- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07796035
Understanding Communication Barriers in Acute Care: A Mixed-Methods Needs Assessment Among Healthcare Providers Caring for Non-Verbal Patients With Spinal Cord Injury and Tracheostomy in the ICU
Communication impairment is common among critically ill patients who are mechanically ventilated, have tracheostomies, or have neurological injuries such as spinal cord injury. In acute care settings, inability to communicate contributes to patient distress, impairs symptom assessment, and may delay care. Although a range of communication supports exist, many are difficult to use in patients with severe weakness, limited endurance, or fluctuating cognition. More advanced assistive communication systems, including eye-tracking and brain-computer interface platforms, have shown promise in chronic neurological populations but have not been well adapted to the practical realities of acute care.
This study will use a sequential exploratory mixed-methods design to better understand communication barriers in acute care from the perspective of frontline healthcare providers. In the qualitative phase, semi-structured interviews will be conducted with nurses and speech-language pathologists working with patients who have spinal cord injury, tracheostomy, or other causes of impaired verbal communication in ICU and related acute care settings. Findings from these interviews will inform development of a structured survey to be distributed to a broader group of nurses and speech-language pathologists. Qualitative and quantitative findings will then be integrated to identify priority communication needs, limitations of current strategies, and practical requirements for future assistive communication tools. Findings will inform development of clinically relevant communication solutions for acute care environments.
Обзор исследования
Статус
Условия
Подробное описание
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Jason Chui, MBChB, FRCPC
- Номер телефона: 66378 604-875-4111
- Электронная почта: jason.chui@ubc.ca
Учебное резервное копирование контактов
- Имя: Shirley Lim, BSN, BS-HRIM
- Электронная почта: shirley.lim@vch.ca
Места учебы
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British Columbia
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Vancouver, British Columbia, Канада, V5Z 1M9
- Vancouver General Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- be a healthcare provider such as physicians, registered nurses, speech-language pathologists, occupational therapists, or physiotherapists;
- work in ICU, spine, neurosurgical, or related acute care inpatient settings;
- have experience caring for patients with impaired verbal communication, including patients with tracheostomy, mechanical ventilation, or spinal cord injury; and
- be able to provide informed consent. A small subset of family caregivers may also be included if they have direct experience supporting communication for patients with impaired verbal communication in these settings.
Exclusion Criteria:
- Individuals not directly involved in the care of patients with impaired verbal communication in the relevant clinical settings
- Trainees who are not yet independently practicing, unless they are participating in an independent clinical role
- Family caregivers without direct experience supporting communication needs in the acute care setting
Учебный план
Как устроено исследование?
Детали дизайна
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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High-priority Communication Needs in Acute Care
Временное ограничение: At completion of the 3-5-minute survey on Day 1
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Communication needs identified as high priority by healthcare providers based on their ratings of the importance and frequency of communication needs experienced by patients with impaired verbal communication in acute care settings.
The survey will also assess which communication functions healthcare providers consider most important for inclusion in future assistive communication interfaces.
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At completion of the 3-5-minute survey on Day 1
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Priority of Communication Needs in Acute Care
Временное ограничение: Stage 1 interviews and Stage 2 survey; approximately Months 3-4
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Healthcare providers' ratings of the importance and frequency of communication needs experienced by patients with impaired verbal communication in acute care settings.
Priority communication needs will be identified through thematic analysis of interviews and quantified in the Stage 2 survey using importance and frequency ratings.
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Stage 1 interviews and Stage 2 survey; approximately Months 3-4
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Current Communication Strategies and Perceived Limitations
Временное ограничение: Stage 1 interviews and Stage 2 survey; approximately Months 3-4
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Identification and characterization of communication strategies currently used by healthcare providers, including low-technology and augmentative and alternative communication approaches, and perceived limitations or barriers associated with their use.
Findings will be derived from qualitative interviews and summarized quantitatively in the survey where applicable.
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Stage 1 interviews and Stage 2 survey; approximately Months 3-4
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Priority Communication Functions for Bedside Use
Временное ограничение: Stage 2 survey; approximately Month 4
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Healthcare providers' prioritization of communication functions considered most appropriate for a simplified bedside assistive communication interface.
Participants will select a limited number of communication functions from those identified during the qualitative phase.
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Stage 2 survey; approximately Month 4
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Workflow and Implementation Feasibility Requirements
Временное ограничение: Stage 1 interviews and Stage 2 survey; approximately Months 3-4
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Healthcare providers' perceptions of practical requirements for implementing assistive communication tools in acute care, including acceptable setup time, training requirements, workflow integration, and environmental or clinical barriers.
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Stage 1 interviews and Stage 2 survey; approximately Months 3-4
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Communication System Functional Requirements
Временное ограничение: Stage 1 interviews and Stage 2 survey; approximately Months 3-4
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Identification of functional and interface requirements for future assistive communication systems, including required communication tasks, presentation/interface considerations, contextual information, and usability requirements.
Requirements will be identified through thematic analysis and prioritized using survey findings.
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Stage 1 interviews and Stage 2 survey; approximately Months 3-4
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Соавторы и исследователи
Спонсор
Соавторы
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- H26-01406
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .