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Host Elizabeth H. Mack, MD, MS, FCCM, is joined by John Lin, MD, to discuss the transformative impact of the ICU Liberation Bundle (ABCDEF) on caring for critically ill children. This episode delves into the Pediatric Critical Care Medicine article, "Caring for Critically Ill Children With the ICU Liberation Bundle (ABCDEF): Results of the Pediatric Collaborative," exploring the implementation, outcomes, and the potential for enhancing pediatric ICU care (Pedtr Crit Care Med. August 2023; 24(8):636-651). Dr. Lin is Associate Professor of Pediatrics, Critical Care Medicine, and Service Chief for Respiratory Failure and Sepsis in the PICU, as well as the Medical Director of Respiratory Care at St. Louis Children’s Hospital in St. Louis, Missouri.
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Transcript:
Dr. Mack: Hello and welcome to the Society of Critical Care Medicine Podcast. I’m your host, Dr. Elizabeth Mack. Today we’ll be speaking with Dr. John Lin, and we’ll be talking about the article, “Caring for Critically Ill Children With the ICU Liberation Bundle (ABCDEF): Results of the Pediatric Collaborative,” published in August 2023’s Pediatric Critical Care Medicine. To access the full article, visit pccmjournal.org. Dr. Lin is an associate professor of pediatrics in the Division of Pediatric Critical Care Medicine at Washington University School of Medicine in St. Louis, Missouri. He is the PCCM fellowship program director and also serves as the medical director for respiratory care in St. Louis Children’s Hospital. Welcome, Dr. Lin. Before we start, do you have any disclosures to report?
Dr. Lin: I don’t have any relevant disclosures, but I do want to say thank you to you, Dr. Mack, as well as the Society of Critical Care Medicine for this opportunity to talk about our results and to continue to emphasize and disseminate the importance of PICU Liberation as an initiative in our field.
Dr. Mack: Awesome. Thank you so much for this important contribution to the literature. I really enjoyed digesting it myself. Just a few questions for you. It looks like this all started with an RFA from SCCM. Can you tell us a little bit about those early days in 2015, how you identified the eight sites, and what that looked like back then?
Dr. Lin: Sure, I’m happy to go over that. There were actually nine sites originally that responded to SCCM’s RFA, something I learned when I joined an ICU Liberation leadership meeting back in June 2015 at SCCM headquarters. This meeting was the first time I had met the adult ICU Liberation pioneers, Dr. Wes Ely, Dr. Brenda Pun, Dr. Michele Balas, Dr. Mary Anne Barnes-Daly, Dr. Juliana Barr, John Devlin, Joanna Stallings, Pat Posa, Heidi Engel, and the entire SCCM team. It was really a little bit surprising that I got invited, and I can’t really understand still why they chose me to come, but I’m super happy that they did.
When Wes and everyone had applied for the Gordon and Betty Moore Foundation grant, pediatric ICU participation wasn’t part of the original plan. But in response to this RFA, they got nine applications from pediatric facilities, and it clearly demonstrated an interest and support for a pediatric component of this initiative, and this opportunity was just too good to pass up when Wes and everyone were talking about it. It was decided during this meeting that all nine pediatric sites should form a separate pediatric collaborative, and PICU Liberation was born.
Unfortunately, one of the sites had to drop out because of institutional concerns about sharing patient data with SCCM even though it would be de-identified, and that’s how the PICU Collaborative became eight centers. I’m still not entirely sure how the money was allocated to support our pediatric group because my understanding was that the Moore Foundation grant was targeted and spoken for by all of the adult facilities that were participating, but I’m pretty sure that SCCM basically underwrote us, and I’m so grateful to them and our adult colleagues for including us.
It’s interesting to remember that 2015 really was, in my mind, a tipping point for bringing ICU Liberation into the PICU. Martha Curley’s RESTORE paper had just come out in JAMA in January, looking at the impact of protocolized sedation on duration of mechanical ventilation and incorporating a standardized approach to extubation readiness test. Heidi Smith and Wes Ely at Vanderbilt were building on their experience, adopting a delirium screening tool for pediatrics in the form of the pCAM- and psCAM-ICU tool. Chani Traube and Gabrielle Silver at Cornell had just published the CAPD screening tool in March of 2014, following up in May of 2015 with their single-center description of pediatric delirium prevalence and risk factors.
