Dr. Mehul V. Raval - Enhanced Recovery in Children Undergoing Surgery

wait and i har alright so one of we do ahead start a nuisance the top the hour so first of all good wondering. I my welcome you to combine of surf mi n чи grasp around my pleasure. If the did not get one person but we are dear looking forward to its presentation today. Many of you know we established this lecture, a several years back to really highlight individuals who have made a huge impact even the way we kind of think about surgical care or actually let the changes in the surgical care and those that have really kind of transcended surgical disciplines as well as the industry as well. And so today we're going to hear about the evolution and the implementation and the promise of an answer recovery protocols, which we all know is a super hot topic, not only breast insurgents but also for our anesthesia colleagues as well. Now this is an area where a doctor revolves really established himself as a national authority not only in terms of expertise but also as clinical investigation as well as what really looked forward to his talk. As for Dr. Ball's background he's a pediatric surgeon at Burring Children's Hospital associate at the center of surgery and our fourth year in university. He's also the principal investigator of the surgical outcomes and quality improvement center at the Northwestern Institute for Public Health. It is the director of their very successful surgical scholarship program. Now on a national stage Dr. Ball has made enormous contributions in our field not only in terms of the early development of MESQUIP but also the promotion of opioid stewardship and pediatric surgical care to of course like we're going to hear today in hands recovery protocols. He is the author over 150 peer review publications. He invited lecture nearly 200 places and he is extraordinarily well-funded with the number of R-1 bill of grants for the NIH and HRQ including a large multistinist study to promote the implementation of the transfer recovery protocols and of course that we are a very enthusiastic participant. So we are very fortunate to have him with us today at least virtually and really looking forward to his talk. But before I turn it over to my do-one acknowledge the generosity of the White School family as many of you know they are huge manufacturers to not only my department but also our hospital and as they're ongoing generosity that actually helps keep this lecture going is what else we do want to acknowledge appreciation for their support. So at this point I'm going to offer a second as I see it this morning. I just want to take note as you mentioned the White School family has allowed this activity to happen and we're very honored this morning. I don't see the photo. I see that Jane Weissman is joining us for this lecture and we all have to recognize this is an extremely wonderful family. Very important to our department and point doing a solution and very important to meet personally. So Jane I know we can't see you but I hope you can see us. Thank you for getting up so early for the surgery hours and to join us for this important talk that you have made possible. I would like to once again thank you and your entire family please give our best wishes to Stuart and all the rest of the other extended family. Thanks for joining us this morning. I think you'll enjoy this and be proud of what Sean is doing in this arena. Now I know what I'm doing with my whole twin in this arena. So with that I'll go ahead and stop sharing my screen and go ahead and transfer it over to you to take the way my whole. Great well thank you so much for the opportunity to share some of the work that we're doing and for this fantastic lectureship and thank you to the Weightsman family for for benefacting it. And I am really sad that I can't do this in person and see many of you my friends and colleagues in person and go out to dinner and enjoy Boston a little bit and hopefully in your future we'll be able to do that. But in the interim we'll continue to to live our lives through the zoom flat screens and I'm very honored and very happy to be able to present some of the work that we're doing. So I'm going to share my screen and get us started here. And I just want to make sure that you guys can see me some looking at Catherine for a thumbs up and once again thank you to Catherine for helping organize this and and making sure that all the tech stuff is working properly. So I'm going to be speaking with you as Sean mentioned about the study that is titled Enhanced Recovery in Children Undergoing Surgery or Enrich Us. In terms of let's make sure my slides are advancing here. In terms of disclosures I do want to acknowledge a few folks. Here we go. First is the Pediatric Surgical Research Collaborative. This is a group open collaborative hospitals that come together monthly to discuss research ideas. And this is a group that I've been working with for several years now. Several NIH studies have actually come out of this group. Several Marty Relicly studies related to the NEST trial and the Herne and Pre-Matured trial came out of this group and as well as the work that I'm going to be presenting today. It's a fantastic group that allows us to bounce ideas off of each other and they give us a lot of really important feedback early on and any of the sites that are participating in this study are collaborate through the PGSRC on a regular basis. I also want to acknowledge the Coenzin Collitis Foundation. Some of the early work I'll be presenting was funded by a Litwin Pioneers Award from that organization. And finally the actual randomized trial that I'll be speaking about. The Enrich Us Trial is funded by the NIH. So over the next hour, so I want to talk through a couple of major points. The first one is why we need studies that focus on both clinical outcomes and on implementation. I also want to tell you about where we are now in terms of enhanced recovery in 2021 and children's surgery. I'm going to tell you about how we assessed if we were ready for this study this point in time and then go over some of the study details, how it works, who does it include, what you guys need to do as a participating center and what our current status is. So many of you guys have seen this type of curve before. It's the diffusion of innovation. And we know that it takes around 20 years to get evidence from the bench or the cutting edge to the bedside. Anytime we do this type of thing, there's going to be some innovators and early adopters, but unfortunately things get hung up at that point and there's a quality chasm that we've been speaking about for a long time to where the evidence that we create doesn't really make it up to the majority of patients that we treat each and every day. And a lot of these interventions from clinical trials to health services research ultimately fail to be translated into clinical practice and make it out there. So why is that happening? In the United States, we know that less than half of children are currently receiving evidence-based pediatric care. And there's a great quote from L.W. Green in 2006 that says, if we want more evidence-based practice, we need more practice-based evidence. And this has been my experience as well. As Sean mentioned, I've been intimately involved in the development and implementation of the NISQP pediatric program. I've been involved in many local QI projects. I feel like I've mastered the idea of Plandu study-AC cycles. And as we're trying to push this needle forward and make a change, there's some common challenges that we always encounter, things that relate to perhaps the culture, the leadership, the resources that we're allocated. And these things make us frustrated and they make us realize that quality improvement is local and that we really do have some major challenges to implementation to face. And so this is where implementation science comes into play. Implementation science