Pediatric Prehospital Airway Resuscitation Trial (Pedi-PART) – PediaCast CME 096

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Description

  • Dr Julie Leonard and Dr Henry Wang visit the studio as we explore Pedi-PART. This national research study examines advanced airway management for children in the prehospital setting. We detail the study and consider exception from informed consent. We hope you can join us!

Instructions to obtain CME/CE Credit

  1. Read this information page.
  2. Listen to the podcast.
  3. Complete the post-test at Nationwide Children’s CloudCME.

Topics

  • Pedi-PART
  • Advanced Airway Management in Children
  • Exception from Informed Consent

Presenters

Learning Objectives

At the end of this activity, participants should be able to:

  1. Describe PEDI-PART and explain its importance.
  2. Outline the methods used in this study.
  3. Differentiate “informed consent” and “exception from informed consent.”
  4. Recognize how “exception from informed consent” is used in PEDI-PART.

Links

Disclosure Statement

  • No one in a position to control content has any relationships with commercial interests.

Commercial Support

  • Nationwide Children’s has not received any commercial support for this activity.

CME/CE Information

  • In support of improving patient care, Nationwide Children’s Hospital is jointly accredited by the American Nurses Credentialing Center (ANCC), the Accreditation Council for Pharmacy Education (ACPE), and the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for the healthcare team. (1.0 ANCC contact hours; 1.0 ACPE hours; 1.0 CME hours)
  • Nationwide Children's Hospital has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 1.0 AAPA Category 1 CME credits. Approval is valid for 2 years from the date of the activity. PAs should only claim credit commensurate with the extent of their participation.
  • As a Jointly Accredited Organization, Nationwide Children's Hospital is approved to offer social work continuing education by the Association of Social Work Boards (ASWB) Approved Continuing Education (ACE) program. Organizations, not individual courses, are approved under this program. State and provincial regulatory boards have the final authority to determine whether an individual course may be accepted for continuing education credit. Nationwide Children's Hospital maintains responsibility for this course. Social workers completing this course receive 1.0 continuing education credits.
  • Continuing Education (CE) credits for psychologists are provided through the co-sponsorship of the American Psychological Association (APA) Office of Continuing Education in Psychology (CEP). The APA CEP Office maintains responsibility for the content of the programs.

Contact Us

  • CMEOffice@nationwidechildrens.org

 

Episode Transcript

Announcer:     This is Pediacast CME. ♪♪♪ ♪♪♪ Welcome to Pediacast CME, a pediatric podcast for providers. And now, direct from the campus of Nationwide Children's, here is your host, Dr. Mike.

Dr Mike Patrick:     Hello everyone, and welcome once again to Pediacast CME. It is a continuing medical education podcast for healthcare providers. This is Dr. Mike coming to you from the campus of Nationwide Children's Hospital. We're in Columbus, Ohio.

Dr Mike Patrick:     It's episode 96. We're calling this 1 Pediatric Pre-Hospital Airway Resuscitation Trial, which is a mouthful. And so from here on out, we are going to shorten that to PD part. And really we have 2 goals today. A 1 is to raise community awareness for a pediatric study that is launching in many cities across the United States, including here in Columbus.

Dr Mike Patrick:     And the reason for a raising that awareness is because this study comes with an exception from informed consent. And that really is the second goal then today to talk about the importance of exception from informed consent in medical research. Now informed consent is really the foundation of medical research in the 21st century. So explaining a study's purpose and goals and methods and benefits and risks prior to enrolling patients in clinical trials is very important. We want patients and families to have all the information at their fingertips when making decisions.

Dr Mike Patrick:     And in the past, in, in the world of medicine and I'm thinking, you know, back in the sixties and seventies we weren't always great at providing informed consent. In fact, there were some really travesties that took place where informed consent was not obtained. And so we do, that was a terrible, terrible thing. And we do not want to repeat those kind of situations. On the other hand, there are times when informed consent is not practical, such as when a life-or-death situation is at hand.

Dr Mike Patrick:     And In the case of a PD part, we are talking about airway management in critically ill children in the pre-hospital setting. In other words, what is the best method to obtain and secure an airway out in the field in children who are not breathing adequately enough to meet their oxygen requirements. It's an important issue because thousands of children die in the United States from having an inadequate airway in the pre-hospital setting. But if you want to discover the best method, You have to compare methods and you don't have time to obtain informed consent when an airway is needed now And so this is where an exception from informed consent comes into play, you know, we recognize the gravity of a situation It's an important thing to figure out. So how can we act in an emergency, but still stick to the tenets of informed consent in medical research?