At the same time, Karen Chung at McMaster University in Ontario and Sapna Kudchadkar at Hopkins were leading the way in showing us all that early mobilization could be achieved even in the intubated child. So, really, as a field, we were beginning to appreciate the tremendous potential impact that PICU Liberation and the A-F Bundle applied to children could have on critical care outcomes. As a peds collaborative, we took it upon ourselves to think about how to adapt and adopt the adult approach to children of all ages and developmental stages.
We had to consider that a four-month-old couldn’t use words to report pain or anxiety and that a toddler certainly didn’t have the cognitive capacity to exercise executive function and understand that the endotracheal tube in their throat was there to help them. On top of that, at the time our field’s approach to the intubated patient had really been to keep them sedated, thinking that this was the only way to keep them safe, prevent unplanned extubations, and limit the negative psychological impact of being in the PICU.
So not only did we have to develop pediatric-specific approaches, we had to overcome a lot of entrenched practice in the PICU and understand the barriers and facilitators to implementing this bundle of care, get buy-in from all of the stakeholders, and consider the best implementation approaches that would lead to sustained improvement. That was a big task and, in retrospect, if we had known all of those challenges, I think it would have been even more daunting than it already was.
Dr. Mack: Well, thank you so much for that trip down memory lane. It sounds like quite a heavy lift, but I think the ripple effect has hit many units across the country so I really appreciate the leadership of the collaborative and all those who laid the groundwork before that. As you were doing this simultaneously alongside the adult collaborative, just curious, what did those conversations look like? Were you all seeing similar results? As we all know, children are not little adults, so we’d love to hear about that.
Dr. Lin: Sure. I think, in retrospect, we missed a tremendous opportunity to learn from the adult centers who were doing this at the same time. Because we separated out the pediatric facilities to form its own collaborative, we became kind of a little bit siloed and in some ways separate from everything that was happening on the adult side. Up until our experience with COVID, there really was a perceived chasm between a PICU and an adult ICU with respect to both the types of diseases seen and the way in which care is delivered.
So there wasn’t a lot of crosstalk in terms of, how do you take care of a sedated intubated infant and allow them to be more awake without increasing the risk of them pulling their tube out or just looking so distressed that it would create challenges among everyone who is taking care of them? But since COVID, we know that critically ill patients benefit from the same interprofessional team collaboration that lies at the heart of successful ICU and PICU Liberation implementation regardless of the patient’s age or reason for being in the ICU.
We know that now, and COVID really gave us the proof of that, that we could make this happen, that pediatric specialists within the field of critical care could take care of critically ill adults and vice versa, with guidance, of course, because the underlying disease presentations are different. But this idea of everyone working together, getting on the same page, setting shared goals really applies in both environments.
But back in 2015, given the level of understanding and acceptance of PICU Liberation as an attainable approach for caring for critically ill kids, I think it was the right thing to do to have all the peds sites form a separate collaborative. We certainly learned from each other’s PICU experiences, but I do wonder how an adult ICU team working through similar struggles of implementation could have helped us.
At the same time, would we have truly appreciated the fact that the lessons learned in an adult setting held value for us? Or would we have thought that the normal range of cognitive and developmental stages seen across the entire pediatric age range would just make it too different from what our adult colleagues were dealing with? It’s a question that I don’t have an answer to, but I do think that perhaps we could have leveraged a little bit more how each of the participating adult sites were addressing these challenges. There certainly was a lot of conversation among the ICU Liberation leadership and our PICU Liberation Collaborative leadership, but all of the learning calls, all of the resources were really just pediatric specific and shared among our eight participating sites.
Later on, we certainly were inspired by Mary Anne Barnes-Daly’s 2017 paper describing the influence of ICU Liberation applied across seven California community adult ICUs. She showed that bundle implementation had a dose response and that increasing bundle compliance reduced mortality, reduced incidence of coma and incidence of delirium. Then the follow-up paper based on the adult ICU collaborative that had over 15,000 adults, a number that just doesn’t seem to ever be attainable in the pediatric side. Her paper in 2019 showed similar dose response effects of ICU Liberation.
Dr. Mack: Well, thank you for that, and it is quite interesting to think about how COVID really changed the way that we interact with the adult world and how many of us became little adult ICUs, so I appreciate that perspective. Can you tell us a bit about your primary independent variable for all of your correlation analysis being bundle utilization percent?
