Trial Outcomes & Findings for Vidatalk Communication Application: Usability, Acceptability and Efficacy Study (NCT NCT02921776)

Results Overview

Aim 3 - Mean item score of daily by patient self report using a single item Likert-type scale from the Ease of Communication Scale (ECS) where scores range from 0 "not hard at all" to 4 "extremely hard"

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

147 participants

Primary outcome timeframe

Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU

Results posted on

2022-03-31

Participant Flow

Patients were screened for eligibility by critical care research coordinators and referred to the study coordinator and research assistant for bedside eligibility screening and recruitment.

Participant milestones

Participant milestones
Measure	Aim 1- VidaTalk Post-extubation Aim 1 is a two group iterative design preliminary to clinical trial. Group 1 \& 2 will each consist of five previously mechanically ventilated patients who will be recruited from the ICUs at the OSUMC 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. 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	Aim 2 - VidaTalk Intubated Usability testing preliminary to Clinical Trial. 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 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-	Nurse Focus Group - PreClinical Trial Phase ICU nurses were recruited to participate in qualitative focus group interviews regarding their impressions of the VidaTalk tablet app for use with mechanically ventilated patients, their experience (if any) of using the app, and general perspectives about communicating with mechanically ventilated ICU patients. We also elicited suggestions for app improvement. Group interviews were conducted by the PI in a hospital conference room away from patient care.	Aim 3 - VidaTalk Tablet App Test the clinical efficacy of VidaTalk with MV patients by examining qualitative \& 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. 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.	Aim 3 - Attention-control 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 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.	Nurse Focus Group - VidaTalk RCT ICU Nurses who had experience with using the VidaTalk tablet app with mechanically ventilated patients were recruited to participate in focus group interviews to obtain their perspectives and experience on using the application as well as suggestions for app improvement. Group interviews were conducted by the PI in a hospital conference room away from patient care.	Aim 5-VidaTalk Efficacy in Family Caregivers - VidaTalk Group 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. VidaTalk (Intervention) Group receives brief introduction, instruction sheet and completes ICU bedside visitation log with dates and times of visits.	Aim 5 Family Caregiver - Attention Control Usual care condition for family communication with mechanically ventilated patients. Family caregivers receive tablet instruction sheet (no VidaTalk app). Family caregivers were asked to enter dates and times of visits into ICU bedside visitation log.
Overall Study STARTED	13	23	7	31	32	7	18	16
Overall Study COMPLETED	11	15	7	23	26	5	7	9
Overall Study NOT COMPLETED	2	8	0	8	6	2	11	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Aim 1- VidaTalk Post-extubation Aim 1 is a two group iterative design preliminary to clinical trial. Group 1 \& 2 will each consist of five previously mechanically ventilated patients who will be recruited from the ICUs at the OSUMC 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. 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	Aim 2 - VidaTalk Intubated Usability testing preliminary to Clinical Trial. 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 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-	Aim 3 - VidaTalk Tablet App Test the clinical efficacy of VidaTalk with MV patients by examining qualitative \& 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. 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.	Aim 3 - Attention-control 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 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.	Nurse Focus Group - VidaTalk RCT ICU Nurses who had experience with using the VidaTalk tablet app with mechanically ventilated patients were recruited to participate in focus group interviews to obtain their perspectives and experience on using the application as well as suggestions for app improvement. Group interviews were conducted by the PI in a hospital conference room away from patient care.	Aim 5-VidaTalk Efficacy in Family Caregivers - VidaTalk Group 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. VidaTalk (Intervention) Group receives brief introduction, instruction sheet and completes ICU bedside visitation log with dates and times of visits.	Aim 5 Family Caregiver - Attention Control Usual care condition for family communication with mechanically ventilated patients. Family caregivers receive tablet instruction sheet (no VidaTalk app). Family caregivers were asked to enter dates and times of visits into ICU bedside visitation log.
Overall Study patient deterioration, fatigue	2	6	0	0	0	0	0
Overall Study Withdrawal by Subject	0	2	1	1	0	8	1
Overall Study Death	0	0	2	0	0	0	0
Overall Study extubation or early discharge	0	0	5	5	0	0	0
Overall Study Lost to Follow-up	0	0	0	0	2	3	6

