SCCM Resource Library-Year in Review: Research Section: Recent Lessons Informing Future Critical Care Research

Video Transcription

Good afternoon, everyone, and welcome to the Research Section Year in Review, Recent Lessons Informing the Future of Critical Care Research.  My name is Donna Aranyak, and I've had the privilege to serve as the Research Section Chair this past year.  The topics for this session include the learning health system, after the dust settles, how  do we optimize care for the post-intensive care syndrome patient in the clinic, and improving practices in the ICU, results of the SECM Rapid Cycle Surveys.  The objectives for this session are to explore the technical and ethical challenges of health  systems research, how to choose testable hypotheses and strategies for obtaining institutional  engagement, to describe the putative benefits of a post-ICU clinic and strategies, barriers  and solutions for successful implementation, and evaluate different models being developed for ICU staffing given a shortage of trained intensivist labor, and to compare the costs,  benefits, and limitations of different models for different ICU settings, including the impact on billing, patient safety, and academic concerns. Thank you, Donna.  Today I'm going to talk about the learning health care system. First some disclosures. I have funding from the CTSA, that is for a learning health care system platform, and  that's probably the only one that's actually pertinent to this talk. You can see some other funding that I have there, and then I'm a consultant for three  companies, Cumberland, Avisa, and SidaVale, none of which have anything to do with the learning health care system. What are we going to do in this talk?  We're going to compare and contrast comparative effectiveness versus pragmatic versus explanatory trials. We're going to describe learning health care system pragmatic trials.  And then I'm going to walk through some cases to discuss both advantages and disadvantages of learning health care system studies. So what are pragmatic clinical trials?  Well, there's a spectrum of trials that ranges from clinical efficacy trials all the way to clinical practice, which actually isn't trials, but is actually just the practice  of medicine. And you can see pragmatic clinical trials sort of fall in the middle. They have a number of features.  First, they aim to improve practice, inform policy or decisions, and test new interventions in a real-world setting. They usually involve large heterogeneous study populations.  Their outcomes are simple, clinically collected data, often from the EMR. The study interventions are simple and implemented as part of usual care without needing a requirement  for strict compliance, and the patient or practice randomization is to an interventional usual care versus an other kind of current treatment or usual care.  Explanatory trials test a causal research hypothesis. They're trying to determine efficacy, and that is whether an intervention works under ideal conditions.  Pragmatic trials help users choose between options for care, and they're trying to determine  effectiveness or whether an intervention works under usual conditions in which it might be applied.  There have been some publications about a pragmatic diagram, or PRECIS, which is the Pragmatic Explanatory Continuum Indicator Summary.  And you can rate a trial as to how pragmatic it is based off of this diagram and this figure. You can see there are some things on here that are rateable for pragmatism.  Flexibility of the intervention, practitioner expertise, eligibility criteria, adherence to the interventions, compliance, outcomes, etc.  And when you do this, you can actually get different figures based off of how pragmatic each trial actually is. What about the learning healthcare system?  So pragmatic trials are done within a clinical practice, and that's a learning healthcare system. It's the far right side of this spectrum of trials.  And a learning healthcare system has a similar definition to a pragmatic trial. It is a pragmatic trial embedded within a real world setting of clinical practice.  That's the definition of a learning healthcare system. But you can see that the rest of these bullets are essentially the same as you saw during  a pragmatic trial and how we define a pragmatic trial. Let's look at this a different way. So this is efficacy research and traditional research, and it's separate.  It's distinct from clinical care. You can see it here on the bottom. Clinical care on the top, it kind of runs through, it happens, it runs its own machinery.  Research happens in tandem, but not integrated into it, just in tandem with it and sort of as a separate entity. You take new drugs and devices or existing therapies.  You run them through the research. You get an answer, but often that answer doesn't relate to clinical practice. It's too narrow. It's too long.  It's an overestimate of the benefit or an underestimate of the harm. And so what we're trying to do is find a better way to test existing therapies, and we do  that within a learning healthcare system. Let's look at this a different way. There's arbitrary variation in clinical care.  So you have a patient with a condition and at least two available therapies. If there's evidence for one of those therapies superior for the patient, hopefully the patient  gets whatever evidence, whatever therapy is superior, the evidence shows is superior. If neither therapy is known to be superior for the patient, then there's a somewhat arbitrary  picking of whether the patient gets therapy A or therapy B. This arbitrary could be what the doctor wants, what the insurance pays for.  There could be a number of factors in there, but it's essentially an arbitrary distribution of therapy A and therapy B. The patient still experiences the benefits and the risks of  those therapies because they get those therapies, but the results are not generalizable and not understandable in order to understand which of those therapies is actually better.  And so it doesn't generate evidence that can then be used in subsequent patients as to know which is superior for that patient.  