Support Tool for Families of High-Risk Children With Heart Disease During Hospital Admission and After Discharge

September 15, 2025 updated by: Deepika Thacker, Nemours Children's Clinic
The goal of this study is to pilot the "support tool" in the Nemours Cardiac Center to assess acceptability and feasibility. This tool will be offered to 5 high-risk families, and they will be asked to complete a survey. In addition, healthcare providers including bed-side nurses and cardiologists will be asked to complete a survey to assess the feasibility of the tool.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Despite advances in the care of children with heart disease, those affected often remain in need of complex care after hospital discharge. Multiple medications, tube feeds, and medical equipment are a few of the care needs parents face upon leaving the hospital. Unsurprisingly, many parents report problems in the transition of care from the hospital to the home. Clinical providers express frustration related to challenges with family education and communication around the time of discharge. Research is required to identify intervention strategies to improve parent/ caregiver confidence with caring for their child after discharge and reduce unintended resource utilization after discharge including clinical deterioration, unplanned 30-day readmissions, emergency department (ED) visits and nonadherence to outpatient appointments.

In Aim 1 of the study, the investigators identified the modifiable barriers, perceived needs, and opportunities for intervention to support parents/ caregivers in meeting the care needs of the high-risk child with heart disease after discharge by conducting semi-structured qualitative interviews with parents/ caregivers and healthcare personnel. And based on participants' responses, the investigators developed a support tool to improve parent/ caregiver comfort with caring for the high-risk child and improve post discharge outcomes. The objective of this study is to pilot this support tool in 5 high-risk families in Nemours Cardiac Center and assess the acceptability and feasibility based on their experience.

Study Type

Interventional

Phase

  • Not Applicable

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
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Nemours Children's Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Parent/Caregiver Group-

Inclusion Criteria:

• Parents of a child with congenital heart disease and planned discharge from the Nemours Cardiac Center.

Exclusion Criteria:

• Non-English and Non-Spanish speaking families.

The Healthcare providers group is pre-identified and they will be invited to provide feedback through semi-structured qualitative interviews only. They will not receive any intervention. Their participation will be voluntary.

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Parent/Caregiver of high-risk children with heart disease
The parent/caregivers of high-risk children with heart disease coming to the Nemours Cardiac Center for care will be offered a "support tool" and will be asked for it's acceptance and feasibility through their experience.
Other: NCC Support Toolkit

Pre-discharge intervention-

  • Set expectations for parents/caregivers to spend time bedside and attend rounds
  • iPad for the families to use the Nemours App, download education materials and Facetime communication with medical personnel.
  • Download Nemours App and teach them how to use it
  • Education materials- to ease the use of medications, Oxygen and feeding
  • Assistance with transportation, child care, parental work schedule for discharge teaching

Post Discharge intervention (Day 1-2):

• Video/Facetime call with the family to check equipment, home environment and answer questions about medications and formula

Post discharge intervention (Day 3-7):

• Phone call to the family to ensure transportation for their first follow-up appointment, answer questions about medications, Oxygen and feeding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of support tool
Time Frame: 12 weeks
By administering surveys to 5 families
12 weeks
Feasibility of support tool
Time Frame: 12 weeks
By administering surveys to the bed-side nurses and cardiologists.
12 weeks

Collaborators and Investigators

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

Sponsor

Nemours Children's Clinic

Collaborators

National Institute of General Medical Sciences (NIGMS)

Investigators

  • Principal Investigator: Deepika Thacker, MD, Nemours Children's Hospital

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)

November 29, 2023

Primary Completion (Actual)

April 30, 2024

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

May 30, 2023

First Submitted That Met QC Criteria

June 21, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Support Tools
  • U54GM104941-10 (U.S. NIH Grant/Contract)

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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