Strategies for Long-Term Participant Engagement

Jillian Agnew, Senior Clinical Research Nurse at St. Johns Center for Clinical Research, shares insights on the power of personal connections in keeping trial participants engaged. From navigating trial fatigue to overcoming protocol challenges, hear the nuances of patient interactions that shape the success of long-term trials. Tune in to learn how to foster meaningful connections to create lasting participant retention and engagement.

Transcript

Mike Pierre: 0:00

Greetings, and thanks for being a part of the Society for Clinical Research sites on SCRS Talks. I'm your host today, Michael Pierre, project manager here at SCRS. Get ready to dive into a space where we discuss pressing clinical research industry issues. We celebrate noteworthy achievements and we foster a deeper connection within the research community. This is a space to amplify voices and perspectives that shape the landscape of clinical research. Today we have Jillian Agnew. She's a senior clinical research nurse with the St. John's Center for Clinical Research. All right. Good to see you again. And why don't you just give us a little Introduction about yourself and your current role.

Jillian Agnew: 0:42

So i've been a registered nurse for about 13 years. My main background, was hospital nursing for a very long time. I started in the emergency room. I moved to critical care which was definitely my love for a long time. That was probably my favorite role until I found research. But I've done home health, care coordination, public health. I kind of stumbled upon the research position that I am in now. I had left my job at the health department and was just looking for something more PRN. This site was looking for a nurse to do injections and phlebotomy part time. And so I said, you know, that would definitely cover me for a little while, while I figure out what I want to do next. And. The more time I spent at the site, reading the protocols, seeing the patients that were coming in, the interactions between the patients and the site staff, I realized that this was a very different type of nursing, and one that I was very interested in. There was just so much job satisfaction every time that I was there. And I think a lot of it has to do with the fact that these patients are volunteers and they want to be there. They want to hear what you have to say. They want to do things to make their health better. And it's just a whole different population than what I had been used to. So I was definitely hooked for sure. This is research is for sure where I, where I meant to be.

Mike Pierre: 2:03

Okay. And so to get to the heart of the conversation here, which is on patient retention, why do you think patient retention is crucial for long term outcome trials?

Jillian Agnew: 2:12

Well, first and foremost, a long-term outcome trial the data that they're trying to collect, that data's not gonna be valid if you don't have a large majority of the patients stick with it that were enrolled in the beginning. The scientific validity of the study really depends on patient retention. Just one of the key factors for clinical trial success. So, if you don't have the data, then you're not going to have the answers that you're looking for. Retention issues on their own really can put a major backlog on trials. It costs money to recruit patients. It costs money to retain patients. And then if you think about it from the patient side, you know, there are patients out there that are waiting for some of these drugs to hit the market. And they could be potentially life saving. So the more delays that you have, the more patients that you have drop out of these trials and things like that, the longer it's going to take for these drugs to get to market. And, and some of these patients on the receiving end might not be able to benefit from them in time.

Mike Pierre: 3:08

And your experience with long term outcome trials in cardiovascular health, what's a long term trial for you?

Jillian Agnew: 3:17

So long term trials are usually more than two years. I have a trial that is upwards of six years as planned. Trials that are not labeled as, outcome trials typically have a set end date. This is a 52 week trial. This is a 48 week trial. This is a however long, but you know that there's a specific end date. For cardiovascular outcome trials they are looking for a specific number of events to happen within a high risk population in order for the study to end. So there's no set end date per se, but they have A general idea of how long the study is supposed to last based on, you know, their statistical calculations of how many patients they're going to need to have enrolled in order to meet that outcome goal.

Mike Pierre: 4:08

And what are some common challenges that you face in maintaining this patient retention through the duration of a long term trial like that?