If you take this and you actually make it so that instead of an arbitrary division between therapy A and therapy B, you have a random division between therapy A and therapy B,  then you get the same benefits and risks, but you actually gain knowledge as to which of these is superior.  It's a randomized trial and you get knowledge as to which of these is superior to the others. And this is a learning healthcare system.  So that's as an integration then of research within clinical practice. So you're doing research within the actual clinical practice and it requires everybody be on board.  The patients, the clinicians, the hospital leaders, the biostatisticians, the ethicists, the pharmacists, you name it, everybody has to be on board with this learning healthcare  system concept. You take common treatments for common conditions, you study them within clinical practice, you get generalizable and representative results.  And then you can apply them back to the population. So let me give you some examples of how this is done. This is actually probably our best example of this.  This is the SMART trial comparing balanced crystalloids and saline in critically ill adults.  And as many of you know, balanced crystalloids and saline are both isotonic fluids, but they differ in composition. So saline is all sodium chloride, 154 milliequivalents of both.  Balanced crystalloids are either lactator ringers or plasmolyte. They have less sodium, less chloride, and a little bit of other positive ions, cations,  potassium, calcium, magnesium, and then both of them have an organic anion. Lactator ringers has lactate, plasmolyte has acetate.  In the SMART trial, we took a pragmatic trial design to study these effects. And what we did was we did a cluster randomized multiple crossover trial of adults admitted  to five ICUs at Vanderbilt. And each month, the ICU was randomized to either balanced or saline fluids.  Saline for the medical ICU in June, balanced in July of 2015, saline in August, etc., etc. All five of the ICUs participated.  All five of them had monthly variation in what was the default fluid for that ICU for that month. How did we do this? We did it two ways.  This is our medicine dispenser, it's called a Pyxis. We only put the fluid that that month was randomized to in the Pyxis.  So if it was a saline month, only saline was in the Pyxis, you could still order a balanced fluid, but you had to order it and it had to come up from the pharmacy.  And we did this so that in situations where I said to the nurse, hey, go grab some fluid for this patient, they would get the randomized study fluid.  The other thing we did was we had a practice alert. And so if I would try and order saline in a lactator ringers or plasmolyte month, it  would try and direct me to a balanced fluid, giving me the option of ordering saline if  the patient had any of these outs, hyperkalemia, brain injury, or a specific attending request. So what are the advantages of trials like this?  First you get a large, broadly generalizable patient population. As you can see, in the SMART trial, we enrolled 15,800 patients from all of our five ICUs across the ICUs.  And it's a large, generalizable patient population with almost no exclusion criteria.  You get rapid enrollment, larger sample size, and it's more cost efficient. So here you can see some of the learning healthcare system studies that we've done.  You enroll 15,000 patients in 22 months or 9,000 patients in 12 months. And you can enroll lots of patients in a hurry and at a relatively cheap cost.  So on average from these, we're enrolling 308 patients per month at a cost of about $16,000, sorry, about $3,000 per trial.  So relatively inexpensive and efficient.  And the last one is you get real world results and you can pull data from an automated electronic health data capture. So here are the results of the SMART trial.  You can see that the balanced crystalloids reduced the incidence of major adverse kidney events, which was either death, doubling of your creatinine, or new dialysis while  you were in the hospital. And you can see the different outcomes here compared to saline. This is a clinically relevant difference and clinically applicable difference that can  be applied right to practice.  There are other unique advantages. So you can do a, because you have a large, broad patient population, you can actually  check a heterogeneity of treatment effect for disease subgroups. So here I'll show it to you for patients with sepsis in the SMART trial.  This is actually norepinephrine equivalents. The blue is balanced. The red is saline. And you can see the balanced fluid actually reduces shock and reduces the norepinephrine  equivalents required to treat patients throughout the course of this study.  You can do the same thing with, look at the same thing with lactate levels. Even though this was mostly lactated ringers, balanced fluid resulted in lower lactate levels  than in saline.  What about outcomes? Here are the outcomes, specifically death, a 5% reduction in death by using balanced fluids in patients with sepsis.  And we know these and we have a reasonable number of patients, it's about 800 in this group, because we did a large trial, pragmatic trial in the learning healthcare system.  There's also early initiation of time-sensitive treatment. Well, what does that mean? Well, what we actually did in SMART is that once we got up and running, we coordinated  the emergency department and the operating rooms so that their fluids were the same as the ICUs where they tended to admit patients.  So the ED was coordinated with the medical intensive care unit, the trauma intensive care unit, and the surgical intensive care unit.  The ORs were coordinated with neuro and cardiac.  And what that allowed us to do was instead of in a traditional randomized trial where a patient gets whatever fluid they're going to get in the ED, then they get whatever fluid  they're going to get in the operating room, then they get whatever fluid they're going to get in the ICU, they finally get randomized and enrolled in the trial and they get the  study fluid.  In the learning healthcare system, with the coordination we had, patients got the same fluid throughout their hospitalization.  So they got the trial fluid for all of their fluids that were administered throughout their hospitalization.  