Episode Transcript
Interviewer: Childhood respiratory emergencies are one of the most common reasons people call an ambulance or emergency medical services. And previously paramedics had limited options for treating on-site before transferring to an emergency department. However, a new clinical trial is investigating if some commonly used hospital medications can be used by EMS to effectively treat respiratory emergencies in the field.
Dr. Sarah Becker is the Salt Lake City site investigator for the Treating Respiratory Emergencies in Children Study, which is also known as T-RECS for short. Dr. Becker, first of all, for this study who is included in it?
Dr. Becker: Inclusion criteria are for patients that are from ages 2 years old to 17 years old, who are experiencing life-threatening wheezing or severe asthma exacerbation and clearly need some kind of intervention.
T-RECS Study Objectives: Medication Usage in the Field
Interviewer: Tell me a little bit about the study. What are we trying to find out?
Dr. Becker: What we're trying to figure out is if the treatments that we commonly use in the hospital for children who are experiencing those symptoms, the medicines typically used are albuterol, dexamethasone, and ipratropium, if we use those earlier in the course of their illness, by first responders, by EMS providers and paramedics, if we can improve their overall outcome. Outcomes include decreased admission rate, and decreased admissions to the ICU. Our hope is that by giving medicine sooner in the field, we'll have better outcomes.
The Importance of Early Medication Administration
Interviewer: And why do you believe that giving the medication earlier would lead to better outcomes?
Dr. Becker: What we've come to understand, especially with life-threatening wheezing or severe asthma exacerbations, is that it tends to be a progressive process. So the longer the time that has passed and symptoms have started, the worse off we tend to be if we have not intervened. So the hope is that if we give those treatments even, you know, an hour or two sooner than they would if they were in the hospital, we could profoundly impact their outcomes.
Interviewer: And is there some question about whether or not that that would work? Is that the purpose of the study?
Dr. Becker: No, there's no question as to whether these medicines work. They've been studied and studied and studied some more. They're tried and true, and they're old medicines that people who are asthmatic are quite familiar with. It's just whether the earlier administration is helpful to their outcomes, and if we can responsibly and safely administer them in the field.
Opting Out of T-RECS Study: Exception from Informed Consent
Interviewer: Oftentimes if somebody is going to participate in a clinical trial, they opt-in to do that. And I understand permission to participate in this particular trial is a little different. Can you explain how it's different?
Dr. Becker: So this is a study that falls under a category, an FDA category called the Exception from Informed Consent, which generally means that in an emergency situation, if your child is experiencing life-threatening symptoms that need intervention before we can appropriately get, you know, legal consent, we will need to start administering those medicines immediately, using our best clinical judgment to make that choice. So, you know, we won't be able to necessarily in that moment get consent from parents. We may need to just give them medicines and then ask for permission to participate in the study after the fact.
Interviewer: And if a parent decided to opt out, what would that process look like?
Dr. Becker: All the paramedics that are going to be participating in this study are going to be getting training on how to kind of go through the workflow of treating these patients. One of the first steps will be to tell parents, "We are going to give these medicines to your child because we think that your child needs these medicines. You should also know this is part of a research study." They'll have a script, and they'll tell the family what's going on.
So in that first couple of moments with that communication, a parent has every right at that moment to say, "I do not want to participate in this study. I do not want my child to receive those medicines." And that's the most probably direct and fastest way to opt-out.
Another way is we can provide the phone number and email address for our study team so that you can contact us ahead of time and be added to what's called an opt-out list, so that we know going to certain homes that that is not a potential study subject. Or if after the medicines have been given, you don't really have any interest in participating in the research component, you know, you're okay with the medicine, just don't want to participate in the research component, when the research team calls you to discuss this, you can say you opt out at that point too.
Opting In: Risks and Benefits Consideration of T-RECS Study
Interviewer: Dr. Becker, as we wrap this up, it sounds like this is something that if a parent is listening to this interview now, they should have in mind if they want to participate or not. Being asked in the moment, when your child is having an incident, could be a little stressful to make a decision. Help that parent go through the risks versus the benefits in your mind so they can have that answer ready if they do find themselves in this unfortunate situation.
Dr. Becker: In my mind, the risks are really the risks of the side effects of the medicines themselves. So, for example, these medicines have been known to sometimes elevate the heart rate, and make humans, especially children, a little bit more excited or agitated. One of the medicines can slightly increase, you know, pressure inside the eyes, not to a pathologic level, but slightly. And so those side effects may not be worth the risk to parents. And so if those side effects are, you know, intolerable, then those are the families that should opt-out.
I will say that we use these medicines a lot for, you know, life-threatening wheezing or asthma. And, in general, they're very well tolerated. They are short-lived. They only last as long as the medicine lasts. And so it's just a matter of deciding, you know, risk versus reward with regards to getting those medicines.
Interviewer: And when making that risk versus benefits decision, what are the benefits?
Dr. Becker: So the benefits of these medicines are well-known. They are medicines that have been used for decades and are the definitive treatment for life-threatening wheezing and severe respiratory distress because of asthma. You know, the side effects are there, yes, but like I said, these could save a child's life. And in the cases where that isn't even a risk, it could very well potentially decrease the risk of a child needing to be admitted overnight to the hospital, because we gave those medicines sooner rather than later.
T-RECS Study Contact Information
Interviewer: One final question. If a parent has heard this conversation and they would like to discuss more for their particular situation, you know, some of the side effects you mentioned, is this something they could talk to their pediatrician about?
Dr. Becker: They could definitely talk to their pediatrician about it, and they could also contact us at the email address and phone number that we provide for our research team. They're very well-versed in talking about those things as well.
Interviewer: That's great. What is the email address and the phone number?
Dr. Becker: The email address is pemresearch, all one word, @hsc.utah.edu. That's pemresearch@hsc.utah.edu. The phone number for our research office is area code 801-986-0962.