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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01NR020487-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
| Duke University | OTHER |
| East Carolina University | OTHER |
| Boise State University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nursing Home Residents in intervention | Experimental | All Nursing Home residents in the facility during the 8 month intervention period |
|
| Nursing Home Residents in baseline | No Intervention | All Nursing Home residents in the facility during the 12 month baseline period |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SEM Scanner | Device | Implementation of the SEM Scanner as part of weekly standard skin assessments of sacrum and heels |
|
| 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 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) period |
| 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 |
| 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 |
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
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| Name | Affiliation | Role |
|---|---|---|
| Barbara M Bates-Jensen, PhD | Univeristy of California Los Angeles | Principal Investigator |
| Tracey L Yap, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Large proprietary nursing home chain faciity #3 | Kennett Square | Pennsylvania | 19348 | United States | ||
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: Weeks 1-52 of Usual Care, Weeks 53-87 of Intervention | This group includes residents in Facility A. During Weeks 1-52, individuals resident in the facility received usual care. During Weeks 53-87, individuals resident in the facility received the intervention. |
| FG001 | Sequence 2: Weeks 6-57 of Usual Care, Weeks 58-92 of Intervention | This group includes residents in Facility B. During Weeks 6-57, individuals resident in the facility received usual care. During Weeks 58-92, individuals resident in the facility received the intervention. |
| FG002 | Sequence 3: Weeks 8-59 of Usual Care, Weeks 60-94 of Intervention | This group includes residents in Facility C. During Weeks 8-59, individuals resident in the facility received usual care. During Weeks 60-94, individuals resident in the facility received the intervention. |
| FG003 | Sequence 4: Weeks 10-61 of Usual Care, Weeks 62-96 of Intervention | This group includes residents in Facility D. During Weeks 10-61, individuals resident in the facility received usual care. Original plans during Weeks 62-96, individuals resident in the facility received the intervention. However, the facility withdrew from the study in Week 73. |
| FG004 | Sequence 5: Weeks 15-66 of Usual Care, Weeks 67-101 of Intervention | This group includes residents in Facility E. During Weeks 15-66, individuals resident in the facility received usual care. During Weeks 67-101, individuals resident in the facility received the intervention. |
| FG005 | Sequence 6: Weeks 29-80 of Usual Care (Lookback), Weeks 81-115 of Intervention | This group includes residents in Facility F. During Weeks 29-80, individuals resident in the facility received usual care (Lookback). During Weeks 81-115, individuals resident in the facility received the intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lookback |
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| ||||||||||||||||||
| Intervention |
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Residents later deemed ineligible due to dates in the facility are not included. After removing ineligibles, the number of residents starting only the Lookback period was 2168, the number of residents starting only the Intervention period was 1166, and the number of residents starting in both periods was 720, for a total number of 4,054 unique participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants in the Usual Care (Lookback) and Intervention Periods | Residents later deemed ineligible due to dates resident in the facility are not included. Because some residents were resident in the facility during both study periods, the total number of unique participants is 3,982. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Residents later deemed ineligible due to dates in the facility are not included. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | New Pressure Injury Prevention Initiated | At least one Pressure Injury Prevention action newly initiated defined as electronic health record (EHR) documentation | Practices analyzed for participants presented in Baseline Characteristics. | Posted | Count of Units | assessments_with_skin_damage | From 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) period | assessments_with_skin_damage | assessments_with_skin_damage |
|
From enrollment to end of Lookback study period at facility (up to 52 weeks) and from beginning of Intervention period or enrollment to end of Intervention period at facility (up to 35 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants in the Usual Care (Lookback) Period | Residents later deemed ineligible due to dates resident in the facility are not included. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara M Bates-Jensen | School of Nursing, University of California, Los Angeles | 626-437-8543 | batesjen@sonnet.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 19, 2026 | Mar 19, 2026 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 20, 2026 | Feb 20, 2026 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 20, 2026 | Feb 20, 2026 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| OTHER |
nursing home residents residing at any time in the facility during a 12 month baseline followed by 8 month intervention
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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 |
| Large proprietary nursing home chain facility #1 |
| Kennett Square |
| Pennsylvania |
| 19348 |
| United States |
| Large proprietary nursing home chain facility #4 | Kennett Square | Pennsylvania | 19348 | United States |
| Large proprietary nursing home chain facility #5 | Kennett Square | Pennsylvania | 19348 | United States |
| Large proprietary nursing home chain facility #6 | Kennett Square | Pennsylvania | 19348 | United States |
| Large proprietary nursing home chain facility #7 | Kennett Square | Pennsylvania | 19348 | United States |
| Large proprietary nursing home chain facilty #2 | Kennett Square | Pennsylvania | 19348 | United States |
| Deemed ineligible after review of admission dates |
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| Continued after Lookback Period |
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| Enrolled after Intervention begun |
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| COMPLETED |
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| NOT COMPLETED |
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|
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Residents later deemed ineligible due to dates in the facility are not included. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Residents later deemed ineligible due to dates in the facility are not included. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Residents later deemed ineligible due to dates in the facility are not included. | Count of Participants | Participants |
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| Region of Enrollment | Region for all participants in the study | Residents later deemed ineligible due to dates in the facility are not included. | Number | Participants |
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| Region of Enrollment | Region for residents in the Lookback Period | Residents later deemed ineligible due to dates in the facility are not included. | Number | Participants |
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| Region of Enrollment | Region for residents in the Intervention Period | Residents later deemed ineligible due to dates in the facility are not included. | Number | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| assessments_with_skin_damage |
|
|
| Secondary | Time to Pressure Injury Prevention Initiation | Number of Days from skin assessment until EHR documentation of Pressure Injury Prevention | Not Posted | Jul 2026 | Mean | Standard Deviation | Days | 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 | Participants |
| Other Pre-specified | Sacral and/or Heel Pressure Injury Occurrence | EHR documentation of sacral and/or heel PrI | Number of participants with at least one sacral or heel pressure injury during study period | Posted | Count of Participants | Participants | 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 |
|
|
|
| Other Pre-specified | Time to Pressure Injury Occurrence | Number of pressure injury free days since prior pressure injury occurrence, if ever. | Not Posted | Jul 2026 | Mean | Standard Deviation | Days | 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 | Participants |
| 297 |
| 2,888 |
| 0 |
| 2,888 |
| 0 |
| 2,888 |
| EG001 | All Participants in the Intervention Period | Residents later deemed ineligible due to dates resident in the facility are not included. Some residents continued from the Lookback period to the Intervention period, so are counted in the total number at risk during this period. | 192 | 1,886 | 0 | 1,886 | 0 | 1,886 |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Intervention Period |
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