Frail community-dwelling older people with incontinence are at high risk for falls, urinary tract infections (UTIs), incontinence associated dermatitis, pressure ulcers, and poor quality of life creating costly sequelae for patients and health care systems. Contributors to these poor outcomes include a hesitancy to seek treatment for incontinence due to stigma, functional limitations hindering travel to appointments, and being unaware of conservative treatments for incontinence and the impact of poorly fitting body-worn incontinence products (1). When patients can no longer manage incontinence at home, their risk for admission to the hospital, acute rehabilitation, and nursing home escalates, irrespective of age and gender (2). Additionally, in the USA 45 states require health insurers to provide body-worn incontinence products to Medicaid enrollees and have been encouraged to reduce costs associated with these products. These sequelae can be minimized if incontinence is optimally managed at home, but patients need support implementing conservative treatments and guidance on selecting proper incontinence products. Novel approaches are needed to create incontinence treatments that remove barriers such as, distance, stigma, and access. Therefore, we created a telephone counseling intervention provided by the suppliers of incontinence products as a novel, accessible, convenient, discreet, and affordable solution to provide appropriate incontinence products and conservative treatments to frail community-dwelling older adults. We present the study design and baseline characteristics of participants enrolled in our ongoing study.   

This study will evaluate the effectiveness of the Incon@Home intervention in community-dwelling Medicaid enrollees aged 55-90 with incontinence. Apriori power analysis indicated a sample size of 160 would have 90% power to detect a moderate cost reduction of 5% with a type 1 error rate of 0.05 with a conservative dropout rate of 30%. The specific aims include:

Aim 1: Evaluate Incon@Home’s effectiveness at reducing older adults’ incontinence severity, development of falls, UTIs, incontinence-associated dermatitis, pressure ulcers, health related quality of life, and satisfaction with the intervention.   

Aim 2: Evaluate the cost-effectiveness of Incon@Home at reducing incontinence-related product costs and health care utilization of incontinence-associated (i.e., UTI, pressure ulcers, dermatitis, falls) and all-cause emergency department, clinic, and home health visits, as well as, hospital, rehabilitation, and nursing home admissions.

This implementation study uses a single group pretest posttest design and retrospective insurance claims data analysis. For claims data each participant will act as their own historical control by comparing outcomes to their data in the 3, 6, and 9 months prior to enrollment. It is guided by the NIH framework for Dissemination and Implementation Science which provides guidance for the planning, delivery, and evaluation of implementation studies (3). The study protocol was reviewed and deemed exempt from oversight by the University of Pennsylvania IRB as authorized by 45 CFR, 46.104 category 3,2. Participants provided oral consent prior to enrollment.  
The 9 month intervention consists of semi-monthly or monthly structured telephone coaching sessions provided by incontinence product representatives who received specialized training and supervision from continence nurses. Sessions focus on voiding behavior, bladder training, nutrition, medication adherence, mobility, falls, skin health and urinary and fecal leakage using an individualized incontinence management tool and teach-back. Sessions also address appropriate incontinence product selection and usage.

Aim 1 person level outcomes include: incontinence severity measured with the International Consultation on Incontinence Questionnaire short form (ICIQ-SF); falls, UTIs, incontinence- associated dermatitis, and pressure ulcers measured with investigator created questions; health related quality of life measured with the Incontinence Impact Questionnaire Short Form (IIQ-7); general health related quality of life measured with the EQ-5D-5L; and satisfaction with the intervention measured with the global improvement rating scale for urinary incontinence studies.   

Aim 2 health care cost outcomes include: incontinence product usage measured with the ICIQ PADPROM; shipped incontinence product costs; and incontinence related and all cause emergency department, clinic, and home health visits, as well as, hospital, rehabilitation, and nursing home admissions reported in claims data.

We had a pool of 1316 potential participants from two insurance providers aged 55 years or older who received body-worn products from our incontinence product supplier. We were able to contact 354 potential participants of whom 87 were eligible. See Figure 1 for flow of participants through the study.  

To date we have enrolled 63 adults ranging in age from 56-85 with a mean age of 66(7.82) years and mean BMI of 36(9.14). Over 90% are female, 24% are Black, 3% are American Indian/Alaskan Native, 70% are White and 3% reported other races or ethnicities. Most (70%) are considered frail using the Vulnerable Elders Survey. Only 29% of participants receive home health services mainly from home health aides (19%), registered nurse visits (14%), and physical therapy (2%). Of the 52% that live with a spouse or others, 21% of them require assistance with toileting. Over 62% use a walking assistive device, and 10% use a wheelchair. 

Participants’ mean(sd) ICIQ-SF score is 13(5.28), the mean(sd) IIQ-7 score is 52(31.89) and 21% have bowel incontinence. The mean(sd) EQ-5D-5L index is 0.41(0.31). 

Participants’ incontinence product use is summarized in Figure 2. Body worn product use in order from most common to least common is pull-up protective underwear, underpads, bladder control pads, panty liners and briefs with tabs. Male guards and booster pads were not used. Many participants also use wipes, gloves, and barrier creams. Ten percent add toilet paper or paper towels inside their wearable products.

In this ongoing implementation study, we successfully partnered with an incontinence product supplier and two insurance providers to design and implement an incontinence telephone counseling intervention for frail community-dwelling older adults. We identified a diverse group of frail older adults receiving Medicaid with severe incontinence. We are among the first researchers to describe incontinence product usage by this vulnerable population.

Novel approaches using implementation science are needed to provide accessible and affordable incontinence treatments to frail community-dwelling older adults. We will provide updated baseline data and eagerly await the conclusion of our study to determine its effect on patients and health care systems. We anticipate outcomes that will be of interest to insurers across the United States.

M. Fader, A. Cottenden, C.  Chatterton, H. Engqvist, S. Eustice, D.K. Newman, et al., An International Continence Society (ICS) report on the terminology for single-use body worn absorbent incontinence products, Neurourol. Urodyn. 39 (8) (2020) 2031–2039. https://doi.org/10.1002/nau.24488
D.H. Thom, M.N. Haan, S.K. Van Den Eeden, Medically recognized urinary incontinence and risks of hospitalization, nursing home admission and mortality, Age Ageing 26 (5) (1997) 367–374. https://doi.org/10.1093/ageing/26.5.367
G. Neta, R.E. Glasgow, C.R. Carpenter, J.M. Grimshaw, B.A. Rabin, M.E. Fernandez, et al., A framework for enhancing the value of research for dissemination and implementation, Am. J. Public Health 105 (1) (2015) 49-57. https://doi.org/10.2105/ajph.2014.302206