Dr Mike Patrick:     These are the questions that we will answer today as we explore the PD part study and exception from informed consent. In our usual PDACAST fashion, we have a couple of terrific guests traveling along with us. Dr. Julie Leonard is an emergency medicine physician at Nationwide Children's Hospital and our site principal investigator for the PD-PART study. Dr.

Dr Mike Patrick:     Henry Wang is an emergency medicine physician at Ohio state at the Wexner medical center, and he is the overall principal investigator for PD part. We'll welcome them shortly, but first a few reminders. Don't forget you can find PDA cast CME wherever podcasts are found. We appreciate when you subscribe to the show so you don't miss an episode and please consider leaving a review wherever you listen to podcasts. We also offer category 1 CME credit and it's pretty easy to claim.

Dr Mike Patrick:     Simply listen to the podcast, which you are about to do, and then head over to the show notes for this episode at pdacastcme.org. You'll find a link to the post test in the show notes. Follow that link to Cloud CME, take and pass the post test and the category 1 credit is yours. You will want to click on the materials link once you're over at Cloud CME and you also need an account that you're signed into. All of those things are free.

Dr Mike Patrick:     The category 1 credit is also at no cost to you. And we offer that credit to many pediatric professionals, of course, physicians, but also nurse practitioners, physician assistants, nurses, pharmacists, psychologists, social workers, and dentists. And since Nationwide Children's is jointly accredited by all of those professional organizations, it's likely we offer the exact credits you need to fulfill your state's continuing medical education requirements. Of course, you want to be sure the content of this episode matches your scope of practice. Complete details are available at pediacastcme.org.

Dr Mike Patrick:     Also want to remind you the information presented in our podcast is for general educational purposes only. We do not diagnose medical conditions or formulate treatment plans for specific individuals. Your use of this audio program is subject to the Pediacast CME Terms of Use agreement, which you can find at pediacastcme.org. So let's take a quick break. We'll get Dr.

Dr Mike Patrick:     Julie Leonard and Dr. Henry Wang settled into the studio, and then we will be back to talk about PD part and exception from informed consent. It's all coming up right after this. Dr. Julie Leonard is a pediatric emergency medicine physician at Nationwide Children's Hospital and a professor of pediatrics at the Ohio State University College of Medicine.

Dr Mike Patrick:     She also serves as the site principal investigator for the PD part study at Nationwide Children's. Dr. Henry Wang is an emergency medicine physician at the Ohio State University Wexner Medical Center and a professor of emergency medicine at Ohio State. He also serves as the principal investigator for the entire PD Part study. That is the topic of our podcast this week, PD Part, but before we get into that, let's give a warm PDA cast welcome to our guests, Dr.

Dr Mike Patrick:     Julie Leonard and Dr. Henry Wang. Thank you both so much for being here today.

Dr Julie Leonard:     Dr. Mike, thanks for having us. We're super excited to be able to talk about the study that's coming to the Columbus area.

Dr Henry Wang:     Likewise, Mike, thank you for having us here today.

Dr Mike Patrick:     Yeah, we really appreciate you guys taking time out of your busy schedules and joining us. Julia, let's start with you. Just give us sort of a brief overview of the PD-PART study. What exactly is this?

Dr Julie Leonard:     Yeah, this is a study that is going to be occurring in the pre-hospital setting, so outside of the hospital, and it's a study about the airway management for children who have respiratory failure at home or at school or at a sporting event or out in the community and we're going to be studying how EMS responds to those emergencies.

Dr Mike Patrick:     Yeah and This is not only in the Columbus area where Nationwide Children's is located, but really you guys are doing this through 65 EMS agencies throughout the United States. So this really is a national study, not just a regional thing, correct?

Dr Henry Wang:     That's correct. There are 10 cities involved in the PD PAR trial and over 65 EMS agencies. This is 1 of the largest EMS pre-hospital studies that has ever been put together.

Dr Mike Patrick:     Yeah, and the plan is I understand for this to run for about 5 years and it is starting in the spring. What is the goal of this study, Henry?

