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Time-limited trials.

We’ve all probably used them before. We meet with patients and families. We agree to either start or continue a particular treatment to see if it helps in some specific way over some defined period of time. If it works as hoped, great, we continue the treatments. If not, we stop them. At least that is how it’s supposed to go.

On today’s podcast we talk all about these time-limited trials with Dong Chang and Ricky Leiter. Dong was the lead author of a JAMA IM article looking at the outcomes of training staff to use time-limited trials as the default communication and care planning approach for critically ill patients in intensive care units. Ricky is the lead author of the accompanying editorial and palliative care physician extraordinaire.

We discussed with Dong and Ricky about the results of the JAMA IM study, which were pretty darn impressive. The intervention resulted in significant reductions in duration of ICU stay (7.4 v 8.7 days), fewer invasive procedures, but no change in mortality, and no change in family satisfaction rating (which was high before and after the intervention). We discuss potential reasons why the intervention worked, some limitations of the study, the role uncertainty plays in decision-making, and so much more (including nudging from our last podcast).

If you want to read more about time-limited trials, check out these articles as well

From the trial, here are the suggested steps to the family meeting with sample language:

Chart showing sample language for family meeting steps

Eric: Welcome to the GeriPal Podcast. This is Eric Widera.

Alex: This is Alex Smith.

Eric: And Alex, who do we have with us today?

Alex: We are delighted to welcome Dong Chang, who is a pulmonary and critical care physician, intensivist and associate professor at Harbor UCLA Medical Center and UCLA Medical School in Los Angeles. Welcome to the GeriPal Podcast, Dong.

Dong: Thank you so much. Thanks for having me.

Alex: And we’re delighted to welcome back Ricky Leiter, who is an attending physician in the Department of Psychosocial Oncology and Palliative Care at the Dana-Farber Cancer Institute and Brigham Women’s Hospital in Boston. Welcome back to the GeriPal Podcast, Ricky.

Ricky: Thanks so much. Great to be back.

Eric: And we’re going to be talking about Time-Limited Trials. Dong just published a paper, not too long, I guess it was an April actually, on Time-Limited Trials in patients with advanced medical illness and who are at risk for non-beneficial ICU treatments, published in JAMA IM. Ricky did an editorial. Was it with James Tulsky?

Ricky: It was.

Eric: Both, fabulous reads. We’re going to be diving deep into that, but before we do, we always ask for a song request. Who has a song request for Alex?

Ricky: I do. Yeah. So given the subject matter and in honor of the late great drummer, Charlie Watts, Alex, if you can play Time Is On My Side by The Rolling Stones.

Alex: Yeah. Great drummer. Did see him in concert once when Rolling Stones did their first reunion tour. Incredible. Yeah, just a gentlemen with sticks. Okay, here we go just a little bit. (Singing).

Eric: That was excellent. And perfectly aligned with the topic at hand today, Time-Limited Trials. I’m going to turn to you first. How did you even get interested in this as a subject?

Dong: Yeah, well, I became the ICU director at Harbor UCLA Medical Center. It was born out of this, seeing a lot of non-beneficial treatments in the ICU for patients that have a lot of advanced illnesses. And, that’s a very complex topic in terms of why this occurs. But one of the things that we certainly recognized was that there was imperfect communication between clinicians and our family members, a lot of misunderstandings about what the ICU treatments would do. And so what we really wanted to create was a quality improvement intervention that really dove down on trying to improve that communication, provide structure on it, and then really discuss patient preferences and values and what a course of ICU care would do in the context of all that. And a time-limited Trial, which is just simply agreements between clinicians and their family members to try certain ICU treatments for a period of time, was a way that we operationalize that idea of trying to improve that communication.

Eric: And Ricky, I feel like Time-Limited Trials, it’s a concept that’s been out there for a while. You’re a palliative care clinician. Do you use them? Do you see them frequently?

Ricky: I do. Yeah. I use them a lot, I would say. One of the things I do clinically is I work on our kidney palliative care service. So, we see a lot of patients whose kidney function isn’t great. They may need dialysis. We’re not sure if it’s going to make them better. And in that situation, we’ll often use Time-Limited Trials, get everyone around the table, us, the nephrologist, oftentimes the critical care docs or the medicine people on the medicine floors and the families and say, “Look, let’s try this for a week and see what happens.” And if they get better great, and if they don’t, then we’ll change course. So, yeah, I think they’re incredibly valuable tool, clinically.

