This prospective study consisted of (1) a descriptive cross-sectional part describing communication difficulties related to mechanical ventilation as experienced by intensive care professionals and patients, and (2) an experimental randomized crossover part comparing the use of a conventional low-tech communication board and a high-tech eye tracking technology-based device to improve communication effectiveness of intensive care mechanically ventilated patients.
Sample size: The health professionals sample size is estimated by convenience to 100 professionals based on the accessible population in the study site (i.e., 95% of the health professionals from the study site). The patients sample size is estimated to 44 patients based on statistical calculation (with a type 1 error rate of 5%, a type 2 error rate of 10% and an allocation ratio of 1), including two groups of 22 patients. Intervention: The cross-sectional part involved the healthcare professionals through the "state of the art questionnaire" and the patients through the "ease of communication scale". The crossover part then randomized the patients from the cross-sectional part into two groups and the communication interfaces were divided into two time periods: group A received eye tracking/communication board sequence and group B received communication board/eye tracking sequence. For each period, the communication interfaces were evaluated through the "intervention form". The communication board provides simple messages based on orthographic and iconic content. The eye tracking computer-based system enables the production and construction of simple or complex messages (including word processing with spelling suggestions and voice synthesis), also based on orthographic and iconic content. Statistical analysis: The numerical data will be analyzed quantitatively using R software (version 2016 3.5.3). The Gaussian distribution will be estimated by mean/median comparison, histogram symmetry, quantile-quantile distribution and shapiro-wilk test. Statistical analysis of the crossover variables (treatment-period interaction, period effect, and treatment effect) will be performed using the Mann-Whitney (ordinal variables) and chi-square (binary variables) nonparametric tests. A p-value less than 0.05 was considered significant. The non-numerical data will be analyzed qualitatively by thematization and categorization. Ethics approval and consent to participate: The study protocol was approved by the Ethics Committee of the Hospital of Liège as Central Committee and the Hospital of Charleroi as Local Committee (number: B70720183767, reference: 2018/268). The information and consent documents intended for healthcare professionals and patients were validated by both Ethics Committees. Written informed consent was obtained from all participants (healthcare professionals and patient's legal representative) included in this study. All procedures performed through this study were in accordance with the 1964 Helsinki Declaration and its later amendments.
The comparison between the communication board and eye tracking, conducted as a crossover, generates a randomization of the patients (from the cross-sectional part) into two groups and the communication interfaces were divided into two time periods: group A received eye tracking/communication board sequence and group B received communication board/eye tracking sequence.
University of Liège
Liège, Belgium
State of the art questionnaire - communication difficulties related to mechanical ventilation as experienced by healthcare professionals.
Self-administered questionnaire assessing the difficulties to communicate with intubated or tracheostomized patients, the avoidance of interactions with patients, the perception of the help that could be provided by alternative communication systems and the interest in learning to use these systems.
Time frame: Before the use of communication interfaces.
Ease of communication scale (ECS) - communication difficulties related to mechanical ventilation as experienced by patients.
Multidimensional scale completed through an assisted interview and covering the difficulty to be understood; to communicate physical needs, thoughts, and feelings with notably relatives, nurses and physicians; and to ask questions about care and health status.
Time frame: Before the use of communication interfaces.
Quantity of messages transmitted through the communication board.
Communication effectiveness indicator, collected through the intervention form.
Time frame: During the use of communication interfaces.
Quantity of messages transmitted through the eye tracking.
Communication effectiveness indicator, collected through the intervention form.
Time frame: During the use of communication interfaces.
Success rate for the communication board.
Communication effectiveness indicator, collected through the intervention form.
Time frame: During the use of communication interfaces.
Success rate for the eye tracking.
Communication effectiveness indicator, collected through the intervention form.
Time frame: During the use of communication interfaces.
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
44
Level of satisfaction for the communication board.
Communication effectiveness indicator, collected through the intervention form.
Time frame: During the use of communication interfaces.
Level of satisfaction for the eye tracking.
Communication effectiveness indicator, collected through the intervention form.
Time frame: During the use of communication interfaces.
Communication content for the communication board.
Communication effectiveness indicator, collected through the intervention form.
Time frame: During the use of communication interfaces.
Communication content for the eye tracking.
Communication effectiveness indicator, collected through the intervention form.
Time frame: During the use of communication interfaces.
Difficulties of use related to the communcation board.
Communication effectiveness indicator, collected through the intervention form.
Time frame: During the use of communication interfaces.
Difficulties of use related to the eye tracking.
Communication effectiveness indicator, collected through the intervention form.
Time frame: During the use of communication interfaces.