Diane Newman: Welcome to UroToday's Bladder Health Center of Excellence. I'm Diane Newman, the center's editor, and with me here today is Dr. Edward Kim. He's a urogynecology fellow at the University of Pennsylvania. Dr. Kim is going to talk to us about some innovative research that he reported at the International Continence Society on a texting platform for self-care of interstitial cystitis in women. I have to also disclose that I'm also one of the investigators on this research. Welcome, Dr. Kim.

Edward Kim: Thank you, Dr. Newman, for having me on UroToday. I'm really pleased to share with our audience and our listeners our research study on interstitial cystitis. So, we set out to develop a patient-centered smartphone based program for self-management of IC. We called the platform ERICA after Educational and Remote Interstitial Cystitis Aide. This is our multidisciplinary team of urogynecologists, urologists, psychologists, pelvic floor physical therapists, and healthcare innovation experts.

Most patients with IC state treatments did not work or even worsened their symptoms. Current treatment recommendations are not patient-centered, in a sense that they don't take into account their social or work obligations or take into account their values or their treatment desires.

Our focus group study found that patients desire self-management to achieve a sense of empowerment, structured treatment plan, as opposed to being given a list of treatments to try, more support and guidance from providers to avoid medications and rather holistic and integrative approaches, and this is not to say that they're averse to medications and procedures, but rather that they want to try things that are more first and second-line and more conservative to be able to be independent from providers, not be tethered to hospitals and procedures. They also prefer remote delivery of treatment content to mitigate access barriers and other logistical barriers.

We had three objectives. First, to develop a conceptual framework for the management of IC, then, develop a digital platform that remotely delivers first and second-line AUA guideline treatment for IC/BPS, and to perform a feasibility testing of the newly developed platform for 30 patients. When we were setting out to develop a digital platform, we wanted to focus on text messages and not apps, as apps are expensive to develop and difficult to maintain for developers and sometimes can pose access barriers for patients as they require installation, account creation, and frequent updates. Text messaging on the other hand, is a low cost and it's available to all smartphones.

We applied a discipline method called Rapid Cycle Innovation to build our platform. This is a series of mini pilots that eventually feed into one another to develop into a final platform. On first cycle, we perform the contextual inquiry where we observe patients interacting in real life with the prototype platform. Then we solicit their feedback from exit interviews and monitor their text messages. And then we performed the quantitative and quantitative analysis of what we saw and then revise prior to the next cycle and so on and so forth until we got to the final platform. The metrics that we're looking for in each cycle was engagement and accuracy.

How we came up with the prototype content and also the conceptual model was through reviewing the literature for evidence-based treatments, also combined with focus group studies at IC/BPS patients, the consultation with expert advisory panel, developed the conceptual model of self-management of IC, and also the video modules for treatment content.

This is what the conceptual model looked like. The one arm was provision and delivery of treatment content. So first and second AUA guideline treatments of education and behavioral modification, bladder retraining modules with urge suppression, CBT modules, manual pelvic PT modules, and medication reminders and answers to common questions about meds, and then check-ins and supportive messages and messages of encouragement that were texted out to patients. They impacted the biopsychosocial domains of IC/BPS, and according to the biopsychosocial theory of chronic illnesses, there are three domains that all must be addressed for patients with chronic conditions, biological, psychological, and social. The mediators will increase insight into IC/BPS, better emotional regulation, and improved adherence.

The outcome that we're looking at and hoping to achieve or increases self-efficacy, defined by a patient's belief that they can self-manage and also self-treat their conditions on their own independently, and also that can lead to, hopefully, a decreased symptom-related disability.

The video modules were this. There are 38 video modules on patient education and bladder health, cognitive behavioral therapy techniques for chronic pain and anxiety management, guided mindfulness, and pelvic floor physical therapy with a special focus on manual pelvic trigger point release with a pelvic wand. The provision of support and guidance and also the check-in went something like this. A little busy diagram, but essentially it starts out with the system asking, how bothered have you been by your IC symptoms in the past week? And depending on what the patient said, the system generated an appropriate response that lets you, as the last resort, offer for a callback from an in-person clinician on call.