is the study and application of methods that integrate evidence-based research into our day-to-day practice. And this is a fantastic conceptual model that was published a few years ago. And I want to walk through this model and explain parts of it to you. First and foremost, we really need to have more attention on pre-implementation. And so what does that mean? It means that we need to do the right background work before we start to try to change our practice. We need to make sure that there's some surgical effectiveness studies and that we're picking the right interventions. The next thing is that we really need to understand our context, the settings in which we are practicing. So we can better be ready to implement when the time comes. The best analogy I can think of is this is like telling the soil of your garden before planting the seeds. And how do you really understand the setting? You need to make sure that you've engaged all the stakeholders, folks like the providers that are actually going to be doing the delivery of care. But also in the receiving end, you want to get the patient perspective, you want to get the provider and the family perspective as well. And it's only then that you can really step into the implementation process as we typically think about it in terms of quality improvement. So to me, implementation science and quality improvement are actually two sides of the same point. Quality improvement emerged from industry. It's all about systems level work to improve the quality and safety of care that we deliver. We measure quality improvement performance to assess for things like process measure compliance or order set utilization, things along with those lines. Implementation science really evolved from behavioral science. It uses theory-based models to promote the systematic uptake of evidence-based interventions into day-to-day practice. It really focuses on the scientific study of timely uptake or adoption. So what do we mean by that? What we mean is how acceptable an intervention is. Is it feasible? Is it sustainable? And those are the things that really allow us to make the changes that we want to make. So the study that we design has an equal focus on effectiveness as well as implementation outcomes. And it's an equal hybrid type 2 study design. So this graphic kind of describes the different ways that we can look at this. But for this specific study, the Enrich us study, we have some effectiveness outcomes that we all care about as clinicians, things like length of say or opioid utilization or even health-related patient-reported outcomes. But equally, we need to have an eye on implementation outcomes like adoption, feasibility, sustainability. And so this study is designed that way. And I'm going to walk you through how we kind of came up with the different metrics. As I mentioned just a couple of slides ago, implementation science really builds upon frameworks. Frameworks that allow you to make sure that you're not missing anything or having any blind spots when you're going to implement a major change. So we use the five AIS or active implementation frameworks. And the five frameworks are things like usable innovations, teams, drivers, stages, and improvement cycles. So this next slide is very busy, but I'm going to walk you through just a couple of highlights or bullets about how we address each of these different five domains of the five AIS for the Enrich us study. So the first one was usable innovations. So for us, what that means is that we have things like order sets that are ready to go. Patient-facing materials so that we all don't have to recreate the wheel and make patient educational materials and things along those lines. Teams, we understand that the importance of teams and the success that we'll have if we have the right people at the table. So we really are focused on creating an implementation team at each and every one of our hospitals or sites. And this has to be a multi-disciplinary team that includes stakeholders from anesthesia, from the patient perspective, from quality improvement, from surgery, etc. We also create teams that we put together into a little learning collaborative so we can all learn from each other and get best practices and ideas of how things are being done at one center and how that might translate to another. The next thing is drivers. We know that there's some really key drivers. And to me, these are things like having your leadership really buy in and believe what you're doing when you're embarking upon a quality improvement project. And that way when you run into the inevitable obstacles, you have the right resources in place to drive through them. Next is stages. So there's got to be pre-implementation time as I described. There's going to be some time where you're going to be going through the steps of implementing and doing your plan to study axiophiles. And then there's going to be sustainability phases and things along those lines. And last, the PDSA cycles with data-driven feedback loops. We need data on a very frequent basis that we know how we are doing and how the things that we're trying to change are either happening or not. So ultimately by employing this type of framework, we should really be able to optimize our initial success, mitigate the obstacles, hopefully before they even come out, foster a lot of collaboration in group learning, provide some structure, and maybe ensure that the data is coming back to you as frequently as you need it. So ultimately, that's where we are with implementation science and why we chose to go down that road as our methodology basis for this study. So I want to pivot a little bit and talk about enhanced recovery. The basic premise of enhanced recovery is that anytime you undergo a surgical procedure, you're going to have some trauma, and we call that control trauma. You're going to have a decrease in your function. And as you can see on this graphic on the x-axis, it takes some time to recover from that trauma and that stress and for your body to get back to normal. The basic idea of enhanced recovery is that are there things that we could be doing to see? I think it's in fact. Are there some things that we could be doing to speed up that process of enhancing recovery? So picture to the top right is, oh, sorry, Versailles, can I remind everyone to please mute? So, I'm Rick Kellyck is pictured in the top right of the slide, and he's been talking about this since 1999. So for once again, over 20 years, he first published his series of sigmoid collectivies. These were open sigmoid colon resections and adult patients and was able to get these patients home with a two-day length of stay in the hospital. People didn't really believe it. They thought that he was making this off, but ultimately he's proven it over and over again. And 20 years later, we're still trying to implement and emulate what I'm Rick Kellyck did. So there's a lot of components to enhance recovery, and I'm not going to go through each and every one of these in great detail, but it starts prior to admission with making sure that we're setting the expectations with the patients and their families very early and often, that we're doing things to kind of optimize their medical comorbidities, which fortunately for us in pediatric clinical care are not as great as they are in the adult world. It moves on to the preoperative phase where we avoid prolonged fasting periods coming into surgery. We load them with carbohydrate drinks. We teach them techniques like deep breathing exercise and mindfulness exercises so that they can perhaps have less anxiety and pain, both preoperatively and postoperatively. In the operating room, we do things like limit our fluids that we're giving our patients, try to utilize blocks, use minimally invasive surgical techniques, avoid drains. And then finally in the postoperative period, we get them up and walking the night of surgery. We advance their diets as they