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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Accuracy of Treatment Decisions Compared With an Expert Reference Standard
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
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.
干预措施: WoundPilot (Device)
结局指标
主要结局
Accuracy of Treatment Decisions Compared With an Expert Reference Standard
时间窗: 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.
次要结局
- Alignment of Wound Assessment Decisions With Expert Reference Standard(During a single assessment session (approximately 2 hours))
- Between-Nurse Variability in Treatment Decisions(During a single assessment session (approximately 2 hours))
- Between-Nurse Variability in Wound Assessment Decisions(During a single assessment session (approximately 2 hours))
- Recognition and Interpretation of Clinical Change(During a single assessment session (approximately 2 hours))
- Usability of WoundPilot (Dutch System Usability Scale)(During a single assessment session (approximately 2 hours))