Congenital Heart DiseaseCHI-RONNCT05185232
Congenital Heart Initiative-Redefining Outcomes and Navigation to Adult Centered Care
An observational study of Congenital Heart Disease and Comorbidities and Coexisting Conditions, run by Children's National Research Institute at 16 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease, Comorbidities and Coexisting Conditions
- What is being tested?
- Impact of gaps in care/loss to healthcare follow-up
- How many people
- 3,000 participants
- Where
- 16 sitesUnited States
- Study dates
- 1 Apr 2022to 30 Jun 2024
- How long will I take part?
- 4 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population will include Adults including Pregnant women
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Age < 18 years
- No Congenital Heart Disease (as classified by ICD9/10 codes)
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Adam Lubert, MD, 513-636-2147, Adam.Lubert@cchmc.org
Nationwide Children's
Columbus, Ohio, 43205
Jamie Jackson, Ph.D, 614-355-3426, Jamie.Jackson2@nationwidechildrens.org
University of Miami
Coral Gables, Florida, 33124
Duke Coordinating Center
Durham, North Carolina, 27701
Keith Marsolo, Ph.D, keith.marsolo@duke.edu
University of Florida
Gainesville, Florida, 32611
Arwa Saidi, MD, 352-273-5631, asaidi@pedcard.ufl.edu
Nicklaus Children's Hospital
Miami, Florida, 33155
Ronald Kanter, MD, 786-624-3526, Ronald.Kanter@Nicklaushealth.org
Louisiana Public Health Institute
New Orleans, Louisiana, 70112
Thomas Carton, Ph.D, 504-715-6726, tcarton@lphi.org
Erica Johnson, MA, 504.609.3941, ejohnson@lphi.org
Ochsner
New Orleans, Louisiana, 70121
Tom Young, MD, thyoung@ochsner.org
Mount Sinai
New York, New York, 10003
Ali Zaidi, MD, ali.zaidi@mountsinai.org
NYU Langone Health
New York, New York, 10016
Dan Halpern, MD, 347-978-6371, Dan.Halpern@nyulangone.org
Columbia Presbyterian
New York, New York, 10034
Weill Cornell Medicine
New York, New York, 10065
Simran SIngh, MD, has9028@med.cornell.edu
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of California
San Francisco, California, 94118
Anushree Agarwal, MD, 415-502-1846, anu.agarwal2@ucsf.edu
Children's National Hospital
Washington D.C., District of Columbia, 20010
Anitha S John, MD, Ph.D, 202-476-2728, anjohn@childrensnational.org
Adebola Owolabi, BSc, (202) 476-7180, bowolabi@childrensnational.org
About this study
Official title: Utilizing PCORnet to Support Transition From Pediatric to Adult Centered Care and Reduce Gaps in Recommended Care in Patients With Congenital Heart Disease
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.
Read the detailed description
ACHD Surveillance Program/Observational Cohort (Aim 1 and Aim 2): To investigate the first two aims of this proposal, the study investigators will design and analyze an observational cohort of subjects >18 years of age with CHD from 14 PCORnet sites. Data is collected retrospectively (5 years prior to initial data query). Each subject with a diagnosis of CHD, > 18 years of age, and at least 1-3 years of retrospective information will be included in the study. Retrospective data will be obtained from the previous 1-3 years to ascertain adherence to recommended care by the ACC/AHA, specific to CHD subtype. Retrospective data collection will be to 1-3 years, with 2 years likely being sufficient to identify our patient cohorts. The investigators will still perform a retrospective data search for 5 years, but will not exclude patients if they do not have data sets for the full five year period.
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.
- Being tested
- Impact of gaps in care/loss to healthcare follow-up
- Keywords
- Healthcare Transition, Healthcare Utilization, Patient Reported Outcomes, Access to Care, Mental Health, Physical Activities, Quality of Life, COVID-19
- Medical subject headings
- Heart Defects, Congenital, Psychological Well-Being, Motor Activity, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact of gaps in care/loss to healthcare follow-upOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Impact of gaps in care/loss to healthcare follow-up | |
| 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. Receives: Other: Impact of gaps in care/loss to healthcare follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Months 9-31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Louisiana Public Health Institute
- Responsible party
- Principal investigator, Anitha John, Children's National Research Institute
- Investigators
- Anitha S John, MD, Ph.D, Principal investigator, Children's National Research InstituteThomas Carton, Ph.D, Principal investigator, Louisiana Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185232
- Sponsor's protocol ID
- Pro00016403
- Acronym
- CHI-RON
- Status last verified
- Jan 2022
- First submitted
- 21 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant data will not be shared with other researchers.
Publications
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.
PubMed 3964990Agarwal 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.
PubMed 31575318Khairy 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.
PubMed 20863956Webb 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.
PubMed 24589850Jackson 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.
PubMed 30561880Broberg 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.
PubMed 25428778Oster 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.
PubMed 23985376Reid 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.
PubMed 14993577
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing PCORnet to Support Transition From Pediatric to Adult Centered Care and Reduce Gaps in Recommended Care in Patients With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT05185232
- Acronym / sponsor ID
- CHI-RON / Pro00016403
- Keywords
- Healthcare Transition, Healthcare Utilization, Patient Reported Outcomes, Access to Care, Mental Health, Physical Activities, Quality of Life, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Louisiana Public Health Institute
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
ACHD Surveillance Program/Observational Cohort (Aim 1 and Aim 2): To investigate the first two aims of this proposal, the study investigators will design and analyze an observational cohort of subjects >18 years of age with CHD from 14 PCORnet sites. Data is collected retrospectively (5 years prior to initial data query). Each subject with a diagnosis of CHD, > 18 years of age, and at least 1-3 years of retrospective information will be included in the study. Retrospective data will be obtained from the previous 1-3 years to ascertain adherence to recommended care by the ACC/AHA, specific to CHD subtype. Retrospective data collection will be to 1-3 years, with 2 years likely being sufficient to identify our patient cohorts. The investigators will still perform a retrospective data search for 5 years, but will not exclude patients if they do not have data sets for the full five year period.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with complex congenital heart disease | – | Other: Impact of gaps in care/loss to healthcare follow-upComplex 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 | – | Other: Impact of gaps in care/loss to healthcare follow-upNon-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will include Adults including Pregnant women
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (2 listed)
- Age < 18 years
- No Congenital Heart Disease (as classified by ICD9/10 codes)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impact of gaps in care/loss to healthcare follow-upThere 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. | Other | Patients with complex congenital heart disease, Patients with non-complex congenital heart disease |
Primary outcome
Rates of healthcare use
Time frame: Month 9-31
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.
Rates of comorbidities
Time frame: Month 9-31
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.
Number of Participants with gaps in care
Time frame: Months 9-31
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Background: PubMed 3964990Ferencz 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.
- Background: PubMed 31575318Agarwal 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.
- Background: PubMed 20863956Khairy 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.
- Background: PubMed 24589850Webb 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.
- Background: PubMed 30561880Jackson 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.
- Background: PubMed 25428778Broberg 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.
- Background: PubMed 23985376Oster 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.
- Background: PubMed 14993577Reid 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.
- Individual participant dataSharing planned: No. Individual Participant data will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anitha S John, MD, Ph.D principal investigator
Children's National Research Institute
Thomas Carton, Ph.D principal investigator
Louisiana Public Health Institute
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Comorbidities and Coexisting Conditions, run by Children's National Research Institute at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anitha S John, MD, Ph.D (2024762728, anjohn@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of healthcare use (time frame: Month 9-31). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05185232, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.