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Using WoundPilot to Support Wound Care Decisions in Patients With Chronic Wounds

24. april 2026 oppdatert av: University Ghent

Evaluation of the Effect of WoundPilot on the Accuracy and Consistency of Clinical Decision-Making in Chronic Wound Care: A Randomized Parallel Vignette Study Among Primary Care Nurses

This study evaluates whether a digital decision support tool, called WoundPilot, can help primary care nurses make more accurate and consistent decisions when caring for patients with chronic wounds.

In daily practice, treatment decisions for chronic wounds can vary between clinicians, even when they assess the same patient. This variation may lead to delays in appropriate care, inconsistent treatment choices, or unnecessary referrals. WoundPilot was developed to guide clinicians through a structured wound assessment and link this assessment to clear treatment recommendations.

In this study, primary care nurses will assess a series of clinical cases either with or without the support of WoundPilot. Their decisions will be compared with an expert reference standard to determine whether the use of WoundPilot improves the accuracy of decisions and reduces differences between nurses.

The results of this study will help determine whether WoundPilot can support more consistent and evidence-based wound care in clinical practice.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Background Clinical decision-making in chronic wound care shows considerable variability, even when clinicians are presented with similar patient information. This variability may result in delayed or inappropriate treatment, inconsistent use of therapies, or failure to escalate care when clinically indicated.

Structured clinical decision support systems (CDSS) aim to reduce unwarranted variation by guiding clinicians through predefined assessment steps and linking these to management pathways. WoundPilot is an evidence-informed CDSS developed to support structured wound assessment and treatment decision-making in primary care.

Objective The primary objective is to evaluate the effect of WoundPilot on the accuracy and consistency of clinical decision-making in chronic wound care among primary care nurses.

Secondary objectives are to:

  • Assess alignment of wound assessment decisions with an expert reference standard
  • Evaluate whether WoundPilot reduces variability between nurses
  • Assess whether nurses better recognize and translate clinical changes
  • Evaluate usability of WoundPilot using the Dutch System Usability Scale (D-SUS)

Study Design

This study is a randomized parallel vignette study conducted among primary care nurses. Participants are randomly assigned to:

  • Intervention group: assessment of clinical cases using WoundPilot
  • Control group: assessment based on usual clinical reasoning without decision support Each participant evaluates a set of standardized clinical cases representing patients with chronic wounds.

Methods Participants include primary care nurses involved in wound care decision-making in home care or nursing home settings.

In the intervention group, participants receive a short training on WoundPilot and use the tool to assess clinical cases. In the control group, participants assess the same type of cases using their usual reasoning and verbalize their decision-making process.

For each case, participants make decisions regarding wound assessment and treatment planning, including supportive therapy, antimicrobial use, debridement, dressing selection, and referral.

An expert reference standard is established by a panel of wound care experts. Participant decisions are compared to this reference.

Outcomes

The primary outcome is the correctness of treatment decisions compared with the expert reference standard. Secondary outcomes include:

  • Correctness of wound assessment decisions
  • Between-nurse variability in decisions
  • Recognition and interpretation of clinical change
  • Usability of WoundPilot (Dutch System Usability Scale) Agreement with the expert reference and between participants will be quantified using appropriate statistical methods, including kappa statistics and mixed-effects models.

Significance This study evaluates whether a structured clinical decision support system can improve the accuracy and consistency of clinical decision-making in chronic wound care. Findings may inform the role of digital decision support tools in supporting evidence-based practice in primary care.

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Belgia
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgia, 9000
        • Ghent University Hospital
        • Ta kontakt med:
        • Ta kontakt med:
        • Underetterforsker:
          • Steven Smet, Master
        • Hovedetterforsker:
          • Hilde Beele, PhD
        • Underetterforsker:
          • Dimitri Beeckman, PhD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Primary care nurses involved in wound care decision-making
  • Nurses working in home care or nursing home settings
  • Nurses who assess and/or adapt wound management in clinical practice
  • Nurses with a qualification corresponding to European Qualification Framework (EQF) level 5 or 6
  • Willing and able to provide informed consent

Exclusion Criteria:

  • Nurses not involved in wound care decision-making
  • Nurses not working in a primary care setting
  • Inability to understand the study procedures or complete the assessment tasks
  • Refusal or inability to provide informed consent

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Reasoning with decision support

Participants in this arm assess standardized clinical cases of patients with chronic wounds using WoundPilot, a digital clinical decision support system (CDSS).

WoundPilot guides users through a structured, stepwise wound assessment, including evaluation of wound etiology, infection, wound evolution, wound bed characteristics, exudate, and wound edges. Based on the assessment, the system provides structured guidance to support treatment decision-making, including recommendations on supportive therapy, local wound management, and referral.

