- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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.
Visão geral do estudo
Status
Condições
Descrição detalhada
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Jason Chui, MBChB, FRCPC
- Número de telefone: 66378 604-875-4111
- E-mail: jason.chui@ubc.ca
Estude backup de contato
- Nome: Shirley Lim, BSN, BS-HRIM
- E-mail: shirley.lim@vch.ca
Locais de estudo
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British Columbia
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Vancouver, British Columbia, Canadá, V5Z 1M9
- Vancouver General Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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High-priority Communication Needs in Acute Care
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Current Communication Strategies and Perceived Limitations
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Communication System Functional Requirements
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- H26-01406
Plano para dados de participantes individuais (IPD)
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