Eric: Yeah. I feel like I’ve used them. And I think the really interesting thing about this quality improvement project that was published in JAMA IM will have link to it on the GeriPal website. It was like a standardized bundle that really pushed for time trials as the default. Why that as potential default, Dong? Why not just like a family meeting intervention that happen to include, like, you can use time trials like a lot of palliative care doctors, at your own whim?

Dong: Yeah. Well, I think one of the reasons that we chose this was that, I certainly don’t have to tell you guys, but we’re less involved in critical care, and we’re far less sophisticated about communication and things like that. And what we wanted to create was some standards. Some approaches that people could… These are really difficult conversations, and we wanted to create some tools and some standards that could really make those conversations a little bit less challenging for ICU physicians. And, we all know that one of the most challenging conversations that we’re going to have in the ICU is, well, I’m really concerned that these invasive treatments, they might not help your loved one or your family member. How do you do that, and how do you create an opportunity for clinicians to really dive into that so that they’re comfortable, but also productive?

Dong: We felt like a Time-Limited Trial was the way to go. It provided structure around those difficult conversations, but it wasn’t just this idea that we’re going to just try this for a period of time. If you dive into our protocol, it really was about creating situations to improve the shared decision-making and have topics that are discussed that really promote that. So, understanding preferences, values really diving down into the risk of all these treatments. So, I think it’s that combination of that.

Eric: We’ve had a lot of people who’ve done a lot of different randomized trials and studies, and there’s always this, like the acceptability of the intervention. And here, when I think about potentially inappropriate or non-beneficial care, is not saying, no, you’re not going to get this thing. It’s like, we’re going to hold on this hope. We’re going to see how things go over the next couple of days, rather than a do or do not kind of approach. It’s this, like, let’s see how much is the time trial also giving critical care doctors and other clinicians making it like a more acceptable intervention, holding onto hope?

Dong: Yeah. Well, I’ll tell you that, as part of our intervention one of the first things that we did was we conducted some focus groups to get the temperature of the ICU physicians, in terms of how they would feel about this, and also clear up any miscommunications about what a Time-Limited Trial was. That was really, really enlightening for me, because the first focus group we had was actually at my own institution at Harbor UCLA Medical Center. And we would talk with our… Now, remember, these are people that I’ve worked with everyday and know very well and their initial reaction was, “Are you crazy?” Because they thought when it was a Time-limited Trial, at the end of that trial, we would be basically telling families we’re going to stop ICU care.

Dong: And they were so uncomfortable with the terminology and that idea. I was actually confused. I was like, “Why is everyone looking at me like I have just lost it? And it was just clearing up that semantics and actually describing exactly what you said, Eric, this is an opportunity to refine prognosis and actually offer some hope and do the things that we want to do, but maybe set some rational limits around it. And once we did that, the room lightened up, everyone understood what we’re trying to accomplish. And it was relatively smoother after that, but it is really about what you’re describing.

Alex: And the key point there is that at the end of the Time-Limited Trial, what do you do? You go back to… You don’t say, well, it’s over, it didn’t work. It didn’t meet the endpoint. We’re going to disconnect event-

Eric: Here’s the contract, you signed it.

Alex: Right. But instead, you go back to the family and you say, “Here’s the information that we’ve gathered from this Time-Limited Trial. This is where we are. This is how far we’ve come in terms of coming close to the end points we’ve talked about.

Dong: Yeah, that’s exactly right. So, we decide what are the main things that we’re going to follow during this Time-Limited Trial? What are the important clinical outcomes that would tell us that the family member is improving or not improving? In reality, we have almost daily communications with them even without formal family meetings. So, there’s a lot of communication at the bedside. So, I think they’re constantly being updated in terms of how we’re doing, but then the family meeting is a more formal, structured discussion that wraps up all the information that we’ve been getting. And then it’s oftentimes another Time-Limited Trial, or maybe we’re at a place where we could be fairly definitive about how things are, and then we’ll make our decisions from there.

Eric: And Ricky having done a lot of these Time-Limited Trials, it sounds like I always think back to Tim Coe’s article in JAMA, I think was like 2011. How to think about Time-Limited Trials. Any tips around structuring these? Because, it could also feel a little bit little goose. Yeah. We’ll meet again. We’ll talk about if it’s working.

Ricky: Yeah. I think those are the ones that don’t go as well. I think the more specific you can be in laying out what we’re looking for, right. What we’re doing and what we’re all hoping for and looking for. And also, I think what I’ve seen is, people will talk about what happens if they get better, and they’ll talk about what happens if they get worse, but they don’t talk about what happens if they’re in the exact same spot, right? And then everyone’s coming back the week later or whatever, and saying, “Whoa, we’re in the same place. What do we do now?” So I think being clear about those three situations can be helpful. And also, I think one thing that Time-Limited Trials do well is they acknowledge uncertainty and they think of acknowledging uncertainty there too, to say, we’re hoping that this gives us more information. And also there may still be things we don’t know at the end of this trial, and that’s okay. And we’re committed to caring for this person, your loved one, and figuring out where to go next.

Alex: Yeah. I’d say I use Time-Limited Trials routinely in the ICU setting, but this is slightly different, right? Because I’m coming as a palliative care consultant, often not on the day that they’re admitted to the ICU. Often after I think you excluded several of these patients from your study potentially. Patients who came in were initially like, “Oh, let’s try this, let’s try that.” And then things aren’t going well. And then attention develops with family members and then they call on palliative care. And in the pre-meeting, I try and refocus the ICU clinicians around let’s go into this family meeting. And let’s with the objective of perhaps presenting a Time-Limited Trial. After we get through prognosis and goals of care and bringing the patient into the room and all of that, let’s talk about how we could frame our next step as a Time-Limited Trial.

Alex: And that, I think is really educational for the ICU clinicians in terms of reframing their thinking because so much in ICU is about, we had a Podcast about nudges, right. And there’s this sunk cost thought, by the time I get there. We put all this work in and we’re just going to continue. And then like Ricky says, they continue with this in the same space and we’re at the same space we were before. And we’ll just continue on that for a long period of time. I don’t really have a question here. It was more of an observation.

Eric: That’s a good observation, Alex. I want to jump into this trial if it’s okay. I’m going to start off with Dong. So, you had three medical centers all in LA, all academic, there were all trainees there. Who did you include in this population? And this is all pre-COVID, right? It was a COVID pre post kind of design.

Dong: Yes. Pre-COVID, pre and post design. And, you’re absolutely right. It was training centers. And I think you certainly have to understand that that adds a wrinkle in terms of both flexibility and trainability, but also how this sustains and thing like that. But in terms of who we included in the patient population, we used a rough guideline from the Society of Critical Care Medicine, that puts categories in terms of the likelihood that someone would benefit from ICU care. But those categories are very, very non-specific. And essentially it comes down to a clinician’s assessment of this is patient going to be so sick, both in terms of their acute level of illness or their existing comorbidities or their functional status, so that these somewhat invasive things that I’m going to have to put them through, they are unlikely to benefit at the end of this, whether it’s because they will be even more functionally limited, or the patient is just so sick, that our chance of recovery is really low.

Dong: And we actually thought about, we grappled with this. Each hospital’s a little bit different. The patients that they see and the people that might be at risk for non-beneficial treatments are a little bit different. And so, just out of the necessity of respecting all of that, and also keeping things practical, we basically left it at the clinicians sense that the patient would be at very high risk for non-beneficial treatment is good enough. We had each of the ICU directors come up with a series of cases that might illustrate for their ICU, the types of patients that we would be interested in. And then we also got feedback from the clinicians. In the end, we also instructed them that we want this to be pretty straight. We don’t want super great cases. We want you to feel relatively strongly that these were patients who were unlikely to benefit from ICU care, and only place that caveat on it as well.

Eric: And, what did you do as far as the intervention?

Dong: Yeah, the intervention was a lot of training. So what we basically wanted to do was try to address all of the barriers that were in place for communication to not occur well. So first was creating expectations and some structure. I know on these Podcasts, you guys have talked so importantly about how communications should be viewed as a procedure. We love procedures in our ICU, and that language resonates with us. And so, we wanted to create something like that. So basically, it was a focus group that as I described, that dives down into what are the barriers? What are we struggling with? What you create for your institution?