Participants receive a brief training on the use of WoundPilot prior to the assessment and then independently evaluate a set of clinical cases using the tool.
Enhet: WoundPilot

WoundPilot is a software-based clinical decision support system (CDSS) designed to support structured wound assessment and treatment decision-making in primary care.

The system guides users through a stepwise assessment process using predefined decision nodes, including evaluation of wound etiology, infection, wound evolution, wound bed characteristics, exudate, and wound edges. Based on the entered information, WoundPilot provides structured guidance to support treatment planning, including recommendations on supportive therapy, local wound management, and referral.

The system incorporates evidence-informed clinical pathways and aims to standardize wound assessment and reduce variability in clinical decision-making.
Ingen inngripen: Usual reasoning

Participants in this arm assess standardized clinical cases of patients with chronic wounds using their usual clinical reasoning, without the support of a clinical decision support system.

Participants independently evaluate each case and make decisions regarding wound assessment and treatment planning, including supportive therapy, local wound management, and referral. They are asked to verbalize their reasoning during the assessment process, which is recorded for subsequent analysis.

No additional training or decision support tool is provided.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Accuracy of Treatment Decisions Compared With an Expert Reference Standard
Tidsramme: During a single assessment session (approximately 2 hours)
Accuracy of treatment decisions will be assessed by comparing each participant's treatment decisions for standardized chronic wound cases with an expert reference standard. Treatment decisions include supportive therapy, antimicrobial therapy, wound cleansing, debridement, choice of wound product, management of wound edges or wound environment, protection of exposed bone or tendon when applicable, referral or contact with another healthcare professional or department, wound swab, and additional technical investigations. Accuracy will be analyzed at the level of individual treatment decision components and as a composite correctness score per case.
During a single assessment session (approximately 2 hours)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Alignment of Wound Assessment Decisions With Expert Reference Standard
Tidsramme: During a single assessment session (approximately 2 hours)
Accuracy of wound assessment decisions will be evaluated by comparing participant assessments with an expert reference standard. This includes classification of wound type, assessment of infection (local, spreading, or systemic), evaluation of wound evolution, wound bed characteristics, presence of hypergranulation or exposed structures, amount of exudate, and assessment of wound edges and surrounding skin.
During a single assessment session (approximately 2 hours)
Between-Nurse Variability in Treatment Decisions
Tidsramme: During a single assessment session (approximately 2 hours)
Variability in treatment decisions between participants will be assessed within each study group. Agreement between participants will be quantified using statistical measures such as Fleiss' kappa to evaluate consistency of treatment decisions across standardized cases.
During a single assessment session (approximately 2 hours)
Between-Nurse Variability in Wound Assessment Decisions
Tidsramme: During a single assessment session (approximately 2 hours)
Variability in wound assessment decisions between participants will be evaluated within each study group. Agreement will be quantified using appropriate statistical methods (e.g., Fleiss' kappa) to assess consistency in the evaluation of decision-critical wound parameters.
During a single assessment session (approximately 2 hours)
Recognition and Interpretation of Clinical Change
Tidsramme: During a single assessment session (approximately 2 hours)
Participants' ability to recognize and correctly interpret clinical changes over time will be assessed by comparing decisions between initial and follow-up case scenarios. Correct identification of wound evolution and appropriate adaptation of treatment decisions will be evaluated against the expert reference standard.
During a single assessment session (approximately 2 hours)
Usability of WoundPilot (Dutch System Usability Scale)
Tidsramme: During a single assessment session (approximately 2 hours)
Usability of WoundPilot will be assessed using the Dutch System Usability Scale (D-SUS), a validated 10-item questionnaire scored on a 5-point Likert scale. The D-SUS provides a total score ranging from 0 to 100, with higher scores indicating better usability.
During a single assessment session (approximately 2 hours)

Samarbeidspartnere og etterforskere

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Sponsor

University Ghent

Etterforskere

  • Studiestol: Steven Smet, Master, University Hospital, Ghent
  • Hovedetterforsker: Hilde Beele, PhD, University Hospital, Ghent
  • Studiestol: Dimitri Beeckman, PhD, University Ghent

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. september 2026

Studiet fullført (Antatt)

1. september 2026

Datoer for studieregistrering

Først innsendt

16. april 2026

Først innsendt som oppfylte QC-kriteriene

24. april 2026

Først lagt ut (Faktiske)

1. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ONZ-2026-0172
  • WoundPilot (Annen identifikator: Ghent University Hospital)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data (IPD) will not be shared due to the small sample size and the risk of potential re-identification of participants, as well as the inclusion of qualitative data (e.g., verbalized reasoning) that may contain indirectly identifiable information.

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Nei

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