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Diane Newman: Welcome to UroToday and our online medical education program. I am Diane Newman. I'm a urology nurse practitioner. And I'm very pleased to introduce a colleague of mine, Dr. Kristine Talley, who's a professor at the University of Minnesota School of Nursing. And I'm excited about this presentation because I'm actually one of the investigators with her. And we're looking at an older Medicaid population, who has urinary incontinence, and assisting them with a counseling program. So she's going to present this study. Welcome, Kris.

Kristine Talley: Great, thank you for having me, Diane. I'm really excited to talk about this study. I am trained as a geriatric nurse practitioner. And so I have two specialties—the specialty of providing primary care for older adults, particularly frail older adults, and then my research, which really focuses on how can we improve incontinence symptoms in frail older people. So this study, I'm very excited about, and we think it will offer a great solution to a very serious problem for frail older people.

First, I want to acknowledge our study team with a bunch of investigators who come from the University of Minnesota, the University of Pennsylvania, and with our industry sponsor, Tenderheart Health Outcomes. Today, I'm going to be discussing why our Incontinence Helping Others Manage at Home intervention has the potential to be a feasible and affordable way to improve urinary incontinence in older Medicaid recipients who are frail and who are still living at home. I just want to disclose that this project was funded by our co-investigator at Tenderheart Health Outcomes.

Over 39% of frail older adults have urinary incontinence and experience related health complications, such as urinary tract infections, skin infections, pressure ulcers, and even falls. And sadly, incontinence is also a leading trigger for relocation to a nursing home for frail older people. Despite these complications, though, treatment-seeking is very low, and often the only option for treatment is conservative management.

Medicaid is the government health insurance program for many frail older adults in the United States. Medicaid pays for incontinence-related health complications and for incontinence containment products used by Medicaid enrollees. And what we're seeing as a trend now is that the use of body-worn, absorbent products is rising and actually challenging state budgets through Medicaid, but also personal budgets as well.

To address this issue, we created the Incontinence Helping Others at Home telephone counseling program. In this presentation, I'll share the study design and baseline characteristics of the participants, as it's an ongoing study that's not completed yet. We recruited and enrolled Medicaid enrollees who were age 55 or older, had incontinence, and were new customers of Tenderheart. To clarify, Tenderheart provides medically necessary incontinence products to Medicaid enrollees, and in the states where we recruited these people, it is a product that Medicaid pays for.

I'm not going to get into this framework in detail, but I wanted to let you know that we used the National Institutes of Health Dissemination and Implementation framework to design this project, which is a single-group, pre-test/post-test implementation project. An implementation project is a little different than a randomized controlled trial, in that we're doing it in real life using real resources and evaluating the real day-to-day, real impact on people without controlling for a lot of confounders.

Today, I'm going to discuss the planning and evaluation plans. I'll note also that this was exempt from institutional review because it's technically not a research project; it's an implementation project. Our intervention includes individualized telephone counseling on conservative management, provided by the trained product representatives of Tenderheart using monthly and bimonthly telephone calls over nine months.

The counseling sessions focus on selecting the optimal body-worn, absorbent products, education on bladder health, and counseling on conservative management strategies. Our group is measuring patient outcomes on incontinence severity, on incontinence complications, on quality of life related to incontinence, and also satisfaction with the program that we've created.

We are also measuring health care cost outcomes, including the cost of single-use, body-worn, absorbent products, and then looking at health care costs related to visits and admissions to hospitals, rehabilitation nursing homes, and the costs associated with falls, pressure ulcers, UTIs, and skin problems that can happen. I will say that some of the health care cost outcomes are coming from Medicaid insurance claim data.

So again, our design is to follow a single group over time, collecting data both prospectively and retrospectively for nine months. We are collecting the patient outcomes and using insurance claims data for health care cost outcomes. Those specific outcomes are listed on this slide.

We enrolled new Tenderheart customers who are Medicaid recipients. We had an initial pool of just over 1,300 new customers, and we were able to reach about 353 to see if they were eligible for the project. In the end, we ended up enrolling 82 participants into the project.

