Hello, my name is Doug White. I'm Vice Chair and Professor of Critical Care Medicine at the University of Pittsburgh School of Medicine. Thanks so much to the organizers for having me. So I'm going to be talking about goals of care planning in critically ill patients. These are my disclosures, none of which pose a conflict with what I'll be talking about today. And so here are my objectives. First I'd like to summarize prior efforts to improve outcomes related to goals of care planning in ICUs, then I'll make the case that the way we've been thinking about how to improve outcomes is flawed, and then finally I'll end by identifying some recent trial results that suggest a path forward for improving goals of care planning in ICUs. So I think I probably don't need to tell anyone in this room that the ICU is a tough place for everybody involved. You know, patients are critically ill and suffering physically and sometimes psychologically. Surrogate decision makers, family members, loved ones, et cetera, often suffer acute psychological distress from the trauma of seeing their loved one critically ill. And there are well-documented breakdowns in communication between clinicians and families, which all sort of culminate in ethically challenging decisions, poorly aligned goals of care between what's happening and what might be consistent with the patient's values and preferences. And this can lead to significant moral distress on the part of clinicians. So what's been done in the past to try to address this? You know, this is not a new problem. It's been known for 30, 40 years that there are concerns about the nature and intensity of care that we sometimes deliver in ICUs. So let's start with what I think is, you know, really one of the absolutely most important studies done in this field. This is the SUPPORT trial. It was published in 1995, so now, you know, almost 30 years ago. And basically what the SUPPORT trial was, was an intervention targeting hospitalized patients with a serious condition and expected six-month mortality of about 50%. And so there were almost 5,000 patients in this trial. The intervention that was tested was that physicians in the intervention arm of the trial received estimates of the patient's likelihood of six-month survival, estimates of their likelihood of surviving CPR, and then estimates of their likelihood of having functional disability at two months. So that's sort of the informational part for the clinicians. And then there was also a specially trained nurse who interacted with patients if they were able, and their families if they were not, to elicit the patient's values and preferences around the use of life-sustaining treatments, and then shared this information with the clinical team and facilitated communication in ways they deemed appropriate. So a, you know, thoughtfully designed intervention focused on informed decision-making. Unfortunately, the trial, the intervention was entirely negative. Really no effect on end-of-life care, no effect on hospitalization costs, no effect on goals of care decision-making, as evidenced by the median time until a DNR order was written, no effect on the degree to which the clinicians knew what their patient's code status preferences were, no effect on the duration of treatment in an ICU prior to death, that's the undesirable states outcome measure here, and then as I said, no effect on end-of-life costs. So a, you know, a really disappointing result calling into question whether an informed decision-making paradigm will actually change outcomes. What I think is really important about the support intervention is that the intervention was grounded in what, you know, we might colloquially call the rational actor model. And this is the idea that if you give people accurate information about the likely outcomes of treatment, in this case in the ICU setting, and also the patient perceived value of those outcomes, that doing so in aggregate will reliably lead to good decisions, you know, optimal decisions to advance the patient's interests that are utility maximizing, logical, rational, et cetera. And so that was the grounding of the support intervention, and it just did not work in that study. And I think that informed choice model as being both necessary and sufficient is what underpins many clinicians' views of what is needed to foster good decision-making in ICUs. And the idea here being that I think a lot of clinicians carry around the mental model that I need to make sure the family understands the patient's prognosis as well as their values and treatment options, and if I've done that, then good decisions will generally follow. So you might say, well, listen, that support trial, that was 30 years ago. Things are different. If we did something else related to information-giving and facilitating values clarification, it would improve outcomes. And so we, in fact, did this. Chris Cox led a study in 13 US ICUs in which we randomized 277 patients who met criteria for prolonged mechanical ventilation to either receive a very guideline-concordant decision aid or usual care. The decision aid was designed to help surrogate decision-makers understand what it means to be experiencing prolonged mechanical ventilation, think through the patient's values and preferences, and also presented them likelihood, prognostic information about the patient's likely outcomes, and then finally gave them information about treatment options other than prolonged intensive treatment such as comfort-focused care and a time-limited trial. So again, a robust information-focused decision aid. And