When there is a decision to be made regarding whether to treat a stroke patient with tPA, time is limited, and it is a matter of life and death. Yet, there is no standard approach for informed consent for these high-pressure cases.
“As a practicing clinical neurologist, it became clear that the standard ethical principles of obtaining informed consent were more challenging to apply in this time-sensitive, complex situation,” says Ann Murray, MD, a practicing neurologist and assistant professor in the department of neurology at West Virginia University School of Medicine.
Ideally, shared decision-making in informed consent occurs in an outpatient environment or research setting, with ample time, plenty of discussion, and a detailed exploration of the patient’s individual perspective. “In a fast-paced clinical setting, this is just not possible,” Murray laments.
Murray and colleagues examined what patients actually want in the informed consent process. They gave 184 participants a hypothetical situation: to decide whether to provide consent for a family member to receive IV-tPA.1 “We wanted to at least start the conversation on informed consent in the acute care setting,” Murray explains.
Three informed consent models were presented, based on parental qualities, statistical data, and a general consent statement. Respondents were equally likely to give consent with all three approaches. More preferred the parental approach. “Based on our experience in clinical practice, the findings were not surprising,” Murray says.
However, this does challenge the current ethical models for informed consent. “In our experience, when patients or families are faced with emergent, high-stakes decision-making, they do regularly ask what the specific provider would do if it was them,” Murray reports.
This, then turns into a much more “parental” discussion. Patients realize that the issues involved are complex, and it is a high-stakes moment in their lives. “They are truly looking for advice, not just medical facts,” Murray observes. Asking the clinician, “What would you do?” makes it personal. It brings the provider’s own values into the discussion, as well as their expertise.
“It is important to recognize that our results suggest a more nuanced approach to consenting, not a one-size-fits-all,” Murray offers.
The paper suggests that patients view statistical discussion of outcomes and risk as less meaningful. “Despite parental approaches being completely out of favor and regularly discouraged in medical training and practice, there are some medical situations where patients actually prefer it,” Murray says.
This is not to suggest that the provider leave the patient out entirely in decision-making. “But, it recognizes that provider expertise and personal input can, and often should, more significantly impact the decision-making process,” she adds.
When urgent decisions must be made, “you have to be flexible in the models of shared decision-making,” says Joshua Uy, MD, geriatric fellowship program director at Penn Medicine in Philadelphia. Paternalism, agent, collaborative, or consumer models are some options.
In an urgent situation, says Uy, “I probe a little bit about the patient. Once I get the lay of the land, I absolutely make a recommendation by saying what I think might fit them best.”
To learn what he needs to know, Uy asks open-ended questions such as “Tell me a little bit about what you’re worried about, and what you’re hoping for.” He then asks, “Tell me what you would like to know about the treatment.” Next, he uses narratives of theoretical vignettes or actual cases, and offers a recommendation. It is not just factual issues that need to be addressed. “Often, the underlying thing to be addressed is the emotional issues,” Uy notes.
Clinicians should be able to explain outcomes in several ways, such as narrative, numerical, or pictorial. “For patients who can’t make decisions, paternalism can be kindness,” Uy says. “When I walk into an auto mechanic shop or a clothing shop, I just need recommendations. I know very little about fashion or cars.”
REFERENCE
- Murray AM, Petrone AB, Adcock AK. Utilization of a parental approach to informed consent in intravenous tissue plasminogen activator administration decision-making: Patient preference and ethical considerations. Neurol Res Int 2019;9240603. doi: 10.1155/2019/9240603.
When there is a decision to be made regarding whether to treat a stroke patient with tPA, time is limited. Yet, there is no standard approach for informed consent for these high-pressure cases.
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