Vidatalk Communication Application: Usability, Acceptability and Efficacy Study

Treatment-induced communication impairment is one of the most common and distressful symptoms
to mechanically ventilated intensive care unit (ICU) patients and is associated with anxiety,
panic, anger, frustration, sleeplessness, and distress.This Phase II Small Business
Technology Transfer Research (STTR) will deliver a comprehensive solution that may help
decrease days in delirium, decrease anxiety levels, and reduce sedation exposure which are
proximal outcomes known to be associated with decreased mechanical ventilation days, shorter
lengths of ICU and hospital stay, and lower healthcare cost. The primary goal of this Phase
II STTR proposal is to further define user requirements and product specifications and
develop a prototype of VidaTalk (previously TouchTalk), a patient-centric, touch pad
communication software, to provide mechanically ventilated (MV) patients an evidence-based
solution for effectively communicating their needs to care providers and family. A secondary
goal is to test the impact of the VidaTalk on clinical outcomes (e.g., patient-reported
communication difficulty and frustration, anxiety, sedation exposure, delirium/coma-free
days, and improved patient and family satisfaction with ICU care). This study will use mixed
methods including observations and interaction with hospitalized patients as they use the
VidaTalk communication tool, surveys and medical record data extraction, product evaluation
and brief interview, satisfaction survey with family members of ICU patients and focus groups
with Registered Nurses. Our Phase I STTR successfully delivered a beta prototype that met
technical feasibility criteria; however, additional requirements emerged as a common theme
from user testing and market analysis. The current study will meet the identified needs for
VidaTalk to operate on android devices, be customizable to patients' unique message needs,
use pictures symbols for communication, and be able to route patient requests to providers
who are not present at the bedside.

Specific Aim 1 (Preliminary to Clinical Trial). Develop a commercial prototype of VidaTalk
that will include multilingual and customizable messages, compatibility with tablet devices,
picture symbols, and integration with mobile communication devices.

Specific Aim 2 (Preliminary to Clinical Trial). Demonstrate usability with iterative user
assessment testing in a clinical setting.

Specific Aim 3. Test the clinical efficacy of VidaTalk via android application with MV
patients by examining qualitative and quantitative endpoints in a clinical setting. Aim 3
hypothesis: MV patients using VidaTalk will demonstrate notable reductions in
patient-reported frustration and communication difficulty, anxiety, sedation exposure,
delirium/coma-free days, and improved patient and family satisfaction with ICU care compared
to MV patients receiving attention-control.

Specific Aim 4. Validation of electronic visual analogue scale, versus current standard paper
scale.

Specific Aim 5. Test the effect of the communication tablet (VidaTalk) on psychological
symptoms in family caregivers.

Aim 1:

Inclusion Criteria:

1. ≥18 years old

2. Able to communicate in English

3. Awake alert, responding appropriately to commands.

4. Normal (aided or unaided) hearing and vision

5. Able to control head, arm and hand movements

6. Physiologically stable and in no acute distress (per nurse report)

Exclusion Criteria:

1. Pre-existing communication impairments

2. Diagnosis of severe dementia or brain injury

3. CAM-ICU positive for delirium

4. unresponsiveness or inattention

Aim 2:

Inclusion Criteria:

1. ≥18 years old

2. Able to communicate in English

3. Awake alert, responding appropriately to commands.

4. Normal (aided or unaided) hearing and vision

5. Able to control head, arm and hand movements

6. Physiologically stable and in no acute distress (per nurse report)

7. Intubated via oral endotracheal or tracheal tube without speaking valve, receiving
mechanical ventilation

Exclusion Criteria:

1. Pre-existing communication impairments

2. Diagnosis of severe dementia or brain injury

3. CAM-ICU positive for delirium

4. unresponsiveness or inattention

Aim 3:

Inclusion Criteria:

1. ≥18 years old

2. Able to communicate in English

3. Awake alert, responding appropriately to commands.

4. Normal (aided or unaided) hearing and vision

5. Able to control head, arm and hand movements

6. Physiologically stable and in no acute distress (per nurse report)

7. Intubated via oral endotracheal or tracheal tube without speaking valve, received
mechanical ventilation during past 48 hours

Exclusion Criteria:

1. Pre-existing communication impairments

2. Diagnosis of severe dementia or brain injury

3. CAM-ICU positive for delirium

4. unresponsiveness or inattention

Aim 5

Inclusion Criteria:

1. Family caregivers of patient participants enrolled in Aim 3 as identified by the
patient or self

2. >/=18 years old

3. Able to read and speak English

4. Non-professional, unpaid caregiver

5. Plans to visit at least 3 days/ week during ICU stay

6. Reliable telephone access (for follow-up assessment)

Exclusion Criteria:

1. Age under 18 years

2. Unable to read and speak English

3. Severe uncorrected hearing loss

4. Self-reported diagnosis of dementia or Alzheimer's

5. Self-reported psychiatric disorder (bipolar disorder, schizophrenia) or substance
abuse requiring inpatient treatment within the last 12 months

6. Unreliable telephone access