Dr Henry Wang:     Well, airway management is 1 of the most important procedures that paramedics perform. They perform this procedure every day as part of their life-saving care for patients with critical conditions such as cardiac arrest, trauma, and respiratory failure. Despite the fact that the paramedics have been performing airway management for over 50 years, we don't have a good understanding of the best strategies when managing the airway in children. So PD-PAR is a landmark study and for the first time will offer some of the most important perspectives and information to guide paramedics when taking care of critically ill children.

Dr Mike Patrick:     Yeah, So as I understand it, we're talking about critically ill children who are having difficulty breathing and for 1 reason or another. And so the pre-hospital folks, so the EMS personnel need to establish an airway and there are multiple ways that that can be done, and you're really trying to get at which is the best way, maybe with the fewest complications, what airway is gonna last and be their best. So what type of airway management techniques are you comparing in this study?

Dr Julie Leonard:     So there are actually 3 ways that paramedics can help assist children with breathing in an emergency. The first is to place a mask over the child's face and to sort of puff breaths or breathe for the child that way. And then the second 2, well, the other 2 ways are more, shall we say, invasive. So 1 would be to put a breathing device into just above the airway, so to more directly get air into the lungs. And then the third way is to actually put a breathing tube or to intubate the patient and put that directly into the patient's trachea and to provide breaths that way.

Dr Mike Patrick:     Yeah. And so then how do you determine what the best method is?

Dr Henry Wang:     PD-PART is a randomized control trial, which means that the intervention is chosen randomly with each case. You might ask, how is that good science? Well, our highest form, the best type of research study, involves randomizing the interventions. If you don't randomize the interventions, then doctors, or in this case paramedics, tend to choose the technique that they're most comfortable with. And we end up with information that may actually be flawed.

Dr Henry Wang:     Flipping the coin is the only way to remove all those biases, and hence why we very much value randomized control trials in today's medical science world.

Dr Mike Patrick:     Is 1 of the things that you're looking at, which method could be best based on the child's age? I mean could it be that there's you know 1 age group that 1 technique is going to be better, but for another age group, it's a different technique?

Dr Henry Wang:     Absolutely. The PD-PART trial is designed to include all children between 1 day old all the way through 17 years of age, because they're all considered children in our medical world. However, as you can imagine, at the end of the trial we will parse the data, we will divide the data into different age groups so that we can understand if any effects we see differ between different age categories.

Dr Mike Patrick:     Yeah, that it's really interesting. And in terms of the outcomes, like what how do you determine that this way was better? Are you looking at like successful attempts, whether the airway is lost, you know, the final outcome of the patient? Like what are the outcomes that you determine like this is better than this 1?

Dr Julie Leonard:     So we, yeah, so we're looking at ICU free days. So the number of days that the patient survives outside of the ICU or critical care unit.

Dr Mike Patrick:     So most of these kids are going to end up in the intensive care unit because they needed this advanced airway and they're probably going to need it as time goes on. And so the thought then is that it's a better airway the less time that they're in the ICU?

Dr Henry Wang:     So since we're talking about life-saving interventions, obviously 1 of the main goals of airway management is to improve survival or to save lives. So of course in this trial we care about life and death. We care about survival as well as death after the stay in the hospital. The use of the ICU stay is another way to express survival. It is a method that we use in the scientific world to give a better sense of how sick an individual patient is.

Dr Henry Wang:     It also gives us a better sense of their pace of recovery from the illness. So if 1 airway device works better than the other, we would expect that among those patients, not only would they have a higher rate of survival, but they should spend fewer days in the intensive care unit.

Dr Mike Patrick:     Okay, so all of these kids obviously are going to end up getting intubated with an ET tube when they're in the intensive care unit. That's the standard of care in terms of long-term airway management. The thought here is that if we can get oxygen delivered quickly, so that then correlates to what is the best airway management technique because we're restoring oxygen fast, then the length of their illness hopefully will be shorter because they had oxygen started again quickly and it was maintained. Whereas if you have a kid whose airway maybe wasn't so great or they had to have multiple attempts and they had lack of oxygen for a period of time before they arrived at the hospital and got intubated, then perhaps they would have a longer ICU stay because of that difficulty with airway management in the field. Is that correct?

