- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Jason Chui, MBChB, FRCPC
- Telefonnummer: 66378 604-875-4111
- E-Mail: jason.chui@ubc.ca
Studieren Sie die Kontaktsicherung
- Name: Shirley Lim, BSN, BS-HRIM
- E-Mail: shirley.lim@vch.ca
Studienorte
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British Columbia
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Vancouver, British Columbia, Kanada, V5Z 1M9
- Vancouver General Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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High-priority Communication Needs in Acute Care
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Current Communication Strategies and Perceived Limitations
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Communication System Functional Requirements
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- H26-01406
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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