Improving Patient and Family Health Using Family-Centered Outcomes and Shared Decision-Making
- Conditions
- Congenital Heart DiseaseCongenital Heart DefectPatient Decision Aids
- Interventions
- Other: Decision AidOther: Values Clarification Exercise
- Registration Number
- NCT04437069
- Lead Sponsor
- University of Utah
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 215
- 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.
- Patients with other types of CHD that are not listed above are not eligible.
- Participants must be 18 years of age or older
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Decision Aid & Values Clarification Exercise Decision Aid Participants view both the Decision Aid and the Values Clarification Exercise Decision Aid & Values Clarification Exercise Values Clarification Exercise Participants view both the Decision Aid and the Values Clarification Exercise Decision Aid Decision Aid Participants view the Decision Aid only
- Primary Outcome Measures
Name Time Method Change in the Brief Symptom Inventory (BSI) Global Severity Index of Global Distress 1 week post baseline & 3 months post-decision The BSI is a validated scale of 53 questions that indicate the degree of stress the participant has experienced within the previous seven days. Answers range in a 5 point Likert scale from 0=not at all to 4=extremely. The scale measures stress, so a lower score is better. Scores are obtained for nine primary symptom dimensions and three global indices of distress.
The primary comparison is the baseline measurement versus 3 months post-decision measurement. We are looking at how those measurements changed.
- Secondary Outcome Measures
Name Time Method Decision Quality - Values 1 week Post-Decision Aid, 1 month post-decision, & 3 months post-decision Six question scale that measures the values that the participant makes while choosing medical treatment. Answers range in a 6-point Likert scale from 1=most important to 6=not as important. There is no right or wrong answer; it is up to patient preference, so no answer indicates a "better" than another.
Brief Symptom Inventory (BSI) Global Severity Index of Global Distress 1 week Post-Decision Aid, 1 month post-decision The BSI is a validated scale of 53 questions that indicate the degree of stress the participant has experienced within the previous seven days. Answers range in a 5 point Likert scale from 0=not at all to 4=extremely. The scale measures stress, so a lower score is better. Scores are obtained for nine primary symptom dimensions and three global indices of distress.
Decision Quality - Knowledge 1 week Post-Decision Aid, 1 month post-decision, & 3 months post-decision 27 questions assessing the participant's knowledge of treatment options for CHD. Participants not in the intervention arm will also take this survey for comparison. 21 of the questions use a dichotomous response format (either "true / false" or "yes/no"); 5 questions are multiple choice. All questions are answered with full access to the decision aid (if not in standard care arm) since participants are not meant to test recall. "Better" scores will be measured by how many questions that a participant answers correctly.
Perinatal Grief 1 week Post-Decision Aid, 1 month post-decision, & 3 months post-decision Measured using the Perinatal Grief Scale which measures grief, coping, and despair following the death of a child. This scale was also adapted for a child who did not die. Answers are on a 5-point Likert scale that ranges from 1=strongly agree to 5=strongly disagree. A higher score would indicate less grief, and would therefore be considered "better".
Trial Locations
- Locations (2)
University of Utah
🇺🇸Salt Lake City, Utah, United States
Primary Children's Hospital Fetal and Pediatric Cardiology Clinics or Cardiac or Neonatal Intensive Care Units
🇺🇸Salt Lake City, Utah, United States