Dr Mike Patrick:     And again, I need to break this stuff down really simply in my mind to understand it.

Dr Henry Wang:     That's correct. With all critically ill patients in the hospital, 1 of our goals is to provide oxygen in a very controlled manner. So typically we'll put a breathing tube into the throat to help control, to deliver oxygen in a very controlled manner. That method is called endotracheal intubation and it's done every day in the hospital. Now paramedics in the United States have performed intubation in the field for 50 years, but we've also discovered along the way that procedures performed in the pre-hospital setting may not come out the same way as when we do it in the hospital.

Dr Henry Wang:     So we've come to realize that it's not so much a question about the device used, but the strategy involved. When I have intubation available, that is a powerful tool, but it also takes me more time as a paramedic to accomplish that task. And I'm also likely to accidentally do a few other things along the way. The other devices are simpler. They maybe do not deliver oxygen as well, but because of their simplicity, I'm less likely to make mistakes along the way.

Dr Henry Wang:     Which 1 ends up ahead, we don't know, and really these are strategies of care that we're comparing in this trial.

Dr Julie Leonard:     I would also add, to build off of what Henry is saying, and beyond making mistakes in the pre-hospital setting, is the idea that these devices take time to insert, and there are limited personnel. So when you receive care in the hospital setting you have multiple people at the bedside to help out and to lend a hand. But our teams that are out in the pre-hospital setting, there will be 1 person that perhaps is on scene that's trained to perform these procedures without a lot of extra support to getting the job done. So it could be really demanding on the provider that's there at the patient side. And so these simpler methods will perhaps streamline and allow the paramedic to get the patient to the hospital faster.

Dr Mike Patrick:     Yeah, that really does make sense that we all know that intubation is going to be the definitive what this child needs, but to Henry's point, in the field you may not have access to a fancy camera that where you can really visualize exactly where the trachea is and that you're in the right spot. You don't have x-ray technology in your ambulance to verify tube placement. So it is It's a more challenging procedure for sure compared to in the hospital. And so I guess the point here is that if you use another technique that's easier and you get it done correctly the first time and you get oxygen established quicker, are you going to have a better outcome even though these are simpler techniques in the field, but then you can wait to get to the hospital for the intubation? And again, we don't know the answer to that.

Dr Mike Patrick:     You know, maybe it is better to have they have to have multiple attempts and and some mistakes in the field with intubation. We just, that's the reason for the study. Is that correct?

Dr Julie Leonard:     Absolutely. And I think that it's, at the end of the day, paramedics are also eager to get the answer to this question. While Henry and I work in settings where we see a lot of patients, you know, and intubate quite often, paramedics, that's a less common event for them and more so for children. You know, it can be a very rare event for them. It can be a once in a career event for them.

Dr Julie Leonard:     So getting this answer is something that we're not only excited about, but you know, people who practice in that environment are very eager to learn.

Dr Mike Patrick:     Yeah. And then I would imagine that some of this is gonna depend on what the cause of the child's breathing difficulty is. And so we wanna eliminate as many variables as possible. So if you have a kid with severe lung disease, like maybe they have a severe pneumonia, or they have asthma, or something that is gonna be more of a prolonged respiratory issue, that could also impact how long they're in the ICU. And so is there a way to sort of differentiate kids who have a primary lung problem versus those who aren't breathing well for some other reason?

Dr Henry Wang:     1 of the biggest challenges in any medical study is the wide variation of patients that you see. People come in different sizes, different heights, have all sorts of different medical conditions, and take different drugs. This is why the randomized controlled trial is so important. It's 1 of the few ways that we can effectively account for all these differences between patients.

Dr Julie Leonard:     To your point at the wide variation, for this study we are not restricting it to cause of respiratory failure, which is very important. And so we will be able to study not only the age differences that Henry talked about earlier, but also centered around what the cause of respiratory failure is. And so for children, it's likely to be equally split between there being an injury event or trauma, there being a respiratory event, like the examples you gave, Mike, in terms of pneumonia or severe asthma, and then cardiac events. So, you know, which are more common in adults, but we do have a particular subset of cardiac events in children.

Dr Mike Patrick:     Yeah, so that's a really important point that you are at least, you're not excluding folks based on a primary respiratory problem, but you are making note of which ones have a respiratory problem going into it and which ones don't so that then, you know, maybe 1 technique is better for those with a respiratory problem versus a cardiac problem or an injury problem. So then what are there, you know, oftentimes with studies there are populations of people who are excluded. Who are excluded from this particular study, Henry?

