CTSI-iPad for Vented Patient Communication

NCT ID: NCT03163823

Last Updated: 2021-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-23
• Study Completion Date: 2020-09-21

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.

Conditions

Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard Communication

Standard of Care communication styles will be used. Patients will receive the standard communication protocol identified by the hospital.

Group Type: PLACEBO_COMPARATOR

Standard of Care

Intervention Type: OTHER

Standard of Care communication methods

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.

Group Type: EXPERIMENTAL

Proloquo2Go

Intervention Type: OTHER

Use of communication application Proloquo2Go modified for the ICU setting on an iPad device

Interventions

Proloquo2Go

Use of communication application Proloquo2Go modified for the ICU setting on an iPad device

Intervention Type: OTHER

Standard of Care

Standard of Care communication methods

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marquette University

OTHER

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Rahul Nanchal

Associate Professor of Medicine and Director of the Medical Intensive Care Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rahul Nanchal, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

9665310

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

27533

Identifier Type: -

Identifier Source: org_study_id