Does that matter? Well, here's the difference between the first eight months where we weren't coordinated and the last 14 months where we were coordinated.  And you can see when we weren't coordinated, you don't really see the benefit of balanced fluids, the similar amount of in-hospital death between the two.  But when we're coordinated and patients get the same fluid throughout their hospitalization, you can see this is where balanced fluid appears to be beneficial.  And you can see the actual odds ratios down here for, sorry, odds ratios here for the 30-day hospital mortality for the two periods.  The other thing a learning healthcare system is, it allows you to conduct studies during a pandemic. So what does that mean? So here's recovery.  Recovery actually is a learning healthcare system. It's a large randomized trial of steroids plus standard of care versus standard of care in COVID-19.  It used both academic and clinical hospitals within the UK National Health Services, an open label design, and it did a short training video for site personnel so that they knew  how to do the study procedures, and a short consent form for patients. But it allowed them to enroll up to about a third of the patients with COVID in the whole United Kingdom.  Here are the results. You all probably know these results. These were landmark results that demonstrated that steroids were beneficial for patients  with COVID that were admitted to the hospital, and they even did heterogeneity of treatment  effect with the subgroups for invasive mechanical ventilation, oxygen only, and no oxygen, demonstrating  that maybe steroids weren't beneficial for patients without oxygen, but were for those with oxygen or on mechanical ventilation.  There's also some challenges of learning healthcare system trials. One is consent. How do you do consent? How do you consent 15,000 people in a trial?  There's different ways of doing this. There's waiver. There's deferred consent. There's EFIC. I'm not going to go into details on it, but it always has to be a thoughtful process in  learning healthcare system trials.  There's whether or not you actually test the treatment effect of an agent or a strategy, and I'll show you that in a minute, and fidelity to the interventions.  So here we are for SMART, and you can see that the doctors, the primary team, could actually give the non-study fluid if they wanted to, and it happened a little bit.  Balanced crystalloids in the balanced crystalloid group were most two liters, but there was about 500 cc's of saline, and the same thing to a lesser extent occurred in the saline  group where some doctors chose balanced crystalloids because they thought that's what was best for their patients.  We tested a strategy of balanced crystalloids as the default in the ICU or saline as the default in the ICU.  Here's another way of looking at this. This is the PEPTIC trial by ANZICS, which was a PPI versus an H2 blocker, and you could see the PPI group, these are red, are PPIs.  Most of the patients got PPIs, and then they switched over to H2 blockers, but a lot of mixing of PPIs in the H2 blocker group or H2 blockers in the PPI group, because again,  doctors were allowed to choose what they wanted to do. The other challenge is non-research personnel performing research. So what exactly does this mean?  Well, I explained to you that everybody has to be bought into doing this research because  you're doing it on the backs of the people caring for the patients, and those are respiratory therapists and doctors and teams and nurse practitioners, and in this trial, people,  medics in the back of an ambulance. So this is a trial of early antibiotics in patients with sepsis, and this is a trial  of early antibiotics in patients with sepsis, which you may know that was published in Lancet  Respiratory Medicine, and if you look at the actual numbers, there's 1,500 in the intervention group and only 1,100 in the usual care group.  How did that happen, that there was such a difference? This is from the manuscript. You can see it said, randomization violations resulted in more patients being included in  the intervention group. The probable reason was over-enthusiasm of EMS personnel wanting to treat as many patients as possible with antibiotics.  To achieve this, some EMS personnel purposefully opened envelopes until they found an envelope instructing randomization in the intervention group.  Obviously, this is not good from a rigor of the clinical trial, but when you include non-research  personnel into your research procedures, you definitely are at risk for this occurring, and you have to make sure everybody understands research and understands how to do research  procedures. So let me finish up by going back to the learning healthcare system. The definition by the Institute of Medicine is a healthcare system in which science, informatics,  incentives, and culture are aligned for continuous improvement and innovation with best practices  seamlessly embedded in the delivery process and new knowledge captured as an integral byproduct of the delivery experience.  But there's a second part to this, and this is our mantra in the Vanderbilt Learning Healthcare System.  You have to learn from what you do, but you also have to do, then, what we learn. So how do you do what we learn?  So here's my ICU, the medical ICU at Vanderbilt, and fluid use around SMART. So during usual care, before we did SMART, 60 to 75 percent of our IV crystalloid use was saline.  During SMART, it's about 50-50 because we were alternating months, and you can see the alternating months in these spikes and troughs here.  So it's about 50 percent saline during SMART.  Once SMART was over and we didn't know the results, we reverted to our norm. We actually went higher than our norm. We went up to 75 percent crystalloid use that was saline.  And in fact, we rolled out Epic during the middle of that, and an Epic rollout didn't keep us from using more saline.  Then we got the results, and the results were published, and we actually put our practice alert back into effect.  And you can see our saline use dramatically decreases, and it's less than 20 percent of crystalloid use in the MICU now because we've implemented our findings back into practice.  