Congenital Heart Initiative-Redefining Outcomes and Navigation to Adult Centered Care
CHI-RON
Utilizing PCORnet to Support Transition From Pediatric to Adult Centered Care and Reduce Gaps in Recommended Care in Patients With Congenital Heart Disease
1 other identifier
observational
3,000
1 country
16
Brief Summary
Congenital heart defects (CHDs) are a heterogeneous group of rare diseases of varying severity, each diagnosis with its unique set of co-morbidities. In addition to the heterogeneity, perhaps the greatest challenge to conducting comparative effectiveness research in CHD patients are the poor rates of successful transition from pediatric to adult centered cardiology care and high rates of gaps in recommend care for adults with CHD. This study will use PCORnet to examine the effects of gaps in recommended care (cardiology visits) on patient prioritized outcomes for adults with non-complex and complex subtypes of CHD. This system will be established through 14 (12 recruiting) PCORnet affiliated institutions and linkage to the Congenital Heart Initiative registry (https://chi.eurekaplatform.org), the first patient powered registry for adults with CHD. This registry launched in December 2020, and is IRB approved at Children's National Hospital (IRB# Pro00014697). Funded by PCORI, this project will recruit patients at the 12 PCORnet affiliated institutions and will invite them to contribute their health records data and then join the established Congenital Heart Initiative. By enrolling patients and linking their PCORnet (health record) data into an existing adult congenital heart disease (ACHD) specific registry, future interventions to reduce gaps in care based on study findings can be rapidly implemented in real-world settings through the strong partnerships established with key CHD stakeholders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Typical duration for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2021
CompletedFirst Posted
Study publicly available on registry
January 11, 2022
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedJanuary 11, 2022
January 1, 2022
1.5 years
December 21, 2021
January 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Rates of healthcare use
The primary outcome will be the number of visits each year to the following clinical settings, which are thought to reflect access to primary care, cardiology care, or specialist care.
Month 9-31
Rates of comorbidities
The study investigators will determine the prevalence rates of comorbidities which will be assessed using the Elixhauser comorbidity index developed by AHRQ. Investigators will compare these outcomes among the various CHD subtypes and among patients who do or don't have gaps in care. Investigators will adjust for a number of potential confounders and covariates including: patient factors, regional factors and hospital factors.
Month 9-31
Number of Participants with gaps in care
Gaps in care will be defined as no cardiology subspecialty visit in \>3-5 years for non-complex CHD subtypes and \>1-2 years for complex CHD subtypes.
Months 9-31
Other Outcomes (4)
Measure of Quality of Life (Patient Reported Outcome)
Month 10-23
Assessing Mental Health (Patient Reported Outcome)
Month 10-23
Evaluating Physical health and functioning (Patient Reported Outcome)
Month 10-23
- +1 more other outcomes
Study Arms (2)
Patients with complex congenital heart disease
Complex congenital heart disease will be defined by previously published classification including those listed in the American heart association/ American college of cardiology guidelines for the care of adults with congenital heart disease.
Patients with non-complex congenital heart disease
Non-complex congenital heart disease will be defined by previously published classification including those listed in the American heart association/ American college of cardiology guidelines for the care of adults with congenital heart disease.
Interventions
There will not be a discrete intervention as part of this study but study investigators will be examining a set of primary and secondary outcomes in patients who have followed recommended cardiac care vs. those who have not.