Dong: And it was a set of didactics to try to explain what we’re doing, non-beneficial treatment treatments and the benefit of Time-Limited Trials. And then the most fun of all was simulation with patient actors. Fortunately, we’re in Los Angeles. So we have plenty of actors. We had people come in, and then we had our fellows and our attendings come and do these simulations of family meetings using the protocol. And that was just a blast, but I think it was also very educational. Then we had a checklist format protocol in place for clinicians to use. We had somebody scheduled the meeting to try to overcome that barrier. And then we had follow-up meetings and feedback meetings to see how things were going.

Eric: And I love in the supplement, you can actually see kind of the format of the family meeting. We’ll have links to that on our GeriPal show notes too. So you can actually see what was expected in these family meetings. So it sounds like, again, a bundle of interventions around family meetings.

Dong: Right.

Eric: Okay. So I’m just going to jump to the results, unless anybody has any other questions

Alex: I have a question. Could you give us a sample? What kind of patient scenario they came up with? Who would qualify for this study in the ICU?

Dong: Sure. So for one of the hospitals, they had a lot of patients who had end stage liver disease, so psoriasis, and it would be very common for them to come in with an upper GI bleed and which they were then placed on the mechanical ventilator getting resuscitation. But it turns out that they were really not doing so well in the outpatient setting that had a slow deterioration of functional status and coming back to [inaudible 00:18:23] all the time, their quality of life was really deteriorating. They had a really high, acute level of illness. They were not a transplant candidate. We didn’t see things down the line that could improve that. And that would be somebody that would be very common for that hospital.

Alex: Yeah. That’s very helpful. Thank you.

Eric: Alright, outcomes. I think this is pretty impressive because if you look… So again, before or after the study pre post, big outcomes, your intervention was associated with a pretty big reduction in ICU stay by a decrease of a day, fewer invasive procedures, no change in mortality and higher family satisfaction. I need to jump to the figure. So, it was like figure two. We’ll see if we can add a picture of it. We’ll probably get sued by JAMA IM on our blog post, but you see it was kind of steady before the intervention started. Length of stay, having her in a little bit of over 10. And then right when the intervention occurred, you see remarkable decrease in length of stay. Ricky, when you saw this, what’d you think?

Ricky: This is a great intervention. How do we bring this to our hospital? Well, I thought it was really impressive and I thought if you look at the the mortality data to that, there wasn’t really a change. I think it shows that the Time-Limited Trials can work. And I think, when I looked at that and then I looked at the components of the meetings, and you see conversations about goals and values, prognostic disclosure, all of the elements of the family meeting that, in our palliative care world, we would want to see, went up. The combination of those two findings gives you a sense that, okay, it looks like we might be increasing goal in coordinate care here for these really sick patients. So, I saw that figure and I was excited.

Eric: What do you think, Dong?

Dong: Yeah. If I could comment on that, I really appreciate that comment. Maybe the other way to look at it was, we were in a position where we had a lot of room for improvement. So because this is a before and after study, think we certainly have to recognize that if you look at just the conversations that we’re having in the pre-intervention phase, there were plenty of opportunities for improvement. We were actually not discussing things like values and preferences. It’s almost embarrassingly low for me, but on the other hand, I think this is consistent with the literature that we have in critical care medicine that the conversations often do go like that, where we’re just discussing medical issues and not discussing some of these other components. So, we tried to make the point that I think environment and contact is really important to try to understand in these sorts of studies. And I think that’s certainly the case with us.

Eric: Yeah. I just want to highlight half of the patients, there was a documented values and preferences in the notes pre and nearly 100%. 98.3% post intervention had documented values and preferences. Is it documented, Dong?

Dong: It’s actually obtained through a study coordinators who were participating as just observers in the family.

Eric: Oh, wow. So, you actually had real live ideas of what was happening during those family meetings. I got a question for you though. I look at figure one and I think, most interventions, it takes time to work. There’s a time to benefit. I start somebody on a stat that takes a couple of years to work. Even a quality improvement. There’s usually a time for people to start using the intervention. So, we’re not going to see a pretty big drop initially as people get used to it. Why do you think you saw a pretty immediate drop?

