RECRUITING

Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The incidence of moderate to severe congenital heart disease (CHD) in the United States is estimated to be 6 per 1000 live-born full term infants. Recent advances in pediatric cardiology, surgery and critical care have significantly improved the survival rates of patients with CHD leading to an increase in prevalence in both children and adults. Children with CHD significant enough to require cardiac surgery frequently also undergo non-cardiac surgical procedures. Analysis of the Pediatric Health Information System database between 2004 and 2012 demonstrated that 41% of children who had undergone surgery to correct CHD in the first year of life also underwent at least one non-cardiac surgery by age 5. With this increased demand for non-cardiac procedures, anesthesiologists, pediatricians and other healthcare providers will encounter patients with repaired or unrepaired CHD and other cardiac diseases in their practice. However, the information provided by national databases lack granularity and the information from single institutional data is limited. This project aims to address this knowledge gap in quantifying the risk for cardiac patients coming for noncardiac procedures and identify the health care resource utilization and system to best care for this patient population. To conduct this study, we will create a multi-institutional collaboration between large and small centers to create a unique dataset spanning all the different variables that need to be considered in risk prediction for these patients including patient variables, hospital setting, and providers. The aggregate multiinstitutional data set may be used for benchmarking for national quality improvement efforts.

Official Title

Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures

Quick Facts

Study Start:2020-10-01
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04604418

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.

Ages Eligible for Study:Not specified to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Males or females ages birth to 21 years.
  2. 2. Patients diagnosed with congenital heart disease
  3. 3. Patients undergoing a noncardiac procedure (surgical or nonsurgical)
  1. 1. Patients with congenial heart disease undergoing a cardiac surgical procedure including pacemakers.
  2. 2. Patients with congenital heart disease undergoing a catheterization(diagnostic or interventional) or an electrophysiology study

Contacts and Locations

Study Contact

Viviane Nasr, MD
CONTACT
617-355-6225
viviane.nasr@childrens.harvard.edu
Rachel Bernier
CONTACT
857-218-5348
Rachel.Bernier@childrens.harvard.edu

Principal Investigator

Viviane Nasr, MD
PRINCIPAL_INVESTIGATOR
Boston Children's Hospital

Study Locations (Sites)

University of California, Los Angeles
Los Angeles, California, 90095
United States
Children's National Medical Center
Washington, District of Columbia, 20310
United States
Children's Healthcare of Atlanta - Egleston Hospita
Atlanta, Georgia, 30322
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Texas Children's Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

  • Viviane Nasr, MD, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

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 Registration Dates

Study Start Date2020-10-01
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2020-10-01
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • Perioperative risk prediction
  • Adverse Postoperative Outcomes

Additional Relevant MeSH Terms

  • Congenital Heart Disease in Children