can tolerate. We try to avoid opioids. We really make sure the expectations are set. And we audit this entire process to make sure that we're really checking the boxes off. This is just another graphic demonstrating how abbreviated the time horizon can be when you implement enhanced recovery. This one is an example from the adult spine world. What you can see here is by doing things like once again limiting their NPO time, avoiding urinary catheters using regional blocks, using minimally invasive procedures, et cetera. It just really takes the time for recovery down to as low as possible. So there's a tremendous amount of data to support this. There's been over 13 randomized control trials, hundreds of publications in the adult literature. There's even an international ERAS society in hand for recovery after surgery society. If you take this entire body of work and reflect on it, what you'll see is that ERAS results in a two to three day reduction in length of stay on average. And it decreases the weight of complications by about a third. And there are no increases in readmissions. So this is very well proven. The evidence is there. The evidence is for adult colon surgery, stomach surgery, GYN oncology, whipples, liver surgery, you name it. And so the question that we had when learning about this was what about pediatric surgery, what about children, how much evidence is out there for us to look at. I want to point out two things about this. The first one is that this is a study from 2016. So this tells you that the body of work that I'm presenting you guys today really started five plus years ago when we embarked on answering these types of questions. And so when we reviewed the literature, we found about five studies that really had a multi-component enhanced recovery protocol. It was not called enhanced recovery. Sometimes it was called you know rapid return to function and fast tracking. And there's all kinds of names people were using in the early days. But nonetheless, we found five studies that kind of met the criteria for enhanced recovery protocols. And it wasn't that complicated. It wasn't the 20 or 25 things I flashed on the screen earlier. It was really just a few essential elements that they were doing. They were doing some preoperative counseling. They were trying to standardize their anesthetic protocols. They were using minimally invasive surgical techniques. They were avoiding in tubes, minimizing the fasting period, and getting these kids up and walking as soon as they could after surgery. That was it. Very simple. Everything highlighted here is where they were able to demonstrate decreases in length of state for a variety of different procedures that we do in children each and every day. These were mostly GI procedures or urologic procedures, but nonetheless this was pretty impressive. If you look at the current body of work that's out there since even when we published this review, the number of articles about enhanced recovery in children is skyrocketing exponentially. If you look out there now, what you'll find are that they're enhanced recovery protocols for children undergoing bariatric procedures, tetas procedures, same day discharge papers about things like colosysectomy and appendectomy. Our neurosurgery and orthopedic surgery colleagues in the pediatric world are now doing this for their spine patients. In urology, we have enhanced recovery protocols for children undergoing hypospatial surgery and complex bladder reconstructions. Even our plastics, ENT and OMFs colleagues are doing this for cleft repairs and I can go on and on and on. This is really booming and becoming a mainstream part of everyday clinical practice. So if I could summarize all of this literature, what I would say is that we know that there's limited data. These are mostly single center studies and yes, they have small samples, but across the board, enhanced recovery protocols appear to be promising. And the next steps were really the question of can we modify and adapt these pathways for children and are we ready to adopt them? So to address that next question, we did a survey of the American Pediatric Surgical Association. We had about a 25% response rate, which is relatively on par for what we have for our professional societies, response rates for surveys. And reassuringly, what we saw was nearly 60% of surgeons said that they were already implementing or extremely prepared and willing to implement many of the components of enhanced recovery. In fact, when we queried about the 21 different adult GI and colorectal surgical, enhanced recovery elements that are out there, 14 of the 21 elements were uniformly found to be acceptable to pediatric surgeons. What was really neat about the survey were the other things that we didn't ask about that surgeons thought would be a good idea to include things like maybe nurse driven advancement of diet and discharge. Having routine postoperative follow up with a phone call or an outpatient visit, or I should say now in 2021, a telehealth visit, 24 to 48 hours after discharge, just the mixture of things are going well at home. Using things like assembly in a sentence, rawetry or chewing gum. And one person even brought up a really cool idea, which was that for young parents, we often have them tour the labor and delivery ward before their delivery day. Why not have our patients come and walk the floor of the ward they're going to be staying in after their elective GI surgery so that they can get to know the nurses and the nurses' station and the floor and the rooms and things like that. Many surgeons were enthusiastic about participating in a prospective study, but it wasn't everybody. There were some definitely some negative feedback that we received. This is one quote that sticks out. It says, I would say the major barrier to implementation would not be institutional, but would be convincing a surgeon like myself that a checklist applied to every patient is better than individualized care. And this mentality, this sentiment still exists in our field. And I would say that if I had flown on a plane from Chicago to Boston today to come visit with you guys, if I had gotten on the plane and the pilot said that no, I'm just not interested in doing the checklist today, I'm pretty sure I would have gotten off the plane right away. And that's the world that we're living in now, right? And we've looked at the aviation industry as a leader and for so many things related to quality and safety. But we still understand that this is one of the challenges that we're facing in our field. So the next step that we took was to say, well, we know that about 14 of the 21 adult enhanced recovery elements are things that pediatric surgeons are either doing or are extremely ready to do. But there were about seven others that are pretty contentious here. So we need to think about those because those are either going to make us a break us. If people find one or two major flaws in what we're proposing, people aren't going to be willing to do this. So we need to do to address that. And so we address that with a modified del-fight process using the Rand UCLA methodology. Now, many of you may be familiar with that methodology, but if not, I'm just going to briefly explain what this means. It basically means we put together an expert panel. And we went through it in a very systematic or iterative way. The first thing we did was we had this expert panel take each of this contentious elements and rate whether they thought it was appropriate to include for children. Then we get a pre-thuro literature review about each and every one of those elements and provided a summary of that literature review to these experts. And then we brought them together for an in-person expert panel session. This was held in conjunction with the AAP meeting back in 2018. And then we did a post-rating. And it's that final post-rating that we really care about. Now, the expert panel was really fun. And