univentricular condition
* Intended to undergo Norwood procedure
Exclusion Criteria:
* None
Inclusion Criteria
Inclusion Criteria:
* Fetuses or newborns diagnosed with HLHS or other univentricular condition
* Intended to undergo Norwood procedure
* Fetuses or newborns diagnosed with HLHS or other univentricular condition
* Intended to undergo Norwood procedure
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
15 Months
NCT Id
NCT02852031
Org Class
Other
Org Full Name
Children's Hospital Medical Center, Cincinnati
Org Study Id
2015-3866
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC) - A Collaborative Initiative to Improve Care of Children With Complex Congenital Heart Disease
Primary Outcomes
Outcome Description
The purpose of this data sharing is to facilitate QI and research activities. As more information is gathered in this registry, the study team will determine the data analyses methods to determine if the knowledge gained led to changes in care delivery and/or to better patient outcomes.
Outcome Measure
Relationship between the implementation of changes in care delivery with changes in the process
Outcome Time Frame
15 months
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Infants diagnosed with HLHS
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
1
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Nicole Sutton
Investigator Email
nsutton@montefiore.org
Investigator Phone
718-741-2343