Using WoundPilot to Support Wound Care Decisions in Patients With Chronic Wounds
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Ghent
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
WoundPilot
DeviceWoundPilot 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Reasoning with decision supportExperimental treatment 1 intervention
Group B: Usual reasoningNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Accuracy of Treatment Decisions Compared With an Expert Reference Standard
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.
Time frame
During a single assessment session (approximately 2 hours)Secondary outcomes
1
Alignment of Wound Assessment Decisions With Expert Reference Standard
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.
Time frame
During a single assessment session (approximately 2 hours)2
Between-Nurse Variability in Treatment Decisions
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.
Time frame
During a single assessment session (approximately 2 hours)3
Between-Nurse Variability in Wound Assessment Decisions
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.
Time frame
During a single assessment session (approximately 2 hours)4
Recognition and Interpretation of Clinical Change
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.
Time frame
During a single assessment session (approximately 2 hours)Sponsors and contacts
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Source ClinicalTrials.gov
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