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

May 15, 2023 updated by: Children's Hospital Medical Center, Cincinnati

National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC) - A Collaborative Initiative to Improve Care of Children With Complex Congenital Heart Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
  • United Kingdom
      • London, United Kingdom
        • Not yet recruiting
        • Evelina London Children's Healthcare
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aaron Bell, MD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Completed
        • Children's of Alabama
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Phoenix Children's Hospital
        • Principal Investigator:
          • Joseph Graziano, MD
        • Contact:
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Recruiting
        • Arkansas Children's Hospital
        • Contact:
        • Principal Investigator:
          • Dala Zakaria, MD
    • California
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Children's Hospital Los Angeles
        • Contact:
        • Principal Investigator:
          • Jay Pruetz, MD
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Mattel Children's Hospital
        • Principal Investigator:
          • Nancy Halnon, MD
        • Contact:
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Lucile Packard Children's Hospital-Stanford
        • Contact:
        • Principal Investigator:
          • Sharon Chen, MD
      • Sacramento, California, United States, 95816
        • Recruiting
        • Sutter Medical Center-Sacramento
        • Contact:
        • Principal Investigator:
          • James Hill, MD
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis Children's Hospital
        • Contact:
        • Principal Investigator:
          • Andrew Pelech, MD
      • San Diego, California, United States, 92123
        • Recruiting
        • Rady Children's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jessica Haley, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado
        • Contact:
        • Principal Investigator:
          • Jonathan Kaufman, MD
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Recruiting
        • Nemours Cardiac Center, A.I DuPont Hospital for Children
        • Contact:
        • Principal Investigator:
          • Erica Del Grippo, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Children's National Medical Center
        • Principal Investigator:
          • Sarah Clauss, MD
        • Contact:
    • Florida
      • Gainesville, Florida, United States, 32606
        • Recruiting
        • University of Florida-UF Health
        • Contact:
        • Principal Investigator:
          • Jennifer Co-Vu, MD
      • Miami, Florida, United States, 33155
        • Recruiting
        • Nicklaus Children's Hospital
        • Contact:
        • Principal Investigator:
          • Madalsa Patel, MD
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Arnold Palmer Children's Hospital
        • Contact:
        • Principal Investigator:
          • Elise Riddle, MD
      • Saint Petersburg, Florida, United States, 33701
        • Recruiting
        • Johns Hopkins All Children's Hospital
        • Contact:
        • Principal Investigator:
          • Benton Ng, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Children's Healthcare of Atlanta
        • Contact:
        • Principal Investigator:
          • Martha Clabby, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Ann and Robert H. Lurie Children's Hospital of Chicago
        • Contact:
        • Principal Investigator:
          • Kiona Allen, MD
      • Oak Lawn, Illinois, United States, 60453
        • Recruiting
        • Advocate Children's Hospital
        • Contact:
        • Principal Investigator:
          • Andrew Vanbergen, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Hospital for Children at IU Health
        • Principal Investigator:
          • Anne Farrell, MD
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Children's Hospital
        • Contact:
        • Principal Investigator:
          • Benjamin Reinking, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Louisiana
      • Jefferson, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Hospital for Children
        • Contact:
        • Principal Investigator:
          • Ivory Crittendon, MD
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland Children's Hospital
        • Contact:
        • Principal Investigator:
          • Alicia Chaves, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan C.S. Mott Children's Hospital
        • Contact:
        • Principal Investigator:
          • Katherine Bates, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Recruiting
        • Children's Hospital and Clinics of Minnesota
        • Contact:
        • Principal Investigator:
          • Christine Hills, MD
      • Minneapolis, Minnesota, United States, 55454
        • Recruiting
        • University of Minnesota Masonic Children's Hospital
        • Contact:
        • Principal Investigator:
          • Kavisha Shah, MD
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • Batson Children's Hospital-University of Mississippi Medical Center
        • Contact:
        • Principal Investigator:
          • Stephanie Ghaleb