Dong: Yeah. Well, that’s a really good question. It actually touches a little bit on why do we see a benefit in the first place? And it’s hard to piece out with a multifactorial intervention. I will say that we did allow a little bit of time for practice to catch up, meaning that we didn’t collect data immediately after training. We allowed for a little bit of time, we allowed clinicians to play with it a little bit. There was a month period in which we were training, just observing and then starting the data collection after that. So, I think the practice did start to hit whatever equilibrium we’re going to allow it to hit. But the other things that we should definitely keep in mind was, in addition to the contents of the meetings and meetings were occurring more frequently and earlier, and that in and of itself might have an effect on making decisions a little bit earlier in the ICU and so forth. So, that could certainly affect the ICU length of stay. I do think the content matters though. And I think by the time that we were collecting data, I think the family meetings were very rich with the sorts of things that we wanted people to talk about.

Eric: And I guess in any of these types of studies, again, practical, they’re happening in real life, they’re not 100% standardized. There’s always this question of, okay, but what really worked here? Was it time trials? Was it earlier family meetings which occurred here? Was it more addressing values and preferences? Was it things like nudging that you encourage people to do? We used to always talk about, as you can imagine, every Podcast, now we’re talking about nudging and every Podcast, because I also noticed that in your guide on having these family meetings, it’s like in such circumstances, most patients and family members choose to change the goals of ICU care towards focusing on comfort, recognizing that invasive treatments are unlikely to reverse illness. So, that was part of the Time-Limited Trial discussion, which I learned from our nudging Podcast is nudge, right? Most patients, and people don’t want to be not like most patients or most family members. What do you think worked here? Or, can we even say what worked here?

Dong: I can’t really say what worked, but if I had to guess, I would say, I think it has to be the combination of stuff. I think they’re synergistic. And, we had a letter to the editor and a reply, and I tried to make the case that… The question was… Well, part of the question was, it’s this multi-component thing, you need to piece out what worked and what drove the outcomes. But I made the case that it’s perhaps synergistic. What’s the point of having an early meeting, if we’re really not discussing the things that are going to be helpful in shared decision making? What’s the point of having a meeting at day seven when so many things have happened, and then now we’re talking about, “Well, completely changing the direction and saying, “Okay, let’s now try to get to know the patient at this point, and talk about Time-Limited Trials at this point.” I think they have to work together. And I do think there’s a synergistic component, but I certainly recognize the need to try to really isolate what might be the most effective part of the intervention, but I think they work together. I think it’s different in different people. And I think it’s really hard to piece out.

Eric: What do you think, Ricky?

Ricky: I agree. I agree. I think it would be very hard to separate the components of this out, anyways, right? I think to do a Time-Limited Trial without components of eliciting someone’s goals and values and talking about prognosis, I don’t know what that’d be a bad Time-Limited Trial. And so, I think that, we do know that conversations around goals and values, when we talk about prognosis, they have benefit, right? Although, the data in the ICU have been kind of variable. And so, I think Dong’s findings, given what the intervention is, I don’t know how much it matters exactly what’s going on so that it really works. And this is a good strategy.

Eric: Well, you bring up variable, right? Some interventions. In my mind, one study comes directly into my mind is the JAMA Carson article on Chronically Critically Ill Patients. In the title, it has the word palliative in it. Oh, it’s Palliative Care Led Meetings, which were usually one or two fast food style meetings to talk about prognosis goals and new leave. And that actually increased PTSD symptoms and patients. It potentially hurt people. At least that’s a Fox News said. But it tells us, potentially… I love that trial because it tells us what not to do in palliative care. Some people say it’s not a palliative care trial. I think it is a palliative care trial.

Eric: And it tells us, fast food palliative care does not work. Just going in, going out for chronically critically ill patients, probably not the best. And it was a really important study because it tells us what not to do. I love this one because it tells us, “Hey, this is a great intervention for quality improvement project.” It’s longitudinal. There’s a lot of great primary palliative care going on here. We don’t know. Right, Dong. I read this in your letter to the editor reply. We don’t know whether or not palliative care was increased or decreased in this group. Right?

Dong: That’s correct. Yeah. It’s something we should have collected. We just didn’t have-

Eric: Maybe a follow-up study there.

Dong: Yeah. But, I don’t know if it’s a mechanism, but maybe it’s an explanation. One thing that I wanted to mention in terms of our results that I don’t know if that helps explain some of the results in the findings, but if you look at the supplement, one of the things that we offered was the length of stay over the course of the study and the pre and post intervention phase. And so, the length of stay goes something like this, there’s a lot of variability. It goes up and down. And I know the listeners can’t see my hands and moving around, but there’s just a lot of long ICU stays. And then we have this baseline of your typical ICU stay. Lots of spikes, lots of spikes. And then in the post intervention phase, a lot of those spikes get either attenuated or go away.

