ABPM: Holistic Blood Pressure Data and the Patient Experience – Part 2
Patricia Castellano and Emily Olsson explore how sites can benefit from developing a stronger relationship with their ABPM device vendors. They also address strategies for successful repeat ABPM sessions when a patient is non-compliant, and how ABPM achieves a type of holistic data not possible with other BP measurement methods. In part 1, we discussed improving data quality and the patient experience.
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Patricia Castellano and Emily Olsson explore how sites can benefit from developing a stronger relationship with their ABPM device vendors. They also address strategies for successful repeat ABPM sessions when a patient is non-compliant, and how ABPM achieves a type of holistic data not possible with other BP measurement methods.
Patricia Castellano, Senior Director of Product Management at ERT, is joined by Emily Olsson, CCRP, from the University of North Carolina Chapel Hill for an in-depth look at the keys to implementing a successful ABPM protocol in a cardiac safety trial.
Improving ABPM through Better Site/Vendor Relationships [04:10]
Sites that don’t have much experience with ABPM shouldn’t hesitate to reach out to device manufacturers to ask for training or assistance when needed. Other external teams and experts may also be willing to provide ABPM insights. Vendors who can provide customizable software with easy-to-read outputs are ideal.
Achieving Successful ABPM Repeat Sessions [07:37]
If a patient is non-compliant or produces unusable data, a repeat ABPM session may need to be scheduled. Discuss the outcome of the original session with the patient and identify how the experience can be improved. Proactively manage the expectations of individuals in patient groups that may experience repeat inflations – such as elderly or obese patients – and provide them with tips and tricks that can help improve their comfort and compliance.
Using Home Blood Pressure Monitoring (HBPM) Instead of ABPM Comparing Compliance with ABPM to Other Blood Pressure Monitoring Methods[12:01]
Home blood pressure monitoring provides more comprehensive blood pressure data than a single measurement in the clinic. However, patients are typically not well-educated on how to use a home blood pressure device and may fall out of compliance over the duration of the collection period. This results in data that isn’t a true reflection of their blood pressure.
Intro: Welcome to the Trial Better Podcast. This week we dive into part two of our ABPM discussion with host Patricia Castellano and guest Emily Olson. Last week we discussed the value of ABPM data and how to train site teams on using the monitors. This week we’ll move away from the site experience and focus more on the patient, how the patient experiences the ABPM device, how to troubleshoot potential problems and tactics to improve patient compliance. We have an exciting discussion lined up, so stay tuned to this episode of Trial Better.
Patricia Castellano: Hi everyone and welcome to this installment of the Trial Better Podcasts. My name is Tricia Castellano, and I’m a lead with the Product Management team for ERT’s cardiac safety product line, and I’ll be your podcast host this week. In today’s podcast, we’re going to cover best practices for ambulatory blood pressure monitoring and blood pressure in clinical trials and we’re going to talk at length about the best ways to get patient compliance. And today we welcome our featured guest who is Emily Olson from the University of North Carolina. So, Emily, you had a lot of experience, you had a lot of extensive experience with hypertension and helping hypertensive patients and clinical trial patients in doing the best job collecting blood pressure. But we know that there’s a lot of site personnel that participate in trials having limited or no exposure to ABPM, and that can really be a challenge. What would you suggest is the best way to get those coordinators, that site personnel to understand the aspects of ABPM and do a good job in supporting your patients?
Emily Olson: Yes, so that’s part of the reason we created the course where you and I met Tricia, was to be able to train study teams and to really help them understand the value of ABPM and to give them best practices and to give them some familiarity with the equipment. However we certainly understand that it’s not always a possibility for teams, and so truly I think the best thing to do is if you are in a practice, if you’re starting a study that’s going to be utilizing ABPM, you should play with the equipment. You should wear, actually wear the ABPM for 24 hours.
You should experience what your participant is going to experience. I would have participants who would say to me, like, Oh, come on, you didn’t really wear this thing. How do you know? And I could honestly say, no, I did, I wore it for 24 hours. I wanted to throw it across the room in the middle of the night. I get it, I feel for you, but you know, this is the data that we’re going to get. Here’s why it’s important, and here are some things that you can do to make your experience more tolerable or to make your experience better while you’re wearing it.
As far as the study teams go too, we definitely recommend having good templates and good forms. So, we always had a one-page instruction sheet that our coordinators would use to sit down actually with the participants and go through point by point. We also would have meetings on a regular basis to take a look at the data that was coming in and see were there any issues, were there any sort of trends that we could see, about where we were losing data for participants and what we could do in our education to try to improve that. So, if we saw that routinely at night there were, there was trouble, that people were routinely taking it off while they were sleeping. We sort of would come up then with a strategy about, okay, we really need to emphasize that in our training with our participants so that we can communicate the importance. But you know, certainly all blood pressure devices take training, they take experience and they take buy-in both from the clinician and from the participant. So, I think if you’re going to be using ABPM, you definitely want to read the research, you want to understand why it’s important. You want to understand the benefits of the data from ABPM as opposed to clinic blood pressure measurements or home blood pressure measurements and how those can all be complimentary.