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy Hospitals and Clinics
        • Contact:
        • Principal Investigator:
          • Matthew Moehlmann, MD
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • St. Louis Children's Hospital
        • Contact:
        • Principal Investigator:
          • Mayte Figueroa, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Children's Hospital and Medical Center-Omaha
        • Contact:
        • Principal Investigator:
          • Christopher Curzon, DO
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • The Children's Hospital of Montefiore
        • Contact:
        • Principal Investigator:
          • Nicole Sutton, MD
      • New Hyde Park, New York, United States, 11040
        • Recruiting
        • Cohen Children's Medical Center Northwell Health
        • Contact:
        • Principal Investigator:
          • Elizabeth Vinas, RN, MD
      • New York, New York, United States, 10016
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University- NY Presbyterian
        • Contact:
        • Principal Investigator:
          • Anne Ferris, MD
      • Rochester, New York, United States, 14642
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Levine Children's Hospital-Sanger Heart and Vascular Institute
        • Principal Investigator:
          • Amy Svenson, MD
        • Contact:
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University Medical Center
        • Principal Investigator:
          • Michael Camitta, MD
        • Contact:
    • Ohio
      • Akron, Ohio, United States, 44308
        • Active, not recruiting
        • Akron Children's Hospital
      • Cincinnati, Ohio, United States, 45242
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Children's Hospital
        • Principal Investigator:
          • Francine Erenberg, MD
        • Contact:
      • Cleveland, Ohio, United States, 44092
        • Recruiting
        • University Hospitals Case Medical Center - Rainbow Babies & Children's Hospital, Pediatric Heart Center
        • Contact:
        • Principal Investigator:
          • Sarah Plummer, MD
      • Columbus, Ohio, United States, 43023
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Doernbecher Children's Hospital
        • Contact:
        • Principal Investigator:
          • Christina Ronai, MD
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 22908
        • Not yet recruiting
        • PennState Hershey Medical Center--PennState Health Children's Hospital
        • Contact:
        • Principal Investigator:
          • Vincent Aluquin, MD
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
        • Principal Investigator:
          • Therese Giglia, MD
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • Children's Hospital of Pittsburgh of UPMC
        • Contact:
        • Principal Investigator:
          • Evon Morell, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Frances Woodward, RN, PNP
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Recruiting
        • Le Bonheur Children's Hospital
        • Contact:
        • Principal Investigator:
          • Ranjit Raju Philip, MD
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Monroe Carell Jr. Children's Hospital at Vanderbilt
        • Principal Investigator:
          • David Parra, MD
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • Children's Medical Center of Dallas
        • Contact:
        • Principal Investigator:
          • Thomas Zellers, MD
      • Fort Worth, Texas, United States, 76104
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital
        • Principal Investigator:
          • Elena Ocampo, MD
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Recruiting
        • Primary Children's Hospital
        • Contact:
        • Principal Investigator:
          • Dongngan Truong, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • UVA Children's Hospital
        • Contact:
        • Principal Investigator:
          • Jeffrey Vergales, MD
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Inova Children's Hospital
        • Contact:
        • Principal Investigator:
          • Harish Rudra, DO
    • Washington
      • Seattle, Washington, United States, 98105
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin, American Family Children's
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sharda Srivinivasan, MD
      • Milwaukee, Wisconsin, United States, 53201
        • Recruiting
        • Children's Hospital of Wisconsin
        • Contact:
        • Principal Investigator:
          • Nancy Rudd, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Infants diagnosed with HLHS

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hypoplastic Left Heart Syndrome
Infants diagnosed with Hypoplastic Left Heart Syndrome (HLHS)
Other: Collaborative Learning Network

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Garick Hill, MD, Cininnati Children's Hospital Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

May 1, 2026

Study Completion (Anticipated)

May 1, 2028

Study Registration Dates

First Submitted

May 19, 2016

First Submitted That Met QC Criteria

August 1, 2016

First Posted (Estimate)

August 2, 2016

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-3866

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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