Skin Change Actions by Nursing (SCAN)

Biophysical Detection of Skin Changes to Cue Pressure Injury Prevention in Nursing Homes

Pressure injuries, local areas of damage to the skin and underlying soft tissue that are costly and painful, are often preventable with timely use of prevention strategies. Identifying early pressure induced tissue damage among nursing home residents by nursing staff during routine skin assessment is critical for this process. Finding early damage can prompt nursing home staff to start prevention actions and may allow viable tissue rescue, reducing other health problems or death. We propose use of sub-epidermal moisture (SEM) measures as the cue for nursing home staff to start prevention care. SEM provides early detection of skin damage by as much as 5 to 10 days prior to other methods, eliminates the inherent structural bias in visual skin assessment for residents with dark skin tones, and demonstrates a model of care using technology innovation in poorly-resourced healthcare settings to provide bedside, real-time, point-of-care feedback that is can be used immediately by nursing staff.

In this study, nursing staff will use a device (the Provizio SEM Scanner) as part of standard skin assessments. The staff will use the values from the Provizio SEM Scanner during these assessments to decide if residents need preventive care for their skin. The study will look at these decisions and residents' subsequent health outcomes.

The study will also use information about residents' skin health and prevention actions during the 52 weeks before the study as a comparison.

Study Overview

• Status: Active, not recruiting
• Conditions: Pressure Injury
• Intervention / Treatment: Device: SEM Scanner

Detailed Description

Pressure injuries (PrIs), commonly located over bony prominences, are local areas of damage to the skin and underlying soft tissue (often not initially visible) caused by pressure and shear forces. These costly injuries, up to $151,000 per PrI, are associated among nursing home (NH) residents with reduced quality of life, pain, depression, and mortality. Prevalence and incidence of PrI have not declined and facility-acquired PrIs (FAPrIs) have actually increased over the last decade in NHs despite use of standardized prevention care. In fact, nursing home FAPrI rates are nearly double (5.4%) hospital FAPrI rates (2.9%).For nursing staff, the standard method of detecting changes in skin is conducting a visual assessment for skin discoloration; this visual detection coupled with risk assessment, serve as the customary trigger for initiating PrI prevention strategies. However, by the time reddened skin (erythema) is detected, significant damage is already present. The lag time between skin change associated with PrI formation and visual detection of the change eliminates the potential for PrI prevention strategies to be effective. Furthermore, visualization of potential PrIs is complicated by the challenge of discerning discoloration on persons with dark skin tones which, makes NH residents from minority or under-represented racial/ethnic groups more at-risk, thus leading to a significant health disparity. Multiple studies have shown racial/ethnic health disparities in PrI prevalence and incidence, severity, time to development and healing In fact, disparities in PrI prevalence, when comparing Black and white NH residents, are pervasive and persistent. Early detection of skin and tissue changes occurring as a PrI develops is a fundamental component in effective implementation of PrI prevention protocols.

Technological advances in biophysical measures have strengthened the capacity to detect early changes in tissue characteristics, for any skin tone, thus facilitating prevention care. A subclinical PrI can be readily identified at the dermal, and muscle tissue layers with a biophysical approach. Measurement of subepidermal moisture (SEM) using surface electrical capacitance is one biophysical method that has been shown to detect and predict early pressure damage. The SEM Scanner, a device used to date only in acute care hospitals, provides a biophysical measure of local inflammation and edema related to early pressure damage with a numerical result that serves as a cue for nursing staff to initiate PrI prevention with subsequent successful reduction and sustained decline in FAPrI incidence occurring. This technology's effectiveness has been demonstrated in hospitals; and this study will be the first to extend the use to NHs, a setting that is low in resources and desperate for assistance in this area. An embedded pragmatic stepped wedge clinical trial design will be conducted in 6 NHs within a single NH company with standardized operating procedures and PrI prevention protocols. We will examine whether SEM assessment results reflecting detection of early pressure damage can serve as an effective cue for NH nursing staff initiation of PrI prevention actions with the goal of reducing FAPrI rates over a 8-month intervention period. Specific aims are to:

Aim 1. Determine if early pressure damage detected by SEM assessment at time of visual skin observation of NH resident sacral and heel areas is effective in cueing the initiation of NH standard PrI prevention.