Eligibility Criteria
Study population will include Adults including Pregnant women
You may qualify if:
- For Aims 1 \& 2, participants will be deemed eligible to participate if they meet the following criteria:
- Age greater than or equal to 18 years at the time of initial data query
- Diagnosis of Congenital Heart Disease with at least one inpatient, outpatient, or emergency room visit within 8 years prior to the time of the initial data query
- Retrospective data available for 1-3 years prior to initial data query
- For Aim 3, participants will be deemed eligible to participate if they meet the following criteria:
- Age greater than or equal to18 years at the time of initial data query
- Diagnosis of Congenital Heart Disease with at least one inpatient, outpatient, or emergency room visit within 6 years prior to the time of the initial data query
- Contact Information (email, address, and/or phone number)
- Email access through internet connected device or smartphone (Android or iOS)
- Can read/write English well enough to fill out on-line surveys
You may not qualify if:
- Age \< 18 years
- No Congenital Heart Disease (as classified by ICD9/10 codes)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
University of California
San Francisco, California, 94118, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Children's National Hospital
Washington D.C., District of Columbia, 20010, United States
University of Miami
Coral Gables, Florida, 33124, United States
University of Florida
Gainesville, Florida, 32611, United States
Nicklaus Children's Hospital
Miami, Florida, 33155, United States
Louisiana Public Health Institute
New Orleans, Louisiana, 70112, United States
Ochsner
New Orleans, Louisiana, 70121, United States
Mount Sinai
New York, New York, 10003, United States
NYU Langone Health
New York, New York, 10016, United States
Columbia Presbyterian
New York, New York, 10034, United States
Weill Cornell Medicine
New York, New York, 10065, United States
Duke Coordinating Center
Durham, North Carolina, 27701, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
Nationwide Children's
Columbus, Ohio, 43205, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Related Publications (8)
Ferencz C, Rubin JD, McCarter RJ, Brenner JI, Neill CA, Perry LW, Hepner SI, Downing JW. Congenital heart disease: prevalence at livebirth. The Baltimore-Washington Infant Study. Am J Epidemiol. 1985 Jan;121(1):31-6. doi: 10.1093/oxfordjournals.aje.a113979.
PMID: 3964990BACKGROUNDAgarwal A, Thombley R, Broberg CS, Harris IS, Foster E, Mahadevan VS, John A, Vittinghoff E, Marcus GM, Dudley RA. Age- and Lesion-Related Comorbidity Burden Among US Adults With Congenital Heart Disease: A Population-Based Study. J Am Heart Assoc. 2019 Oct 15;8(20):e013450. doi: 10.1161/JAHA.119.013450. Epub 2019 Oct 2.
PMID: 31575318BACKGROUNDKhairy P, Ionescu-Ittu R, Mackie AS, Abrahamowicz M, Pilote L, Marelli AJ. Changing mortality in congenital heart disease. J Am Coll Cardiol. 2010 Sep 28;56(14):1149-57. doi: 10.1016/j.jacc.2010.03.085.
PMID: 20863956BACKGROUNDWebb G, Landzberg MJ, Daniels CJ. Specialized adult congenital heart care saves lives. Circulation. 2014 May 6;129(18):1795-6. doi: 10.1161/CIRCULATIONAHA.114.009049. Epub 2014 Mar 3. No abstract available.
PMID: 24589850BACKGROUNDJackson JL, Morack J, Harris M, DeSalvo J, Daniels CJ, Chisolm DJ. Racial disparities in clinic follow-up early in life among survivors of congenital heart disease. Congenit Heart Dis. 2019 Mar;14(2):305-310. doi: 10.1111/chd.12732. Epub 2018 Dec 18.
PMID: 30561880BACKGROUNDBroberg C, McLarry J, Mitchell J, Winter C, Doberne J, Woods P, Burchill L, Weiss J. Accuracy of administrative data for detection and categorization of adult congenital heart disease patients from an electronic medical record. Pediatr Cardiol. 2015 Apr;36(4):719-25. doi: 10.1007/s00246-014-1068-2. Epub 2014 Nov 27.
PMID: 25428778BACKGROUNDOster ME, Riehle-Colarusso T, Simeone RM, Gurvitz M, Kaltman JR, McConnell M, Rosenthal GL, Honein MA. Public health science agenda for congenital heart defects: report from a Centers for Disease Control and Prevention experts meeting. J Am Heart Assoc. 2013 Aug 28;2(5):e000256. doi: 10.1161/JAHA.113.000256. No abstract available.
PMID: 23985376BACKGROUNDReid GJ, Irvine MJ, McCrindle BW, Sananes R, Ritvo PG, Siu SC, Webb GD. Prevalence and correlates of successful transfer from pediatric to adult health care among a cohort of young adults with complex congenital heart defects. Pediatrics. 2004 Mar;113(3 Pt 1):e197-205. doi: 10.1542/peds.113.3.e197.
PMID: 14993577BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anitha S John, MD, Ph.D
Children's National Research Institute
- PRINCIPAL INVESTIGATOR
Thomas Carton, Ph.D
Louisiana Public Health Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 4 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director and Principal Investigator, Washington Adult Congenital Heart Program
Study Record Dates
First Submitted
December 21, 2021
First Posted
January 11, 2022
Study Start
April 1, 2022
Primary Completion
October 1, 2023
Study Completion
June 30, 2024
Last Updated
January 11, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share
Individual Participant data will not be shared with other researchers.