Improving Patient and Family Health Using Family-Centered Outcomes and Shared Decision-Making
Overview
- Phase
- N/A
- Intervention
- Standard Care (Control)
- Conditions
- Patient Decision Aids
- Sponsor
- University of Utah
- Enrollment
- 135
- Locations
- 2
- Primary Endpoint
- Change in the Brief Symptom Inventory (BSI) Global Severity Index of Global Distress
- Status
- Active, Not Recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
Angie Fagerlin
Professor & Chair, Department of Population Health Sciences
University of Utah
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
Arms & Interventions
Standard Care (Control)
Participants will receive standard care and will not view either the Decision Aid or the Values Clarification Exercise
Decision Aid
Participants view the Decision Aid only
Intervention: Decision Aid
Decision Aid & Values Clarification Exercise
Participants view both the Decision Aid and the Values Clarification Exercise
Intervention: Decision Aid
Decision Aid & Values Clarification Exercise
Participants view both the Decision Aid and the Values Clarification Exercise
Intervention: Values Clarification Exercise
Outcomes
Primary Outcomes
Change in the Brief Symptom Inventory (BSI) Global Severity Index of Global Distress
Time Frame: 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 Outcomes
- Decision Quality - Values(1 week Post-Decision Aid, 1 month post-decision, & 3 months post-decision)
- Brief Symptom Inventory (BSI) Global Severity Index of Global Distress(1 week Post-Decision Aid, 1 month post-decision)
- Decision Quality - Knowledge(1 week Post-Decision Aid, 1 month post-decision, & 3 months post-decision)
- Perinatal Grief(1 week Post-Decision Aid, 1 month post-decision, & 3 months post-decision)