A PARALLEL ARM, CONTROLLED TRIAL OF THE EFFECTIVENESS OF A SMART SENSOR FOR CONTINENCE CARE (THE ARCTICC STUDY)

McCreary M1, Hunter K2, Nazari S1, Asaana P1, Rajabali S1, Wagg A1

Research Type

Clinical

Abstract Category

Continence Care Products / Devices / Technologies

Abstract 184
ePoster 3
Scientific Open Discussion ePoster Session 12
Friday 20th November 2020
16:15 - 16:20 (ePoster Station 4)
Exhibition Hall
Conservative Treatment Gerontology Incontinence Prospective Study
1. Department of Medicine, University of Alberta, 2. Faculty of Nursing, University of Alberta
Presenter
M

Megan McCreary

Links

Abstract

Hypothesis / aims of study
Urinary incontinence (UI) is highly prevalent amongst older residents of nursing homes (NH) with estimates varying between 43 - 79%.  Incontinence is distressing and embarrassing for the individual, challenges personal dignity and is not without associated adverse health outcomes.  UI is associated with an increased incidence of urinary tract infection, particularly in users of continence pads, and a risk of falls and fractures and of depression as well as a profound impact on quality of life and needs for care, something of great importance to care  providers, particularly in times of resource constraint [1].
Given the high prevalence of moderate to severe cognitive impairment and associated physical disabilities in the NH residents of today, only a minority can successfully be managed with interventions such as prompted voiding.  The majority of residents are managed by check and change routines but evidence suggests that, given limitations of this approach, UI is poorly managed in this setting.  An institution centred, rather than person centred approach to UI care has also been reported [2].  
In the majority of NH, continence assessment is a labour intensive process which requires residents voiding and continence patterns to be assessed over a period of time by a method of “ask, check and change.” The requirements of this process often lead to sub-optimal performance and the resulting care plans and delivery of care are compromised.  
Potential for technological solutions to standardize continence assessment and  facilitate improved management has been rarely explored.  A single study of a telemonitoring system for incontinence in the acute hospital setting failed to reach its primary endpoint although a single published study of an Australian telemonitoring system in NH did result in improvement in continence care outcomes [3]. 
This study examined an alternative system for electronically aided construction of individualized continence care plans with the aim of improving continence care for NH residents and reducing continence care related resource use in NH.
Study design, materials and methods
This was a prospective, quasi-experimental, controlled clinical trial of the use of an electronic incontinence identification system (Tena Identifi) versus usual care on the quality, resource use and outcomes of continence care for older NH residents.. Tena Identifi is an integrated electronic monitoring system based upon a wearable continence pad which allows registration of resident’s micturition patterns over a 72 hour period, allowing an individualised continence care plan to be constructed. The intervention included training for staff and support for analysis of continence data. The study enrolled NH residents eligible for a continence assessment in two separate wings (1 usual care and 1 intervention arm) of a single NH with little staff crossover.   Outcomes included between group change in pad absorbency (primary outcome, calculated as category of pad absorbency multiplied by number of pads/24h), time for construction of continence care plan following assessment, daily number of pads used, care aide time spent in continence care, cost of continence products, number of wet checks and pad leakage episodes, resident Quality of Life measured by QoLAD, activities of daily living measured by Barthel Index.  Any harms (e.g. falls, deterioration in skin health) were prospectively gathered. All residents, or their surrogates, gave written informed consent to participate.
In a previous study the proportion of residents able to reduce their pad absorbency by one category was 35%. With an estimate of 10% similar change in the usual care group, an alpha of 0.05 and power of 0.8, the required sample size for each group was 43.
Results
In total, 46 residents were recruited into the usual care arm and 43 into the intervention arm. At baseline, the two groups were not well matched (Table 1). At 8 weeks there was a statistically significant change in the proportion of residents achieving a reduction in 24h pad absorbency; (50.6%, p=0.034) favouring the intervention arm.  Other between group changes are shown in Table 2. For the intervention arm, between study baseline and end of study, there were statistically significant changes in the absorbency (mean (SD)) of night pads used (8.431 (4.30) v 6.89 (3.57), p=0.011), 24h pad leakage episodes (0.54 (0.49) v 0.30 (0.36), p=0.016), the dollar cost of pads at night (1.10 (0.52) v 0.87 (0.42), p=0.009) and in reported resident quality of life (29.23 (4.27) v 30.39 (3.50), p=0.028).  Apart from reported quality of life (26.54 (5.76) v 28.24 (4.93), p=0.049), there were no statistically significant changes in any variable between study baseline and end in the usual care group.  Mean time to construct a continence care plan using the Identifi system was 4.9 days. No adverse events were reported during the trial.
Interpretation of results
Use of the Identifi system resulted in significant differences being achieved in the absorbency and cost of pads at night, allowing more appropriate pad usage. There was a trend to reduced time spent in continence care and reduction in the number of pad leakages but these changes did not reach statistical significance. The absence of significant findings may have been a sample size problem or as a result of recruitment bias, favouring the usual care group. Overall, the Identifi system resulted in improved continence care for NH residents overnight with the potential for a reduction in cost and time spent in continence care.
Concluding message
A technological solution offering standardized assessment of continence care resulted in improvements in care for NH residents.
Figure 1 Table 1. Demographics and baseline variables
Figure 2 Table 2. Between group change between baseline and end of study
References
  1. Neurourol Urodyn. 2009;28(4):288-294.
  2. Journal of Advanced Nursing. Feb 2011;67(2):228-250.
  3. Journal of Clinical Nursing. Nov 2014;23(21-22):3069-3076.
Disclosures
Funding Essity Health and Hygiene AB Clinical Trial Yes Registration Number ClinicalTrials.gov Identifier: NCT02511314 RCT No Subjects Human Ethics Committee University of Alberta HREB Pro00056791 Helsinki Yes Informed Consent Yes