it was really a multi-disciplinary team of pediatric surgeons, anesthesiologists, pediatric anesthesia, pain experts, GI docs, nurse practitioners, and even some patient representation with a father of a patient and an actual patient himself being a part of the panel. The seven contentious elements that we adjudicated were mechanical bowel prep, perioperative fasting, VTE prophylaxis, use of standardized anesthetic protocols, NG2 utilization, goal directed fluids, and hyperglycemia management. Here's a quick graphic that explains our data to you along the x-axis or the different expert panel members, along the y-axis is an appropriateness score. Appropriateness to include this element in our protocol, with 10 being should be included or highly appropriate. Everything that's a blue diamond is the pre-meeting survey responses from our experts. So, for example, this illustration is avoiding prolonged perioperative fasting. The range here was anywhere from 1 to 10. The post-meeting survey, after we had looked over the literature and discussed it in person, sent people home to think about it, and they came back to and voted again. All the ratings were 9 or 10. And so, this element makes it in. We say this is appropriate to include in our enhanced recovery protocol. So, here is all seven. Five of the seven made it in after the final post-meeting survey, but I want to focus on the two that did not and kind of explain why not. The top left panel shows avoidance of mechanical bowel preparation. Now, I don't need to preach through the choir, and I know Sean has published a lot on this in his own right. There is no consensus in the world of adult or pediatric colorectal surgery about the optimal bowel prep for folks undergoing surgery. The pendulum is swung from no bowel prep needed at all to everyone should be getting a mechanical only if they add in oral antibiotics. Our group at Lurie, I can speak to what we're trying to settle on, is a mechanical with oral antibiotic prep, and we're trying our best to work with specialty pharmacies to get oral versions of Neomycin and metronide is all available as best we can. It is a struggle though. It's a struggle. And so, with the challenges both in terms of the evidence that's out there supporting a singular recommendation, as well as the challenges that our patients and families face and getting the medications that we ourselves are prescribing, we couldn't really include that, but it doesn't mean that you and your center cannot. It's just an idea that as a group, we're not endorsing any type of mechanical bowel prep recommendation. The bottom right panel is much more straightforward. The adult literature immensely supports the use of slidey scale insulin to keep people in a normal glycemic state in the period of period. And as you guys are all aware, we don't routinely walk around doing finger stick blood glucose checks on our post-op patients every four hours after surgery. That's just not a thing that we do in children's hospitals. It's not a part of our normal scope of practice. And so for that reason, that element did not make it into the final recommendation. So this is a graphic and I apologize as a little fuzzy, but as you can see on the far left of your screen, the adult enhanced recovery protocols have about 21 elements. We adjudicated those with the national survey, got it down to 14 that we're in. We then did the expert panel to see how appropriate it was to include the next line of them and we picked five of the seven. And so our final modified pediatric enhanced recovery protocol has about 19 elements. So simultaneous to that work being done, we were thinking about piloting this at our own center, down in Atlanta, at Emory University, under the leadership of Kurt Heiss. And what we did was we began to implement this and I'm going to share with you the pilot data that we put together. From 2012 to 2014, we considered that our pre-implementation time period and from 2015 to 2016, that was our post. We had about 43 patients in the pre-implementation period and 36 patients in the post-implementation period. These patients were undergoing legitimate gastrointestinal surgeries, Iliocectamies, total colectamies, proctectamies of J-Pouch creations, philiosomy reversals for the most part. Many of these patients had inflammatory bowel disease, 90% or 80% had inflammatory bowel disease. And this is really important to us, about 70 to 100,000 children in the United States currently live with inflammatory bowel disease, about 15% of these children will undergo surgery within five years of diagnosis. So this is one of the major areas that we wanted to focus on. And here's our data with time again along the x-axis, the y-axis on the left and the box plots represent the number of enhanced recovery elements that were being utilized. And you can see we started off implementing about four or five or six of these elements at the beginning of our study. But by the end, after our we we stepped into implementation, we were able to double that number up to 12 or even 14 elements that the patients were getting. The median length of stay is the blue reverse check mark is what I'll call it. And as you can see, we started off with a length of stay around five or six days. And as time went on, we were able to get our length of stay down to two to three days. This was the first demonstration that by implementing enhanced recovery, we could see a clinical effectiveness that was measurable in terms of the length of stay decreased by 50%. Here are some of the other outcomes that we studied. The top left panel looks at introoperative fluid utilization in the red line, overlayed once again with that reverse check mark of length of stay for all of these panels. The top left panel, introoperative fluid used went from about 10 ml per kilo per hour in the operating room down to four ml per kilo per hour. We think this helps with postoperative edema, maybe even ilias. The top right panel, introoperative opioid utilization, we took it down to essentially zero. The bottom left panel, postoperative opioid utilization, once again almost down to zero. And then time to regular diet and the final bottom right panel. We were getting everyone to a regular diet, unpost update one. So what do we conclude from our pilot study that these types of enhanced recovery protocols for children undergoing GI surgery, they were feasible, they were safe. We could expect shorter length of stay, we could expect less opioid use, and we had no increases in terms of complications or readmissions. This is an update of that same data with an additional year in 2017, as you can see that check mark kind of tabled off at around three days. And then in terms of sustainability, we were able to sustain and maintain around 10 to 12 elements of enhanced recovery. Still room for improvement, even in Atlanta, but nonetheless, we were able to maintain about 10 to 12 elements there. This follow-up study also looked at discharge opioids. This is in the height of the opioid pandemic that we were facing and continue to face in the United States. Pre-implementation of our enhanced recovery protocol, we had about 80 to 90% of our patients going home with an opioid prescription. By 2017, we had that down to about 25% of patients going home with an opioid prescription. The other great thing that came out of this pilot work was essentially the nuts and bolts of implementation, something that we're now calling our implementation toolkit. As you can see on this screen, we had patient education materials on the bottom left corner. We gave patients these little passports so that they were actively involved in their care. And each day, they knew what needed to be checked off and worked really hard to get there. It was really awesome to see their engagement. We have order sets and clinical care pathway guidelines that we can share with folks. And in the top left panel, I want to highlight this. This is our local