Background: Heart attack and stroke affect over 1.5 million US patients annually. These conditions are serious, stressful, and frightening and require immediate treatment. Clinical trials can lead to improvements in care. However, we generally ask patients for their consent to be in research studies, and situations requiring immediate care make informed consent very difficult. Studies have suggested that patients find it hard to understand research decisions in these situations but often appreciate being asked permission to be enrolled. This project will develop a patient-centered approach to decisions about enrollment in clinical trials during conditions like heart attack and stroke.
- Aim 1: Clarify patients’ and surrogates’ experiences, concerns, and preferences regarding enrollment decisions in heart attack and stroke research.
- Aim 2: Develop context-sensitive processes for involvement in decisions about research participation for key types of clinical trials in heart attack and stroke.
- Aim 3: Assess the impact of a novel, patient-centered process for enrollment decisions within a clinical effectiveness trial.
- Aim 1: We will do phone interviews with 300 patients (150 heart attack and 150 stroke) who have been enrolled in heart attack and stroke trials to learn about their experiences and views of consent. Follow-up interviews will be done when needed.
- Aim 2: Using what we learn from Aim 1, we will create model approaches to consent for common types of trials in heart attack and stroke. Patients, patient advocates, and research reviewers will provide feedback on these models, and we will make them publicly available.
- Aim 3: We will study one model process by starting to use it midway through a trial for heart attack or stroke. We will include at least 150 patients and compare patients’ experiences and satisfaction with the new process and with standard consent. We will also ask researchers about the new process.
Patient Outcomes: This project will help researchers know more about how to treat patients with respect when doing research on treatments for severe, emergent illnesses such as heart attack and stroke.
Patient and Stakeholder Engagement: A patient advisory panel consisting of 8–10 patients will be set up for this study and will be led by the head of the Emory Patient and Family Advisory Council. This panel will meet at least four times a year, and panel members will be paid as members of the team. The panel will play a major role throughout the study—reviewing results, setting priorities, and helping to create tools for the study.
Anticipated Impact: This project will advance PCORI’s aim of conducting research in a patient-driven way. It will inform efforts to determine the best rules for and approaches to consent in emergent illness, provide examples for researchers around the country, and develop tools we can use to further study these issues in the future.