Improving Patient and Family Health Using Family-Centered Outcomes and Shared Decision-Making

Launched by UNIVERSITY OF UTAH · Jun 17, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how different decision-making tools can help parents make choices about their newborns or unborn babies diagnosed with serious heart conditions known as congenital heart disease (CHD). Parents will be randomly assigned to one of two groups: one group will use a web-based decision aid on its own, while the other group will use the decision aid along with a tool that helps clarify their personal values and preferences. The goal is to see if these tools can improve the well-being of families facing tough decisions about treatment options or comfort care.

To be eligible for the trial, parents must have a fetus or newborn diagnosed with specific life-threatening CHD conditions, such as Hypoplastic Left Heart Syndrome or Ebstein's Anomaly. Both parents are encouraged to participate, but it is okay if only one does. Participants will be asked to share their experiences and feelings about decision-making three months after the baby is born or, in some cases, after a decision to end the pregnancy. This study aims to provide valuable insights into how families can be better supported during difficult times.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • Patients with other types of CHD that are not listed above are not eligible.
• • Participants must be 18 years of age or older