R39 Real-world evidence evaluating a novel early-detection device for HAPU reduction

Martin Burns, MBA1, Rachael Lester, MBA1 and Rachael Lawrence2, (1)Bruin Biometrics, Los Angeles, CA, (2)RL Biostatistics, Ltd, Cheshire, United Kingdom
Introduction: The purpose of the Pressure Ulcer Reduction Program (PURP) is to evaluate the clinical utility of an early-detection technology measuring local levels of sub-epidermal moisture (SEM), in reducing avoidable hospital-acquired pressure ulcers (HAPUs) and improving patient outcomes when incorporated into clinical workflow in real-world settings.

Methods: PURPs were conducted at hospitals in the UK, Spain, and Canada. PURPs were structured to evaluate impact on HAPU rate and ability to incorporate into clinical workflow over 1 to 6 month periods. Local nursing staff tailored PURP structured to be appropriate for their clinical setting. Nursing staff were trained to use the SEM Scanner, a device for assessment of sub-epidermal moisture, which has been shown to be an early indicator of pressure damage. Clinicians were provided with clinical interpretation: that patients exhibiting SEM scores of ≥0.6 may have underlying pressure-induced damage. Patients were intervened upon using hospital standards for care for HAPUs prevention.

Results: Over 600 patients were scanned (heel, sacrum) across Emergency, Elderly Care, Orthopaedic Trauma, and ICU departments. HAPU incidence observed was 1% across all patients. In 5 of 9 participating hospitals, nurses observed zero HAPUs during the evaluation period.  Participants provided baseline HAPU rates (from the same ward in previous time period) for comparison. 7 of these 9 hospitals observed reductions in HAPU rates of 88% or more.

Discussions: In real-world clinical settings, the use of SEM measurements has demonstrated meaningful clinical benefit in ability to detect the early development of HAPUs. The data suggest that utilization of SEM values aids in clinical assessment and decision making for prevention of HAPUs by providing quantitative, real-time information about patient’s tissue health to facilitate earlier intervention. Implementation of the device provided facilities with a first-time opportunity to use objective “trigger” to initiate care team dialogue and decision-making for targeted patient care.