So what have I tried to teach you in this learning health care system session? Learning health care system trials can improve efficiency of cost and enrollment.  You can enroll big numbers for relatively small costs. Learning health care system studies have many advantages, but they also have some challenges.  And in general, they represent an example of a pragmatic trial platform for comparative effectiveness research that can quickly change practice. Thank you for your time.  Hello, everybody. I'm Carla Seven. I'm the director of the ICU Recovery Center at Vanderbilt, and it's my pleasure to be  here today to talk to you about optimizing care for patients with post-intensive care syndrome.  I do have some modest funding from the Society of Critical Care Medicine and the Department of Defense related to some of the work that I'm going to be discussing today.  And I'd like to start by just making sure that everyone knows what post-intensive care syndrome is or PICS.  Then I'm going to talk about some of our options to prevent, screen, and diagnose post-ICU syndrome with a specific focus on what's new in post-ICU care with a focus  on the literature that came out in 2020. And of course, no discussion of intensive care medicine or post-intensive care syndrome  in 2020 would be complete without some discussion about COVID and the effects that it's had  on our healthcare systems. And then I will just briefly mention some emerging evidence and future directions in this area.  So the post-intensive care syndrome was really a term that was come up with in 2012 by a  group in the Society of Critical Care Medicine to put a name to this constellation of problems that patients were having after a critical illness.  And physicians are probably most familiar with the physical impairments, which include profound muscle weakness and loss, neuropathies, and decrements in pulmonary function.  But there are also significant cognitive impairments affecting executive function and mental processing speed, among other things.  Mental health decrements, including depression, anxiety, and post-traumatic stress disorder.  And the families of these patients are greatly affected and may also be depressed, anxious, and suffering from PTSD.  This population has a high burden of chronic health conditions, which is something that requires our attention as intensivists.  However, this syndrome is not something that we see in just a snapshot, but we are learning that recovery from critical illness really starts in the ICU at the time of critical  illness. And this recovery can be quite long and for many patients may be something that they're living with for the rest of their lives.  So at each transition after the ICU, there's an opportunity for us to intervene and potentially improve recovery for patients.  And these transitions are also quite impactful for patients and for families, which is something that we're still learning about.  Unfortunately, although our specialty, critical care, has been improving and changing over the past 30 or 40 years, our interest in ICU survivor outcomes has leapt ahead of our  evidence about what to do for these patients and families. You can see on the left-hand panel here, all critical care citations in the solid line  and randomized controlled trials in the dotted line here, sort of keeping pace a little bit lower.  ICU survivor outcomes, there's a lot of interest as expressed by publications, but randomized  controlled trials or the gold standard evidence of what to do for these patients is lacking.  Absence of evidence, however, is not evidence of absence. There's clearly a problem that begins with the critical illness in our space, the ICU.  And patients and families tell us that there should be some option to go back to have some closure to the care that they received in the ICU.  This is from a qualitative study by Joe McPeak et al. And as one patient said in that study, yes, I'm glad to be alive, but also I have these  other problems that people are just kind of ignoring. And in 2020, the Society of Critical Care Medicine did publish this international consensus  conference on prediction and identification of long-term impairments after critical illness,  which in summary agreed that the prediction of post-ICU problems and providing some anticipatory guidance to survivors of critical illness are tasks that we need to take on  as ICU researchers and clinicians.  So what can we do? There are many things that are already being done. And most patients who survive a critical illness, if they get any aftercare, will receive that  aftercare in the primary care setting. But there's emerging popularity of these post-ICU recovery clinics, which are often  multidisciplinary, and many of these were pushed into existence by COVID.  The COVID pandemic has also pushed forward the use of telemedicine in general and for this population in specific.  And several of these post-ICU clinics also integrate or have adjacent to them peer support as a way to improve recovery for patients after critical illness.  But as we learned from this qualitative study, which was published by Haynes et al. in 2019, there are significant barriers to creating post-ICU aftercare programs, and I'm going  to touch on some of these with the emerging literature today. Lack of funding has been an issue, lack of recurring space, identifying which patients  might benefit from post-ICU services, and then actually having patients and family attend these services have all been identified as barriers to providing this type of care.  But I think for those of us who are interested in post-ICU care, we also have to acknowledge that we have a long way to go, even within the realm of critical care, in raising the  awareness of post-ICU problems. In this study that was published in Australian Critical Care in 2020, Rye et al. noted that  of a survey of 198 ward clinicians, so these were clinicians who were taking care of patients  after they left the ICU, fewer than half of the respondents, 44%, were even familiar with the term post-intensive care syndrome.  Encouragingly, however, 66% expressed a desire for more training and education around the ongoing health concerns of ICU survivors.  So there's a lot to be learned, but I think the medical community as a whole, and intensive care clinicians in specific, are really interested and engaged in this problem.  