Dr Henry Wang:     As with all research studies, we are very selective about the patients that we include in the research trial. And as you would expect, there are certain children that we are excluding from this trial. Some are for because of government rules or regulations. So for example, any prisoners, those in juvenile detention, or pregnant females will be excluded from the study. But others are excluded for good clinical reasons.

Dr Henry Wang:     So for example, children with a pre-existing tracheostomy are excluded. And that's because in typical paramedic practice, they wouldn't necessarily be providing life-saving airway care to a child with a pre-existing tracheostomy. So basically it gives you an example of some of the challenges we have when designing these types of studies.

Dr Mike Patrick:     Yeah, and if folks have a do not resuscitate order because they have a chronic illness and maybe they're in hospice care, obviously they're not going to be included either. And then I did understand that like 1, you know, newborns who are born at home, those are also excluded from the study, correct?

Dr Henry Wang:     Newborns present very special and different challenges and so therefore we excluded them from this study.

Dr Mike Patrick:     Yeah. And then what are for those people, so it sounds like really other than what you just mentioned, anybody that is between a day old and less than 18 years of age are going to be included. What are the benefits of being a participant in this study?

Dr Henry Wang:     All of the interventions used in the PEPAR trial are part of standard care. These are used every day by paramedics on all critically ill adults and children. The difference in this trial is that on different days they are told to use different devices. And so at a baseline no patient is exposed to any additional risk and in fact they're all getting the benefit of standard methods of airway management. The benefits that we derive as a society, as a whole, from studies are extremely important.

Dr Henry Wang:     To better care for children today and in the future, we need to generate knowledge. And carrying out very structured studies like PewDiePie is the only way that we can generate that important knowledge. When you ask the paramedics what do they challenge, what challenges them when they're taking care of a child, part of it is fear. The fear that in face of this very critically ill children I have to make split-second decisions and sometimes I'm not sure what the best decisions are. They see this type of study as really helpful to their practice because we'll be able to get them crystal clear information about the absolute best strategy or approach to use in critically ill children.

Dr Henry Wang:     And that will make the resuscitation easier, faster, and a lot more and and will put them at ease as they're caring for these very sick children.

Dr Mike Patrick:     Part of, and the reason I ask that question about the benefits is because I also want to, I do want to ask about the risks. So I think this is important because as we consider informed consent with research projects, Part of that, and really when we get informed consent for medical procedures as well, we want to inform the parent, okay, these are the benefits of doing this, these are the risks of doing this, we believe the benefits outweigh the risks, otherwise we wouldn't be suggesting it. And let's talk about that together and arrived at a joint decision of what we're gonna do for your child, what's in the best interest. And so in this particular case, we have exception from informed consent, which we're going to talk about. But I really did want to lay out like what are the benefits of this, but also what are the risks of this, because that's something that parents are gonna are gonna want to know.

Dr Mike Patrick:     And I would suspect that 1 of the risks, and please tell me if I'm wrong about this, is that although pre-hospital personnel are trained in all of these ways, we all get into ruts and we all have a way of doing things that are more familiar, more comfortable to us, which can impact outcomes. And so if I'm a parent and I have EMS provider who says, I feel more comfortable doing it this way, but I have to do it this other way because your child is in a research study, that to me is something I would wanna know as a parent. Am I wrong about that?

Dr Julie Leonard:     We really don't know the answer to this question. So what the paramedic may think that they're doing is the right thing may not be the right thing because there's never been a study of this kind. And So leaving it up to, which is the practice right now, leaving it up to the choice of the paramedic is, is again, it could be guided by fear. It could be guided by some misconceptions about the procedures and the effects of the procedures. And again, it could be influenced by a lot of other aspects of clinical care.

Dr Julie Leonard:     So the way I would look at risks in this study, because of the type of study, are really actually perhaps you know not things that people usually would think about. So this is really a study of current practice and standard of care. And as we've mentioned, all of these are options in clinical care right now. So nothing is a new technique that's being studied. So the paramedics are all trained on these 3 items.