Aim 2. Examine the association between NH standard PrI prevention and SEM assessment and NH residents' characteristics (age, gender, risk, skin tone, race, ethnicity, BMI, Cognitive status) and their interactions on individual NH residents with regard to initiation of PrI prevention and PrI occurrence.

Aim 3. Explore if SEM usability, NH, and nursing staff characteristics influence the adoption and assimilation of early PrI detection and subsequent PrI prevention practices.

Results from this study will increase our knowledge and advance PrI prevention science and nursing practice. Furthermore, the clinical utility and relevance achieved with real world testing and staff delivery will help NHs with high PrI incidence by adding to the clarity of preventive nursing practices. These results will also be used for developing specialty policies and guidelines like the international PrI prevention clinical practice guidelines.

• Study Type: Interventional
• Enrollment (Actual): 4733
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Kennett Square, Pennsylvania, United States, 19348
      • Large proprietary nursing home chain faciity #3
    • Kennett Square, Pennsylvania, United States, 19348
      • Large proprietary nursing home chain facility #1
    • Kennett Square, Pennsylvania, United States, 19348
      • Large proprietary nursing home chain facility #4
    • Kennett Square, Pennsylvania, United States, 19348
      • Large proprietary nursing home chain facility #5
    • Kennett Square, Pennsylvania, United States, 19348
      • Large proprietary nursing home chain facility #6
    • Kennett Square, Pennsylvania, United States, 19348
      • Large proprietary nursing home chain facility #7
    • Kennett Square, Pennsylvania, United States, 19348
      • Large proprietary nursing home chain facilty #2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Study Population

Nursing home residents

Description

Nursing home residents:

Inclusion Criteria:

For intervention, must reside in nursing home at least 1 day during 8-month study period and be at least 18 years old at study start.

For baseline period: Must reside in nursing home at least 1 day during 52-week lookback period and be at least 18 years old at study start

Exclusion Criteria:

For intervention: Did not reside in nursing home during 8-month study period or younger than 18 years old For baseline period: Did not reside in nursing home during 52-week lookback period or younger than 18 years old

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nursing Home Residents in intervention; All Nursing Home residents in the facility during the 8 month intervention period	Device: SEM Scanner; Implementation of the SEM Scanner as part of weekly standard skin assessments of sacrum and heels; Other Names: Provizio SEM Scanner
No Intervention: Nursing Home Residents in baseline; All Nursing Home residents in the facility during the 12 month baseline period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New pressure injury prevention initiated	At least one Pressure Injury Prevention action newly initiated defined as electronic health record (EHR) documentation	From date of identified skin damage through 3 days later, assessed up to 8 months for intervention period or up to 12 months for baseline period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to pressure injury prevention initiation	Number of Days from skin assessment until EHR documentation of Pressure Injury Prevention	Number of days from date of identified skin damage through 3 days later, assessed up to 8 months for intervention period or up to 12 months for baseline period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sacral and/or heel pressure injury occurrence	EHR documentation of sacral and/or heel PrI	From at least 3 weeks since prior pressure injury occurrence (if ever), assessed up to 8 months for intervention period or up to 12 months for baseline period
Time to pressure injury occurrence	Number of pressure injury free days since prior pressure injury occurrence, if ever.	Number of days from date of new pressure injury occurrence (from at least 3 weeks since prior pressure injury, if ever), assessed up to 8 months for intervention period or up to 12 months for baseline period

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Institute of Nursing Research (NINR); Duke University; East Carolina University; Boise State University
• Investigators: Principal Investigator: Barbara M Bates-Jensen, PhD, Univeristy of California Los Angeles; Principal Investigator: Tracey L Yap, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2023
• Primary Completion (Actual): February 22, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: November 7, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Nursing homes; technology implementation; sub epidermal moisture
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Skin and Connective Tissue Diseases; Pressure Ulcer
• Other Study ID Numbers: 22-001256; 5R01NR020487-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes