Bioethics and Cardiology
his research group is led by Dr. Neal Dickert and conducts research focused on ethical issues relevant to cardiology practice and clinical research. In the area of research ethics, this group has conducted projects related to clinical research in acute care, recruitment for clinical trials, and the ethical aspects of study design. This group also conducts research related to shared decision-making in clinical cardiology.
Current Projects
Patient-Centered Approaches to Research Enrollment Decisions in Acute Cardiovascular Disease (P-CARE)
Principal Investigator- Neal Dickert, MD, PhD
Funder- The Patient-Centered Outcomes Research Institute Project Number ME-1402-10638
This project is designed to develop patient-centered approaches to consent for clinical trials testing treatments for severe, emergent illnesses like heart attack and stroke. These conditions are serious, stressful, and frightening and require immediate treatment. Studies have suggested that patients and decision-makers find it hard to understand research decisions in these situations but usually want to be asked permission before being enrolled. The P-CARE Study is developing a patient-centered approach to decisions about enrollment in clinical trials during conditions like heart attack and stroke. The study involves:
• Aim 1- Interviewing patients and decision makers for patients who were enrolled in heart attack or stroke trials to learn about their experiences and views of consent.
• Aim 2- Working with a panel of patients to develop patient-centered, patient-driven approaches to consent for key types of heart attack and stroke trials.
• Aim 3- Implementing a patient-centered consent process/form (from Aim 2) into an actual trial and studying patients’ and researchers’ experiences using it.
A special patient advisory panel was formed for this study. They have worked as part of the P-CARE team to develop consent processes (including consent forms) that reflect what is most important to patients and family members who are asked to be in acute stroke and heart attack research studies. Other patients, Institutional Review Board members, researchers, and ethicists have provided comments and feedback on the simplified, focused consent forms the panel has developed. Below are examples of patient-centered forms developed by the panel. These forms were not used in the actual clinical trials, and the trial and study device and/or medication names have been changed.
• Example 1 (Procedural Intervention versus Medical Therapy)- A study of catheter-based treatment versus standard medical therapy for patients with late-presenting stroke.
• Example 2 (Procedural Intervention versus Medical Therapy)- A study of early use of a balloon pump versus standard medical therapy in patients with large heart attacks.
• Example 3 (Single Arm Device) - A study of a new tool to remove blood clots from the brain in patients with stroke.
• Example 4 (Comparison of Two Routes of Administration of Medication) - A study of whole versus crushed antiplatelet medication tablets in heart attack.
• Example 5 (Comparison of Two Medical Strategies) - A study comparing aggressive versus more permissive blood sugar control in patients with stroke.
• Example 6 (New Medicine versus Standard Medication)- A study comparing a new IV medicine versus standard oral medicine in patients with heart attack.