Dr Julie Leonard:     But as we go through this process, we are gonna be collecting information about patients and monitoring and providing some extra monitoring around their clinical care. And as that, we're gathering patient name, patient birthday, and collecting information. So the biggest risk is really 1 of loss of privacy. So, and because we're gathering information about patient's care. So again, that's something that we usually, you know, the patient has the right to their private information and it's protected.

Dr Julie Leonard:     And in the context of a research study, we will be gathering information about the patient that we otherwise would not collect that information in that format. And so we take some extra precautions in this setting to make sure that this information is tightly secure and guarded and doesn't inadvertently get released. But again, back to Henry's point, the reason to do the study is these are 3 common practices and we want unbiased application of those practices. And so therefore, that itself is not deemed necessarily a risk of the study.

Dr Henry Wang:     Mike, let me underscore a very important safety principle of the study. The paramedics have access to all airway management techniques available at all times. And while the study prescribes a preferred strategy for each day of the month, paramedics at under all circumstances are instructed to use what they feel is necessary if it's needed to preserve, protect patient safety. They arrive on scene and they realize that, for example, there's too much bleeding from the mouth. They absolutely need to put some type of tube in the mouth and throat.

Dr Henry Wang:     They are by all means permitted to do that. And we of course track that information very precisely because we are in a clinical trial. And because we are in a trial, we are able to track that information very precisely and to understand its implications.

Dr Mike Patrick:     So even though we have this trial, we're still letting the pre-hospital personnel, the EMS providers, use their clinical judgment if there is some extenuating circumstance that would ask them to do something else.

Dr Julie Leonard:     So I think, yeah, this building off what Henry's saying. So right now in practice, our providers, again, have choice of any of these 3 options. You know, depending on their individual agency, there might be some limitations in what's available to them, but in general, and to Henry's point, the protocol is recommending what their first airway attempt should be, and that's the comparison. But if they find themselves in a situation where clinical care would, you know, direct them to use a different intervention, they are able to practice usual care for that patient.

Dr Mike Patrick:     Yeah, and I don't mean to draw this out, I just, because there isn't an exception from informed consent, like this is the kind of conversation that before a research study, before someone is enrolled, these are the kind of questions that parents would ask, right? And when we have an exception from informed consent, they don't necessarily have the opportunity to ask those questions. And so I think batting this around in terms of benefits and risks as we're informing a community is an important thing. What exactly is then an exception from informed consent?

Dr Julie Leonard:     Yeah. So I think that exception from informed consent, so you, Mike, you've already outlined very nicely what informed consent is, is presenting the risks and the benefits and then the individual or the individual's proxy to have the autonomy to choose, right, and whether they're involved or not. An exception from informed consent is exactly designed for the scenario that is under study in Henry's study, in that there is not time under these critical situations to stop clinical care and identify a representative for the patient and to perform a full informed consent procedure where all of the risks, all the benefits are outlined and then consent is obtained and then the interventions performed. This is a life-saving intervention and it has to be performed as soon as the clinician identifies the fact that they need to breathe for the patient. So exception from informed consent is delaying that consent procedure until there's a point in clinical care where the legal representative for the patient can sit down with a representative from the study and discuss the study and the ongoing participation in the study and whether or not they want their child to continue to be monitored closely for the study outcomes and for their information to be collected and included in this study.

Dr Mike Patrick:     Yeah, and that really is 1 of the main purposes of this podcast is to get the information out there so that hopefully it won't be a surprise to parents if this come up. Now obviously not every parent in Central Ohio is listening to this podcast and so there I'm sure there are lots of ways that you are letting the community know about this and in all of those cities too that are that are participating, right Henry?

Dr Henry Wang:     The process of exception from informed consent was developed over 20 years ago by Food and Drug Administration. They developed a series of rules because of the recognition that we need to have high-quality research studies of emergency conditions, but it's impossible to get prospective consent from these critically ill individuals. The exception from informed consent rules have been used for dozens of research trials since their inception, and they're being used here in the PD PART trial. 1 of the most important parts of exception from informed consent is the notion of community consultation and public disclosure. So we are required as a study network to share information about the study with community members and to get feedback from community members about the research before the research takes place.

Dr Henry Wang:     So this effort has been ongoing for the last 4 months in all 10 cities participating in the trial. There have been extensive interviews with individuals, meetings with community groups, as well as very proactive social media campaigns spreading information about the trial and bringing in individuals to the study website to provide information about the trial and to glean their opinions about this type of research. So by all means, there is a very proactive attempt to ensure that the community is very well aware of the research study.