unfortunately, what we found is, again, that the intervention was not effective. There was no effect on decisions to transition to comfort-focused care, no effect on healthcare utilization, no improvement in surrogates' psychological outcomes measured three months after ICU stay in terms of depression and anxiety and post-traumatic stress, and concerningly, no effect on the accuracy of surrogates' prognostic expectations. And the real concern that I saw from this study is that surrogate decision-makers remained quite optimistic about patients' likelihood of surviving to a year compared to both the mortality or the model-derived prognostic estimates and then actually what happened to them. So surrogates were both overly optimistic, and they were also overly aggressive in the kinds of treatment paths they chose for patients compared to what they reported the patient would choose for themselves. These data were both sobering to me, and I think really pointed to some limitations of the informed choice model as both necessary and sufficient. And so, you know, I think one of the really interesting things about these trials is that they fly in the face of a huge amount of evidence from other domains of medicine that decision aids are quite effective for people facing a variety of health and screening decisions. So this is just a meta-analysis of 105 studies, 31,000 participants, and the gist of what they found with this meta-analysis is across a wide variety of decision contexts, people exposed to decision aids are better informed, clearer about their values, and have more accurate risk perceptions, growing evidence that decision aids may improve values-congruent choices. That's obviously not what we've seen in the ICU setting, and it just begs the question, well, you know, what's going on here? And I would speculate that it has something to do with the nature of the decisions being made. You know, if you really look at the kind of decisions that were being studied in the Cochrane review, they were for things like whether to undergo PSA testing or not, whether to undergo colorectal cancer screening, or, you know, for women who are considering birth control, the pros and cons of different options for birth control. And so there's something just substantially different about these decisions and the decisions that surrogate decision-makers are facing in the ICU context, and I might couch that or explain what that is by looking at some of the recent qualitative studies on this topic, and what comes through in all three of these studies that I've put up here, and the one that I'll focus on was led by Yale Schenker here at Pitt, is when you really explore family members' experiences making decisions for a critically ill loved one, there's a lot more going on than just the informational challenges of the situation, and I think this quote nicely summarized the issue. Surrogates experience significant—this is a conclusion from the paper—surrogates experience significant emotional conflict between the desire to act in accordance with their loved one's values and not wanting to feel responsible for a loved one's death, on the one hand, and then also their desire to pursue any chance of recovery. What I think this is driving home is that these are not just cognitive decisions that good information will reliably lead to good outcomes. There's both emotional and psychological complexity to these decisions that may be just as powerful an influencer of the ultimate decisions. So sort of shifting away from a purely informed choice approach, palliative care consultation, specialty palliative care consultation, seems ideally designed to improve patient and family outcomes in the ICU setting. So I want to just talk a little bit about palliative care intervention as one way to improve goals of care planning in ICUs. And so just sort of scooting back, what are we talking about when we talk about specialty palliative care? Well, this is the definition from CAHPSI, which is one of the leading national organizations on palliative care. Palliative care is specialized medical care for people with serious illness. It focuses on providing relief from the pain, symptoms, and distress of a serious illness. It's a team-based approach involving doctors, nurses, social workers, and other specialists focused on improving quality of life. By determining patients' goals of care through skilled communication, treating distressing symptoms and coordinating care, palliative care teams meet patients' needs and help them avoid unwanted and expensive crisis care. So I think that's a nice summary and also highlights conceptually why palliative care consultation or specialty palliative care might be especially well-designed to address both the cognitive and psychological aspects of making surrogate decisions. So the box here on the slide just shows the consensus domains of high-quality palliative care consultation. And again, I think they really target the kinds of interventions that are probably needed to support family members facing difficult goals of care decisions in ICUs. So what would work? You know, what would count as working regarding specialty palliative care consultation to improve goals of care planning? I've just listed a number of different outcome measures that could be assessed here. You know, the ones that have largely been assessed in the existing trials, and I'll summarize those in just a second, are utilization outcomes around cost and length of stay, DNR rates, hospice use. But arguably, what we're really trying to get at here with these kinds of interventions is did the intervention