Communication Strategies for Mechanically Ventilated Patients in Intensive Care Units

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparative Analysis of Communication Board and Eye Tracking in Intensive Care Mechanically Ventilated Patients

Conditions
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Mechanical Ventilation Complication, Communication, Nonverbal

Intervention / Treatment
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* Device: Comparison between communication board and eye tracking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria - healthcare professionals: Working in the intensive care unit (study site). Exclusion Criteria - healthcare professionals: Lack of consent. Inclusion Criteria - patients: Being hospitalized in the intensive care unit (study site), Awake with a Richmond Agitation-Sedation Scale (RASS) between restless (+1) and drowsy (-1), Age of 18 years or older, French speaker. Exclusion Criteria - patients: Lack of consent, Severe visual impairment (e.g., blindness).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Intra-individual comparison of 2 treatments divided into 2 time periods, so as to constitute 4 experimental conditions. The order of the treatments allocation, organised according to 2 sequences (A-B and B-A), induces a randomisation of the included patients into 2 groups. The wash-out period between the 2 periods is not applicable in this study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Communication board<br>The communication board consists of a printed paper interface with a size of 42 x 30 cm. | Device: Comparison between communication board and eye tracking<br>* 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.<br>|
| Experimental: Eye tracking<br>The eye tracking device combines a laptop computer with a screen size of 29 x 16 cm, an eye tracker (PCEye Mini, Tobii dynavox, Danderyd, Sweden), an interface generated by a communication software (Communicator 5, Tobii dynavox) and a telescopic support. | Device: Comparison between communication board and eye tracking<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Before the use of communication interfaces. | 
| Quantity of messages transmitted through the communication board. | Communication effectiveness indicator, collected through the intervention form. | During the use of communication interfaces. | 
| Quantity of messages transmitted through the eye tracking. | Communication effectiveness indicator, collected through the intervention form. | During the use of communication interfaces. | 
| Success rate for the communication board. | Communication effectiveness indicator, collected through the intervention form. | During the use of communication interfaces. | 
| Success rate for the eye tracking. | Communication effectiveness indicator, collected through the intervention form. | During the use of communication interfaces. | 
| Level of satisfaction for the communication board. | Communication effectiveness indicator, collected through the intervention form. | During the use of communication interfaces. | 
| Level of satisfaction for the eye tracking. | Communication effectiveness indicator, collected through the intervention form. | During the use of communication interfaces. | 
| Communication content for the communication board. | Communication effectiveness indicator, collected through the intervention form. | During the use of communication interfaces. | 
| Communication content for the eye tracking. | Communication effectiveness indicator, collected through the intervention form. | During the use of communication interfaces. | 
| Difficulties of use related to the communcation board. | Communication effectiveness indicator, collected through the intervention form. | During the use of communication interfaces. | 
| Difficulties of use related to the eye tracking. | Communication effectiveness indicator, collected through the intervention form. | During the use of communication interfaces. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive care unit, Mechanical ventilation, Alternative communication, Eye tracking, Communication board