Patients Retain Little From Cath Lab Informed-Consent Conversations

A new study is calling into question the value of the informed-consent process for patients undergoing cardiac catheterization: investigators say the vast majority of patients, when questioned after their procedures, are unable to recount the risks and benefits associated with transradial and transfemoral approaches.

Still, nearly all patients in the study reported being satisfied with their level of involvement in the shared decision-making process. Taken together, the findings suggest there is a gulf between the patient’s understanding of the procedure and his or her perceived level of involvement and satisfaction.

“We found that despite us doing informed consent, and telling the patients about their options, very little was retained from the consent process,” said senior investigator Mladen Vidovich, MD (University of Illinois, Chicago). “They remembered very little, but were they happy with the treatment? Absolutely,” he added. “So there is clearly a disconnect.”

Talya Miron-Shatz, PhD (Ono Academic College, Israel), one of the study’s co-authors, said its purpose was to determine what patients wanted in terms of vascular access and if they knew what was happening during the procedure. She noted that informed consent is a legal process and that a lot of information is presented to a patient who might be quite anxious or nervous.

They remembered very little, but were they happy with the treatment? Absolutely. Mladen Vidovich

“We don’t know if they understand the medical jargon,” she told TCTMD. “If we’re up for a medical procedure, half of our brain could be taken up with fear and anxiety. . . . I’m sure everybody in this study did the best job they could [during the informed consent process], but maybe there’s something in this process geared [more] toward obtaining legal consent than it is toward achieving comprehension.”

Deferring to the Doc

To TCTMD, Vidovich said medicine is shifting toward a patient-centered model where the physician presents the risks and benefits of different treatments so that the patient, with his or her own preferences and goals, can be part of the decision-making process.

“I wanted to know as an interventionalist how people choose and how much they know,” said Vidovich.

The study, which was published April 23, 2019, in the American Journal of Cardiology, was performed at a large tertiary academic medical center where interventional cardiologists default to transradial access for cardiac catheterization. In total, 100 patients referred for cardiac catheterization completed an open-ended questionnaire that was designed to assess their knowledge of the procedure and the risks and benefits of transradial and transfemoral access.

Overall, 99% of patients knew the name of the procedure and 84% of patients correctly described the purpose of the catheterization. In total, 82% of patients were treated via the radial artery. While transradial access was the preferred approach for 43% of patients, 8% preferred transfemoral access, and the remainder deferred to the physician or had no preference.

“Patients really let us decide what we should do, which was then radial because we’re a 90% radial-first center,” said Vidovich.

Understanding the Risks and Benefits

Patient knowledge about the risks and benefits of transradial and transfemoral access was low, with more than 80% unable to recall the procedure risks for either access site that had been explained to them when they gave their informed consent. One-third accurately described the benefits of the procedure they underwent, and 11% accurately listed the benefits of the alternative procedure. Only 15% accurately described the risks of their own procedure and 19% correctly identified the risks of the alternative access site.

“It was a little bit disappointing for me that the recollection was very, very poor,” said Vidovich.

Despite this, 96% of patients said they were satisfied with their level of involvement in the decision-making process, with college-educated and non-college-educated patients feeling equally involved. On a scale of 1 to 10, with 10 representing maximal physician-patient collaboration, patients reported an average score of 8.3.  

Herbert Aronow, MD (Lifespan Cardiovascular Institute, Providence, RI), who was not involved in the study, said he wasn’t surprised by how difficult it was for patients to retain information about the risks and benefits of cardiac catheterization. “No matter how well trained we are in ‘lay speak,’ we are often having these conversations at a time that can be overwhelming for patients and their support systems,” he said. “As a consequence, they may not understand or retain all the relevant details.”

Aronow believes the lack of retention is more likely attributable to the “emotionally-charged nature” of the conversation rather than the subject matter. “If we are good at explaining complex topics to patients—and we must be in order to excel as physicians—their health literacy shouldn’t be an obstacle. We can test patient understanding by asking them to ‘teach back,’ or explain the procedure to us. Similarly, we can facilitate retention of this material by allowing them sufficient time to digest the material before signing the contract,” he explained.

Involvement Strengthens Patient-Doctor Relationship

Miron-Shatz said patient involvement varies across the spectrum, with some patients wanting to be involved in selecting their treatment while others are content with a short conversation where the physician simply explains what he or she is about to do. That preference is completely subjective, and there is no value judgment attached to the patient’s wish to know very little or a lot, she said. 

Even in emergent situations, where physicians have limited choice as to what they plan to do, inclusion in the process is still very important to patients, said Miron-Shatz. With access for cardiac catheterization, it could be argued that while the physician could simply choose the best approach based on his/her assessment of the risks and benefits; the thinking is that patients involved in the decision-making process have an active role in their health, which can translate into better adherence to medications and lifestyle changes, said Miron-Shatz.

For Vidovich, increased knowledge is helpful since it strengthens the relationship between physician and patient. Like Miron-Shatz, Vidovich noted that a well-informed patient tends to be more compliant with medical therapy, changes to lifestyle, and follow-up with subsequent appointments.

For Aronow, though, while it’s important to determine if a patient has a strong preference for one vascular access site versus another, that decision probably doesn’t need to be routinely included in the consent process. “The operator should explain to the patient that there are multiple potential vascular access sites that may be utilized and that he or she will typically use whichever maximizes the safety and effectiveness of the procedure,” he said.