deliver or help deliver goal-concordant care? Did it lead to good symptom control, and did it improve family psychological outcomes? So let's see where things are in terms of the existing evidence. Well, sadly, the evidence base is quite thin and of low quality. This is some quotes from the recent SCCM guidelines for family-centered care in ICUs, and this is their evidence summary about the utility of palliative care consultation in ICUs was as follows. There are limited data, including five very low to low-quality studies that suggest that proactive consultation of palliative care decreases ICU and hospital length of stay among certain groups, and that those groups were patients who were critically ill and also had advanced dementia, advanced cancer, who were comatose after a cardiac arrest, who had an intracerebral hemorrhage and were mechanically ventilated, or who were of advanced age and had multi-organ system failure. There are a number, obviously, of limitations to the existing evidence. First, none of these studies were randomized trials. They all utilized essentially a pre-post design, and some with historical controls. Second, all of the sample sizes were quite small, generally less than 100 patients. And then the results were inconsistent across the effects on utilization outcomes. But in my view, what is perhaps the biggest limitation is that these trials did not assess the impact of palliative care consultation on patient and family-centered outcomes, as well as long-term psychological distress, goal-concordant care, families' perceptions of the patient-centeredness of care delivery in the ICU. None of these things were assessed. And in fact, Rebecca Aslikson wrote what I think is a really nice paper that was a systematic review of palliative care interventions in the ICU, and one of their conclusions was that the field could benefit from a definitive, well-powered, well-designed, multi-centered controlled trial evaluating proactive palliative care in the ICU setting as compared to usual care. I think that summed it up perfectly, that we just don't really right now have the data to say one way or the other whether specialty palliative care consultation is going to reliably improve goals of care planning in the ICU setting. I should say that Ma and colleagues at Barnes-Jewish, WashU, and St. Louis recently contributed to the evidence base, and I think in an important way. They conducted a single center, what they call the cluster randomized trial. It was in two ICUs, and it was essentially a pre-post study in two different ICUs among 199 patients who met a palliative care screen trigger indicator for palliative care consultation based on existing recommendations for palliative care triggers. And I've listed all those palliative care triggers here, but the bottom line is they were enrolling people who are basically at high risk for morbidity or mortality in the ICU setting. So it's really a disease and prognosis-focused trigger to enter the trial. They randomized them to, well, it was a pre-post study, so the control arm did not get palliative care. The intervention did get specialty palliative care consultation. And what they found is that those who received palliative care consultation had higher rates of DNR-DNI status, 51% versus 23. More transfers to hospice, less tracheostomy, and less post-discharge ED and hospital visits. The intervention, interestingly, had no effect on ICU or hospital length of stay, no effect on total hospitalization costs, and no effect on total 30-day mortality. And again, I think what is a significant limitation, which the authors acknowledged, is that they did not study patient and family-centered outcomes like, was the care perceived to be more goal-concordant, and was there a reduction in patient's, sorry, or surrogate decision-makers' psychological symptom burden like depression symptoms, anxiety symptoms, and post-traumatic stress symptoms. So I think, you know, the beginnings of some good progress in the field, but I would say we still really lack the needed evidence for whether palliative care consultation is effective in this context. And so we're, I just want to mention, we're in the midst of conducting a patient-level randomized controlled trial of early integration of palliative care specialists into the ICU setting. This is funded by the National Institute on Aging. I've listed here the reference to the protocol paper. We are, as I said, randomizing at the individual patient level, 500 critically ill patients who meet at least one of the palliative care triggers, again, sort of focused on disease-based or prognosis-based triggers for palliative care consultation. We're doing this in five Pennsylvania hospitals, and we're also doing pre-specified subgroup analyses not based on the patient's prognosis, but based on the family's perception at baseline of their palliative care needs using a measure called the NESS scale that Chris Cox has adapted for the ICU setting. And we're also looking at subgroups across minoritized racial and ethnic groups. So the nature of the palliative care intervention is worth saying a little bit about. This is an intervention that is being delivered by palliative care consultants who are board certified. And in addition, there is a requirement for family meetings within 48 hours of enrollment and then at least every five days thereafter that both the ICU team and the palliative care team attend. So the goal is to have the ICU team and the palliative care team integrated in their care delivery processes. There's also daily palliative care visits as per usual with