So also from the consensus conference, there was this table which sought to identify whether we can predict which patients will suffer from post-intensive care syndrome, and there  are certainly characteristics of the patient that can be identified before critical illness during the critical illness, and after the critical illness that may correlate with a  higher risk of post-intensive care syndrome in these three domains of cognition, mental health, and physical function.  So if you're very frail or you have pre-existing cognitive dysfunction, for example, you're likely to have post-ICU problems, memories of frightening experiences in the ICU predict  post-ICU PTSD, for example. These are some of the things that we can look at to try to predict which of our patients would benefit from post-ICU services.  So if we have these post-ICU services, which tools can we use to actually diagnose post-intensive care syndrome?  There was a strong consensus or recommendation from the consensus group that the use of Montreal  Cognitive Assessment Test is quite useful for diagnosing cognitive deficits after post-ICU, after an ICU stay.  The Hospital Anxiety and Depression Scale, or HADS, is widely used to diagnose anxiety and depression.  And then there was less agreement, but still widespread use of, for example, the IES-R, the abbreviated IES-6, that's the Impact of Events Scale, for diagnosing or screening  for post-traumatic stress, and then the use of the six-minute walk to gauge physical function. EQ-5D is also an assessment of mobility and self-care, as well as activities of daily  living that can be used in the post-ICU setting. So this is a paper that came out from the CAREN study, the Collaborative Assessment of ICU Recovery Needs Study.  Joe McPeak was the first author on this one as well, and it identified some of the components  of an ICU recovery program that are in existence for those centers that have ICU recovery programs.  Care coordination, the provision of educational materials, goal setting, being multidisciplinary,  expectation management, and socioeconomic assistance for patients and their families were all heavily highlighted in these programs.  And I think it's worth noting, again, from the CAREN study, this concept that not only can we help patients with post-ICU programs, but we can help ourselves with post-ICU programs.  So assessing post-ICU programs and seeing patients after the ICU stay actually drives improvements back into the ICU, and this may take the form of quality improvement, improving  morale of staff, which is especially important now during the pandemic, identifying roles for survivors, and helping us understand patient experience.  I encourage you to look at this paper. There's another figure, which I didn't have time to put in today, that details some of  the other benefits or mechanisms by which improvements can be made in the ICU based on ICU aftercare programs.  And this is, you just heard from Todd Rice about learning health systems. This was a study that utilized that program here at Vanderbilt looking at hospital readmissions  after critical illness, and these patients were randomized to receive either an ICU recovery bundle, which included an invitation to join the clinic, but also education given prior  to discharge and a hotline for patients to call if they encountered problems before their first follow-up visit.  And it's quite faint here, but you can see that there is a separation here in between the dotted line, which was the patients who received the ICU recovery bundle and patients  who received usual care in terms of readmissions with a decrease in readmissions seen especially in the early post-hospital period, which is a time we know is fraught for problems  for these complex patients. And there's also emerging evidence that just came out in 2020 that these clinics can be cost effective.  This is a paper out of Geisinger that has quite a comprehensive multidisciplinary team clinic model that is case management heavy.  So the nurse case manager has frequent contacts with the patient and family by phone even before their multidisciplinary clinic visit.  And since Geisinger is self-insured, they were able to estimate that even accounting for the time and cost of the staff and resources that went into the clinic, the estimated annual  cost savings for this population was between $250,000 and $423,000 per year. And this was also associated with decreased mortality in the intervention group.  So what has COVID-19 wrought? We certainly have seen shifts in our critical care and how we provide critical care, how we're able to provide critical care for these patients.  We're seeing an increased use of sedation, increased use of benzodiazepines, which we had been trying to get away from for many years, longer times on the ventilator, decreased  ability to mobilize patients early in the ICU stay, minimal family visitation, if any, in many settings. And of course, our resources and our staff have been very stretched.  This is an illustration on the right here from Beer and Kamdar. This was not a 2020 paper, but this was a pre-COVID study of mobility and activity in the ICU.  And this bottom B panel is a 24-hour epic of ICU patients compared to a normal control here in the A panel.  And you can see how little our patients were moving even before we were suffering from the impacts of the COVID-19 pandemic. So a lot of work to do there.  And as I mentioned, seeing patients in the post-ICU arena can teach us a lot, even pre-COVID. But now we're faced with this new disease, and it's more important than ever that we  see these patients to learn what the natural history is of COVID-19. And we're starting to see some early outcomes from post-ICU clinics that is teaching us a lot about COVID-19.  This is a study from the University of Virginia, which followed a consecutive series of post-COVID, post-ICU patients.  And this is an illustration of their cognitive evaluations, which you, I think, can see are quite abnormal. And I'll encourage you to read that case study.  It's quite an impressive effort considering that many of their patients were also uninsured and did not speak English as a primary language. This is another example.  