CTSI-iPad for Vented Patient Communication

Study Overview
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Brief Summary
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This study will enroll 75 mechanically vented adults in the ICU to compare self-reported ease of communication, patient satisfaction, and patient anxiety and frustration levels between a group using a communication application on an iPad and a group using standard methods of communication while mechanically vented.

Detailed Description
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The Investigators will randomize patients to either an iPad application available for communication or usual care. An existing iPad communication application (Proloquo2Go) that allows picture or text to voice communication was tailored to needs of adult mechanically ventilated (MV) patient. In the tailored application, common messages for an adult MV population are depicted on picture tiles organized into folders. When patients touch a picture tile either additional message options appear or a phrase or word is spoken by the device. Access to a pop-up keyboard on each screen allows patients to easily type unique text to voice messages. Intervention: Patients will be randomized to either an iPad with the tailored communication application or usual care. Patients randomized to the iPad group will be given a brief introduction to the communication application and then will be asked to communicate four messages to verify understanding. Patients who are unable to successfully use the iPad with the initial introduction will remain in the study. Research staff will continue to assist the patient daily and a speech language pathologist will be consulted to facilitate the patients ability to use the device. The iPad will remain at the bedside to be used for communication as desired for the remainder of the time the patient is on the ventilator. A manual providing instruction for the iPad and application operation will be at the bedside of all patients randomized to the intervention group. Research staff will visit patients daily to assist with any problems encountered and will also be available by phone to assist as needed. Although patients will be encouraged to use the iPad for communication, use of other strategies or tools will not be restricted.

Official Title
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A Randomized Controlled Trial of an iPad for Patient Communication During Mechanical Ventilation

Conditions
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Respiratory Failure

Intervention / Treatment
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* Other: Proloquo2Go
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sufficient motor and visual function to allow use of touch screen Mechanically ventilated Awake and able to participate in informed consent discussion Exclusion Criteria: Non-English Speaking Receiving ventilator support prior to admission. Delirium present in the last 24 hours Tracheostomy Structural Neurological Injury (such as stroke or traumatic brain injury) Coma Deep Sedation (Richmond Agitation Scale > -2)

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard Communication<br>Standard of Care communication styles will be used. Patients will receive the standard communication protocol identified by the hospital. | Other: Standard of Care<br>* Standard of Care communication methods<br>|
| Experimental: iPad with Speech App<br>Use of application Proloquo2Go on iPad device. The application being used is called Proloquo2Go which is the intervention portion. The iPad is the device used to access the application. | Other: Proloquo2Go<br>* Use of communication application Proloquo2Go modified for the ICU setting on an iPad device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of Communication | Patient self-reported ease of communication during mechanical ventilation measured using a Likert scale | 30 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Anxiety | Patient Anxiety while Mechanically Ventilated in an ICU measured by VAS anxiety | 30 Days | 
| Patient Satisfaction | Mechanically ventilated ICU patient satisfaction with device measured using a Likert scale | 30 Days |