palliative care consultation in the hospital setting. And then daily check-ins between the palliative care team and the ICU team to formulate care plans. The whole goal here is to try to not have what I think of as like parallel processes between the ICU team and the palliative care team and instead to have them both collaborating to support the patient and family. So we don't yet know what the trial results are. We are targeting, as I said, 500 patients. We've enrolled about 310 at this point. So we expect in the next year or so that we will have a completed data collection or completed enrollment. And then we have follow-up to six months. So stay tuned for the answers to this, but I think this will be a positive or negative, a helpful contribution to the literature on the value of palliative care consultation in the ICU setting. And these are the, just so you see, these are the outcome measures that we're looking at. And we are targeting not only utilization outcomes, but also patient and family-centered measures like psychological symptom burden, goal concordance of care, measures of patient-centeredness of care, et cetera. That said, even if this intervention shows that palliative care consultation is effective in improving outcomes in the real world, I think there are some challenges. Actually, let me just say it a different way. There are some real challenges to palliative care consultation being effective. One is, many ICU stays are only a few days long. And so there's limited ability to deliver what we might think of as an adequate dose of palliative care consultation, whatever the benefits may be. Second, it's possible that the ICU team does a pretty good job already and mostly meets patients' and families' needs. And therefore, the ability to detect a difference may be hard to do. And then finally, it's not entirely clear that it's possible for ICU teams and palliative care teams to really coordinate care well. And if that there is complexity in care coordination between the two services, this might dilute any potential benefits. And in my view, one of the other really, I think, important policy-level issues to think through when we consider having palliative care consultation be the path forward for improving goals of care planning is the concern about shortages of palliative care specialists. And these are two papers from two different domains of medicine analyzing how many patients are there, both in the ICU setting, and this is the study on top from Meihua, and then in the palliative, I'm sorry, in the advanced cancer setting, who would need palliative care consultation if all of those who were recommended to receive it actually received it. And what they've both found is that there are not nearly enough palliative care specialists. So Meihua found that there would be between 1.1 and 1.5 million ICU patients per year who meet disease-based triggers, a need that is unlikely to be met by the existing workforce of specialized palliative care providers, which is to say, if all these palliative care docs did is take care of ICU patients, there still wouldn't be enough palliative care specialists. Similarly, Yael Schenker's conclusions from ASCO's recommendations, they recommended palliative care consultation for all patients with advanced cancer. They concluded that this would require more than double the existing full-time equivalents of palliative care specialists. So we have a workforce problem here if it turns out that palliative care consultation is effective in the ICU setting. Okay, so stepping away from the palliative care, specialty palliative care approach, let's think about another approach to improve goals of care planning in the ICU setting, and that's adding essentially a family navigator or a family support person to the ICU team to help them navigate the complexities of goals of care planning. And this is, Randy Curtis has done great work in this, did great work in this regard. He and his team conducted a multicenter randomized controlled trial of 168 patients with respiratory failure who were at high risk of death, and they randomized the patients and their families to the involvement of what they described as a communication facilitator to support them through the ICU stay. And this communication facilitator was trained in family support and mediation theory. It was a nurse or social worker who delivered tailored support to family based on their coping styles, and then facilitated communication with the ICU team. And the idea here was that the communication facilitator would essentially help identify, both prevent conflict and identify both intrapersonal and interpersonal conflict and help both the family and the ICU team work through these conflicts. So what they found is some promising results in terms of surrogate decision-makers' symptoms of depression, anxiety, and PTSD. That's all what's on this slide. At six months, they found lower depression scores in the intervention group compared to the control group. And they also found lower PTSD scores, symptom scores in the intervention group compared to the control group, though it didn't quite reach statistical significance. I would just flag that this is promising in a field where there has been very little in terms of moving the needle on any patient or family-centered outcomes with interventions to improve goals of care planning. They also looked at hospitalization costs and length of stay. What they found is that overall, the intervention did not affect ICU length of stay, but amongst decedents, i.e. people who died in the hospital setting, they found that the