Dong: And the way that I interpreted that was, not that these were outlier cases. But if you think about what a Time-Limited Trial is doing, is really trying to put some patient centered boundaries around those cases that really have this protracted ICU invasive, the momentum that you guys are talking about. And, I do think that part of our intervention was to just take some of those things and just want the outliers and make sure that we’re not providing this extended period of ICU treatments, breaking that momentum that we oftentimes have as ICU physicians, to invest and do more and more and more and do that. So I think that’s one of the explanations for why we started [inaudible 00:29:56]. If you look at our mean versus our median, it totally reflects the mean drop is a lot greater

Eric: And it had a bigger impact on the people who died. Is that right?

Dong: That’s correct. Yeah.

Eric: Why is that? Why you think?

Dong: Well, what I would hope for is the idea that for the patients who were unlikely to survive ICU care, and benefit from ICU treatments, that we were able to identify those people and identify them through longitudinal assessments. And then they had some boundaries placed on the amount of suffering and things that they would have to go through. I was really, really nervous that we might have some unintended consequences and the escalation and treatments that would be reflected in differences in mortality. Fortunately we didn’t, but I think we have to recognize that that’s always a danger to this sort of a conversation and intervention.

Alex: I noticed that about half of the study were Latinx patients. I’m wondering if professional translators were used during these family meetings, or how you handled potential language issues. I don’t know if they had limited English proficiency or not.

Dong: Yeah, it is very common in all three hospitals for us to have people that aren’t super comfortable with English, family members and so forth. We do use translators and we kept this very pragmatic and practical. But in all honesty, we also have the benefit of, a lot of people in Southern California are very good at speaking Spanish. So language concordance was common because a lot of our staff do speak Spanish, but we didn’t use interpreters as necessary.

Alex: Yeah. So, Ricky, here’s a question. How broadly should we think about Time-Limited Trials? When I think about them, I think as you wrote wonderfully in your essay, that Time-Limited Trials are a way of helping us manage our uncertainty, and they help us manage uncertainty over time. Because when most people write about uncertainty, I’ve written about uncertainty, other people have written about it. We often think about the uncertainty in the moment and what Time-Limited Trials allow us to do is to manage that uncertainty in conversation with family members of seriously ill patients over time, and to narrow down that uncertainty in repeated conversations, because as we know, as Eric said, palliative care is not ideally an initial one-time consult. And that goes for consulting palliative care and for primary palliative care. I wonder if you have more to say, or if you want to share some of your thoughts about the management of uncertainty with Time-Limited Trials.

Ricky: Yeah. No, I think it’s a great question. A great point. Because when I read your study, Dong, the thing that jumped out at me, clearly the results for the patients, but I was thinking about it like how this affects the clinicians in the ICU, and this is one of the things that we write about is… And I’ve seen this happen in residency and it happens with us in palliative care too, is there’s a sense of therapeutic nihilism, right? This person’s never going to benefit from the ICU. And once that narrative sets in, it can be really hard to break. And those are often cases where we’re called into palliative care, right? Where the ICU team may be saying, “Look, we don’t think this person’s going to get better. We want to protect them from further intensive interventions, more suffering.”

Ricky: And the family is not there. It’s not where their goals and values are, and that leads to frustration and communication challenges. And I think what the Time-Limited Trial does is it injects uncertainty into the clinician’s judgment, right? By necessity, you’re saying, “Hey, I’m hoping right there with you, that this person gets better, that what we’re doing in the ICU is helpful. And, I’m worried that it may not be. And here’s how we can think about it going forward.” So, you think about your medical decision making, where you’ve got your pre-test probability and your post-test probability, and all of that stuff we learned making the clinical epi people will teach us. And, a Time-Limited Trial is the same thing, right. You’ve got your pre Time-Limited Trial prognostic estimate as a team, and then you do the trial and you adjust based on the results of the trial to think about a post-test prognostic estimate. And so, I think just injecting that uncertainty for the clinicians, it’s a nudge, right? It’s a nudge to say, we don’t know what’s going to happen here. So let’s align with the families, hope for the best and prepare for the worst.