implementation team meetings that we held every month. And during those meetings, we would talk about emerging literature. We would make sure that all the right stakeholders are nurses on the front lines of the PACU, of the pre-operative area, of the floor were there. We had our Stoma nurses there, our anesthesia colleagues. We had a really fantastic team. And we would talk about the patients that we had just taken care of in the past few weeks so that we could share lessons learned or failures. We also talked about the patients that were coming up. So we would know what to expect and really be ready for them as we move forward. And I think that having these regularly scheduled monthly implementation team meetings was really fantastic. So let me bring back this framework again, this thing that we talked about at the very beginning. I talked a lot at the beginning of the lecture today about the importance of understanding your setting, your context, and hearing from your providers that are going to be implementing this on the front line, and also hearing from your patients and the families through focus groups. And so that was our next thing. And this was funded by the Cones and Colitis Foundation. Now we're still analyzing and putting together the management that will come out of the patient and provider focus groups, the parent provider focus groups. But this was from our surgeons, anesthesia colleagues, and including many of you guys there at Boston Children's who participated in our survey and then our hour long interviews over the past year or two. And so what we found in this paper and hearing from our teams that are at the 18 centers that are going to be doing the Enrich Us trial, is that on average our teams are doing about six enhanced recovery elements at baseline. A lot of the things that are doing being done well are the things that are happening in the operating room. A lot of folks are employing minimally invasive surgical techniques. We are using a lot of regional blocks. We are doing our timely antibiotics. We're trying to avoid drains. And so those are things that folks endorse, self-induced that they were doing already. But there were also some really important obstacles to implementation that were identified. Things like resistant colleagues or standardized care or having anesthesia colleagues buy into this was really, was really highlighted in our interviews. There were other things that were making people nervous about things like having the right electronic medical record adaptations, like order sets being able to be built in a timely fashion, and how we are going to be going about doing the actual data collection. Because a lot of these elements aren't things that you can easily abstract retrospectively from a chart. So we took all that together and I want to pause for a moment and kind of reflect on this research art. And I specifically want the folks in the audience today that are students or residents or fellows or junior faculty to take note of a couple of points I want to make. The first one is if you look at this body of work that led to a funded R01 from the NIH. I want to note two things. The first one is the first author on every one of these papers was either a student or a research fellow. I also want you guys to take note of the senior author. The senior author was not me. The senior author on the vast majority of this work was Kurt Heitz. But he was gracious enough to be, allow me a junior faculty member to be the last author on every one of these manuscripts. For those of you that know Kurt, you know how this is his modus operandis. This is how the guy works and he is very happy to promote others. But for me having a mentor like him walk me through this while I was able to do some of the research work and bring that aspect of the rigor to the work that we were doing, I think created an amazing team of multiple layers of mentees and really an unselfish approach to try to make the care that we deliver to patients better each and every day. The second thing I want you to notice is that each one of these papers is published in either the journal of pediatric surgery or the journal of search-core search. You don't have to have everyone of your manuscripts in the New England journal or in JAMA in order to be funded as an investigator. This just speaks to incremental steps moving the field forward and whatever baby steps we can take each and every day. The last thing is the overall research art. Every study resulted in the next question that we then pursued. So a lot of the times as health services and outcomes researchers were asked, what are you just doing another database study or are you just doing another chart review? How is this really going to move the field forward? It's only if we take that next step and think about what questions remain unanswered that we'll be able to really move our arcs forward. So I just wanted to reflect on that just for a moment. So where are we now? So the Enrich us study, which once again stands for enhancing recovery in children undergoing surgery. This is a prospective study, so five year study which we hope to enroll 1260 patients across 18 different centers. It's perhaps one of the largest prospective studies of its type ever been proposed in pediatric surgery. Here are the 18 sites along with the site principal investigators listed. And what I just want to point out is that it's a very geographically diverse group of hospitals. There are purposefully some free standing children's hospitals in the mix and there are also some smaller children's hospitals nested within adult centers that were included as well. Hospital volumes are quite variable at these different centers and once again we want to have that diversity in terms of our participating hospitals. So that that heterogeneity can make sure that we can generalize the results of our study later on in the future. The way that the study works is that every site has that local implementation team. A surgeon and anesthesiologist, maybe a pediatric liaison or advocate, a quality improvement leader, a project coordinator, and other key stakeholders. But each site has their own team and then we take six of the hospitals and we put them together randomly into one of three clusters. And that's what we have in terms of the cluster randomization. So individual patients are not randomized but rather the hospitals are randomized to step into implementing enhanced recovery. And then we have what's called a step wedge design. And what that means is that each cluster will eventually get to implement enhanced recovery. So let's just walk through this for a moment. The first cluster in the initial phase is just in the control phase. They'll step into the intervention phase for about a year and then have two years of sustainability data. Cluster 2 has a year of baseline data collection, a year of implementation in about a year and a half of sustainability. And then cluster 3 has a year and a half timeline of baseline data collection, a year of implementation, and then a year of sustainability. And so to better illustrate that, I mean, I'm actually going to try to show a video that we created about four minutes or so long and I'm hoping it projects. If it doesn't, I'm happy to skip over it, so just let me know. Welcome. We've created a short video to tell you about the enriched us trial. Enrich us stands for enhancing recovery in children undergoing surgery. Enhanced recovery is a patient-centered approach that follows an enhanced recovery protocol. With such a protocol, a multidisciplinary team can help patients recover more quickly after their surgery. Enhanced recovery protocols, otherwise known as ERPs, are well developed and implemented in adult surgery. But data and pediatric surgical populations are lacking, which is a key motivation for this study. The enriched us protocol incorporates evidence-based treatment strategies that span all phases of perioperative care. Some