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National Collaborative to Improve Care of Children With Complex Congenital Heart Disease (NPC-QIC)

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ClinicalTrials.gov Identifier: NCT02852031
Recruitment Status : Recruiting
First Posted : August 2, 2016
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Tracking Information
First Submitted Date May 19, 2016
First Posted Date August 2, 2016
Last Update Posted Date April 10, 2018
Study Start Date May 2016
Estimated Primary Completion Date May 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 1, 2016)
Relationship between the implementation of changes in care delivery with changes in the process [ Time Frame: 15 months ]
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02852031 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title National Collaborative to Improve Care of Children With Complex Congenital Heart Disease
Official Title National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC) - A Collaborative Initiative to Improve Care of Children With Complex Congenital Heart Disease
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.
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 15 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Infants diagnosed with HLHS
Condition Hypoplastic Left Heart Syndrome (HLHS)
Intervention Other: Collaborative Learning Network
Study Groups/Cohorts HLHS
Infants diagnosed with HLHS
Intervention: Other: Collaborative Learning Network
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 1, 2016)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2028
Estimated Primary Completion Date May 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Fetuses or newborns diagnosed with HLHS or other univentricular condition
  • Intended to undergo Norwood procedure

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages up to 15 Months   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Bridget Butz (513)803-9166 bridget.butz@cchmc.org
Listed Location Countries Canada,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02852031
Other Study ID Numbers 2015-3866
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available.
Responsible Party Children's Hospital Medical Center, Cincinnati
Study Sponsor Children's Hospital Medical Center, Cincinnati
Collaborators Not Provided
Investigators
Principal Investigator: Jeffrey Anderson, MD Cininnati Children's Hospital Medical Center
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date April 2018