Patricia Castellano: Now I know some of the, so you’re really familiar with several of the different typical ABPM devices that are used in clinical trials. You have a lot of experience with them and you included even some vendors in your training program to show kind of the differences across the devices, and in general they all looked pretty the same. And you all, in general and how they performed and you had to look at the data and see, Hey, there’s four hours of data that’s missing while the patient was sleeping and you talk to that person specifically about that. Or I see a lot of movement artifact during this time. When you find out what was going on, for those sites that don’t have the experience that you do, don’t know how clearly, quickly look at the data and they’ve already kind of gone through their whole investigation about what that can mean. You think it’s helpful too, for some of those ABPM programs that kind of give them a quick review about where there might be gaps in the data or what the gaps might mean?
Emily Olson: Yes absolutely, and I think that’s something that at least in our experience, many of the vendors and manufacturers have a pretty extensive knowledge, obviously right about their own product. And so if there’s ever any question about what the data looks like or what it means or how it could be improved, we always found, and certainly in the beginning, even ourselves, right when we were new to doing the ABPM and with different monitors and different machines. We would routinely reach out to the company and just say like, Hey, we’re experiencing this. Is this something that your other customers have run into? Do you have any advice for us?
Or can you give us some expertise from your end, from the back end on what this might mean, or on how we can address this. I know many of the softwares are customizable, so we typically use the Suntech Oscar twos, but we’ve used many different ones and they all have pros and cons. But the software and the output are a big part of it, and you want to see, is this easily understandable both to the clinicians and then to the patient or the participant. We found that reviewing the results with the participant also had a really, really strong impact on their investment, and having sort of the experts’ interpretation of the result, who would of course be the licensed PI, licensed physician to make those interpretations and then communicate those back. But yes, I would always say for teams that are less experienced with blood pressure in general and especially with these ABPM devices, asking for training from the manufacturer of the device that you’re getting, or reaching out to other experts in the, in the country. Our team is always happy to talk with other programs, with other teams about our lessons learned and our advice on the administration of ABPM or other blood pressure devices. And I know that some of the other faculty that helped to co-run our course up at Columbia University are also very happy to talk with teams. And we understand this is a new thing and it’s not something that a lot of clinics have experience with, but we really, we feel that it’s incredibly valuable for our patients and for our participants and think that the literature supports that. And so, we want to do what we can to sort of help share our knowledge and our lessons learned.
Patricia Castellano: So, some studies actually require, because occasionally studies do experience a lot of lost data on a session and that they don’t want to lose a patient, so they’ll go ahead and plan to repeat that ABPM. What’s your experience with that? Do you find that patients, that really reduces compliance with those patients or is there, are there strategies in helping to get a repeat that then is successful, so you don’t have to lose that patient?
Emily Olson: Sure. I think a lot of that, again, depends on your study coordinator, right? Or on the clinician, that’s the boots on the ground, sort of dealing with the person who’s doing the ABPM session. Certainly, a repeat session is an annoyance for the participants or the patient, but if you can sit down and sort of talk through the original session with them and say here’s where we were missing data, was there something going on? Was it uncomfortable? Did you remove it and what can we do? And talk about what were your experiences with the original session and how can we improve those experiences so that we get good data. And certainly, there are certain groups of people and certain body types that are more or less prone to repeat measurements, to getting good data or to be annoyed by the monitor itself.
So, we found that patients with larger arms, so typically who are obese or even we had a couple of younger men with that were sort of like bodybuilders that have very muscular arms. And in both cases, they had trouble, the cuff had trouble getting readings. Of course, you always want to make sure you’re using an appropriately sized blood pressure cuff. That was a very, very big thing for us as far as compliance with these people with larger arms, was to make sure that we had the appropriate size cuff for data quality and also for their comfort, and then managing their expectations.
So if you saw someone who you knew they were likely to have a little bit more trouble with the monitor, the monitor was likely to have more trouble getting readings, you would try to manage their expectations and let them know that. And then same with the elderly or people with more frail or sensitive skin, often they experience a little bit more not adverse effects necessarily, but more they were more uncomfortable. It was more likely that their arm might be bruised, or an abrasion would occur from the cuff. And so again, managing expectations and then learning sort of tips and tricks, we would sometimes put some paper tape on this one particular part of the cuff that tended to irritate people. Or to tell them to slide a tissue between their skin and the cuff. So just little things like that, that could really help improve their experience, which then improves compliance as well.