examples of the enriched us protocol elements include family education and counseling, mindfulness training, avoiding drains and tubes, and non-opioid pain regimens. Although each enriched us protocol element is independently simple, implementation of the combined elements requires substantial care coordination among surgery, anesthesia, and nursing care providers. Our previous research suggested that implementation of a pediatric-specific enhanced recovery protocol for GI surgery helps patients recover sooner after surgery and have shorter length of stay, reduces opioid use, and improves outcomes. The purpose of this study is to learn more about the effectiveness of this promising intervention in pediatric patients, and the enriched us study will specifically evaluate whether the enriched us protocol can be implemented at 18 hospitals, and which enriched us protocol elements improve clinical outcomes. So how are we going to study this? 18 pediatric hospitals are taking part in the study, which makes this one of the largest pediatric surgery studies of its type. Together, the 18 hospitals will recruit and enroll approximately 1216 pediatric gastrointestinal surgical patients ages 10 to 18 years. Data will be collected from patients' electronic medical records, and both patients, if we'll denote, and parents and their guardians will be asked to complete quality of life assessments before and after surgery. There will be three phases of the study that every hospital will be in. Enrich us is a step-wedge randomized trial, which is an innovative way to study how a hospital-level intervention works. This means that individual patients will not be randomized. What are you expected to do? Each hospital will need to create an implementation team that includes a surgeon champion, anesthesia champion, patient advocate liaison or PAL, hospital-level quality improvement leader, data extractor, and project coordinator. There may be other key stakeholders that you identify. Then, your hospital will be randomized to one of three clusters made up of six hospitals in each cluster. There are three phases, and each cluster will be in a phase for varying periods of time. The first phase is the control phase, when data from patients at each hospital before the protocol intervention will be used as the control data. Next is the intervention or implementation phase, allowing each cluster to implement the Enrich us protocol at a different time. The cool thing is, eventually everyone will get the intervention. The last phase is sustainability, which allows for assessment of both the impact of the intervention and fidelity of implementation and sustainability. To make the implementation easier and more fun, each cluster will form a learning collaborative group and meet during monthly video-based conference calls. You will discuss how you tailor the Enrich us protocol to fit within your hospital's workflow, organization, and protocols. These conferences will also be audio-recorded by the research team to better understand what it takes to truly implement the Enrich us protocol. This study is expected to offer a safer and more satisfying surgical experience for children undergoing elective gastrointestinal surgery and a greater benefit for future patients by defining the best standard of care. For details about the specific elements of the Enrich us protocol, visit the study website. We are excited to have all of you be a part of the Enrich us study. Great. Well, thank you for watching the video. I might have gotten hung up a little bit, but it is available on the website and we'll be able to provide that link to everybody if it didn't come through clear. So we are super excited to actually announce the first six hospitals that were randomized to be in the first cluster. That will be stepping in implementation beginning on in April. So next month and lo and behold, Boston Children's is one of the sites amongst these six and so we're very excited to begin working with the Boston team on implementing enhanced recovery. Our original start date was supposed to actually be a year ago, April of 2020. And as we're all experiencing and have experienced, there was no way we were going to start a 18th center trial across that spans across from coast to coast in the United States in the midst of a COVID pandemic. And so there were some significant delays secondary to COVID in terms of getting started. I'll also mention that there was there's a new and not relatively new NIH mandate that these types of multi-center trials be coordinated under a single central IRB or an SIRB. Each one of our sites is struggling with how to navigate this requirement. There are not clear ground rules. And in fact, we wrote a GM a viewpoint about this that's under review right now saying that we need better guidance from both the NIH and the governing bodies of IRBs to really understand what the role of a single central IRB is. And so there were things that we've learned along the way, along the past year that have been really eye opening but nevertheless did delay some things at some sites. Our actual start date was July 1st, 2020 and enrollment was exceedingly slow on the order of across 18 centers only enrolling one or two patients a week. And I was getting immensely nervous that we were not going to be able to do this study. But fortunately we've picked up our enrollment. We're averaging about seven to ten patients per week now, which is exactly what we need to do in order to get to our goal of getting 1200 plus patients enrolled in this study. And we're currently at about 135 patients. My I'm going to go over to include an exclusion criterion just a moment. But in general, my hope is that we really have to be mindful of the fact that we had these multiple delays and as many patients as we can enroll, we need to try and reach out to them and get them enrolled. And your study team at Boston Children's is doing great with screening. In terms of stepping in, as I mentioned, cluster 1 is stepping in implementation in April of 2021, which is next month. We have about 12 months to work with the six hospitals in cluster 1 to get them up and running. We are doing a variety of things to get ready for that. So as I mentioned, the challenges we had a single central IRB. There was another challenge, which is how we're going to abstract the right data. And so we've created a pretty extensive red tap database. And we have some tabloos software for regular data reports that we've created now. Each site has data collectors that have been trained on utilizing the red cap software. And it's pretty extensive. It's not simple. And there's a lot of details out there that are hard to abstract retrospectively. So for those of you that are participating as surgeons or anesthesiologists, if you get an email asking a question about a specific element and whether it was used or not, please work with your data abstractors and try to help them give us as completed data pictures we can have. The volume estimates that we had were based on self-report. And when you really peel back the onion layers a little bit more, I think our volumes are probably smaller than we initially anticipated in our sample size calculations. But nonetheless, once again, we need to make sure we capture each and every patient that could be eligible for enrollment. The anticipated challenge is moving forward. We really need to make sure that each site has a really engaged implementation team that can have the right traction in place to succeed. And then we want all of our sites for participating in our monthly learning collaboratives as well that we're doing as a group across the nation with the five other hospitals that are in your cluster. And I know it just needs more zoom meetings, but nonetheless, I think this is actually going to really be a fun and fruitful experience. So to remind folks what we're who we're trying to enroll in terms of the inclusion and exclusion criteria, we're looking