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Azioni di cambiamento della pelle da parte dell'assistenza infermieristica (SCAN)

14 settembre 2026 aggiornato da: Barbara Bates-Jensen, PhD, RN, FAAN, University of California, Los Angeles

Rilevazione biofisica dei cambiamenti cutanei per la prevenzione degli infortuni da pressione nelle case di cura

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.

Panoramica dello studio

Stato

Completato

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

4733

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Nursing Home Residents in intervention

All Nursing Home residents in the facility during the 8 month intervention period

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

Altri nomi:
  • Provizio SEM Scanner
Nessun intervento: Nursing Home Residents in baseline

All Nursing Home residents in the facility during the 12 month baseline period

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
New Pressure Injury Prevention Initiated
Lasso di tempo: 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

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to Pressure Injury Prevention Initiation
Lasso di tempo: 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

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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Sacral and/or Heel Pressure Injury Occurrence
Lasso di tempo: 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

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
Lasso di tempo: 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

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Barbara M Bates-Jensen, PhD, Univeristy of California Los Angeles
  • Investigatore principale: Tracey L Yap, PhD, Duke University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

4 dicembre 2022

Completamento primario (Effettivo)

22 febbraio 2025

Completamento dello studio (Effettivo)

30 giugno 2026

Date di iscrizione allo studio

Primo inviato

19 ottobre 2023

Primo inviato che soddisfa i criteri di controllo qualità

7 novembre 2023

Primo Inserito (Effettivo)

13 novembre 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 22-001256
  • 5R01NR020487-02 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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