Dr Mike Patrick:     And a part of that notification does involve some websites and we are going to put links to those websites in the show notes for this episode over at pdacastcme.org. It's episode 96 And I know you have a website really for each of the cities that are involved. There's ones that is particular to Columbus. There are informational videos. There's explanations of what exception from informed consent is.

Dr Mike Patrick:     Frequently asked questions. There's information for healthcare providers. There's a Spanish version. And so we're going to have all of those links in the show notes so folks can find those easily and be able to not only look that up for themselves, but also to share it in your own social media. You know, a lot of primary care docs out there have websites for their office or they might have a Twitter feed or a Facebook feed and these would be excellent resources to share in those feeds just so the folks in your particular practice if you're in a city that's impacted by this that you can share that with your population of patients.

Dr Mike Patrick:     And so again, we will, we'll put that in there in the show notes for everybody.

Dr Henry Wang:     Thank you. The websites will be live throughout the entire trial and the intention is to continuously provide information to anyone who is interested.

Dr Mike Patrick:     Yeah. And then finally, Julie, can you just kind of walk us through from the parent's perspective, what does this look like in terms of when you, you know, obviously in the field, you know, it's, it's a very adrenaline producing, you're really worried about your kid. It's a whirlwind really as your child's being resuscitated. Then you get to the hospital and things are more stable. Then what does that look like then, you informing a parent that you would like for them to continue to be a part of this study?

Dr Julie Leonard:     Absolutely. So, as you mentioned, Mike, this is a, you know, a very emotional situation for a family when they have a child that needs critical interventions. And so our job as the research staff is to first let the physicians and nurses and care team render care so you know when the patient arrives at the hospital their care will be you know the number 1 priority and the focus will be on taking care of the child. Once during the patient's, the child's clinical course, there comes a point where the patient has stabilized and we have the family at bedside, members of our research staff will meet with the family and explain to them the clinical study and walk through the process of informed consent. We'll, you know, notify them that the child was enrolled in a clinical trial that was under exception from informed consent and what that meant, the risks and benefits of the study and what the elements of the ongoing data collection would entail.

Dr Julie Leonard:     And then at that juncture, the family has the choice to continue their child's enrollment in the study or withdraw their child from the study. And you know, we try to find the soonest feasible opportunity to do that and to give the guardians the choice for their child. But again, being sensitive to the fact that oftentimes in these situations, there are other decisions that are needing to be made and we want to make sure that we allow the clinical care to take precedence and find that opportunity where we can insert ourselves without distracting the family from other decisions and their child.

Dr Mike Patrick:     Yeah, And that totally makes sense and I think that I would imagine most parents would continue their child in the study because you know the the main intervention has already been done at that point and it's just a matter of following them along and that's gonna add information you know that can be helpful to other kids in the future and moving forward.

Dr Julie Leonard:     Yeah, I think that, you know, choice is an important element and sometimes, you know, families do elect not to continue their child's engagement in the study. We hope that through shows like this, where we can talk about the importance of research, talk about how it actually benefits mankind in the future, but your child in the moment in terms of it's sort of like having an extra set of eyes on your, you know, the child's care and that there are just some real, real benefits that have been proven over time. And, you know, we hope that by participating in podcasts that sort of educate the public about research, we sort of demystify what that means, you know, to be involved in a clinical study.

Dr Mike Patrick:     Yeah. Yeah, absolutely. Speaking of clinical studies, I just wanted to talk very briefly about emergency medicine in general at the Ohio State University. Henry, you are a very much an academic emergency medicine program as opposed to a really community-based program. I'm sure you have lots of research studies that are going on, right?

Dr Henry Wang:     Yes, 1 of the most important missions of any academic department of emergency medicine is to contribute to the science. Without the science, we don't expand knowledge. Without the expanded knowledge, we don't improve upon our care. And so it's important that we all participate in this process. And 1 of our major missions as an academic department is to continue to increase the body of knowledge under underlying emergency care.

Dr Henry Wang:     At Ohio State University, we have a very vibrant emergency medicine research division. There are at least 12 faculty who have NIH research funding and we have millions of dollars in research funding and activities going on at any given time.