for 10 to 18-year-olds. They must be English or Spanish speaking based on the concerns that we have available. We're looking for patients and they're going elective GI surgery. The majority of these patients will be electively scheduled inflammatory bowel disease patients with either Crohn's disease or Ulsterative colitis. But we are looking for others. Perhaps a trauma patient that has a stoma and a stoma taking down other examples that have come up over the last several months or folks that had a had a mesentary mass and needed a bowel resection or things along those lines. Just this past week, somebody had a 12-year-old undergoing a lads procedure for symptomatic malnutrition and we're including that patient as well. So it's not just IBD patients. It's also elective GI surgery patients. So please keep an eye out for any patients that you think may qualify and talk to your study team. In terms of exclusions, we are excluding patients that have exclusive parianate, pariannal disease, patients with significant colonic dysmetility, patients with short bowel or patients that are unable to consent or assent for a variety of reasons. And so those are the patients that we're excluding. All right, here are some headshots and I hope I got them all right. I'm searching on the internet and having you as some of these into us. But you have a fantastic team at Boston Children. So that we've already been working with to navigate many of the IRB issues and get the study up and running. And you guys have already been enrolling patients in the baseline data collection period. Craig and Jill have been fantastic to work with along with all the other folks that listed on this screen. And your study team has been really engaged with our coordinating center. And many of the suggestions that you guys have created or suggested are things that we are now trying to facilitate and create because I think they're great ideas. And I think that this is definitely a two way street. And as you guys come up with innovative things or things that you think would be helpful, part of the learning collaborative is that we're going to share that and disseminate that with the rest of the centers and hopefully all learn from each other. So once again, thank you guys for being engaged and we're really looking forward to continuing to work with you. One of the suggestions was could we really have a handout that describes the roles of the different members of the implementation team. And so we've created these and we've created even team member specific handouts as well. And so these are things that will be coming down the pipe in just a few days. I hope. We're also creating a guidebook with clear milestones. So as we step into implementing enhanced recovery over the coming year, we have fantastic, a fantastic 12 month curriculum lined up. We have professors from the Kellogg School of Business that talk about change management. We've got sessions dedicated to engaging leadership and creating your elevator pitch. We've got sessions that are topic specific like interoperative protocols for anesthesia led by folks across the nation that are authorities on this topic area and agreed to be lectures within this 12 month curriculum. We've got patients and families coming to share their experiences with us. We've got nursing perspectives from the preoperative area, from the recovery area and from the ward talking about the challenges that they face. It's really going to be a fantastic 12 month experience for all of us to participate in. We have different workflows for enrollment and I'm not going to go through all the details of these, but basically if you identify a patient ahead of time, that's best. But even if you don't realize that they could be a good candidate until the morning of surgery, we've got workflows that you can get them consented and enrolled into the study that morning. We have patient facing material. We've partnered with a friend and colleague from Inside Out Care. This is an individual that many of us have worked with on a variety of quality improvement projects. And she's made a very fantastic patient facing user interface that's web based and smartphone based that is going to be tailored by you branded with your Boston Children's logos with all your specific information. If you have videos that you want the patients to watch, if you have checklists, you need them to do stoma nurse appointments, compliance with medications or whatever the case may be, you can create a workflow that the patients will then check off and that your teams can then use to make sure that patients are moving through your system as nimble away as they can. There are some funds. This is an NIH funded study. It is not the same as an industry funded study. These are relatively modest reimbursements. And I know that and that's one of the challenges that we've had to navigate. But nonetheless, there's been some startup and some close out funds that are reallocated to your site. Data collection is burdensome as I've mentioned. We're giving $350 per patient that's enrolled. There are patient incentives to create to, I'm sorry, to complete the quality of life surveys. They create, they complete one survey in the preoperative time period, which can be done as late as minutes before surgery if you need it. There's a early postoperative survey that is given on basically post-offer day two. And so the vast majority of patients will still be in house. And I think the compliance will be high. And then the last one is the most challenging one. It's about a four week survey that they complete. They get $20 for the first one, 30 for the second and 50 for the third. And so they can get $100 per patient or family for completing these surveys. And so far, we've got about 70 or 80% survey completion on the part of the families. And so it's, I think that's actually pretty solid. And hopefully we'll get better as time goes on. We're hoping that you guys can enroll at least 20 patients. And truthfully, at Boston Children's, we hope it would be even more than that. 20 patients per year. And so we do have some lower volume sites that are, that probably don't see 20 patients in three years. And so we really need our larger centers to pick up the slack there. I think that as we move forward based on what I know about your volumes at Boston Children's, I expect you guys will be one of our top performing sites. I just want to give a quick shout out to my team. And this is our study team based out of Northwestern and at Ellery Children's. We've got a fantastic group of folks that are here each and every day to help make sure that we can navigate this study and pull it off. Many of you know that have been involved in this study. We will know Aaron, Wymore, or Peter Graffey. These are our project manager and project coordinators. We have research fellows working on this statisticians, grants administrators behind the scenes. And so it's just a really fantastic team of folks that are dedicated to helping make sure that you are successful. Reach out to us in whatever way we can do to support you guys. And so to wrap things up, I'll mention that we do have a website. It is www.enrich-us.org. The video that I showed earlier is there. So if you want to show it to peers or colleagues that you think are interested in hands-procure and want to learn more about the study, they can get some of that material there. The email address is here and then we've created this logo. It's a colorful kid that's up and running. Hopefully after surgery. I've told you what Enrich us stands for. And then there's 18 stars representing the 18 centers in the study. This is my family and I just want to say once again thank you for the invitation to come present our work. Hopefully you guys have found it to be something that you're excited about. And I'm very excited to be working with you guys as I've mentioned. Thank you to the Waisen family again for the invitation and benefiting this