ABPM: Improving Data Quality and Patient Compliance – Part 1
ABPM is the gold standard in blood pressure data collection. Patricia Castellano and Emily Olsson examine how underlying tenets of patient-centricity and empowerment can improve the collection of ABPM data through increased patient compliance, and how sites can benefit from staff training and commitment to ABPM. In part one of our ABPM episodes, find out how to successfully capture ABPM data and improve patient compliance. In part 2 where we explore the patient experience and take a holistic view of blood pressure data.
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ABPM is the gold standard in blood pressure data collection. Patricia Castellano and Emily Olsson examine how underlying tenets of patient-centricity and empowerment can improve the collection of ABPM data through increased compliance, and how sites can benefit from staff training and commitment to ABPM.
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.
Enhancing Data Quality and Value with Hands-On Training [02:31]
Hands-on training provides benefits to both patients and site staff. Participants who receive training feel more engaged in the ABPM data collection process and are more likely to be compliant. Site coordinators who wear the ABPM cuff as part of their training develop a deeper understanding of the device and can better relate to and communicate with patients. A focus on training improves data quality and, ultimately, usability in clinical and medical applications.
Improving ABPM Patient Compliance [04:21]
Participant preparation can help sites achieve higher patient compliance rates. Standardized instruction sheets and troubleshooting tips and tricks can increase trust between the patient and the site coordinator and empower patients in their ABPM experiences. Coordinators should set realistic expectations about ABPM and how it can be uncomfortable and intrusive, and be available to patients who have questions about ABPM or their device. A transparent relationship between the patient and the site coordinator is critical to compliance.
Successfully Implementing ABPM [09:09]
Successfully implementing ABPM requires training, experience (or a willingness to ask questions), and buy-in from both sites and participants. An important initial step is to gain an understanding of the patient experience by wearing the ABPM device. Schedule internal meetings on a regular basis to identify trends and issues that can be improved with better site or patient education.
[Intro]: Welcome to the Trial Better podcast. Inspired by a recent FDA guidance, we dive into blood pressure monitoring and clinical trials and the technologies we can leverage for better data. We also explore ways to improve patient compliance with ambulatory blood pressure monitoring. Leading this week’s discussion is host Patricia Castellano, and featured guest Emily Olson. Stay tuned to trial better!
Patricia Castellano: [0:32] Hi, everyone. Welcome to this installment of Trial Better podcast. My name is Tricia Castellano, and I’m the lead with the product management team at ERT cardiac safety division, I am the host to your podcast this week and today we welcome our featured guests, Emily Olson from the University of North Carolina. Hi, Emily and thanks so much for joining us today.
Emily Olsson: [0:53] Thanks for having me!
Patricia Castellano: [0:55] Sure. Emily, we met a couple of years ago and you are part of an expert team of hypertensive researchers, who were doctors and study coordinators, and they were sponsoring a unique ambulatory blood pressure training program. At the time you were the clinical research coordinator for the hypertensive research program at UNC Chapel Hill and you told me you participated in many clinical trials where you were responsible for collecting over a thousand ABPM recordings. Your training program is great and it focused on the why and how of using ABPM monitor blood pressure, why did you feel it was so important to put together a team of experts to provide hands on training on best practices with a BPM monitoring?
Emily Olsson: [1:36] Yeah, so we were very fortunate. I have 11 years experience as a clinical research coordinator and as a project manager, and as you said, worked primarily in hypertension research. So we did do studies that utilize ambulatory blood pressure monitoring, as well as other blood pressure measurements. The importance of doing it correctly and really engaging the participant or the patient in the process is incredibly important, if you’re going to be doing this, you really want to make sure that you’re getting good data and that the patients or the participants are compliant with the measurements of the monitoring. And really, the best way to do that is to understand the tool that you’re using, to understand how it works and what the experience is going to be like for the person wearing it. I think as a coordinator, really spending the time training other teams on how to appropriately communicate with the patient, to communicate with your participants that makes all the difference in the quality of data that you get for blood pressure measurements.
