CTSI-iPad for Vented Patient Communication (iPad)
Primary Purpose
Respiratory Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proloquo2Go
Standard of Care
Sponsored by
About this trial
This is an interventional supportive care trial for Respiratory Failure
Eligibility Criteria
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)
Sites / Locations
- Froedtert Memorial Lutheran Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Standard Communication
iPad with Speech App
Arm Description
Standard of Care communication styles will be used. Patients will receive the standard communication protocol identified by the hospital.
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.
Outcomes
Primary Outcome Measures
Ease of Communication
Patient self-reported ease of communication during mechanical ventilation measured using a Likert scale
Secondary Outcome Measures
Patient Anxiety
Patient Anxiety while Mechanically Ventilated in an ICU measured by VAS anxiety
Patient Satisfaction
Mechanically ventilated ICU patient satisfaction with device measured using a Likert scale
Full Information
NCT ID
NCT03163823
First Posted
March 9, 2017
Last Updated
May 18, 2021
Sponsor
Medical College of Wisconsin
Collaborators
Marquette University
1. Study Identification
Unique Protocol Identification Number
NCT03163823
Brief Title
CTSI-iPad for Vented Patient Communication
Acronym
iPad
Official Title
A Randomized Controlled Trial of an iPad for Patient Communication During Mechanical Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 23, 2017 (Actual)
Primary Completion Date
September 21, 2020 (Actual)
Study Completion Date
September 21, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Marquette University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Communication
Arm Type
Placebo Comparator
Arm Description
Standard of Care communication styles will be used. Patients will receive the standard communication protocol identified by the hospital.
Arm Title
iPad with Speech App
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Proloquo2Go
Intervention Description
Use of communication application Proloquo2Go modified for the ICU setting on an iPad device
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Standard of Care communication methods
Primary Outcome Measure Information:
Title
Ease of Communication
Description
Patient self-reported ease of communication during mechanical ventilation measured using a Likert scale
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
Patient Anxiety
Description
Patient Anxiety while Mechanically Ventilated in an ICU measured by VAS anxiety
Time Frame
30 Days
Title
Patient Satisfaction
Description
Mechanically ventilated ICU patient satisfaction with device measured using a Likert scale
Time Frame
30 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rahul Nanchal, MD, MS
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Froedtert Memorial Lutheran Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share.
Learn more about this trial
CTSI-iPad for Vented Patient Communication
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