CTSI-iPad for Vented Patient Communication

Not Applicable

Completed

• Conditions: Respiratory Failure
• Interventions: Other: Standard of Care; Other: Proloquo2Go

• Registration Number: NCT03163823
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-02-23
• Study First Submitted: 2017-03-09
• Study First Submitted QC: 2017-05-19
• Study First Posted: 2017-05-23
• Primary Completion: 2020-09-21
• Study Completion: 2020-09-21
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-18
• Last Update Posted: 2021-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. Sufficient motor and visual function to allow use of touch screen
2. Mechanically ventilated
3. Awake and able to participate in informed consent discussion

Exclusion Criteria

1. Non-English Speaking
2. Receiving ventilator support prior to admission.
3. Delirium present in the last 24 hours
4. Tracheostomy
5. Structural Neurological Injury (such as stroke or traumatic brain injury)
6. Coma
7. Deep Sedation (Richmond Agitation Scale > -2)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Communication	Standard of Care	Standard of Care communication styles will be used. Patients will receive the standard communication protocol identified by the hospital.
iPad with Speech App	Proloquo2Go	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.

Primary Outcome Measures

Name	Time	Method
Ease of Communication	30 Days	Patient self-reported ease of communication during mechanical ventilation measured using a Likert scale

Secondary Outcome Measures

Name	Time	Method
Patient Anxiety	30 Days	Patient Anxiety while Mechanically Ventilated in an ICU measured by VAS anxiety
Patient Satisfaction	30 Days	Mechanically ventilated ICU patient satisfaction with device measured using a Likert scale

Trial Locations

Locations (1)

Froedtert Memorial Lutheran Hospital; 🇺🇸 Milwaukee, Wisconsin, United States