Jillian Agnew: 4:15

You know, trial fatigue can be a really big one. Patients who are really gung ho about the trial in the beginning come to all their visits, they're excited about it. And then, you get into year number two, two and a half, year three, and all the visits tend to be a little bit of the same. At that point, they are stretched out every three months, every six months and things like that. But they'll see a pop up on their calendar and be like, Oh, the study is still going on. And so they can get, you know, a little tired of it. And that is a crucial time where your retention efforts have to be really, really strong. You want to make sure that you are working as hard as you can to maintain your rapport with those patients. Reach out to them. Just check in on them, even if it's not on a scheduled study visit timeline. Just show them that they are on your mind. It really does go a long way in keeping them engaged in the trial. Some patients have issues with side effects of the study drug. They think that any little thing that happens with them once they start study drug is automatically associated with the drug which, usually is not the case. But when a patient has that in their mind, it's kind of hard to change their mind. So when those things come into play, protocol flexibility is really important, and I know we'll kind of get to that in a few minutes., But accidental unblinding also, can be a challenge in these longer trials. You know,, Labs that are not typically drawn at a regular, physician visit, like, a high sensitivity C reactive protein or some of these other markers that are in these cardiovascular outcome trials. They have them drawn outside of the study, and they see that the number hasn't necessarily changed from the beginning of the trial, that can be a difficult conversation because they start to believe, well, I must be on placebo. So what's the point of doing all this? It's a lot of my time. It's a lot of my effort. I'm driving here. You know, all of these things. So that's that can be a bit of a challenge. Sometimes you really want to make sure you have other reasons why it's important for them to stay in the study that they can, that they can buy into. And then, of course, you know, enrolling the wrong patients from the start. There are many reasons why patients enroll in clinical trials. Some of them do it strictly for the stipend, the monetary compensation that they get for all of their in clinic visits. Some of them do it just because their doctor told them to. They will do anything their doctor tells them to do without question, and that is not always the best thing. Because their doctor may tell them, I want you to do this trial, and they say, okay. But their doctor is not telling them, I want you to go to every single visit. I want to make sure you're on time for your visits. I want to make sure you are compliant with your study medication. So getting them in the door is one thing, but keeping them there is another. So the more altruistic reason the patient has for joining a trial in my experience, the more likely they are to remain in the trial and see it through to the end.

Mike Pierre: 7:05

And a lot of that retention probably falls on to the coordinator, who's usually the main contact for the subject in the trial.

Jillian Agnew: 7:12

Yeah.

Mike Pierre: 7:12

Well, how important is protocol flexibility for patient retention? And do you have any examples of what to look for?

Jillian Agnew: 7:19

Yeah, so protocol flexibility can have a huge impact on your retention rates. Every study has the same dream goal, which is all the patients that they randomize make all of their visits, they show up on time, they're compliant with all their drugs, they have no side effects and they adhere to the complete protocol throughout the duration of the trial. That would be a pipe dream for pretty much any study, but we all know that the likelihood of this is less than 0 percent because it's just life happens and things get in the way and the more stringent your protocol, the more likely it is that you are going to have discontinuations or protocol deviations and things like that. So the flexibility of the trial really needs to keep the patient in mind. The population that they're looking for, what are their circumstances? What does their life look like? Is it a heart failure trial with reduced ejection fraction, where these patients are constantly going to the doctor? Or is it something a little less involved where they don't have a ton of visits all over the place. Medication holidays that are allowable in the protocol is really helpful. Sometimes patients just need a break from having to remember on top of all their other medications, I got to take my study drug. This is a once a month thing I can't forget. If a patient decides to come off of study drug for a little while because we're trying to figure out, okay, well, is this side effect actually related to the drug or is it just kind of a coincidence? We want to do a medication holiday for that, but allowing the patients to restart when they're ready is another flexible part of the protocol that is helpful. If a patient comes off of IP and is not allowed to go back on IP, but the study wants them to remain in the trial for all of their regularly scheduled office visits. That's kind of a hard sell for some patients. If they have out of town family members that are sick or they have to travel for some reason are phone call follow ups allowable? Can we follow up with medical records? Is there a home health option? Some study protocols allow direct to patient drug shipment. So if they can't make it into the clinic on a refill day then we can get the drug to them and they can continue without missing any of their doses. Is there travel assistance or do they provide a transportation option for patients who may have car trouble for some reason, or if they're loved one who typically brings them is unable to make it. How do we offer them as many options as possible to keep them on the protocol so that the study can be completed on time with as few protocol deviations as possible? That's really the idea behind flexibility in a protocol.