Patricia Castellano: So you even when your patients walked in, you kind of thought about, gee, what do I know of the nuances of this particular population perhaps, like you mentioned obese patients, which we know often can be a challenge in ABPM. So, you kind of put that into consideration when the first time you met with that subject is sort of plan how much time you would want to ensure you’re spending with it, well spending with them. I think that sounds like a really great way to handle those difficult populations. And I know we’re going to see more inflations on particularly those big patients, right? Because the device might have trouble reading the blood pressure measurement and hyper inflate and then they might have to go to repeat. So besides just even the comfort level, they’re probably even going to be exposed to more total inflations across that monitoring period. It sounds like that’s a good thing to be sensitive to.
Emily Olson: Yes absolutely, and just managing that expectation and giving them tips and tricks; You know as soon as you hear it inflate, try to be still, let your arm just hang. We had people that would be like carrying groceries from the car, that would just stop between the grocery store and the car and relax their arm and let it get the measurement, knowing that if it didn’t get that one, it would try again. And so yes, just managing expectations and letting them know what’s coming and what they can do to reduce the frequency of the measurements. Now they can’t always, the troubleshooting doesn’t always work. But it gives them a little bit more power and investment and their participation in this session.
Patricia Castellano: Now you mentioned the different ways to collect blood pressure ABPM, you mentioned home monitoring. So, you’ve had experience with doing those. Can you tell me a little bit more about how those two things compare because we have heard questions from drug developers, about you can’t use home blood pressure monitoring in place of ABPM because I’m so worried about compliance issues. Tell me a little bit about your experience with those two types.
Emily Olson: Yes, so we certainly use home blood pressure monitoring as well, and in that larger study that we did, we actually used both. So, they were sort of complimentary in the study ABPM and HBPM. You know we tend to find in our experience that the home blood pressure monitor, gave a better picture than just the single measurement in the office, right? You get a few more measurements, you’re getting some experience with them in their own environment as opposed to in the clinical environment. But we find that often patients and participants are not well educated on how they should be using the device properly. Their physician or the team often says like, Oh yes just go pick one up at Walgreens or whatever it is, and go home and take your blood pressure measurement, a few times in the morning and few times in the evening, write those down and bring them back.
And you know, the truth of the matter is that with those machines, you really should be using sort of a protocol to take your blood pressure similar to a clinical measurement, right? You should be sitting quietly for five minutes before you take your blood pressure. You want to be sure that you’re comfortable with your feet flat on the floor, that you’re not talking, that your ankles aren’t crossed, those kinds of things. And patients often don’t know that. And so, the data that you’re getting back, is not necessarily a true reflection of their blood pressure. And then we also find that like the clinic measurement, it’s a little bit skewed by environment and by time of day, right?
So people might take it at times when they are more prone to being relaxed or when they’re more prone to being stressed out and that you’re still only getting these snapshots, perhaps you’re missing if they have high blood pressure while they’re at work. If they have sort of situational high blood pressure that you’re missing that on these other ends of the spectrum or vice versa. If they have three kids under the age of four at home and their home life is more stressful than their daily life, that can also cause the readings to skew one way or another. And then the last thing we found with it is that patients were not always compliant. because it was over a longer period of time.
So, with home blood pressure measurements, typically you’re saying, please over this next week, over this next month, take your blood pressure measurements. And with our studies we actually would hook up, but we would ask them to record them on with pen and paper. And then when they brought the machine back, we would actually plug in a little printer and print out the time and the date and the measurement of everything and compare the two.
And we actually found that often our participants were fudging the truth a little bit. Either they were not reporting correct numbers based on the measurements that were taken or we even had a few instances where the person just took all of their measurements that morning. They just did like 20 blood pressure measurements that morning and reported it back as being over the course of a full week. So, I mean I think there’s going to be pros and cons with any way that you do it. Certainly, more information is better than less, but it’s really in any of these cases all about properly educating your patient or your participant about how to do these measurements appropriately, and then really stressing the importance of it. If you bring me 20 measurements from this morning and I based my care decision on that, I’m not really basing it on a true picture of what your blood pressure has done over the past week.
Patricia Castellano: Well, we’ve had a great conversation today. Thank you so much Emily. Your insights and experience have just been really valuable in helping us to understand, your best practices with blood pressure monitoring and particularly what to consider to get the best out of the patient compliance. So, thank you so much and I hope.
Emily Olson: Absolutely thank you.
Patricia Castellano: Thank you, and I hope everyone stays tuned for our next installment of the Trial Better Podcast Series. Thank you.
Outro: Once again, thanks to both Tricia and Emily for your discussion on ABPM. To our listeners, thanks for tuning in. If you heard something you like, please shoot us a message at firstname.lastname@example.org or leave us a comment. That’s it for this week. See you all next time on the Trial Better Podcast.
Emily Olsson is a certified clinical research professional experienced in planning, implementing, and overseeing clinical projects in a variety of therapeutic areas. She has a passion for research bolstered by a focus on compliance, quality assurance, process improvement, and high participant enrollment and retention.