Status:
RECRUITING
Improving Patient and Family Health Using Family-Centered Outcomes and Shared Decision-Making
Lead Sponsor:
University of Utah
Collaborating Sponsors:
American Heart Association
Conditions:
Patient Decision Aids
Congenital Heart Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is a randomized clinical trial where participants (parents of a fetus or neonate diagnosed with a life-threatening congenital heart disease (CHD)) will randomly be assigned to either receiv...
Detailed Description
The diagnosis of a life-threatening pediatric heart condition impacts both the future of a child and the health and quality of life of the family. Parents of a child with this diagnosis are faced with...
Eligibility Criteria
Inclusion
- Parents whose fetus/neonate was diagnosed with a life-threatening CHD that meets eligibility criteria below without restriction based on gender, race, age, or socioeconomic status.
- We will request participation from both parents but will not disqualify families if only one parent participates.
- Eligibility Criteria: Parents whose fetus/neonate was diagnosed with a life-threatening CHD that are offered the choice between intervention and comfort care (and in some cases termination). This is limited to the following diagnoses: Truncus Arteriosus, Pulmonary Atresia with Intact Ventricular Septum, Complex Single Ventricle, Complex Single Ventricle with Heterotaxy, Hypoplastic Left Heart Syndrome (HLHS), and Ebstein's Anomaly of the Tricuspid Valve.
Exclusion
- Patients with other types of CHD that are not listed above are not eligible.
- Participants must be 18 years of age or older
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT04437069
Start Date
October 1 2020
End Date
June 30 2025
Last Update
January 24 2024
Active Locations (2)
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1
Primary Children's Hospital Fetal and Pediatric Cardiology Clinics or Cardiac or Neonatal Intensive Care Units
Salt Lake City, Utah, United States, 84108
2
University of Utah
Salt Lake City, Utah, United States, 84108