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Набор скоро начнётся NCT07562269

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

Без фазы С лечением Wound Complication Wound Care Wound and Injuries

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: WoundPilot.
Кому может быть актуально
Состояния в реестре: Wound Complication, Wound Care, Wound and Injuries. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бельгия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство 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

Первичные конечные точки

  • Accuracy of Treatment Decisions Compared With an Expert Reference Standard [Срок оценки: During a single assessment session (approximately 2 hours)]
Вторичные конечные точки (5)
  • Alignment of Wound Assessment Decisions With Expert Reference Standard [Срок оценки: During a single assessment session (approximately 2 hours)]
  • Between-Nurse Variability in Treatment Decisions [Срок оценки: During a single assessment session (approximately 2 hours)]
  • Between-Nurse Variability in Wound Assessment Decisions [Срок оценки: During a single assessment session (approximately 2 hours)]
  • Recognition and Interpretation of Clinical Change [Срок оценки: During a single assessment session (approximately 2 hours)]
  • Usability of WoundPilot (Dutch System Usability Scale) [Срок оценки: During a single assessment session (approximately 2 hours)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Бельгия · 1 центр
  • Ghent University Hospital — Ghent

Публикации

  • 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

Идентификаторы

NCT: NCT07562269 · ONZ-2026-0172 · WoundPilot

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