Eric: Well, it’s interesting because in this study you had clinicians. To get enrolled as a patient, you had to have a clinician say, “They’re at very high risk for non-beneficial care.” And then what happened is, 40% were still alive on hospital discharge. So, that tells you that… Again, was it high risk or they thought really likely that they were going to have non-beneficial care? What was the actual enrollment? It sounded a lot more subjective, and it turns out like it was a little less than a coin flip. What are your thoughts on that, Dong?

Dong: Well, I think our biases and prognostic care centers are well-known, especially in the ICU. I think that that point doesn’t have to be made. But on the other hand, maybe the one thing that I could also add is that, what we didn’t capture that we absolutely should is, what were they like on discharge? So, it’s quite possible that their quality of life may have been severely compromised. I have a feeling that’s the case, but I also think there were many cases where the clinicians felt like this might be non-beneficial and they were pleasantly surprised. And I think a Time-Limited Trial really allows for that sort of thing. And you can also get, as Ricky said, a little bit more certain about how things are just by allowing for a little bit of time.

Dong: A point that I also wanted to make was that, in addition to the effects on the clinicians, I think there was a profound effect at the Time-Limited Trial on the surrogate decision makers and the family. And it was very common for us to have had family members that just simply didn’t know what was going to happen in the ICU, and not understand what it means to have a tube in the throat, to occasionally even be bound to have these medications that are infusing in. And just being able to see that again, in pre-COVID times, and see how much the nurses and the physicians paid attention to details and came by, I think that put us on the same team. And, I think that was really important. It was something that we just simply can’t capture with data and place in an article, but it was really, really nice to see.

Ricky: That’s actually a question I had for you, Dong, if it’s okay, Alex.

Alex: Yeah.

Ricky: Yeah. I was wondering, have you collected circuit level outcomes at all? Eric was talking about surrogate family PTSD, and some other studies or Dugway study looked at anxiety and depression. And I’m just wondering if you’ve looked at it or you plan to in the future, so we kind of understand the longer-term effects of this.

Dong: Yeah. And you make such an excellent point about that in the editorial. I think it’s something that we have to do, especially things like trying to capture anxiety, depression, and PTSD at a later time point. I think that’s been really well done by Dugway and others, and we certainly need to do that. What we did was we tried to at least capture some information on satisfaction. I think we had a little bit of a ceiling effect of everyone was extremely generous with their comments on their satisfaction. And so we couldn’t really piece out whether it changed over time, but we also did some qualitative studies that we’re still working on right now. Just trying to gauge people’s perceptions on the decision-making and how the experience was. I think it’s really complex. For the most part, my sense is that people appreciated the opportunity to be in a Time-Limited Trial, but we even heard feedback, like when you said that, that we’re going to meet again in five days, those are five grueling days at times. And, all of that has to be respected as well.

Alex: Yeah. Here’s something I teach my trainees. Okay. This is like blowing up Time-Limited Trials, maybe a little bit too far, but it’s counter because most clinicians, right. They think about everything is open-ended. They don’t think about things as having a test period, for example. So I like to tell my trainees, everything is a Time-Limited Trial. Life is a Time-Limited Trial, right. We’re always gathering more information and then reassessing as we go through our life. Well, maybe at the end of life, we don’t get to say “I’d like some more, please.”

Eric: Alex, when does it become like just kicking the can down the road? Like, “Oh, we don’t have to make a decision. Now we can make it later.” What is it about just delaying an inevitable decision?

Alex: Yeah. I think at some point it gets to be delaying in inevitable decision. And I’m somebody who often the teams will consult me. Right. And they’ll say, “We really feel that this treatment is done beneficial. We need it to end, help us end it.” And I turn back to them and I say, “We need to meet the patient, form a relationship with them. Get to know them, get to know what’s important to them or their surrogate, their family member. Get to understand what their values are, what they’re hoping for, what they’re afraid of, what their goals and values are.” And then talk about prognosis. What’s likely ahead. And then we could talk about, let’s think… And then I often recommend rather than jumping to let’s stop this, because it doesn’t seem to align. Well, let’s see, should we continue to try this for another, whatever life sustained treatment, for another period of time. But I’ll vary that period.

