NCT04437069

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 receiving a web-based decision aid (DA) alone, or receiving the decision aid that includes a values clarification exercise. Because of the novel use of decision aids in CHD in an acute setting, we will also compare participants receiving the DA in a randomized control trial to a prospective observational population of families faced with similar decisions without a DA (control group). We have designated the Brief Symptom Inventory Global Severity Index of Global Distress 3 months post-birth or death/termination as our primary outcome measure.

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 the stress of comprehending extensive information about the diagnosis and treatment options, and are required to make immediate and profound choices about interventions that will have long-lasting repercussions. To provide the best care at this challenging time, it is crucial to find methods to improve parent-provider shared decision making (SDM) and to encourage the inclusion of both patient-centered and family-centered outcomes. One method commonly used to improve SDM are decision aids (DA). DAs are designed to 1) provide accurate and balanced information; 2) clarify patients' values; and 3) improve SDM skills. A Cochrane review showed that DAs contribute to effective SDM by: 1) increasing knowledge of the diagnosis and treatment options, 2) increasing patient and practitioner participation in SDM, 3) reducing uncertainty and decisional conflict, 4) improving concordance between preference and treatment received, and 5) improving patient-provider communication. Values clarification exercises (VCE) are occasionally included in DAs to help patients clarify their values about the treatment decision. Although these exercises are often used, they are poorly tested. Previous systematic reviews have failed to identify rigorous research studies to answer questions regarding whether VCE improves patient decision making processes. This project aims to determine the impact of the DA with and without the VCE on longitudinal parent mental health, decision quality and perceptions of patient-provider communication. Specifically, we will test the impact of decision aids (DA vs. no DA, and DA with and without the VCE) on mental health outcomes (e.g., anxiety, complicated grief), decision quality (e.g., quality of the decision, parent-provider communication), and provider experience (e.g., satisfaction with interacting with patients who used the tool). In the development of the DA and VCE, we conducted focus groups and interviews in Utah, Illinois, Washington, D.C, and North Carolina with parents whose fetus/neonate had been diagnosed with complex CHD. The main goal of this study is to determine the impact of the DA with and without the VCE on longitudinal parent mental health, decision quality and provider experience.

Conditions

• Patient Decision Aids
• Congenital Heart Disease
• Congenital Heart Defect

Interventions

Type	Name	Description
OTHER	Decision Aid	Participants will view a Decision Aid (delivered as an app) that provides them with information regarding congenital heart disease, as described in the literature. The DA is tailored to the specific diagnosis of the fetus/neonate, so that participants are only viewing information about their baby's specific CHD diagnosis (and not other types of CHD). This is shown using videos and diagrams to clearly explain the defect, what their treatment options are (surgical intervention, comfort care, or termination), and personal stories from other parents who have dealt with the same diagnosis before (including both positive and negative outcomes). The DA was developed according to the International Patient Decision Aid Standards (see http://ipdas.ohri.ca/) (IRS# 14-13332).
OTHER	Values Clarification Exercise	The Values Clarification Exercise is a process that aids patients in clarifying their values and goals to improve alignment of their preferences with their chosen treatment. It was developed according to the International Patient Decision Aid Standards. It includes ten values that were chosen based on feedback from the parent investigators and clinicians. The ten values are: 1) discomfort to the child, 2) time in the hospital, 3) risk that the child will have impairments, 4) need to provide home medical care, 5) chronic medical care/decisions, 6) financial issues, 7) life in adulthood, 8) impact on the family, 9) beliefs about doing everything medically possible, \& 10) life expectancy. Each value has a sliding scale where the user can compare 2 treatment options at a time. They are asked which described situation feels better for them and their family.

Timeline

• Start date: 2020-10-01
• Primary completion: 2025-11-30
• Completion: 2026-07-30
• First posted: 2020-06-18
• Last updated: 2026-02-12

Locations

2 sites across 1 country: United States