Mike Pierre: 9:54

Okay, and then how do we improve retention rates? What are some ways that you've found over the years that work well or not? What are ways to build and maintain lasting relationships with the trial participants?

Jillian Agnew: 10:11

Yeah. So we have to remember that first and foremost, these patients are volunteers. They do not have to be here. They tend to take their own medical visits very seriously. Especially at least in my experience with my cardiovascular outcome trials, these patients have a lot of cardiac issues. They know how important it is to go to their, their cardiology appointments and things like that. They take those very seriously. Adding a clinical trial visit on top of that is, it's asking a lot, especially when they have to come in pretty frequently. So it's our job really as the clinical research team to make sure that the reasoning behind the retention and and why it's so important is reinforce with them on a regular basis. Every single visit when a patient comes in, there should be some type of discussion about retention and it doesn't have to be anything too intense. But just a reminder that says, Hey, you know, I just want to make sure you remember that if something comes up or if you can't make your next visit, just call me and let me know. It's not a big deal. Stuff that we can work around. We know that life happens. You really want them to know that you are flexible so that they don't feel bad when they have to cancel a visit or reschedule something. Sometimes what that looks like is guilt on their part, and then they end up not calling at all, and then you have a loss to follow up, which you do not want.

Mike Pierre: 11:26

Right.

Jillian Agnew: 11:26

So you want to make sure that they know it's okay if they can't make a visit exactly the way that they're supposed to. The other thing that's really important is showing interest in your patients. And not just as a study participant, but as a person. If they share these little tidbits about their life with you, that is huge. That's really big in building rapport. And, those are things that you should follow up on with them. I have patients that come in regularly who like to talk about their grandkids, or the cruise that they just went on or I have a patient who just got a new puppy. So those are all things that I like to jot down when I'm in a visit with them and then when I'm prepping for my next visit with them, I'll go back and look and say, Oh, that's right they told me about this. I want to make sure I ask them about that. And that just keeps like a running personal dialogue with them in addition to the clinic visit. When these patients get busy, when their lives get busy, especially if they have caretakers that come to these visits with them and they have to make a decision of we're too busy right now, we just have to trim some of the fat off of our schedule. You do not want to be part of that fat that gets trimmed. You want to be on the inner circle you know. The goal, I think, really would be to have your patient in their mind say, I don't want to miss my visit with Jillian. I really, really love going to the clinic for my visits with Jillian. How can I make this work in my schedule? And, the only way that you're really going to get to that point is if you are continually building rapport with your patients. Another great way to do that is to make sure you have a very friendly staff. The person who answers the phone or the person who they first see as they walk through the door is crucial. You want to have flexible hours. You know, most clinics are only open nine to five ish. I mean, on average, just regular business hours. But people also work regular business hours. So do you have availability early in the morning for them to come in for their fasting blood draws? Do you have one or two nights a week where you guys are open a little bit later? So patients can come after work. Do you have weekend hours? If you draw labs in your clinic. How good is your phlebotomist? Because nobody wants to be a pin cushion when they're a volunteer, especially. So you need to have excellent phlebotomy if that's something you offer at your site. Knowing your protocols inside and out is also huge. I had a patient call me when I was at Costco after work one day telling me that he was out of town. He had to go up to North Carolina and take care of one of his family members and that he was going to have to drop out of the trial. Now, thankfully that patient was in a trial that had a lot of flexibility. Many of the things that I mentioned earlier were all possibilities in this clinical trial. So we were able to keep the patient in the trial. We're doing phone call follow ups right now. They did not want to do the direct to patient shipping. For the study drug, which is fine. So they're on a temporary medication holds, but they are scheduled to be back in the area next month. And they will have a set of labs drawn and will go back on study drug. And that's a really important patient when you're able to retain. So that's awesome. But really overall, it's a relationship. So in all relationships take work, right? A marriage, a mother- daughter relationship, friendships, any, any kind of relationship that is worth, continuing takes a lot of work. You get out what you put into these relationships. So if you want high retention rates, you have to put in a maximum amount of effort and show your patients that you care about them, not just as a patient. And not just as a subject number. But as a person. That goes a really long way.