intervention was associated with a significantly shorter ICU length of stay in the intervention arm compared to the control arm. And they also found a significant decrease in costs in the intervention arm amongst decedents, but no difference amongst survivors of the ICU stay. So that approach was adding a family support specialist to the ICU team. But another approach beyond that and beyond specialty palliative care consultation is focusing on what we think of as primary palliative care delivery in the ICU setting. And basically, this is the idea that the core components of palliative medicine are delivered by the interprofessional ICU team rather than by palliative care specialists. And the box in this slide basically just outlines what that entails. This would be basic management of pain and symptoms, basic management of patients and families with symptoms of depression, anxiety, and then basic discussions about prognosis, goals of treatment, suffering, and code status. And so then this is what we hope, I think already that we hope that our ICU team can do. And specialty palliative care in this model would be left for essentially the hard cases, lots of conflict or families who are having intense psychological distress, cases of what might be thought of as potentially inappropriate or futile treatment. So we sought to assess whether an intervention that is delivered by the interprofessional team and is a family support intervention can improve outcomes. So this is the idea of really focusing on, can we not use specialty palliative care and not use adding someone to the ICU team, but instead train up the existing interprofessional team to better support families? And so we conducted a stepped wedge, cluster randomized trial comparing usual care to protocolized family support delivered by the ICU team. We did this among 1,420 incapacitated, critically ill patients at high risk of death or severe functional impairment, as well as their surrogate decision makers. And the outcome measures that we assessed were surrogate decision makers, long-term psychological distress in terms of anxiety, PTSD, and depression. We assessed family members' perceptions of the patient-centeredness of care, their perceptions of the quality of clinician-family communication, and then the utilization outcomes of length of stay and hospital costs. So the intervention was a multi-component intervention delivered, as I said, by the interprofessional ICU team, and it was really driven by nurse leaders in each ICU. So I'll show you the family support pathway in a moment, but the idea here is that the nurse leaders underwent 16 hours of advanced communication skills training to support families who were tasked with the role of surrogate decision making. And the training was really grounded not merely in the cognitive informed choice model, but also grounded in the need to attend to the strong emotional considerations that come up when individuals are faced with high stakes decisions for others. And so this is just a slide showing the components of the intervention. The idea is that the partner nurse, this is what they were called, interacts with the family essentially from the start of the ICU stay. So from day one throughout the ICU stay, every day the partner nurse is touching base with the family, providing emotional support, assessing their needs, trying to answer basic questions, and then also listening for what I would call nascent conflict that needs to be brought to the attention of the clinical team. In addition, the intervention involved structured family meetings occurring within 48 hours of admission, and then at least every five to seven days thereafter. And at these meetings, the partner nurse arranged them, he or she met with the family beforehand to help them get ready for the meeting, then was there during the meeting and helped the family ensure that their questions were asked and that key domains of important information were conveyed. And then finally sat with the family after the family meetings and helped them debrief. And this is just a screenshot of the question prompt list that the partner nurses used to work with families before each family meeting to help them identify what are their main questions to ask of the clinical team. Both they could check the ones here that were targeting around prognosis, patient's values and preferences, what treatment options exist, what milestones might be appropriate to be looking for. And then also the partner nurse went over with the family the kinds of questions that doctors often ask in this context. And so the kind of things that the partner nurse talked through with the family in advance of the family meeting was, have you ever been involved and been focused on making decisions for someone else before? And if not, the partner nurse talked to the family about what are the ethical bases of making surrogate decisions, i.e. focusing on the patient's values and interests rather than the family's own interests. Talking a bit about what was the patient's functional status like before the hospitalization. And then doing some basic values elicitation. Has your loved one ever talked about the treatment preferences and their treatment preferences and values? What they didn't do, I think is equally important, they didn't discuss prognosis, they didn't make any recommendations, they didn't talk about treatment options. They really left that to the physician lead of the team and focused more on making sure those conversations arose but not leading them. And so what we found is our primary outcome was the surrogate