- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jason Chui, MBChB, FRCPC
- Número de teléfono: 66378 604-875-4111
- Correo electrónico: jason.chui@ubc.ca
Copia de seguridad de contactos de estudio
- Nombre: Shirley Lim, BSN, BS-HRIM
- Correo electrónico: shirley.lim@vch.ca
Ubicaciones de estudio
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British Columbia
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Vancouver, British Columbia, Canadá, V5Z 1M9
- Vancouver General Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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High-priority Communication Needs in Acute Care
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Current Communication Strategies and Perceived Limitations
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Communication System Functional Requirements
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
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Inicio del estudio (Estimado)
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Finalización del estudio (Estimado)
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Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
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Otros números de identificación del estudio
- H26-01406
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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