For 30 patients with IC/BPS, they interacted with ERICA for 6 weeks. Every Monday and Wednesday they received core modules for 2 weeks, and then they could choose between one of the three PT, CBT techniques for managing anxiety, and guided mindfulness. And then every Friday, on parallel, they received the weekly check-in and messages support via the dialogue algorithm with, again, the last resort being offered a callback by a clinician on call.

We were looking for narrative feedback on the content from patients, also the number of callback requests and a validated questionnaire called System Usability Scale to assess how usable a digital platform is that's been used by the software development industry. From a patient's perspective, all that being said, what do they see? So, every Friday they get a message, a check-in, text messages, asking about their symptom bother. Depending on what they say, the system generates an appropriate response, again, with the last resort being a call back by a clinician on call. The video module that they get is, again, every Monday and Wednesday. They receive a video module, a link to essentially YouTube, a private link that they can use to watch their modules, and they only progress if they say they've watched the module and texted back.

This is what the final platform looked like as an overview. For the first 2 weeks, every Monday and Wednesday, they receive one of the core modules. And then for the next 4 weeks of participation, they choose one PT, CBT techniques, or guided mindfulness. But all throughout on the parallel, they received this weekly check-in and supportive messages, again, with the last resort being a callback by a clinician.

This is the demographic data of the 30 participants, the average age was 32 years old, most identify with white race, most actually had college or greater education level, and a lot of them had the classic comorbidities of IC/BPS of anxiety, depression, IBS, and other chronic pain conditions. ICSI and ICPI scores show that they have moderate symptom severity and moderate symptom bother. On average, they had 2 years of duration with IC, and a lot of them had tried first and second-line treatments before, and all of them, actually, were prescribed urinary analgesics and only 17% were prescribed amitriptyline before.

Overall, the qualitative analysis of the themes of the exit interviews and text messages showed us that patients really prefer the term IC over BPS, as bladder pain syndrome gives them a stigma of chronic pain condition, and some patients actually didn't feel that bladder pain syndrome really captured accurately what they're feeling. They also desire for self-efficacy, again, this sense of empowerment, independence, and that they also want to share decision-making, more capacity to do so, to really say what they really thought was helpful for them. And so this notion of being able to choose between PT, CBT, and mindfulness really gave them this sense that they actually were choosing their own adventure, so to speak.

Onto the results. All 30 patients completed a program, 79 median number of text exchange between each patient and the platform, 89% participant response rate and engagement, 87.8 SUS, System Usability Scale, indicating a highly usable platform, only two call-back requests for on-call physician to call back, and the narrative feedback really revolved around appreciation for remotely accessible evidence-based treatments and confidence in their ability to implement lessons that they learned for self-management or symptoms. Some of the illustrative quotes included, "I felt empowered", "I didn't feel alone in figuring this out", "I wish I had known all this about IC earlier", and "I felt that my care team really cared about me".

In conclusion, we developed a feasible, low-cost patient centered smartphone-based platform for IC/BPS self-management and we're currently in phase II, incorporating patient feedback into the design, overall revamping the platform, and then evaluating the clinical efficacy of the platform for 50 patients with IC/BPS. I'm happy to answer any questions Dr. Newman has about the platform, and thank you for allowing me to share the slideshow on our project.

Diane Newman: Yeah, this is, to me, really cutting edge as far as a way to involve patients in self-management. But tell, me who helped you with this, design the program? There had to have been an engineer who was behind the actual design of the texting platform.

Edward Kim: Yeah, and that's a great question, because as clinicians, this is not our forte, per se. However, what was really great about the Center for Healthcare Innovation here at the University of Pennsylvania is that they had a lot of experience with building a healthcare-oriented platform, a digital platform. They've done that for COPD symptom management, palpitations, and also even things like weight loss management, medication adherence, appointment reminders. So they have had experience with delivering some of the healthcare content using texting platform. But this definitely was a unique challenge also for them to help us develop essentially modules and a little more sophisticated algorithm for symptom triage and management. But it was definitely a learning, and also a really great exciting, opportunity for all of us involved to build a platform.

