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Skin Change Actions by Nursing

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06127524
Acronym
SCAN
Enrollment
4733
Registered
2023-11-13
Start date
2022-12-04
Completion date
2026-06-30
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Injury

Keywords

Nursing homes, technology implementation, sub epidermal moisture

Brief summary

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.

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.

Interventions

Implementation of the SEM Scanner as part of weekly standard skin assessments of sacrum and heels

Sponsors

University of California, Los Angeles
Lead SponsorOTHER
National Institute of Nursing Research (NINR)
CollaboratorNIH
Duke University
CollaboratorOTHER
East Carolina University
CollaboratorOTHER
Boise State University
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

nursing home residents residing at any time in the facility during a 12 month baseline followed by 8 month intervention

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
New Pressure Injury Prevention InitiatedFrom date of newly identified skin damage through 3 days later, assessed up to 8 months for intervention period or up to 12 months for usual care (Lookback) periodAt least one Pressure Injury Prevention action newly initiated defined as electronic health record (EHR) documentation

Secondary

MeasureTime frameDescription
Time to Pressure Injury Prevention InitiationNumber 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 periodNumber of Days from skin assessment until EHR documentation of Pressure Injury Prevention

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORBarbara M Bates-Jensen, PhD

Univeristy of California Los Angeles

PRINCIPAL_INVESTIGATORTracey L Yap, PhD

Duke University

Participant flow

Pre-assignment details

The study used a step-wedge design. We enrolled 4,733 unique individuals. Because our study periods were sequential, some residents participated in both study arms, as they were resident in the facility during the relevant study periods.

Baseline characteristics

Characteristic
Age, Continuous
Intervention Period
71.51 Years
STANDARD_DEVIATION 14.05
Age, Continuous
Lookback Period
72.45 Years
STANDARD_DEVIATION 13.74
Age, Continuous
Overall study
71.95 Years
STANDARD_DEVIATION 13.98
Ethnicity (NIH/OMB)
Intervention Period
Hispanic or Latino
705 Participants
Ethnicity (NIH/OMB)
Intervention Period
Not Hispanic or Latino
1181 Participants
Ethnicity (NIH/OMB)
Intervention Period
Unknown or Not Reported
0 Participants
Ethnicity (NIH/OMB)
Lookback Period
Hispanic or Latino
862 Participants
Ethnicity (NIH/OMB)
Lookback Period
Not Hispanic or Latino
2026 Participants
Ethnicity (NIH/OMB)
Lookback Period
Unknown or Not Reported
0 Participants
Ethnicity (NIH/OMB)
Overall Study
Hispanic or Latino
1266 Participants
Ethnicity (NIH/OMB)
Overall Study
Not Hispanic or Latino
2788 Participants
Ethnicity (NIH/OMB)
Overall Study
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
Intervention Period
American Indian or Alaska Native
338 Participants
Race (NIH/OMB)
Intervention Period
Asian
12 Participants
Race (NIH/OMB)
Intervention Period
Black or African American
43 Participants
Race (NIH/OMB)
Intervention Period
More than one race
122 Participants
Race (NIH/OMB)
Intervention Period
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Intervention Period
Unknown or Not Reported
220 Participants
Race (NIH/OMB)
Intervention Period
White
1151 Participants
Race (NIH/OMB)
Lookback Period
American Indian or Alaska Native
429 Participants
Race (NIH/OMB)
Lookback Period
Asian
18 Participants
Race (NIH/OMB)
Lookback Period
Black or African American
47 Participants
Race (NIH/OMB)
Lookback Period
More than one race
129 Participants
Race (NIH/OMB)
Lookback Period
Native Hawaiian or Other Pacific Islander
3 Participants
Race (NIH/OMB)
Lookback Period
Unknown or Not Reported
737 Participants
Race (NIH/OMB)
Lookback Period
White
1525 Participants
Race (NIH/OMB)
Overall Study
American Indian or Alaska Native
649 Participants
Race (NIH/OMB)
Overall Study
Asian
25 Participants
Race (NIH/OMB)
Overall Study
Black or African American
72 Participants
Race (NIH/OMB)
Overall Study
More than one race
186 Participants
Race (NIH/OMB)
Overall Study
Native Hawaiian or Other Pacific Islander
3 Participants
Race (NIH/OMB)
Overall Study
Unknown or Not Reported
919 Participants
Race (NIH/OMB)
Overall Study
White
2200 Participants
Region of Enrollment
United States
2888 Participants
Sex: Female, Male
Intervention Period
Female
894 Participants
Sex: Female, Male
Intervention Period
Male
992 Participants
Sex: Female, Male
Lookback Period
Female
1395 Participants
Sex: Female, Male
Lookback Period
Male
1493 Participants
Sex: Female, Male
Overall Study
Female
1934 Participants
Sex: Female, Male
Overall Study
Male
2120 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
297 / 2,888192 / 1,886
other
Total, other adverse events
0 / 2,8880 / 1,886
serious
Total, serious adverse events
0 / 2,8880 / 1,886

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026