Mike Pierre: 14:56

Yeah, your examples there. It sounds like retention is more reliant on personality than medicine.

Jillian Agnew: 15:09

When it's av volunter. That's a big deal. They don't have to be here, we tell them you can leave a trial at any time for any reason with no penalty, which is true. They can. They truly are volunteers. However, on the research side, on the staff side, when we hear the possibility that somebody might want to leave a trial, a lot goes into it on our side. Having to make sure the study team knows, make sure the PI knows and different studies have different procedures for mitigating a lot of these reasons why patients would want to leave. So if we can avoid that, we will try.

Mike Pierre: 15:46

Have you ever had someone tell you that they are staying in this trial because of their relationship with site staff or the investigator? Like they say, yeah, I would have left this years ago, but I like coming back here to see all of you.

Jillian Agnew: 15:58

Yeah, we have a number of patients like that actually that are in some of these shorter trials, actually some of these cholesterol trials that are double blind placebo controlled. I've had patients come in before and say, I know I'm on placebo, but I just love coming in here. You guys are so fun. And so we've had that before. We also have a lot of repeat patients at our site. They'll finish a trial and they'll be so upset that it's their last day. I was like, well, is there anything else that I can go into? Do you have anything else for me? So we have a good number of re enrollers that go into another trial because they like being here. They want to be here.

Mike Pierre: 16:31

Since what you're describing is not An advertising budget item, so there's nothing as far as I know. All the trials, the contract I negotiated, there was never an advertising budget that says we spend a lot of time with these people. And we call them all the time, we keep in touch and we give personal encouragement to stay in the trial. So is it ever something there at your site where the PI might say, you're spending too much time, talking, it's not in the budget, or do you have ways to go to build that kind of, it sounds like a lot of time and effort to me to be part of a trial that's for something that's not covered in the budget.

Jillian Agnew: 17:13

Yeah, I mean. There are a couple of ways to look at it. I mean, you are going to put in the effort to retain these patients one way or another. You either put it in on the front end, visit to visit, or you put it in on the back end when you've already lost them or are about to lose them with all of the hoops that you have to jump through as a site based on what the sponsor wants you to do to try and keep them enrolled.

Mike Pierre: 17:34

Right.

Jillian Agnew: 17:35

So we're a freestanding research site. We are not a medical clinic. We don't have patients coming in to see providers on a daily basis. We only see research patients and that's it. So we're not regulated by insurance companies or anything like that with the amount of time we can spend with our patients or how many patients we have to see in a day. So my study visits, the majority of them really will be completed at least the protocol side of things within 20, 30 minutes tops, but all of my visits are scheduled as 45 minutes to an hour just in case. And that covers a lot of that extra time in case they want to chat with me about something or show me some pictures or if they have concerns about anything. That also gives me time to reach out directly to the PI if they're not here that day via text and get an answer for them almost immediately. I mean, our PIs are very responsive on the days that they're not here in clinic. So that also goes a long way with them. And if there's a day where they're not really up for chatting and they just want to do their study visit and be on their way, then that's some extra time built into my day where I can make some extra notes about them or get my documentation done instead of having it all build up towards the end of the study. But as far as monetizing it, I have no idea how that works. It's, it's not part of the advertising budget and it's just something that we do.

Mike Pierre: 18:54

That's great. Well, I know you're busy, and so I'd like to thank you for your time today for sitting down with me for a few minutes to talk about this subject. So thanks a lot, Jillian. Now as we wrap up, everyone, don't forget to explore more site focused resources on our website, myscrs. org. You'll find a wealth of content and publications, plus the opportunity to save your spot for upcoming webinars and SCRS summits held throughout the year. Thanks for tuning in, and we can't wait to have you back for even more enriching content. And thanks again, Jillian. Nice talking to you.

Jillian Agnew: 19:27

Thanks for having me.