Dr. Lin: Sure. We took that approach, really modeled after the way in which Mary Anne and Brenda approached their adult analysis. While an incredible amount of time and resources were devoted to implementing each bundle element across our eight centers, we wanted to really focus on the clinical impact because what we needed to demonstrate was that there was a clinical impact to provide some evidence to all of the work that was ongoing rather than relying on, in some ways, faith that this was the right thing to do.
There has been a ton of literature talking about individual bundle elements or individual centers approaching this. But as a scaled-up model of implementing this simultaneously across eight centers, ours is the first report. We focused then on four clinically relevant outcomes of interest, and our exposure variable became the bundle utilization percent looking at PICU length of stay, duration of invasive mechanical ventilation, delirium incidence, and mortality.
We chose these four because we felt that they represented truly impactful clinical outcomes that were meaningful. We looked at bundle utilization percent for each individual PICU day as well as then the entire PICU stay for each patient. This allowed us to assess both how bundle utilization over the entire PICU course correlated with our four outcome measures and how each day’s bundle utilization correlated with those same four outcomes on the following PICU day.
Dr. Mack: Thank you so much. It sounds like quite a lot and thankfully there was a model from the adult world to lay that groundwork. In several cases, bundle utilization dropped in this four- to seven-month implementation period of the 11-month total study period. What are your thoughts on this? Why do you think this was the case?
Dr. Lin: That’s a great question. Just to clarify for our listeners, we had a total study period of 11 months, and we divided this 11-month period into three separate periods. The first three months, we considered as baseline or pre-implementation before each of the sites began rolling out new initiatives based on the A-F Bundle. Then the eight-month implementation period, after efforts began, we divided into the first four and the last four implementation months.
Looking at all six bundle elements, it was bundle elements E and F that had a lower utilization rate in the first four intervention months compared to the three baseline months. Bundle element C didn’t see any change in utilization across any of the three study periods, while the other three elements, A, B, and D, all saw a stepwise increase in utilization from pre- to initial to final implementation months. Why we saw a dip in E and F utilization during the first four implementation months when compared to pre-implementation isn’t clear to me.
We were really focused on the clinical outcomes and bundle utilization, so we missed an opportunity to collect granular data about how each center conducted their own implementation efforts using rigorous mixed-methods approaches, so I can’t say. I can hypothesize, but I would just be guessing. I think it demonstrates that large-scale implementation efforts can have unintended consequences, and truly understanding and picking out the details of how implementation efforts translate into performance is a key step of moving forward in our understanding of not just ICU Liberation and PICU Liberation, but care in general as it’s delivered in the PICU.
Dr. Mack: Thank you so much for that. Your group had some interesting findings related particularly to mortality. Can you share with us those results in a nutshell?
Dr. Lin: Sure. Briefly, we did not see an association between bundle utilization, either the day-specific or the subject-specific, on three of the four clinical outcomes of interest, specifically, ICU length of stay, duration of mechanical ventilation, and delirium incidence didn’t have a correlation with differences in bundle utilization. We did, surprisingly, see this association between increasing bundle utilization and decreased mortality odds ratio for both day- and subject-specific analyses. For each patient, a 10% increase in bundle utilization across the entire PICU stay, the subject-specific analysis, correlated with a 34% reduction in mortality odds ratio. This dose response was really surprising and quite tremendous.
In fact, even a day-specific analysis showed that a 10% increase in bundle utilization on any given day correlated with a 1.4% reduced odds ratio of death on the following day. While certainly unexpected, this tremendous association suggests that what we do on any given day, in addition to what we do over the entire PICU course, really matters. Understanding why we see that association is really the future work that has to happen. It’s also not clear why we observed this association with odds of mortality without seeing a similar correlation with the outcomes that would seem to be closely tied to mortality.
This disconnect certainly raised several questions for us that we talk a bit about in our discussion and it forces us, I think, to be skeptical about our observed association between bundle utilization and reduced mortality. A possible explanation could be that each successive day of survival allowed the team to have another day’s opportunity to utilize each bundle element, and with each successive day of PICU stay, perhaps the teams became more attuned to ensuring utilization of each bundle element on that and each successive day.
In this scenario, survival would be actually the independent variable that influenced increased bundle element utilization. To really understand this, we need to turn to methods that allow us to really understand how teams make decisions, how care and workflow influence the next day’s efforts. We can turn to systems engineering and human factors analysis as separate fields from, specifically, medicine to find ways in which we might begin to understand this better.
Dr. Mack: Thank you so much. It’s interesting to think about the time period of the collaborative and all that has happened since then. Just curious, what’s happened to the collaborative and to these efforts in general since 2017? Do you know, have their results been sustained? Certainly this topic, I know, has caught on like wildfire across the country.
Dr. Lin: Yeah, for sure. I think that the work that the PICU collaborative invested in has translated into the pediatric-specific component of SCCM’s overall ICU Liberation initiative. Since 2017, ICU Liberation has been a standing committee for SCCM. Every year since then, there’s been both a pediatric and an adult cochair. I think it’s one of the only committees within SCCM that has that division or that combination of both pediatric and adult expertise built into the way in which the committee is structured.
This permanent presence at a national level has been a key component, I think, of sustaining momentum across our field. The growing body of literature describing current practice, implementation approaches, and the short- and long-term impact of various elements of the A-F Bundle has been tremendous. A couple of just even recent examples: the 2022 PANDEM guidelines that detail approaches and best practice recommendations for dealing with pain, agitation, delirium, neuromuscular blockade, early mobilization.
This year’s PALISI group published practice guidelines for pediatric ventilator liberation, and then all of the ongoing investigations into pediatric delirium risk factors and associated morbidity are continuing to contribute to the literature. Sapna Kudchadkar’s current PICU Up! stepped-wedge trial is looking at the ability of a multifaceted strategy to optimize early mobility and evaluate the impact on mechanical ventilation duration, delirium incidence, and functional outcomes.
All of this work really is focusing on various combinations or individual elements within the overall bundle, but all of it really comes down to this idea of what we created as our original vision and mission statements for our work. When we started the PICU Liberation Collaborative, we created a vision and mission statement. Our vision was to allow every PICU patient to resume pre-illness quality of life and developmental progression as soon as possible after PICU and hospital discharge, assuming that the reason for PICU admission didn’t lead to permanent changes in neurocognitive or physical function.
Our mission statement then was to leverage each center’s areas of expertise, success, and experience to identify best practices for the A-F Bundle that met and continue to meet the broad range of physiologic, neurocognitive, developmental, and disease-specific characteristics that are seen in critically ill children. So, while the PICU Liberation Collaborative as a stand-alone group isn’t meeting any longer, I think that it’s really expanded beyond our eight centers to include most, if not all, PICUs across the country. As we talked about before we started recording, I think that every single center is really looking at how to incorporate some or all of the tenets that underlie PICU Liberation.
Dr. Mack: Thank you so much. I certainly think this work was a catalyst for much that we’re seeing across the country. Is there anything else you’d like to share with our listeners today?
Dr. Lin: Sure. I really just want to express my gratitude and thanks. I wanted to thank all the people who made the PICU collaborative possible, our adult colleagues who led the way and inspired us to think about what was possible. SCCM has really been the common thread that’s held us all together, and I really am in awe of the dedication, the commitment, and all of the efforts, not just our eight center teams have demonstrated, but all of the people who work in the PICU have demonstrated.
All the professionals out there who are continuing to increase our understanding of the clinical impacts of the bundle elements, how those bundle elements impact both immediate- and long-term PICU outcomes, and all the people who are trying to figure out the best implementation strategies and define what the best practices are. All of these collective efforts, in my mind, are the way we will continue to move the needle on reducing all of the morbidities our patients accrue during a PICU admission and also limiting the challenges that they have to overcome after they go home.
Dr. Mack: Thank you so much for challenging the notion that these morbidities are part of the cost of care, and I really appreciate the collaborative’s efforts in putting together all of this work, this publication, and to you for sharing today with us. This concludes another episode of the Society of Critical Care Medicine Podcast. If you’re listening on your favorite podcast app and like what you heard, consider rating and leaving a review. For the Society of Critical Care Medicine Podcast, I’m Dr. Elizabeth Mack.
Announcer: Elizabeth H. Mack, MD, MS, FCCM, is a professor of pediatrics and chief of pediatric critical care at Medical University of South Carolina Children’s Health in Charleston, South Carolina, USA.
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