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Patient-centered approaches to research enrollment decisions in acute cardiovascular disease
Investigator (PI): Dickert, Neal
Performing Organization (PO): (Current): Emory University, School of Medicine, Department of Medicine, Division of Cardiology / (404) 727-8147
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2015
Final Year: 2020
Record Source/Award ID: PCORI/ME-1402-10638
Funding: Total Award Amount: $1,068,196
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: 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 these situations 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. Objectives: Specific aim 1 is to clarify patients' and surrogates' experiences, concerns, and preferences regarding enrollment decisions in acute myocardial infarction (AMI) and stroke research. Specific aim 2 is to develop context-sensitive processes for involvement in decisions about research participation for key types of clinical trials in AMI and stroke. Specific aim 3 is to assess the impact of a novel, patient-centered process for enrollment decisions within a clinical effectiveness trial. Methods: Aim 1: We will interview patients who have been enrolled in heart attack and stroke trials to learn about their experiences and views of consent. Interviews will be over the phone and will involve 300 patients (150 heart attack and 150 stroke). Follow-up interviews will be done when needed. Aim 2: Using what we learn from aim 1, the team will create model approaches to consent for common types of trials in stroke and heart attack. 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 stroke or heart attack. We will involve at least 150 patients and will compare patients' experiences and satisfaction with the new process to 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 respectfully when doing research on treatments for severe, emergent illnesses like heart attack and stroke. Patient and stakeholder engagement: A special patient advisory panel will be set up for this study and will be led by the head of the Emory Patient and Family Advisory Council. The patient advisory panel will include 8-10 patients. This panel will meet at least four times a year and will play a major role throughout the study. They will review results, set priorities, and help create tools for the study. They will be paid as members of the team. Anticipated impact: This project will advance PCORI's aim of conducting research in a patient-driven way. It will inform efforts to figure out the best rules for and approaches to consent in emergent illness, provide examples for researchers around the country, and create tools we can use to study these issues further in the future.
MeSH Terms:
  • Cardiovascular Diseases /*therapy
  • Clinical Trials as Topic
  • Georgia
  • Humans
  • Myocardial Infarction /*therapy
  • Outcome Assessment, Health Care
  • * Patient Participation
  • * Patient Selection
  • Patient-Centered Care /*organization & administration
  • Program Development
  • Stroke /therapy
  • United States
  • Universities
Country: United States
State: Georgia
Zip Code: 30322
UI: 20152290
Project Status: Completed
Record History: ('2019: Project extended to 2020\n2018: Project extended to 2019\n2017: Project extended to 2018',)