Our participants were mostly white, educated females with a mean age of 67. But as you can see, we also had good representation of Black older women, with 28% of the sample being Black. Forty-nine percent of these Medicaid recipients live alone—remember, these are frail older people—and 28% received home health services, and 17% were frail enough to require toileting assistance.

So our participants are frail. Their incontinence severity is high, and their quality of life is impacted by incontinence and by frailty. One thing that we're looking at is the types of products that these older people are using for their urine and bowel leakage. What we found was that the most commonly used incontinence products were pull-on pads, wipes, and underpads. But also, you see a lot of people are using gloves and smaller pads besides pull-on pads. One point of interest is that about 14% are still, even though they're receiving absorbent products, putting toilet paper or paper towels in their pad to help supplement the absorbency of the pads that they're using. So we see a pretty wide range of pad usage in this group, but a high usage rate overall.

This is a study of firsts. We successfully partnered with an incontinence product supplier to create an innovative and accessible telephone counseling program to help frail older adults implement conservative incontinence treatments at home. We are also providing the first descriptions of incontinence products used by this vulnerable population. We really hope to impact Medicaid services and help control and contain the cost of these services through this very innovative and approachable intervention.

Next on our plate is to evaluate the program's effectiveness. As I said, we ultimately hope to improve patient health and reduce health care costs for Medicaid. And our ultimate goal really is to create a cost-effective way to get the right product to the patient so that they can age in place longer.

Diane Newman: Thank you so much, Kris. I'm like you—well, being involved in this project is very exciting, isn't it, because there's really no research in this population? And we do know that it's a high-cost population because incontinence is so high.

Kristine Talley: It is, yep.

Diane Newman: And I think that I'm hopeful that with the counseling—and we designed this based on some pilot data that Tenderheart had, showing that they were able to decrease costs, but also to really manage the product selection better and hopefully decrease the amount of products being used by an individual.

Kristine Talley: Another innovative point about it is a lot of these frail older adults, they don't seek treatment for incontinence. One reason is that sometimes they think it's just a normal part of aging. But it's also extremely hard for these people to get to medical appointments, and so they're prioritizing which appointments are absolutely necessary. By providing this over the telephone for a product that they're also receiving really helps them have access to counseling on not only the types of products that they're using, but on other conservative strategies that they can use.

Diane Newman: And what we did as part of this project is we actually trained existing staff that Tenderheart had, because they do talk to their clients who need the products, but we trained them in the different behavioral components.

Kristine Talley: And that's the innovative part of this—training non-health professionals to help provide basic continence advice, which is something that all of us can do.

Diane Newman: You're right, especially with the advent of telehealth that we're now doing for visits. There's no question that a lot of these individuals cannot get in to see someone. And quite frankly, a lot of primary care providers may not ask about this problem, especially about which pad they're using or what's happening with it. If we can do some counseling over the phone, that can hopefully decrease some of the associated medical complications we see, but also costs. I think this really could be really impactful to the whole health care field.

Kristine Talley: I agree. And ultimately, our goal is to improve the health of the older person. We want to prevent skin breakdown that can happen with poorly fitting products or poorly controlled incontinence, pressure ulcers that can develop, and that, as well as helping with the costs for the health care system.

Diane Newman: But I think that one of the most important things that's going to come out of this research is describing this population. There is nothing in the literature on this. All my work over the past 30 years is the cost, the cost to state Medicaid programs, to the individual patient. Nobody really has defined this population, which is so, so vulnerable.

Kristine Talley: Exactly. So as I said, we're a study of firsts. We're the first to describe the product use in this group of older people that are traditionally also hard to recruit into studies and projects. But they're a little easier to access this way because they are getting their products from Tenderheart.

And we know they're frail to start with, so we can target them right away and not have to go through a lot of extra screening to get at this group—about 10% of older people are frail. So if you're thinking about recruiting for a study, it's challenging to find that 10% in the community.

Diane Newman: Well, thank you so much. Again, another really interesting study. And I'm glad you presented it. We're going to be really looking forward to those outcomes. Thanks a lot.

Kristine Talley: Great, thank you, Diane.