Communication Barriers, Eye-tracking Technology, ICU Patients
Conditions
Brief summary
The objectives of this clinical trial are to explore the feasibility of the eye-tracking communication tool in alleviating communication barriers among non-verbal ICU patients. It will also preliminarily investigate the effectiveness of this tool in facilitating communication for these patients. Researchers will compare the eye-tracking communication tool with conventional techniques (such as body language, writing boards, etc.) to observe the feasibility and preliminary effectiveness of the eye-tracking communication tool in alleviating communication barriers. Participants will use an eye-tracking communication tool for augmentative communication for 2 consecutive days.
Interventions
DEVICEEye-Tracking communication tool
An eye-tracking communication tool developed using a human-centered co-design approach.The eye-tracking communication tool consists of an eye-tracker, a tablet, and a floor-standing stand. The tool will be placed at the patient's bedside 24 hours a day to facilitate real-time communication.
body language (e.g., pointing, nodding, shaking the head) and writing boards
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
ICU patient Inclusion Criteria: * aged ≥ 18 years * unable to communicate through normal verbal means due to endotracheal intubation/tracheotomy, muscle or nerve injury, acute/chronic spinal cord injury, etc. * Richmond Agitation-Sedation Scale (RASS) score ranging from -1 to 1 * able to comply with simple instructions for study participation
Exclusion criteria
* blindness or inability to elevate the eyelids that preclude successful participation in eye-tracking interaction tasks * cognitive impairment limiting meaningful participation * severe psychological distress Family members Inclusion Criteria: * aged ≥ 18 years * had visitation experiences during the patient's ICU admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Communication difficulty | up to 2days after enrollment | The degree of communication difficulty in non-verbal ICU patients will be assessed using the Ease of Communication Scale. This tool was revised by Menzel et al.in 1998 and has previously been used to assess communication difficulties among non-verbal patients in the ICU. The scale comprises 6 items, with response options ranging from 0 (no difficulty at all) to 4 (extreme difficulty). The total score ranges from 0 to 24, with higher scores indicating greater communication difficulties. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Well-being and safety | at 4:00 PM daily | The degree of well-being and safety in non-verbal ICU patients will be assessed using the practical co-constructed intensive care patients' well-being and safety scale (TOURS Scale). This scale consists of 4 items, with response options ranging from 0 (not at all) to 3 (very). The total score ranges from 0 to 12, with higher scores indicating better well-being and safety. |
| Satisfaction of family members | up to 2 days after enrollment | Family satisfaction will be assessed using the FS-ICU-24 scale. This scale consists of 24 items and has been well validated for measuring satisfaction among family members of patients admitted to the ICU. The scale comprises two domains: satisfaction with care and satisfaction with decision-making. Each item is scored on a continuous scale ranging from 0 to 100. The domain score is calculated as the sum of all valid item scores within that domain divided by the number of valid items in the respective domain. The total FS-ICU-24 score is computed as the sum of the two domain mean scores divided by 2, with higher scores representing a higher level of satisfaction. |
| Communication burden of ICU healthcare professionals | up to 2 days after enrollment | The communication burden of ICU healthcare professionals will be assessed using the NASA-TLX. This scale has been widely used to evaluate the subjective workload of healthcare providers and covers six domains: mental demand, physical demand, temporal demand, performance level, effort, and frustration. Each of the six domains is scored on a continuous scale ranging from 0 to 100, where a score of 0 indicates the lowest level of the domain and a score of 100 indicates the highest level. |
| Nurses' compliance | through study completion，an average of 2 year | Nurses' intervention behaviors will be documented during unscheduled supervision.The compliance of nurses will be defined as the number of communication sessions conducted by nurses with intervention group patients via the communication tool divided by the total number of communication sessions. |
| Time to functional communication | Day 1 | Time to functional communication will be defined as the time (minutes) from initial eye-tracker calibration to the first successfully confirmed communication need. Success requires patient selection via the eye-tracking interface and confirmation of the primary nurse's interpretation by nodding or head shaking. Times will be recorded in a standardized log, unsuccessful communication during the observation period will be recorded as not achieved. |
| Patient enrollment rate | through study completion, an average of 2 year | The patient enrollment rate is calculated as the number of patients who successfully meet the eligibility criteria and are enrolled in the study divided by the total number of patients screened for eligibility during the study period. |
| Patient withdrawal rate | through study completion, an average of 2 year | The patient withdrawal rate is defined as the number of enrolled patients who discontinue study participation (for any reason) prior to the completion of the predefined study protocol (e.g., intervention course) divided by the total number of enrolled patients. |
Outcome results
None listed