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

24. dubna 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

40

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Belgie
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgie, 9000
        • Ghent University Hospital
        • Kontakt:
        • Kontakt:
        • Dílčí vyšetřovatel:
          • Steven Smet, Master
        • Vrchní vyšetřovatel:
          • Hilde Beele, PhD
        • Dílčí vyšetřovatel:
          • Dimitri Beeckman, PhD

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Přístroj: 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.
Žádný zásah: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Accuracy of Treatment Decisions Compared With an Expert Reference Standard
Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Alignment of Wound Assessment Decisions With Expert Reference Standard
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University Ghent

Vyšetřovatelé

  • Studijní židle: Steven Smet, Master, University Hospital, Ghent
  • Vrchní vyšetřovatel: Hilde Beele, PhD, University Hospital, Ghent
  • Studijní židle: Dimitri Beeckman, PhD, University Ghent

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

1. září 2026

Dokončení studie (Odhadovaný)

1. září 2026

Termíny zápisu do studia

První předloženo

16. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

24. dubna 2026

První zveřejněno (Aktuální)

1. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

1. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

24. dubna 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • ONZ-2026-0172
  • WoundPilot (Jiný identifikátor: Ghent University Hospital)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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