Patricia Castellano: [2:31] Yeah, so your program specifically pointed out that there’s a relationship between quality and the value of blood pressure. So explain to me that connection.
Emily Olsson: [2:41] Yeah, so the largest study that we did was on 420 participants who had borderline blood pressure. So these are participants who were not particularly invested in their blood pressure, not people that were already on medications, that kind of thing and each of those participants did two ABPM session. We had 840 BPM sessions. And we were able to achieve with that in 98% compliance rate in the data quality that we got, we were able to actually use 98% of those measurements that came back to us in our analysis. And the importance of that truly is to be able to, if you’re going to use this data, either to draw conclusions for research study, or if you’re going to be using it clinically, to make decisions about their care and about their quality of life, you want to be basing that on data, that’s real, right? And on data that is of the highest quality and its most representative of their life.
And so we feel that ABPM really captured that the best you know, when you’re just doing office measurements, you get a quick snapshot into their blood pressure into what their blood pressure is doing at that one moment in the office. With home blood pressure monitoring likewise, you’re getting a snapshot into their home life. But those with those methods, you have a little bit less come control over the quality and the scope to so with ABPM data, you’re really getting a full comprehensive picture of 24 hours of their life, the blood pressure patterns, the individual blood pressure measurements, how they’re reacting to their surroundings and to any other input, so any medications or anything like that, that they take while they are using ABPM.
Patricia Castellano: [4:21] That the recent meeting with the FDA because the FDA has been talking a lot about more and more concerned about a relationship between blood pressure while patients on drug and increases small increases, particularly for patients that are taking drugs chronically. And they specifically in your last session this year talked about that compliance, they even said, Hey, we think you might only want to collect two ABPM because we know compliance is an issue. So clearly, they’ve heard about that. But you said you got your study 98% compliance. Did you always have that kind of compliance and your trials?
Emily Olsson: [4:56] Yeah, across all of our studies, we did very well. We always had over 90%. That one that I mentioned was by far our largest study with the most ABPM, you know, in a single population. But we always have really excellent compliance. And I definitely credit that to our preparation, we had an instruction sheet that we spent between 5 and 15 minutes with every single participant at every single ABPM session, going over the sort of purpose why are we doing this? Why should you care? Why is it in your best interest to get good data and to sort of work with us? We would always troubleshoot we would do some examples while we were in the office, right? So we would explain to them how we were putting the ABPM on we would show them how it should be positioned and explain why it needs it was important that it be positioned that way.
We would give them some troubleshooting tips and be very honest and transparent about the fact that it wasn’t going to be the most comfortable 24 hours of their lives, right? That this thing is a little bit annoying and it isn’t A little bit intrusive but that the data quality that we get is so important and that if they’re able to help us achieve good data in the 24 hours, it’s really going to be to everybody’s benefit. And we found that being available also, when they had questions during that 24 hours that we were not available 24/7, but we did try to have a phone number available for them into the evening as well. And they could call and say like, Hey, is this what it’s supposed to be doing? Is this supposed to be taking this many measurements? Is it supposed to feel like this? Or I’m uncomfortable, I want to take it off, you know, is there anything I can do to make it more comfortable. And we found that if we were able to sort of talk them through it and really empower them in their experience of the monitoring session that they did great on the whole.
Patricia Castellano: [6:44] So it sounds like the key was to setting expectations with the subject and not pretend, this isn’t an important thing or that this isn’t going to be maybe difficult or, you know, inconvenient to handle, but you’re confident that they can do it and you walk through.
About the collection, there’s rules about, you know, hey, don’t take it off and shouldn’t shower do No, don’t do this. Don’t do that. But it sounds like you actually help them understand that they might not be compliant and then help them figure out what to do?
Emily Olsson: [7:18] Yeah, yeah. So I mean, certainly when we schedule this session, we make clear to them what the constrictions of the study are right, and what the parameters about showering and such. And so we try to encourage them to schedule it on a day when they don’t have an activity schedule that will conflict with that. You know I remember particularly we had one participant who had a religious water aerobics class that she went to, and so she would not miss it. And so we made sure to schedule it on the day when she was not going to be in her water aerobics class and wouldn’t be having the cause to take the ABPM off. However, certainly we understood and we learned during the course of this that people do take it off. Right, you can, you can tell them and you can explain to them why it’s important. But either they’re going to shower just no matter what you tell them, or they get very uncomfortable and annoyed with it. And so they’re going to take it off. You know, I know on a few occasions, early on in study, as we were sort of learning about this, we had a couple people come back in with the cup upside down, and they swore up and down that they had not taken it off but very clearly they had and had put it back on and incorrectly. And so those are the kinds of things that you just need to deal with as a clinician and as a coordinator, and to understand that these are people’s lives, and they’re going to live them. And then in order to get good data, you have to get them on board with you, right. And so we were explaining as we put the monitor on in the office, you know, here’s where it goes. It goes in this position. This part needs to be over this part of your arm and trying to help them troubleshoot a little bit so that inevitably, when something happened, when something came up, they were able to then get it back on. And to resume the study in a way that still got us quality data, because we had sort of trained them. Certainly we were always emphasizing, you should follow these guidelines that you should not take it off. But in the event that it does need to be taken off, this is how you put it back on. And sometimes we weren’t even that explicit, right? We would just sort of explain it as we were going along. And not necessarily saying, you know, you might take this off, but here’s how to put it back on. But just knowing that that interaction and that education, they would know how to put it back on and they would know how to make adjustments in the event that they weren’t able to follow the guidelines to the T.
Patricia Castellano: [9:40] Your team has a lot of you know, you’re hypertensive experts, you have a lot of experience with this and other diseases like and you know how to run those clinical trials. A lot of sites though, clinical trials don’t focus on hypertension and they don’t have exposure to ABPM. ABPMs Kind of a unique tool to collect blood pressure. So for those sites that haven’t have never experienced blood pressure they haven’t had one required to collect before. What would you kind of advise them in terms of ways to really get comfortable with what it’s about and how to work with your patients?
Emily Olsson: [10:20] Right. And this is part of the reason we’ve developed that course to begin with, to try to communicate with clinicians with teams with study teams, about what the equipment is, and to have some familiarity with best practices and those kinds of things. But certainly not everyone is able to attend those sessions right and so we would definitely recommend I think for me, the first thing is that you should wear the ABPM yourself. I think that is key, both new understanding the experience of the participant or your patient, and also in their trust of you saying, Hey, this is important, and I understand what you’re going through. We had a number of participants, look at you’d be like, oh, but come on, you haven’t actually worn this thing for 24 hours, right? And I could always honestly say like, Yes, I have, and I wanted to throw it across the room halfway through the session, I get it.
But you know, these are the things that you can do. And here’s why the data is important in the end, and what it’s going to help us learn about you and how is going to help us improve your care, we found that a lot of people are actually motivated to do the ABPM to sort of prove their doctors wrong. In some situations, it may be that they don’t want to go on and they don’t trust the blood pressure machine from the office, right? They say, well, that’s just one measurement. You know, how do you know? You can’t, you can’t base it on that. Until a lot of times they’ll do these measurements in order to try to get more data and so you can sort of get them invested that way. Of course, always managing expectations that this is the gold standard, and that this is going to give us the best possible data. But I definitely think that you know for new teams coming in having some standardized sort of forms. So we always had an instruction form that we went over step by step with the participants. We always played with our equipment, we tried to break it right, we tried to do things that would give us poor data so that we would know what to expect. And when we saw poor data from our participants, we would be able to try to figure out with them what was going on, and how we could fix them.
[Outro]: Special thanks to both Tricia and Emily for your discussion on ABPM best practices and technologies. This information is only becoming more and more relevant as regulatory bodies focus on the affect drug therapies can have on blood pressure to our listeners, thanks again for joining us. If you heard something you like, please shoot us a message at firstname.lastname@example.org. or leave us a comment. We’d love to hear from you. That’s it for now. See you 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.