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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Patient Decision Aids, Congenital Heart Disease, Congenital Heart Defect

Intervention / Treatment
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* Other: Decision Aid
* Other: Values Clarification Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Parents randomized using simple randomization into two conditions: one group receives the patient decision aid, and one group receives the patient decision aid and the values clarification exercise. There is no stratified randomization. There are 4 survey time points: 1) Baseline, 2) Post-Viewing of the Decision Aid (or Decision Aid and Values Clarification Exercise), 3) Post-Decision, and 4) Three Months Post-Decision.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care (Control)<br>Participants will receive standard care and will not view either the Decision Aid or the Values Clarification Exercise | |
| Experimental: Decision Aid<br>Participants view the Decision Aid only | Other: Decision Aid<br>* 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).<br>|
| Experimental: Decision Aid & Values Clarification Exercise<br>Participants view both the Decision Aid and the Values Clarification Exercise | Other: Decision Aid<br>* 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).<br>Other: Values Clarification Exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Brief Symptom Inventory (BSI) Global Severity Index of Global Distress | 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. | 1 week post baseline & 3 months post-decision | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decision Quality - Values | 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. | 1 week Post-Decision Aid, 1 month post-decision, & 3 months post-decision | 
| Decision Quality - Knowledge | 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. | 1 week Post-Decision Aid, 1 month post-decision, & 3 months post-decision | 
| Perinatal Grief | 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. | 1 week Post-Decision Aid, 1 month post-decision, & 3 months post-decision | 
| Brief Symptom Inventory (BSI) Global Severity Index of Global Distress | 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. | 1 week Post-Decision Aid, 1 month post-decision | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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values clarification exercise, shared decision making, patient education, patient decision aids, congenital heart disease, congenital heart defect