147
Participants
Start Date
February 19, 2018
Primary Completion Date
June 11, 2019
Study Completion Date
June 11, 2019
Aim 1 - VidaTalk - post-extubation
"Observation of task completion will be made while patients complete a series of messages using the VidaTalk app:~* Tell me you are tired~* Tell me you are having pain~* Rate this pain~* Tell me there is pain in your back~* Tell me your pain is sharp~* Ask to see the doctor~* Write your favorite color by drawing with your finger~* Type How are you? Patients will also complete a 1-item difficulty rating and a 3-item After-Scenario Questionnaire (ASQ) after each task.~Patients will also be asked to (a) comment on the customization of the app and make suggestions; (b) rate the extent to which they would use the device if they were an ICU patient and unable to speak.~Group 1 only:~Patients will be asked about their preferences for customizing the VidaTalk app."
Aim 2 - VidaTalk - intubated
Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Data will be collected by a trained data collector as in Aim 1 with the addition of Ease of Communication and Frustration ratings before and after the testing sequence. To reduce burden, patients in this group will complete the 3-item ASQ one time after all tasks are completed. They will also complete a 13-item System Usability Scale (SUS).
Aim 3 - VidaTalk tablet app
Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 minutes) each day to check user needs and concerns and will review or retrain on message options if needed.
Aim 3 - attention-control with non-VidaTalk tablet
Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet.
Ohio State University Medical Center, Columbus
Vidatak, LLC
INDUSTRY
Ohio State University
OTHER