Patient-Centered Approaches to Research Enrollment Decisions in Acute Cardiovascular Disease [Methods Study], United States, 2014-2019 (ICPSR 39584)
Version Date: Nov 20, 2025 View help for published
Principal Investigator(s): View help for Principal Investigator(s)
Neal W. Dickert, Emory University
https://doi.org/10.3886/ICPSR39584.v1
Version V1
Summary View help for Summary
Some research studies, called clinical trials, test treatments to see if they are safe and effective for patients. Before patients enroll in a trial, researchers ask patients for informed consent. In informed consent, a doctor or researcher explains what the trial is about and the benefits and risks of taking part. Patients then choose whether to enroll in the trial. If a patient is too sick to decide, a surrogate, such as a family member or friend, can decide on the patient's behalf.
Trials that test treatments in health emergencies, such as heart attack or stroke, may need a different informed consent process. Emergency situations can be stressful, and patients may have little time to learn about the trial.
In this study, the research team worked with patients and surrogates who had experience with informed consent for trials in health emergencies. They created a new informed consent process to use for trials about stroke and heart attack.
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Study Purpose View help for Study Purpose
To develop informed consent processes for clinical trials that meet patients' and surrogates' needs and expectations in emergency settings
Study Design View help for Study Design
In this study, researchers assessed patients' and surrogates' experiences enrolling in clinical trials for stroke and AMI. Researchers then partnered with patients to develop new informed consent processes for such trials.
In phase 1, researchers conducted structured phone interviews with 176 patients or their surrogates about their experience enrolling in a clinical trial between 2011 and 2016, while experiencing stroke or AMI. Of these participants, 64% were white, 26% were black, and 5% were Asian. The average age was 59, and 57% were male; 48% had enrolled in a stroke trial and 52% had enrolled in an AMI trial. A subset of 27 participants also completed in-depth key informant interviews. Researchers undertook descriptive and multivariate analyses of structured interviews and qualitative analyses of in-depth interviews.
In phase 2, researchers worked with a patient advisory panel to develop informed consent processes for six different clinical trials based on interview findings. A focus group of five phase 1 participants, additional patient advisors, research ethics experts, and experts in conducting and regulating clinical trials provided input. The team implemented one informed consent process in an ongoing trial for hemorrhagic stroke."
Universe View help for Universe
Patients and surrogates with stroke and acute myocardial infarction (AMI)
Data Source View help for Data Source
Structured interviews, in-depth interviews, and a focus group with patients and surrogates; patient advisory panel feedback
Notes
The public-use data files in this collection are available for access by the general public. Access does not require affiliation with an ICPSR member institution.
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This study is maintained and distributed by the Patient-Centered Outcomes Data Repository (PCODR). PCODR is the official data repository of the Patient-Centered Outcomes Research Initiative (PCORI).