- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jason Chui, MBChB, FRCPC
- Phone Number: 66378 604-875-4111
- Email: jason.chui@ubc.ca
Study Contact Backup
- Name: Shirley Lim, BSN, BS-HRIM
- Email: shirley.lim@vch.ca
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
High-priority Communication Needs in Acute Care
Time Frame: At completion of the 3-5-minute survey on Day 1
|
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
|
|
Priority of Communication Needs in Acute Care
Time Frame: 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.
|
Stage 1 interviews and Stage 2 survey; approximately Months 3-4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Current Communication Strategies and Perceived Limitations
Time Frame: Stage 1 interviews and Stage 2 survey; approximately Months 3-4
|
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
|
|
Priority Communication Functions for Bedside Use
Time Frame: Stage 2 survey; approximately Month 4
|
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
Time Frame: 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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Communication System Functional Requirements
Time Frame: Stage 1 interviews and Stage 2 survey; approximately Months 3-4
|
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.
|
Stage 1 interviews and Stage 2 survey; approximately Months 3-4
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H26-01406
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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