Bundling consent in the ICU

Residents frequently use these bundles but report doubts about their validity.

Requesting consent for multiple procedures on a single form at ICU admission can improve efficiency for clinicians, patients, and families. But while the idea of bundling informed consent for multiple commonly performed procedures has existed for decades, it still poses problems.

“Informed consent, as much as it's a very routine part of what we do in all fields of medicine, is a very complicated process and conversation,” said Asha Anandaiah, MD. “When you take that and expand it to obtaining consent for a number of procedures in an asynchronous fashion from when they may actually be necessary, I think that complexity increases in a multifold fashion.”

She led a recent survey study of 90 U.S. pulmonary and critical care fellowship programs, which assessed the prevalence of bundled informed consent in academic ICUs, as well as how the practice is perceived by intensivists. About 31% of respondents reported using bundled informed consent in their primary academic ICU, according to results published online on Aug. 18 by CHEST. This prevalence is about double the 15% found in a separate study of 100 academic and nonacademic medical/surgical ICUs in the United States, published in May by the American Journal of Critical Care.

In the CHEST study, about one-third (32%) of institutions bundled four procedures or fewer, slightly more than half (55%) bundled five to nine procedures, and 14% bundled 10 or more. The most commonly bundled procedures were central venous line placement (100%), arterial line placement (100%), intubation (77%), mechanical ventilation (77%), paracentesis (59%), and thoracentesis (55%).

Residents were the clinicians most often obtaining bundled consent (64%), although most reported no specific training on its use. Among 28 intensivists who used bundled consent, 85% reported either a positive or neutral attitude toward it; however, only 27% reported confidence that the approach resulted in valid informed consent for each procedure.

Photo courtesy of Dr Anandaiah
Photo courtesy of Dr. Anandaiah

Dr. Anandaiah, program director of the pulmonary and critical care fellowship at Massachusetts General Hospital and Beth Israel Deaconess Medical Center in Boston, spoke with ACP Hospitalist about the findings and their potential implications.

Q: What led you to study this issue?

A: The idea of bundled informed consent … came into the ICU literature in the early 2000s. There was a paper published [in 2003] out of the University of Chicago in JAMA that looked at implementation of a bundled consent process in the ICU there, primarily to address the overall low rates of documented consent for ICU procedures, which tends to happen as a result of the volume and urgency of procedures. And although they showed positive outcomes with that implementation, I think it was unclear over time how much uptake there really was. The hospital where I work clinically in the ICU, Beth Israel Deaconess Medical Center, was an early adopter of bundled consent. It's been in place for … at least a decade, if not more. And in my own practice, I had the opportunity to observe residents attempting to have these bundled consent conversations, and then wondered about benefits versus tradeoffs of that approach. In discussing the issue with both my coauthor of this study and other colleagues around the country, there was an impression that bundled consent in the ICU had increased in prevalence, but there had been no recent literature on the topic. … We thought it was worth, at least for starters, surveying ICUs around the country to see if indeed that was the case … [and] to begin to examine that process and think about how it was perceived and what potential benefits or tradeoffs there may be.

Q: What was your reaction to the findings?

A: It was surprising that one, the prevalence is as high as it is, because it hasn't been really discussed much within the community, in the literature. So it feels as though it's snuck its way into our practice, perhaps, without really being examined. And secondly, I thought it was interesting that there were fairly consistent responses around the perceptions. … Pretty consistently across users and nonusers, bundled consent was rated to be better than individual consent with respect to efficiency and easing burden on patients' families, but was rated lower on the topics of legal validity and ethical appropriateness.

I had done one other study [published in the October 2019 Critical Care Medicine] related to this topic, which involved surveying the residents at Beth Israel Deaconess, … early adopters of bundled consent. So there was an institutional, lived experienced among housestaff with doing it. And we interestingly found similar results with respect to low rates of residents feeling confident that they had obtained valid informed consent. The summary of that study was that the residents were split on whether they generally liked it or not, so some liked it and some didn't, but most—[about] 75%—didn't feel they obtained valid consent through that process. So this study built on that a little bit by surveying experienced intensivists who seemed to share similar perceptions around tradeoffs.

Q: How do you see the balance between those benefits and risks?

A: My impression is the motivation to implement bundled content processes lay in wanting to improve the rates of documented informed consent for ICU procedures, which had historically been perhaps lower than it should have been. The idea [that] at the time of admission to the ICU, asking for consent for a bunch of common bedside ICU procedures would improve the rate of documented informed consent … made common sense. And I think the survey results suggest that, indeed, people think that it does improve efficiency. In addition, there's the issue of the burden on patients and families: They have to be contacted every time there's a new procedure, sometimes in the middle of night, if it hasn't been previously obtained. So both for providers and for patients, and for families in particular, there seems to be a sense of overall improving the expediency and efficiency of the consent process.

The flip side is those issues around legal validity and ethical appropriateness. Now, we didn't define those terms in any way for the survey respondents, so they were just responding to those terms as they interpreted them. But I think perhaps what the lower ratings for legal validity suggest is that it's a challenge to really go through all of the elements of informed consent for multiple procedures in a single conversation, perhaps reflecting concerns that it's not done as comprehensively. Similarly, the ethical appropriateness of consenting for procedures outside the time that they're actually necessary limits the ability to really discuss in detail risks and benefits as they pertain to that particular patient at that particular time.

Q: The study also found that 85% of residents reported receiving no specific training on its use. Did that concern you?

A: Yes. I think that jived a little bit with what I was seeing in my own practice. There's a lot of controversy and lack of clarity on what constitutes informed consent, and then you have relatively inexperienced clinicians having those complex conversations. … In general, we probably could do better with overall training about informed consent conversations, because I think there's more there to consider than perhaps the routine nature implies. But then certainly, when we do something as complex as bundling consent in a critical care setting in particular, when patients are acutely ill and the stakes might feel particularly high, that's definitely a place where we can improve if we are going to move towards bundled consent more and more.

Q: Is this practice more common in academic versus community hospitals?

A: I don't think we know for sure, but the prevalence of 31% that we found is higher than two recently published studies that looked across different types of hospitals. One study of a random sample of hospitals across the nation [published in May by the American Journal of Critical Care] found a 15% prevalence of bundled consent use. Another study [in the October 2016 Intensive Care Medicine] that looked across ICUs in a single state documented a 19% prevalence in the state of Pennsylvania. So there's been a little bit out there looking more broadly, but it's hard to say with certainty.

Q: What are the main takeaway points of this study for hospitalists?

A: I don't know to what extent bundled consent has been considered or if it's been used outside of ICUs, but in many places, hospitalists work in the ICUs where this might be occurring. Overall, the study really just highlights the complexities of informed consent and that we may have competing goals with our informed consent process. So for those who are using or perhaps considering bundled consent—which I think is potentially occurring more in the current era of COVID and changes in processes that are geared towards efficiency and accommodating limited contact with families and surrogates—I think it's important to be aware [that] while there are benefits, many of which are practical, there may be important tradeoffs around the quality of communication, which I think is ultimately what the concerns about legality and ethical appropriateness speak to.

Q: Looking forward, how might the concerns regarding use of bundled informed consent be addressed?

A: I think it's really interesting that nearly a third of (at least academic) medical ICUs are using this process, and perhaps even more now with COVID. This was a very limited study in scope, and I think it raises the idea that if this is a practice that is evolving and increasing in our overall academic medical ICU practice, it's something that is worth examining further. And I think the survey responses around the issues of validity and ethical appropriateness certainly raise questions that should be further explored.