Using WoundPilot to Support Wound Care Decisions in Patients With Chronic Wounds
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: WoundPilot.
- Who it may be relevant to
- Registry conditions: Wound Complication, Wound Care, Wound and Injuries. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Interventions
- Device 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 re
Primary outcome measures
- Accuracy of Treatment Decisions Compared With an Expert Reference Standard [Time frame: During a single assessment session (approximately 2 hours)]
Secondary outcome measures (5)
- Alignment of Wound Assessment Decisions With Expert Reference Standard [Time frame: During a single assessment session (approximately 2 hours)]
- Between-Nurse Variability in Treatment Decisions [Time frame: During a single assessment session (approximately 2 hours)]
- Between-Nurse Variability in Wound Assessment Decisions [Time frame: During a single assessment session (approximately 2 hours)]
- Recognition and Interpretation of Clinical Change [Time frame: During a single assessment session (approximately 2 hours)]
- Usability of WoundPilot (Dutch System Usability Scale) [Time frame: During a single assessment session (approximately 2 hours)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- Ghent University Hospital — Ghent
Publications
- Smet S, Verhaeghe S, Beeckman D, Fourie A, Beele H. The process of clinical decision-making in chronic wound care: A scenario-based think-aloud study. J Tissue Viability. 2024 May;33(2):231-238. doi: 10.1016/j.jtv.2024.03.002. Epub 2024 Mar 1. PMID 38461069
- Smet S, Probst S, Holloway S, Fourie A, Beele H, Beeckman D. The measurement properties of assessment tools for chronic wounds: A systematic review. Int J Nurs Stud. 2021 Sep;121:103998. doi: 10.1016/j.ijnurstu.2021.103998. Epub 2021 Jun 7. PMID 34237439
Identifiers
NCT: NCT07562269 · ONZ-2026-0172 · WoundPilot