decision-maker scores on the HADS scale, which is symptoms of anxiety and depression. And what we found is no effect. At six months, the surrogate decision-maker scores on the HADS were identical essentially in the two groups. Same thing with the IES, which is a measure of post-traumatic stress symptoms. No difference between groups. And so for mitigating long-term psychological distress, long-term psychological distress, this intervention did not work. But on every other outcome that we assessed, the intervention was significantly better than the control arm or the outcomes were significantly better. And let me just walk you through those. So first, families in the intervention arm rated the quality of communication significantly higher than the families in the control arm. This was with the quality of communication scale that Randy Curtis developed. And we looked at this a couple of different ways but we found a significant increase both in the mean score and in the proportion of families with a score above 80 on a zero to 100 scale. We also elicited family members' perspectives of the degree to which care was centered on the patient's values and was also family-centered. And on this scale, a lower score is better and we found a significant, it's a one to four scale, and we found a significant improvement in the patient-centeredness of care in the intervention arm as well as a significant improvement in the proportion of patients or families who reported a score in the lowest quartile, lowest, i.e. best quartile. So although it did not improve their long-term symptoms of psychological distress, it improved their perceptions of communication in the ICU and their perceptions of the degree to which care was centered on the patient and family. I think arguably both important outcomes. We also found that the intervention decreased healthcare costs and utilization of ICU resources. And so similar to what Randy Curtis and colleagues found, we found that ICU length of stay was shorter among individuals who died during the hospitalization by two and a half days and really no change in the ICU length of stay amongst survivors. And again, total hospitalization costs and direct variable costs were significantly lower in the intervention arm compared to the control arm. And we did a pretty careful costing analysis of the intervention. So, you know, this is, we looked at, well, how much does it cost to deploy this? And so we factored into that nurse's time, what their hourly rate was, training costs, and then as well as the cost of implementing this study over time, because it really did take what I would think of as sort of continuous feeding and watering. We had people called implementation specialists going out to the ICUs, helping the partner nurses really deploy the intervention and essentially monitoring for drift over time and their skills. And it was about $170 per patient is what it cost. And so if you just purely look at this from a monetary standpoint, it saved about $6,000 per patient and cost about $170 to deliver. So from that sense, you know, a valuable cost saving initiative for the hospital. And also, you know, I think arguably more importantly, it increased families' perceptions of the patient-centeredness of care. So getting towards wrapping up here, I just wanna restate that I think these data in aggregate suggest that how we used to, and maybe how some still think of what it takes to support families in ICUs and foster good decisions is out of date. And that idea that is captured here, that mindset is I need to make sure the family understands the patient's prognosis, values and treatment options. And if I've done that, then I've done my job and things are gonna go well. I just, I think that that's too limited a conceptualization of what we need done to support families in ICUs. And instead, I would argue that a better view of how to support families in the ICU setting, particularly around goals of care planning is that we need to emotionally support, emotionally and psychologically support families through what is a traumatic experience. We need to give them not only the information they need, but also the emotional and practical support and counsel needed to make good patient-centered decisions. And the way to do this is through deploying reliable family support pathways, and also focusing on improving clinician skills, not only in conveying information, but also counseling and supporting families. So let me wrap up with three conclusions. Just to restate, I think a narrow focus on providing more and better information to patients and families is not sufficient to improve patient, family and health system outcomes. Second, although there are strong conceptual reasons to think that specialty palliative care consultation may facilitate better goals of care planning, there's almost no evidence regarding the impact of palliative care consultation on patient and family-centered outcomes in the ICU setting. And basically only low-quality evidence regarding palliative care consultation's impact on healthcare utilization. And then finally, we're seeing promising results from interventions that in aggregate attend to both the cognitive, relational and emotional aspects of surrogate decision-making, either through family support interventions delivered by family navigators or those delivered by the ICU team. Thanks again for having me, and I look forward to the discussion.

goals of care planning

critically ill patients

ICU

specialty palliative care consultation

family support person

primary palliative care delivery

interprofessional ICU team