Results Summary
What was the project about?
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.
What did the research team do?
The study had two parts. In part one, 176 patients and surrogates took a survey about their experience enrolling in a trial; 48 percent had enrolled in a stroke trial and 52 percent in a heart attack trial. Of these, 64 percent were white, 26 percent were black, and 5 percent were Asian. The average age was 59, and 57 percent were men. The team also interviewed 27 patients and surrogates in depth, to learn more about their experiences.
In part two, the research team created the new process for getting informed consent. A group of five patients from part one, a patient panel, research ethics experts, and trial experts provided feedback.
What were the results?
Most patients taking the survey reported feeling respected during their informed consent process. But patients and surrogates had trouble recalling details about the trial they took part in. For example, 19 percent of patients in stroke trials and 44 percent of patients in heart attack trials didn’t recall any trial details.
Interviews showed that the informed consent process should
- Avoid pressuring people to take part in the trial
- Clearly describe the trial’s benefits and risks and what to expect
- Communicate with people after they enroll in the trial
The new informed consent process included
- Shorter consent forms with focused information about the trial, including risks and benefits that were important to patients
- Information sheets that people could look at during the trial
- A chance for people to ask questions about the trial after they enroll
What were the limits of the project?
On average, people took the survey about past experiences two years after their trial, which may have led to trouble recalling details. The research team and the advisory board creating the new process may not represent the backgrounds of all patients who have health emergencies.
Future studies could test the new informed consent process in clinical trials about emergency care.
How can people use the results?
Researchers can use the results when planning ways to get informed consent from patients enrolling in trials during health emergencies.
Professional Abstract
Background
Informed consent allows patients or their surrogates to decide whether to participate in clinical trials. However, standard informed consent processes are often ill-suited for medical emergencies, such as a stroke or acute myocardial infarction (AMI), when decisions about trial participation must be made quickly.
Objective
To develop informed consent processes for clinical trials that meet patients’ and surrogates’ needs and expectations in emergency settings
Study Design
| Design Element | Description |
|---|---|
| Design | Mixed-methods study |
| Data Sources and Data Sets | Structured interviews, in-depth interviews, and a focus group with patients and surrogates; patient advisory panel feedback |
| Analytic Approach |
|
| Outcomes | An informed consent process for clinical trials in emergency settings |
Methods
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.
Results
Most participants in the structured interviews reported feeling respected during the informed consent process. However, participant recall about the clinical trial informed consent process was low. For example, 19% of enrollees in stroke trials and 44% of enrollees in AMI trials did not remember study details.
In-depth interviews identified elements of the consent process important to patients’ and surrogates’ experience. These areas included having researcher-participant interactions without pressure to enroll in a trial; clear presentation of benefits, risks, and expectations for trial participation; and communication with participants after enrollment.
The new consent process used shorter, three- or four-page consent forms. Other modifications included removing generic information that was not specific to the study and focusing on meaningful risks and benefits. To improve communication after enrollment, the process also included an opportunity to ask questions and provided information sheets that patients or surrogates could reference during the trial.
Limitations
On average, people completed phase 1 interviews two years after trial participation, which may have contributed to low recall. For phase 2, the researchers and advisory panel who developed the new consent process may not have reflected the backgrounds and perspectives of all patients experiencing medical emergencies.
Conclusions and Relevance
The study developed a new informed consent process for enrolling patients in clinical trials in emergency situations.
Future Research Needs
Future research could evaluate the new consent process in trials with a diverse sample of patients receiving emergency care
Final Research Report
View this project's final research report.
Journal Citations
Related Journal Citations
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers suggested that participants’ perception of regret about enrolling in a research study may be hard to distinguish from potential regret or conflict related to the treatment they receive. The researchers added a sentence about this to the limitations section but also commented that in most of the trials examined, treatment was begun almost immediately after enrollment. Therefore, there was really a single decision made rather than two separate ones.
- The reviewers expressed concern that the report did not contain the results of aim 3 interviews. The report instead stated that the interviews at the end of the study did not reflect exposure to the novel consent process and were similar to interviews conducted in aim 1. Reviewers noted that the aim 3 interviews took place after participants may have undergone surgery, which could be an important factor in understanding the informed consent process. The researchers acquiesced to this concern and clarified in the report what themes overlapped between the aim 1 and aim 3 interviews, and the little new information obtained from the latter.
- The reviewers asked how the results of this study could translate to the real world of clinical trial research, since most researchers conducting such trials would not have the resources to develop a highly trained and motivated patient advisory panel to develop their informed consent process. The researchers agreed that this could be a problem and added language to their discussion section suggesting that institutions could create such panels as a resource for several projects.
- The reviewers suggested that the study would have been improved by the addition of non-English-speaking participants. The researchers acknowledged the lack of non-English speakers as a limitation of the study but explained that they had not been able to conduct or analyze the long and highly interactive interviews in other languages. The researchers added that a Spanish-language version of the survey is being used in a follow-up study.