Congenital Heart Initiative-Redefining Outcomes and Navigation to Adult Centered Care
NCT ID: NCT05185232
Last Updated: 2022-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
3000 participants
OBSERVATIONAL
2022-04-01
2024-06-30
Brief Summary
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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.
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Detailed Description
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The study team will specifically investigate frequency of gaps in recommended cardiology follow-up. Gaps in recommended care will be determined by the individual subtype of disease. The investigators will also examine advanced testing and imaging, but that will not be the primary measure of adherence to recommended care. In this cohort, the main outcomes of interest are key comorbidities and healthcare utilization. The investigators will be performing 2 cycles of data searches (March 2022 and January 2024), including the initial search for one year of follow-up after the subject's last cardiology visit.
Of note, with the COVID-19 pandemic, healthcare utilization has been affected throughout the population, not just those patients with rare diseases. To mitigate some of these issues, the study investigators will institute the following. For the data pertaining to the proposed study of loss to care, the retrospective data search in January 2020 (pre-COVID19) will be used and adjusted for lesion follow-up as described. Given the unique circumstances, the study investigators do feel that obtaining data during the COVID-19 pandemic is extremely important for this patient population, especially to identify the factors that might make some patients more vulnerable to loss to follow-up. Therefore, study investigators will analyze the retrospective data from February 2020 - June 2021 as a separate cohort in order to better identify the effects of the pandemic on this population of patients. Many centers (including all within the proposed study) began implementing telehealth visits, and will include this in the data capture.
Prospective cohort through CHI registry linkage (Aim 3): To investigate the third aim of the study, study investigators will design and analyze a prospective cohort design with the goal of establishing a diverse panel of CHD patients who are either (1) adhering or (2) not adhering to recommended care guidelines. Patients with qualifying CHD (ICD9/10 codes) who are \> 18 years of age will be included in the study. Once patients are identified, site-specific PIs and their teams will facilitate enrollment into the Congenital Heart Initiative registry through the Eureka Research Platform with an electronic patient recruitment and engagement platform used with several large research projects. Specifically, patient prioritized outcomes (quality of life, mental health, and physical health \& functioning) will be assessed among registrants who will be stratified by disease complexity and gaps in care.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Impact of gaps in care/loss to healthcare follow-up
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.
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.
Impact of gaps in care/loss to healthcare follow-up
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.
Interventions
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Impact of gaps in care/loss to healthcare follow-up
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
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Inclusion 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
Exclusion Criteria
* No Congenital Heart Disease (as classified by ICD9/10 codes)
18 Years
ALL
Yes
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Louisiana Public Health Institute
OTHER
Children's National Research Institute
OTHER
Responsible Party
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Anitha John
Medical Director and Principal Investigator, Washington Adult Congenital Heart Program
Principal Investigators
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Anitha S John, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Children's National Research Institute
Thomas Carton, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Louisiana Public Health Institute
Locations
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University of California
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Children's National Hospital
Washington D.C., District of Columbia, United States
University of Miami
Coral Gables, Florida, United States
University of Florida
Gainesville, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Louisiana Public Health Institute
New Orleans, Louisiana, United States
Ochsner
New Orleans, Louisiana, United States
Mount Sinai
New York, New York, United States
NYU Langone Health
New York, New York, United States
Columbia Presbyterian
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
Duke Coordinating Center
Durham, North Carolina, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Nationwide Children's
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Agarwal 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.
Khairy 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.
Webb 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.
Jackson 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.
Broberg 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.
Oster 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.
Reid 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.
Other Identifiers
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Pro00016403
Identifier Type: -
Identifier Source: org_study_id
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