Dr Mike Patrick:     Yeah, very impressive. And we'll put a link to emergency medicine at the Ohio State University Wexner Medical Center in the show notes as well. And then Julie, I wanted to ask you about emergency medicine at Nationwide Children's Hospital and also about PCARN, which we have talked about on this program before. What exactly is PCARN and how does that intersect with emergency medicine at Nationwide Children's?

Dr Julie Leonard:     Yeah, absolutely. So PCARN stands for the Pediatric Emergency Care Applied Research Network, and it is now 25 years old. It is a network of 18 children's hospitals across the United States that have partnered to conduct emergency medicine research. Nationwide Children's Hospital is 1 of those 18 hospitals that participate. And we actually lead a grouping of 3 hospitals here that are part of PCORN.

Dr Julie Leonard:     So we're partnered with the University of Pittsburgh Medical Center and Nemours Medical Center in our research efforts within PCORN. So what that means for us at Nationwide Children's Hospital is that we're engaged in many studies that improve the emergency care of children. Right now we have 8 active studies going on in the emergency department that are tied back to this research network. 2 of them are actually pre-hospital trials, 1 being PD part that we have just discussed and another PD dose. So that is the second important element of our research network is that we're partnered with the pre-hospital communities so that we are not just advancing the care of children in the hospital-based emergency care but also the pre-hospital-based emergency care.

Dr Mike Patrick:     And we will put links to PCARN, the Pediatric Emergency Care Applied Research Network, and Emergency Medicine at Nationwide Children's Hospital for folks who would like to learn more about those things. Those links will also be available in the show notes over at pediacastcme.org. So once again, Dr. Julie Leonard with Emergency Medicine at Nationwide Children's and Dr. Henry Wang with Emergency Medicine at The Ohio State University.

Dr Mike Patrick:     Thank you once again for stopping by and chatting with us today.

Dr Julie Leonard:     Thank you. Thanks for having us. We

Dr Mike Patrick:     We are back with just enough time to say thanks once again to all of you for taking time out of your day and making Pediacast CME a part of it. Really do appreciate that. Also thanks to our guests this week, Dr. Julie Leonard and Dr. Henry Wang, both with emergency medicine at Nationwide Children's Hospital and the Ohio State University Wexner Medical Center.

Dr Mike Patrick:     Don't forget you can find Pediacast wherever podcasts are found. We're in the Apple and Google podcast apps, iHeart Radio, Spotify, SoundCloud, Amazon Music, YouTube, and most other podcast apps for iOS and Android. Our landing site is pediacastcme.org. You'll find our entire archive of past programs there, along with show notes, our CME information, our terms of use agreement, and that handy contact program. Reviews are helpful wherever you get your podcasts.

Dr Mike Patrick:     We always appreciate when you share your thoughts about the show and we love connecting with you on social media. You'll find us on Facebook, Instagram, threads, LinkedIn, and Twitter. Simply search for Pediacast. So you have listened to the podcast. Now be sure to claim your free category 1 continuing medical education credit.

Dr Mike Patrick:     Really easy thing to do. Just head over to the show notes for this episode at pediacastcme.org. You'll find a link to the post test in the show notes. Follow that link to Cloud CME, take and pass the post test and the category 1 credit is yours. Again, you'll need to click on the materials link when you get the Cloud CME.

Dr Mike Patrick:     Super easy, right? And again, we do offer credit to many pediatric professionals, including doctors, nurse practitioners, physician assistants, nurses, pharmacists, psychologists, social workers, and dentists. Of course, you want to be sure the content of this episode matches your scope of practice. Complete details are available at pediacastcme.org. And then just 1 more reminder, we do have an evidence-based podcast for moms and dads.

Dr Mike Patrick:     Lots of pediatricians and other providers also tune in. That show is called Pediacast, plain Pediacast without the CME. And we do cover pediatric news and interview pediatric and parenting experts. Shows are available at the landing site for that program, pdacast.org, also available wherever podcasts are found. Simply search for PDACast.

Dr Mike Patrick:     Thanks again for stopping by, and until next time, this is Dr. Mike saying stay informed, keep it evidence-based, and take care of those kids. So long, everybody.

Announcer:     This program is a production of Nationwide Children's. Thanks for listening. We'll see you next time on Pediacast. C-M-E.

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