Vidatalk Communication Application: Usability, Acceptability and Efficacy Study
Nonverbal Communication, Critical Illness
About this trial
This is an interventional supportive care trial for Nonverbal Communication focused on measuring Vidatalk, App, Augmentative and Alternative Communication, iPad, Android, Mechanical ventilation, Patient Communication, Critical Illness
Eligibility Criteria
Aim 1:
Inclusion Criteria:
- ≥18 years old
- Able to communicate in English
- Awake alert, responding appropriately to commands.
- Normal (aided or unaided) hearing and vision
- Able to control head, arm and hand movements
- Physiologically stable and in no acute distress (per nurse report)
Exclusion Criteria:
- Pre-existing communication impairments
- Diagnosis of severe dementia or brain injury
- CAM-ICU positive for delirium
- unresponsiveness or inattention
Aim 2:
Inclusion Criteria:
- ≥18 years old
- Able to communicate in English
- Awake alert, responding appropriately to commands.
- Normal (aided or unaided) hearing and vision
- Able to control head, arm and hand movements
- Physiologically stable and in no acute distress (per nurse report)
- Intubated via oral endotracheal or tracheal tube without speaking valve, receiving mechanical ventilation
Exclusion Criteria:
- Pre-existing communication impairments
- Diagnosis of severe dementia or brain injury
- CAM-ICU positive for delirium
- unresponsiveness or inattention
Aim 3:
Inclusion Criteria:
- ≥18 years old
- Able to communicate in English
- Awake alert, responding appropriately to commands.
- Normal (aided or unaided) hearing and vision
- Able to control head, arm and hand movements
- Physiologically stable and in no acute distress (per nurse report)
- Intubated via oral endotracheal or tracheal tube without speaking valve, received mechanical ventilation during past 48 hours
Exclusion Criteria:
- Pre-existing communication impairments
- Diagnosis of severe dementia or brain injury
- CAM-ICU positive for delirium
- unresponsiveness or inattention
Aim 5
Inclusion Criteria:
- Family caregivers of patient participants enrolled in Aim 3 as identified by the patient or self
- >/=18 years old
- Able to read and speak English
- Non-professional, unpaid caregiver
- Plans to visit at least 3 days/ week during ICU stay
- Reliable telephone access (for follow-up assessment)
Exclusion Criteria:
- Age under 18 years
- Unable to read and speak English
- Severe uncorrected hearing loss
- Self-reported diagnosis of dementia or Alzheimer's
- Self-reported psychiatric disorder (bipolar disorder, schizophrenia) or substance abuse requiring inpatient treatment within the last 12 months
- Unreliable telephone access
Sites / Locations
- Ohio State University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Other
No Intervention
Aim 1- VidaTalk post-extubation
Aim 2 - VidaTalk intubated
Aim 3 - VidaTalk tablet app
Aim 3 - attention-control
Aim 5-VidaTalk Efficacy in Family caregivers
Aim 1 is a two group iterative design preliminary to clinical trial. Group 1 and Group 2 will each consist of five previously mechanically ventilated patients who will be recruited from the ICUs at the OSUWMC (Ohio State University Wexner Medical Center), including discharged patients. Group 1 will use an initial android prototype of VidaTalk tablet application to be assessed for functionality (ergonomics, ease of use, ease of learning, simplicity, effectiveness and user interface) and usability on customizable communication, picture symbols, and integration with mobile communication devices. Group 2 will use an improved alpha prototype of VidaTalk tablet application version engineered from observations made during Group 1 sessions.
Usability testing preliminary to Clinical Trial (Aim 3). Mechanically Ventilated patients will provide feedback on acceptability, will perform test messages with minimal errors, and will rate VidaTalk an overall average score of 4.5 or higher (Likert-type scale; 1 to 7) on usability questions. Prior to implementing these procedures, the company will perform further iterative design assessments and engineer a Vidatalk tablet application prototype. This prototype will be used with a final group of ten (10) intubated patients receiving mechanical ventilation support to field-test the prototype for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Intervention is usability tasks with the VidaTalk app
Test the clinical efficacy of VidaTalk with MV patients by examining qualitative and quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application 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. Intervention will be receipt of VidaTalk tablet application.
35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts. Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, 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. Interventions will be Aim 3 - attention-control with non-VidaTalk tablet.
Aim 5 will test the preliminary efficacy of VidaTalk compared to attention control (AC) on anxiety and depression symptoms in family caregivers during the ICU stay and post-discharge (1-mos; 3-mos; 6-mos) and PTSD-related symptoms post-discharge both qualitatively and quantitatively. Aim 5.a.) Psychological outcomes (anxiety, depression, and PTSD-related symptoms) between the two groups will be compared at each time point and across time. Aim 5.b.) Family caregivers' perceived communication difficulty will be measured .Aim 5.c.) Family caregivers' experience of communication while they were visiting the patient who received the VidaTalk app in the ICU and their emotional reactions to communication with a patient will be measured.