Cardiac Acute Transitioning Care to Home (CATCH) App Data Repository (CATCH)

November 16, 2021 updated by: Children's Mercy Hospital Kansas City

The Cardiac Acute Transitioning Care to Home (CATCH) Data Repository (CATCH App Repository)

This repository will consist of clinically derived data and images of patients with congenital heart disease from the time of birth until they have reached one of the following outcomes: transition to outpatient care that has not resulted in readmission in 30 days after hospital discharge, death, weaned off supplementary feeding tubes, or clinic visits demonstrating clinical stability with their primary cardiologist, or full bi-ventricular cardiac surgery palliation with improvement in hemodynamic stability. This information will be collected for clinical evaluation and diagnostic purposes and will continue to be stored for potential future research application.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Approximately 40,000 infants are born each year with congenital heart disease (CHD), a leading cause of morbidity and mortality in infancy. Progress in surgical, transcatheter, and medical management of newborn CHD has significantly reduced mortality. The CHAMP app (separate IRB # 15030113) has helped to transition high-risk infants with single ventricle congenital heart disease out of the hospital and to second stage cardiac surgery at Children's Mercy Hospital and across the United States with improved survival. Remote monitoring technology and telemedicine is a critical tool to aid clinical care for high risk children with congenital heart disease but has been limited to the single ventricle population in most cases. The benefits of this tool as a standard of care for other children transitioning home may include decreased readmissions, improved weight gain, and remote monitoring for reduced throughput in the emergency room, hospital, and clinic settings. To improve outcomes beyond mortality and into morbidity with other high-risk patients with congenital heart disease, future studies must assess morbidities and quality of outcomes with the application of remote home monitoring with applications like the CHAMP app.

Patients that are discharging from the hospital after complex congenital heart disease surgery and cardiac catheterization are at high risk of events. Adverse outcomes in the year after discharge are of similar magnitude to mortality in hospital and are not only with infants with single ventricle heart disease but may include infants and children that were hospitalized more than 30 days, readmitted to intensive care unit more than once, smaller size for age, younger age at surgery, shunt dependent for pulmonary blood flow, congenital heart disease with complexities such as neurological conditions and supplemental enteral feedings gastrostomy. Over a 6-year period, 6.7% (514/7976) children experienced adverse events including mortality in a report from England after initial discharge from cardiac surgery. In a review of our similar patients from Children's Mercy we have noted a 5.8% mortality in this population.

There is additional focus on expanding transition care in the pediatric cardiac population beyond 30 days after discharge as traditionally followed by the Society of Thoracic Surgeons as a marker of well-state (traditionally 8.3%) and onto 90 days (21% of additional readmissions) to 1 year after discharge. Children had unplanned hospital readmissions during the first year after cardiac surgery that were between 31 and 90 days after discharge that could have possibly been prevented with the aid of remote technology in additional to ambulatory care by a specialized advanced practice nurse. Higher rates of readmissions were seen with those in lower socioeconomic areas (through zip codes), living closer to the hospital (potentially a marker of access to care and rurality), higher STAT category, longer intubation, and longer ICU length of stay were all markers for higher risk of later readmission after 31 days of discharge.

Combining the advancements with CHAMP app with the expert care teams with advanced practice nurses, a new standard of care for an expanded group of high-risk infants and children transitioning home after cardiac surgery and in-hospital care can be established. The research and ability to improve the understanding of how this process can be applied to an expanded population that has been identified as high risk is key for implementation and sustainability of a high risk transition care program.

Study Type

Observational

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Kansas City

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children after hospitalization for heart surgery that required ICU care

Description

Inclusion Criteria:

  • • Subjects with congenital heart disease that have been hospitalized for more than 30 days,

    • Subjects being discharged with readmissions more than twice to critical care areas,
    • Subject with single ventricle physiology that has not been discharged home during the single ventricle interstage period,
    • Subjects that are less than 18 years of age,
    • Subjects with gastrostomy or nasogastric tubes and congenital heart disease,
    • Subjects with congenital heart disease who are at a high risk for transition to the home setting and are not currently enrolled in the CHAMP single ventricle inclusion criteria, and/or
    • Subjects at high risk for events as identified by the Directors of the CATCH app Repository.

Exclusion Criteria:

  • All patients not meeting at least one of the above specified criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of children that had 30 day survival after hospital discharge
Time Frame: 1 month
Survival of child after hospital discharge
1 month
Number of children that had Readmission after initiation hospital discharge
Time Frame: 2 months
Hospital readmission after initial discharge
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

July 29, 2020

Primary Completion (Actual)

May 29, 2021

Study Completion (Actual)

November 15, 2021

Study Registration Dates

First Submitted

July 30, 2020

First Submitted That Met QC Criteria

July 30, 2020

First Posted (Actual)

August 4, 2020

Study Record Updates

Last Update Posted (Actual)

November 18, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001436

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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