Congenital Heart Initiative-Redefining Outcomes and Navigation to Adult Centered Care

Status unconfirmed

Conditions studied: Congenital Heart Disease, Comorbidities and Coexisting Conditions

In brief

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.

Key facts

Study ID

NCT05185232

Run by

Children's National Research Institute

People needed

3000

Starts

2022-04-01

Expected to finish

2024-06-30

Last updated by the study team

2022-01-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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)

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.