This is a case series of two cases of neuralgia parasitica that were diagnosed in a post-ICU clinic in San Diego. Amy Bellenhausen is the first author here.  And they were able to use this knowledge they learned from their post-ICU clinic to improve their care in the ICU and adjusted their proning techniques to avoid further injuries  like these in their ICU patients who were being treated for COVID-19. There are several more projects in the works.  The APICS study, which is addressing post-intensive care syndrome funded by the Department of Defense, which predated COVID and had just finished enrolling for patients with acute  lung injury or finished enrolling during COVID, has been extended for a COVID-specific outcome study.  This is a study looking at outcomes and recovery after COVID patients who were treated with ECMO. And another study that started before the pandemic to look at telemedicine as a way  to deliver a post-ICU intervention, and that is continuing to enroll COVID patients as well. And this study is being led by one of our surgical residents here at Vanderbilt looking  at the effects of limited visitation on our ICU care. So many interesting things that we have to learn still.  Many of these things being pushed forward for better or for worse by COVID-19. I thank you for your attention, and I'd like to thank the Vanderbilt ICU Recovery Center  and the Sibb Center at Vanderbilt, as well as these funders for their support. Thank you.  Hi, my name is Ruth Klinepell, and I'm delighted to be joining this Society of Critical Care Medicine 50th anniversary.  This session is on Year in Review for Research, and I'll be presenting today on some ongoing  surveys that have been sponsored by the Society of Critical Care Medicine and a special work  group that was formed to really look at evolving impact of the pandemic to ICU clinicians. So I have no specific disclosures related to this presentation.  But as I indicated, when the pandemic began in March, the Society of Critical Care Medicine identified the opportunity to launch a series of surveys to members of the organization,  as well as to members of the Critical Care Societies Collaborative, which is representing the four national critical care societies in the U.S.  The American Thoracic Society, the American College of Chest Physicians, or CHESS, the American Association of Critical Care Nurses, and then SCCM.  So we had an interprofessional work group that was formed, and we worked with SCCM. I do want to acknowledge the work of Laura Lewis from SCCM, who helped us with survey  distribution, as well as with Vanderbilt University for assistance with data review. Collectively, we have launched a series of four surveys to date, and over 14,000 ICU  providers have responded to those rapid cycle surveys, predominantly nurses. So we do have to have a shout out to the American Association of Critical Care Nurses, who has  quite a large membership, but also helped us to promote the survey among members of their organization as well.  But in addition to nurses, physicians, pharmacists, respiratory therapists, and advanced practice  providers, including nurse practitioners and physician assistants, were respondents to the surveys. The first survey was launched early during the pandemic in March.  From March 18th to March 25th, the survey was open, and it was a web-based survey that was developed by the work group.  The survey really looked at clinicians' perspectives on how prepared they were to manage the pandemic as it really was evolving.  So this was the first survey, and this was early on in the pandemic. So we had over 4,000 respondents to this first rapid cycle survey, representing nurses, physicians,  advanced practice providers, respiratory therapists, and pharmacists. We also have to acknowledge the American Association for Respiratory Care that also disseminated  the survey to their members, helping us to get responses from respiratory therapists as well.  So at that time in March, just over half of the respondents had cared for a COVID-19 patient.  And with respect to settings, it represented a majority of community hospitals, settings  of ICUs, as well as metropolitan, but we had a variety of respondents from different settings.  In terms of concerns related to caring for COVID-19 patients, a majority of the respondents at that time in early pandemic highlighted that ICU resource shortages were a concern,  followed by staffing, concerns about patient surge capacity. And remember, just over half at this point in time had cared for a COVID-19 patient.  And so many of the respondents were in preparation stages within their ICUs, but certainly looking  at concerns among clinicians with respect to helping to manage these patients within their ICU, and then reflecting what we had seen reported nationally in terms of shortages  of not only equipment, but PPE, as well as staff. With respect to anticipated shortages of personal protective equipment in the ICU, a majority  identified that it was very likely that within their ICU they anticipated a shortage at that point in time.  In terms of preparedness, these responses identified that a majority had identified they had concerns related to caring for a COVID-19 patient.  This again was in early March, and so looking at how to manage these patients, what was the appropriate treatment, how to prepare best within the ICU, how to manage COVID-19  patients and cohort them. Many ICUs had not developed COVID ICUs at that time or were in the process of doing  so, and so the responses reflect concerns about adding critical care capacity as well.  So the second survey was then launched, and this survey was really focusing on the perspectives  of ICU clinicians on the continuing challenges to care, and this was launched during April. And so this again was looking at the current situations within ICU in terms of resources  as well as demands and personal stress that clinicians were experiencing. So as reflected in the prior surveys, a majority of the respondents were bedside nurses, which  gave us a really good idea of what was being experienced by frontline providers as well  as other providers at the frontline, physicians, therapists, respiratory therapists, pharmacists, and advanced practice providers.  