Alex: And I’m curious what period of time were selected in your trial by the intensivist. For something that’s really pretty darn clearly non-beneficial, I’ll have a shorter period of time. For something where I think, there might be something here and particularly with trainees and many of the clinicians in your study, if I’m understanding correctly, Dong, were trainees. They often don’t have a sense of when somebody does have a better prognosis. They look like they’re on the brink of death, but the more seasoned clinicians know that, actually, has as a decent chance to make it through this. And then I find myself as the awkward palliative care clinician and saying, “Actually, there’s a decent chance to make it through this.” I know Eric’s like, “Yeah, you’re just kicking the can down the road.” But Dong, how about the links of time periods in these Time-Limited Trials?

Dong: Sure. It was exactly as you described, Alex, which is it’s really dependent on the clinical situation. So for instance, somebody who is extremely ill, and it looks like they’re going to declare a direction pretty soon, it would be a relatively short Time-Limited Trial. They’re also going through a lot and we don’t really want to extend that any longer than you have to. But there are patients who have chronic critical illness where it might be a week, it might be a little bit longer.

Dong: So, it really depended on the clinical situation. A very common scenario for us was if someone came in and a cardiac arrest, and then we would start to do a series of prognostic assessments at 48 and 72 hours and see where we’re at and start the conversation at that point. So, it really varied. I will say, I loved your comment on everything is a Time-Limited Trial. That’s actually a feedback that we got back from a lot of our clinicians who were initially really reluctant to do Time-Limited Trials. And then at the end, they were saying, “Well, you’re not doing anything special. We do this all the time. This is what we do. We start, and then we see how things go.” And so, I think they came around to your way of thinking, Alex.

Eric: I got one more question, Time-Limited Trial outcomes creep. Where you have a Time-Limited Trial, three days later, outcomes, didn’t meet him, but you meet again and new outcomes are addressed. And we have another Time-Limited Trial. And then the new outcomes. I think we’ve probably seen these scenarios. Ricky, have you seen this? And what do you do around this?

Ricky: Yeah, I think you’ve got to diagnose where the issue is, right? Is it that the team, the clinicians are worried about putting their nickel down and saying, “Look, we tried this it’s not working. We’re not in a great place now, let’s redirect towards comfort.” Or, is it that the family, there’s a communication difficulty there, their prognostic awareness isn’t aligned with ours or they had a misunderstanding. Right. Because I’ve seen both, right. Sometimes it’s the clinicians being like, “I just want to give them some more time.” You’re like, “Well, what are we really hoping for here?” Or, if it’s family distress, I think then we got communication tools for that too. So, it can be appropriate, right, if the situation changes in unexpected ways, but yeah.

Eric: So, you got to diagnose the problem?

Ricky: Yeah.

Eric: Okay. Actually, I said that was my last question, but this is my last question to both of you. Quickly, if you had a magic wand, you can make any changes as far as what should people do with the outcomes of this study, Dong, what are you hoping from ICU clinicians?

Dong: I am hoping that I see clinicians understand the importance of communication done well, trained as a procedure, really, really understanding that it does make a difference, but also understanding context and the proper way to train and really implement that in a way that makes sense for their institution.

Eric: And I love that. We use simulation for a lot of things. We should be using it for communication is just as important as putting an A lines. Ricky, what’s your magic wand for palliative care providers? What should they do differently, if anything, from this study?

Ricky: I think acknowledging prognostic uncertainty and helping teams acknowledge prognostic uncertainty amongst teams, and with patients and families too, early on.

Eric: Yeah. I think that’s the fascinating thing about uncertainty. We always try to think about minimizing our uncertainty, but I think this is a good example of, honestly, this is about increasing uncertainty. We don’t know, like you said, and sometimes patients and family members are hungry for more uncertainty and not less. So with that, thank you both for joining us, but before we let you out of here, Alex, do you want to finish up with a little bit more Time Is On Our Side?

Alex: A little more Time Is On My Side. (Singing)

Eric: Dong and Ricky, big thank you for joining us on this Podcast today.

Dong: Thank you so much.

Ricky: Thanks, it was a pleasure.

Eric: Thank you to Archstone Foundation for your continued support. And to all of our listeners, thank you for supporting the GeriPal Podcasts. Do us a favor, send this out to one of your colleagues and ask them to do a time trial. Listen to GeriPal Podcast for half an hour. If you like it, finish the whole episode. And with that, goodnight everybody.

Alex: Thanks.

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