Diane Newman: Now, you had 38 modules, which is really quite a bit. How long were they, though? Because you sometimes people's attention span isn't that long, so I was wondering what was the length of them, on average?

Edward Kim: Yeah, absolutely. On average, they are less than 5 minutes. We really wanted to make sure that this was engaging and also, as you said, not lose their interest. And so a lot of patients said 5 minutes usually would be enough. That said, the PT modules were shorter so that they can be watched over and over because Denise was demonstrating with the patient actress, how to essentially perform a lot of exercises. And so those were shorter, but usually less than 5 minutes.

Diane Newman: So you really had a lot of material, but you try to really cut it down to just small little amounts as far as just a couple minutes, which I think is really, really good. Can you tell me, a lot of education though in these modules? That's what I find fascinating. We think we educate as clinicians, especially since these women go from provider to provider, clinician to clinician looking for a way to help their symptoms, and you would think that they would understand, but they really enjoyed that education as far as the big causes and what can really help their symptoms.

Edward Kim: Absolutely. That was kind of the feedback that we received, that the education piece, essentially helping them or giving them the tools and the knowledge to really know what they're going through and how they can help themselves, was a really big benefit for them, so that they didn't really need to reach out to a provider or use a call line or contact a clinic and send a message because they already had those tools in their minds.

Diane Newman: But were you surprised that not more of them wanted to talk to a clinician? That's what I found the most fascinating from some of these results.

Edward Kim: Absolutely. We were very surprised that of the 30 patients who interacted with the platform for 6 weeks, only 2 of them requested a callback. And just to give you a little more context, those two calls, one was about hematuria and the other one was what turned out to be actual culture-proven UTI. Those were really helpful for us to also know that, wow, if you give them a lot of information that we really couldn't during that initial clinic visit, a lot of those patients actually are very self-reliant and they really do want to do that on their own. When we ask a lot of them at the exit interview, "Why didn't you ask for a call back?" A lot of them said, one, "I didn't want to really bother anyone." And two, they also wanted to really use what they already learned to help themselves almost as a test run, so that they also know for themselves for a lifelong what to do.

Diane Newman: Yeah, that's what I found. Wow. I would've thought more. The fact that the texting and that information really answered their needs, I just found really surprising. But it's really positive, isn't it? Because you and I know that we could add something like this to our interventions, especially with our time constraints we have, and with someone like a female, a woman, and even male who has interstitial cystitis, it takes a little bit more time to really get through their symptoms and see what works. So this is really an adjunct to a lot of what we do in clinical practice.

Edward Kim: Absolutely.

Diane Newman: Well, thank you very much. And so you're going to go on now and refine it and do more, and you're going to keep it just with women. Is that what you're going to do? Just have women?

Edward Kim: Yeah, for now, we're going to keep it to women patients. We're going to keep it to women patients for now, and as we get better at knowing our audience and really knowing what to offer, we hope to make it wider spread geographically and make it more available throughout different practices, and as you said, Dr. Newman, make it as an adjunct and not a replacement for any kind of in-person visit with providers, because that's really what the key is, is the support and really getting to know and seeing the provider in person, but really using it as an adjunct between those two clinic visits, hopefully initial and the next one, the follow up, so that they've tried all the conservative things and seen our friendly faces and really know what they can do for themselves before they come to us and say, didn't work, worked, and this is what we're going to do next.

Diane Newman: Well, I really commend you because this is wonderful research, and I want the audience to know that you won the award for Cutting Edge Technology at the International Continence Society, which was held in Vienna this past fall, but also that you actually got the research accepted for publication, right?

Edward Kim: Yes.

Diane Newman: It will be out there in the public domain, so if anybody wants more information, they can really access it. Thank you so much for sharing this.

Edward Kim: No, thank you so much for having me on.