Improving health outcomes for families facing congenital heart disease

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

This study tests whether a new online tool that helps parents make decisions about their baby's heart treatment can reduce stress compared to families who don't have this support.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 215 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Utah (other)
• Locations: 2 sites (Salt Lake City, Utah and 1 other locations)
• Trial ID: NCT04437069 on ClinicalTrials.gov

What this trial studies

This clinical trial involves parents of fetuses or neonates diagnosed with life-threatening congenital heart disease (CHD) who will be randomly assigned to receive either a web-based decision aid alone or a decision aid that includes a values clarification exercise. The study aims to enhance shared decision-making between parents and healthcare providers by providing accurate information and clarifying values related to treatment options. Additionally, a control group of families facing similar decisions without a decision aid will be observed for comparison. The primary outcome measure will assess global distress three months post-birth or after a decision regarding care is made.

Who should consider this trial

Good fit: Ideal candidates for this study are parents of fetuses or neonates diagnosed with specific life-threatening congenital heart diseases.

Not a fit: Patients whose fetuses or neonates have other types of congenital heart disease not specified in the study will not benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could significantly improve the decision-making process and emotional well-being of families dealing with life-threatening congenital heart conditions.

How similar studies have performed: Previous studies have shown that decision aids can effectively improve shared decision-making, although the specific use of values clarification exercises in this context is less tested.

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

Where this trial is running

Salt Lake City, Utah and 1 other locations

• Primary Children's Hospital Fetal and Pediatric Cardiology Clinics or Cardiac or Neonatal Intensive Care Units — Salt Lake City, Utah, United States (RECRUITING)
• University of Utah — Salt Lake City, Utah, United States (RECRUITING)

Study contacts

• Principal investigator: Angela Fagerlin, PhD — University of Utah
• Study coordinator: Kirstin Beck, BS

Conditions: Patient Decision Aids, Congenital Heart Disease, Congenital Heart Defect, values clarification exercise, shared decision making, patient education, patient decision aids, congenital heart disease