CTSI-iPad for Vented Patient Communication (iPad)

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure
• Intervention / Treatment: Other: Standard of Care; Other: Proloquo2Go

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Memorial Lutheran Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Standard Communication; Standard of Care communication styles will be used. Patients will receive the standard communication protocol identified by the hospital.	Other: Standard of Care; Standard of Care communication methods
EXPERIMENTAL: iPad with Speech App; 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; Use of communication application Proloquo2Go modified for the ICU setting on an iPad device

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: Marquette University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 23, 2017
• Primary Completion (ACTUAL): September 21, 2020
• Study Completion (ACTUAL): September 21, 2020

Study Registration Dates

• First Submitted: March 9, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (ACTUAL): May 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 20, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 27533; 9665310 (OTHER_GRANT: CTSI of Southeast Wisconsin)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No