At this point in time, I noticed this was a month later, up to 88% had at this point in time cared for a patient with suspected or confirmed COVID, and as reflected here,  we did have a geographic response that paralleled where the pandemic surges were occurring at this point in time in the United States.  And of the 9,000, over 9,000 respondents, they identified a number of important, what they identified as important needs for continuing to manage patients, including, of course,  PPE equipment, adequate staffing, looking at certainly the lab time testing, which was a concern overall, not only having adequate access to lab testing, but the turnaround  time that it was taking, keeping up with information that was evolving in terms of best strategies to manage patients within the ICU, followed by a number of other concerns  with respect to even ventilators, having to use non-ICU staff, and the training that was required to have them managing patients in the ICU, receiving support on an ongoing basis,  and ensuring that there were adequate supplies as well as staffing for patients within the ICU.  Other challenging aspects that were identified in terms of most challenging aspects was really  looking at staff safety to ensure personal safety, as well as concern about transmitting to family members, followed by ones that we know continue today, adequate staffing in  ICU, and looking at managing patients with respect to the care that they needed, as well as ensuring that proper technique was being used for patients, and that decision-making  with respect to available resources was being made. So a variety of concerns at that point in time.  So that was followed by our third rapid cycle survey that was conducted in July over a three  week period, and this survey focused on surge capacity, as well as the adequacy of ongoing supplies and staffing within the ICU.  This also focused on the care that was needed for patients, evolving updated best practices with respect to mechanical ventilation, and proning positioning was reflected in this  survey as well. Patients across the board, again, majority were nurses, but we had representation from all types of the frontline providers within the ICU.  And of interest was that we now see 78% had cared for a patient with suspected or confirmed COVID.  So in July, obviously, clinicians had more knowledge with respect to caring for these types of patients within the ICU.  Some of the concerns that were reported remained significant increases in staffing of all types  of providers with respect to ensuring adequacy of care for patients in the ICU, making modifications  within the ICU team with respect to not only helping with such things as donning and doffing, but also looking at who would be managing care in the ICU, and many academic medical  centers were limiting the types of providers who are caring for patients so that residents, fellows, other nurse practitioner students, and et cetera, were not directly involved  with these patients, but experienced staff as well. Many ICUs at this time had developed a specific COVID ICU or area that had dedicated staff,  and certainly this helped with caring for patients to provide consistency in care. Others reported that they were making more space from other units to expand their ICU  capacity, and then certainly looking at the continued need for ventilator support and having to secure additional ventilators to care for patients, especially in those areas  that were continuing to have surges. And I do need to highlight SCCM's COVID-19 resource page on their website that has the  results of these surveys posted, as well as many additional resources for ICU clinicians. So our fourth survey was just launched in December, and it will extend into January.  This survey is focusing on family-centered care practices and clinician wellness in the ICU, and obviously if you are seeing this and it's within the timeline, we encourage  you to respond to the survey, but we know by the time that Congress evolves and majority see the presentation that we'll have the results at that point in time, and certainly we'll  be communicating those through the SCCM website, as we're particularly concerned about the impact that the ongoing pandemic has had on family-centered care practices.  We know that many ICUs have had to limit visitation, alter visitation, utilize a variety of telehealth  communications, and looking at the impact that that has had is certainly something that we continue to monitor, as well as the impact on clinicians in terms of how they are managing  the ongoing, their ongoing well-being during this time. So sharing strategies that organizations have implemented and that clinicians have found  beneficial will certainly be valuable for the critical care community. So in summary, this session just highlighted an overview of the results of the rapid cycle  surveys that were conducted during the pandemic by the Society of Critical Care Medicine workgroup,  and in terms of looking at the results, certainly looking at strategies that were used to address  ICU care, such things as surge demands, other aspects of care can help other ICUs that may  not have peaked in their surge. And certainly, we know that because of the ongoing pandemic, we need to ensure adequacy for ICU clinicians with respect to supplies and staffing and  leadership supports and emotional support to frontline staff. Here in Nashville, our local newspaper called the Nashville Scene actually dedicated the issue in December to frontline  healthcare workers, identifying them as the 2020 Nashvilleians of the Year. So it was great to see  that our ICU clinicians in our COVID ICU were highlighted. So a shout out to my colleagues  that are working on a daily basis for all of the care that they've been providing, and certainly  looking forward to sharing strategies that we have found useful as we continue to combat the pandemic.  So I look forward to participating in our discussion time during the ongoing Q&A session  for the Congress this year. I'll miss seeing many friends and colleagues at the conference this year, but I'll look forward to hopefully being live the following year in 2022.  So thanks so much. I appreciate the opportunity to present in this session. Thank you.

