improving patient and family health using family-centered outcomes and shared decision-making

Conditions: Patient Decision Aids; Congenital Heart Disease; Congenital Heart Defect

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.

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.

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

Keywords: values clarification exercise shared decision making patient education patient decision aids congenital heart disease congenital heart defect