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

24 avril 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

40

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Belgique
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgique, 9000
        • Ghent University Hospital
        • Contact:
        • Contact:
        • Sous-enquêteur:
          • Steven Smet, Master
        • Chercheur principal:
          • Hilde Beele, PhD
        • Sous-enquêteur:
          • Dimitri Beeckman, PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Dispositif: 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.
Aucune intervention: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Accuracy of Treatment Decisions Compared With an Expert Reference Standard
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Alignment of Wound Assessment Decisions With Expert Reference Standard
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University Ghent

Les enquêteurs

  • Chaise d'étude: Steven Smet, Master, University Hospital, Ghent
  • Chercheur principal: Hilde Beele, PhD, University Hospital, Ghent
  • Chaise d'étude: Dimitri Beeckman, PhD, University Ghent

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juin 2026

Achèvement primaire (Estimé)

1 septembre 2026

Achèvement de l'étude (Estimé)

1 septembre 2026

Dates d'inscription aux études

Première soumission

16 avril 2026

Première soumission répondant aux critères de contrôle qualité

24 avril 2026

Première publication (Réel)

1 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 avril 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • ONZ-2026-0172
  • WoundPilot (Autre identifiant: Ghent University Hospital)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime 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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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