Congenital Heart Disease Clinical Trial
Official title:
Improving Patient and Family Health Using Family-Centered Outcomes and Shared Decision-Making
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Recruiting |
NCT04992793 -
Paediatric Brain Injury Following Cardiac Interventions
|
||
Recruiting |
NCT05213598 -
Fontan Associated Liver Disease and the Evaluation of Biomarkers for Disease Severity Assessment
|
||
Completed |
NCT04136379 -
Comparison of Home and Standard Clinic Monitoring of INR in Patients With CHD
|
||
Completed |
NCT04814888 -
3D Airway Model for Pediatric Patients
|
||
Recruiting |
NCT04920643 -
High-exchange ULTrafiltration to Enhance Recovery After Pediatric Cardiac Surgery
|
N/A | |
Completed |
NCT05934578 -
Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training
|
N/A | |
Recruiting |
NCT06041685 -
Effect of Local Warming for Arterial Catheterization in Pediatric Anesthesia
|
N/A | |
Recruiting |
NCT05902013 -
Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation
|
N/A | |
Not yet recruiting |
NCT05687292 -
Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery
|
||
Not yet recruiting |
NCT05524324 -
Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT
|
N/A | |
Completed |
NCT02746029 -
Cardiac Murmurs in Children: Predictive Value of Cardiac Markers
|
||
Completed |
NCT03119090 -
Fontan Imaging Biomarkers (FIB) Study
|
||
Completed |
NCT02537392 -
Multi-micronutrient Supplementation During Peri-conception and Congenital Heart Disease
|
N/A | |
Recruiting |
NCT02258724 -
Swiss National Registry of Grown up Congenital Heart Disease Patients
|
||
Completed |
NCT01966237 -
Milrinone Pharmacokinetics and Acute Kidney Injury
|
||
Terminated |
NCT02046135 -
Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery
|
Phase 2 | |
Recruiting |
NCT01184404 -
Bosentan Improves Clinical Outcome of Adults With Congenital Heart Disease or Mitral Valve Lesions Who Undergo CArdiac Surgery
|
N/A | |
Completed |
NCT01548950 -
Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension
|
N/A | |
Completed |
NCT01821287 -
Nutritional Failure in Infants With Single Ventricle Congenital Heart Disease
|
N/A |