Video Summary

The Research Section Year in Review session focused on the future of critical care research and covered various topics such as the learning health system, post-intensive care syndrome, and improving practices in the ICU. The session aimed to explore the technical and ethical challenges of health systems research and how to choose testable hypotheses. It also discussed the benefits of post-ICU clinics and strategies for successful implementation. The session highlighted the importance of evaluating different models for ICU staffing given the shortage of trained intensivists and compared the costs, benefits, and limitations of different models. The presentation on the learning health care system explained the concept of pragmatic trials and how they aim to improve practice, inform policy, and test new interventions in a real-world setting. The speaker also discussed the benefits of learning health care system trials, such as large, broadly generalizable patient populations, rapid enrollment, and real-world results. The presentation on post-intensive care syndrome emphasized the need for aftercare programs to support patients and families in their recovery from critical illness. The speaker discussed the challenges in implementing post-ICU clinics, such as lack of funding and space, and highlighted the importance of raising awareness about post-ICU problems among clinicians. The presentation on improving practices in the ICU presented the findings of rapid cycle surveys conducted during the COVID-19 pandemic. The surveys highlighted the concerns and challenges faced by ICU clinicians, such as resource shortages, staffing issues, and the need for ongoing support and training. Overall, the session provided valuable insights into the future of critical care research and the importance of optimizing care for critically ill patients.

Asset Subtitle

Research, 2021

Asset Caption

The Society of Critical Care Medicine's Critical Care Congress features internationally renowned faculty and content sessions highlighting the most up-to-date, evidence-based developments in critical care medicine. This is a presentation from the 2021 Critical Care Congress held virtually from January 31-February 12, 2021.

Learning Objectives

Explore the technical and ethical challenges of health system research, how to choose testable hypotheses, and strategies for obtaining institutional engagement
Describe the putative benefits of a post-ICU clinic and strategies, barriers, and solutions for successful implementation
Evaluate different models being developed for ICU staffing given a shortage of trained intensivist labor
Compare the costs, benefits, and limitations of different models for different ICU settings, including the impact on billing, patient safety, and academic concerns

The Learning Health System
Todd W. Rice

After the Dust Settles, How Do We Optimize Care for PICS Patients in the Clinic?
Carla M. Sevin

Improving Practices in the ICU: Results of SCCM's Rapid Cycle Surveys
Ruth M. Kleinpell

Meta Tag

Content Type Presentation

Knowledge Area Research

Knowledge Level Intermediate

Knowledge Level Advanced

Membership Level Select

Tag Clinical Research Design

Tag Outcomes Research

Year 2021

Keywords

critical care research

learning health system

post-intensive care syndrome

ICU practices

post-ICU clinics

ICU staffing models

learning health care system trials

aftercare programs

	Society of Critical Care Medicine 500 Midway Drive Mount Prospect, IL 60056 USA Phone: +1 847 827-6888 Fax: +1 847 439-7226 Email: support@sccm.org	Contact Us About SCCM Newsroom Advertising & Sponsorship DONATE	MySCCM LearnICU Patients & Families Surviving Sepsis Campaign Critical Care Societies Collaborative	GET OUR NEWSLETTER
© Society of Critical Care Medicine. All rights reserved. \| Privacy Statement \| Terms & Conditions The Society of Critical Care Medicine, SCCM, and Critical Care Congress are registered trademarks of the Society of Critical Care Medicine.