lectureship. And I'm happy to take any questions. Thank you, Mule. That was just absolutely outstanding. I know we have about six minutes for questions. I know they're going to be several from our group, particularly our Enrich us participants. I think my favorite slide was the ART. I really want to emphasize to the residents and the students that is really when embodies moving the needle with health services research. Identifying important problems really pick apart what the issues are in terms of biases and perspectives. You bring all the stakeholders together and you systematically identify what everyone thinks is important and then you bring everyone. And then I think this is just such an incredible example of tackling a really pervasive issue in a very systematic way. So again I think Catherine can we go ahead and open it up for questions? I'm sure there are going to be many. Sean, this is Steve. I want to thank you again so much for joining us. We owe you a dinner. I wish you could join us in person. But I also want to thank you for leading us. The whole project that you started and is taken across the country with these centers is really making a difference. I'm so pleased that we have joined your group and I want to thank Krilyla High and Lindsay Lemire for leading the effort but there's so many others involved and I want to take a time for that. Before I pass on to other questions, I do want once again thank the Weitzman family. I'm pretty sure I see I'm hidden behind a name on the screen. Another member of the Weitzman family who's joined along with Jane and I want to thank all of them for making so many things possible. I think that for making so many things possible including this lecture we understand the future of pediatric surgery depends upon the work that you're doing. They understand this. They've lived this and thank you so much for your leadership nationally internationally in this and thank you again to the Weitzman for making this possible. Great. It's Krilyla High. I just do with echo Steve's sentiments and I must say your comments about leadership buy and it started with Dr. Shamberer and obviously Dr. Fishman has been more than supportive of this along the way and for anesthesia colleagues your your chief Joe Krivera was was really instrumental in the first efforts here in E-RAS. Sabino Chaco is become our anesthesia champion for this in-race study so Jill and Lindsay and I are excited about being in cluster one. Thank you Mahul. We're really looking forward to working with you guys as I mentioned during the talk I think that you know the learning collaborative is going to be an opportunity for us to all learn from each other and and really throw gasoline on this small fire that's been lit and hopefully really have something fantastic happen over the next couple of years. Other questions from the group? We'll be right in for additional questions but we get a few minutes left. I'm very curious about the learning collaborative. You and I have discussed step wedge trials we're we're using that design in our trial looking at reduction of antibiotic utilization postoperatively and I've taken myself that we didn't implement such a thing. I wonder if you can spend a couple minutes giving us a little bit more information about what exactly those are focusing on and what timeline is it early on and that's shared to even those who haven't in the cluster selection yet or is it after they started the cluster selection because there's seen that there might be some kind of cross reactivity or maybe some dirtiness if they get information early before they try to implement whatever the intervention is. Yeah so there's there's multiple layers to that John and I'll address just the learning collaborative one year curriculum that we're going to facilitate first. So the idea there is that there are going to be components of enhanced recovery that are going to come to a surgeon or to a site or to a team very naturally and those are the others that you're going to struggle with and to expect that anyone can implement a quality improvement project that has hypothetically 21 different elements that are moving pieces that you may need to move the needle on is a lot and so we know that implementation is going to take about a year and it may even take more. So the idea was can we be coaching and learning from each other as we encounter the struggles that were all going to encounter as we try to implement this over a course of a year and let's bring everybody together for you know one hour or one and a half hour meetings each month and talk about it. So that was the basic premise. What we wanted to layer into that was frequent data feedback. So one of the biggest challenges that you're well aware of that we faced with this quick pediatric data is that it comes out almost a year in delay and it comes out you know twice a year only and there's really a struggle with being able to take quick action on these data and we know that that data feedback loop is extremely important and so in the learning collaborative one year curriculum months 36, 90, 12 are basically data sessions where we're going to be sitting down and looking at the data and learning from them learning from the data and what we'll be able to do is say that within our within the first cluster of six hospitals Boston Children's may be doing fantastic at a couple of these elements so during that session we want to hear what are you guys doing how are you guys pulling it off and then there may be some other elements that another site is doing really well with and so we want to hear from them so there's a lot of open conversation with real real time updated data and that's going to be happening during the learning collaborative curriculum and as I mentioned during the talk there are other parts that are just a little bit harder to wrap your mind around exactly what does a standardized anesthetic protocol mean right so Dr. Crico might actually have one mind but then maybe she'll learn from what another physician at another hospital is doing in terms of the exact drip ketamine drip rate or the exact dose or type of block that's being utilized and so there's a lot of discussion that's going to happen specific to these topics and so we'll have a session dedicated to that and then early on in the session I think a lot of it has to do with setting the right culture and getting the right leadership in and so we're going to have like I said talks about managing change and these talks are going to be delivered by national and international experts on change management within healthcare systems and organizations and so I think that's important and and then also once again getting getting the right stakeholders in place for the implementation team so it's the combination of all those things that are going to be happening during the 12 month learning collaborative collaborative curriculum and then just quickly to your second point there's absolutely contamination of the subsequent hospitals we're not living in bubbles right this can't be a sterile petri dish so to say this is real world pragmatic implementation of trying to make a change on the front lines there are papers being published about enhanced recovery from the adult world and in pediatrics every day as I mentioned and we're not ostriches with our head in the sand we want that pragmatic aspect to creep in by the time cluster three comes along I can almost promise you that their baseline implementation will be higher than cluster once and just by nature of it being another year of things happening by diffusion and osmosis. Okay well thanks well hello or after the hour and I just want to say again thank you for this incredible talk and in all the insight which is going to be very relevant to future trials as well looking at similar types of things and again thanks for the year of time and the great talk and very much appreciated once again thanks for the opportunity thank you