Baseline Characteristics

number analyzed differs from overall due to missing data

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aim 1- VidaTalk Post-extubation n=13 Participants Preliminary to clinical trial. Grp1+ Grp2 will each consist of five previously mechanically ventilated patients recruited from the ICUs at the OSUWMC. Grp 1 will use an initial android prototype of VidaTalk tablet application assessed for functionality + usability on a series of scripted communication tasks. Grp 2 will use an improved alpha prototype of VidaTalk tablet application version engineered from observations made during Grp 1 sessions. Aim 1 - VidaTalk - post-extubation: Observation of task completion will be made while patients complete messages using the VidaTalk app: Tired, Pain - rating, location, quality, Ask for doctor, Finger writing, Keyboard phrase. Patients will also complete 1-item difficulty rating + 3-item After-Scenario Questionnaire after each task. Patients will rate the extent to which they would use the device if they were an ICU patient unable to speak. Grp 1 only: will be asked their preferences for customizing the app.	Aim 2 - VidaTalk Intubated n=23 Participants Usability testing preliminary to Clinical Trial. 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 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-	Aim 3 - VidaTalk Tablet App n=31 Participants Test the clinical efficacy of VidaTalk with MV patients by examining qualitative \& 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. 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.	Aim 3 - Attention-control n=32 Participants 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 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.	Aim 5-VidaTalk Efficacy in Family Caregivers- VidaTalk Group n=18 Participants 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.	Aim 5 Family Caregiver- Attention Control n=16 Participants Usual care condition for family communication with mechanically ventilated patients. Family caregivers receive tablet instruction sheet (no VidaTalk app). Family caregivers were asked to enter dates and times of visits into ICU bedside visitation log.	Total n=133 Participants Total of all reporting groups
Age, Continuous	55.92 years STANDARD_DEVIATION 15.4 • n=13 Participants	57.57 years STANDARD_DEVIATION 13.41 • n=23 Participants	52.1 years STANDARD_DEVIATION 13.7 • n=31 Participants	53.6 years STANDARD_DEVIATION 14.7 • n=32 Participants	48.94 years STANDARD_DEVIATION 15.84 • n=18 Participants	50.69 years STANDARD_DEVIATION 15.89 • n=16 Participants	52.9 years STANDARD_DEVIATION 14.1 • n=133 Participants
Sex: Female, Male Female	5 Participants n=13 Participants	9 Participants n=23 Participants	13 Participants n=31 Participants	12 Participants n=32 Participants	15 Participants n=18 Participants	15 Participants n=16 Participants	69 Participants n=133 Participants
Sex: Female, Male Male	8 Participants n=13 Participants	14 Participants n=23 Participants	18 Participants n=31 Participants	20 Participants n=32 Participants	3 Participants n=18 Participants	1 Participants n=16 Participants	64 Participants n=133 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=13 Participants	0 Participants n=23 Participants	0 Participants n=31 Participants	0 Participants n=32 Participants	0 Participants n=18 Participants	0 Participants n=16 Participants	0 Participants n=133 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=13 Participants	23 Participants n=23 Participants	31 Participants n=31 Participants	32 Participants n=32 Participants	18 Participants n=18 Participants	16 Participants n=16 Participants	133 Participants n=133 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=13 Participants	0 Participants n=23 Participants	0 Participants n=31 Participants	0 Participants n=32 Participants	0 Participants n=18 Participants	0 Participants n=16 Participants	0 Participants n=133 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=13 Participants	0 Participants n=23 Participants	0 Participants n=31 Participants	0 Participants n=32 Participants	0 Participants n=18 Participants	0 Participants n=16 Participants	0 Participants n=133 Participants
Race (NIH/OMB) Asian	0 Participants n=13 Participants	0 Participants n=23 Participants	0 Participants n=31 Participants	0 Participants n=32 Participants	1 Participants n=18 Participants	0 Participants n=16 Participants	1 Participants n=133 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants	0 Participants n=23 Participants	0 Participants n=31 Participants	0 Participants n=32 Participants	0 Participants n=18 Participants	0 Participants n=16 Participants	0 Participants n=133 Participants
Race (NIH/OMB) Black or African American	0 Participants n=13 Participants	2 Participants n=23 Participants	5 Participants n=31 Participants	4 Participants n=32 Participants	5 Participants n=18 Participants	3 Participants n=16 Participants	19 Participants n=133 Participants
Race (NIH/OMB) White	12 Participants n=13 Participants	20 Participants n=23 Participants	26 Participants n=31 Participants	28 Participants n=32 Participants	12 Participants n=18 Participants	13 Participants n=16 Participants	111 Participants n=133 Participants
Race (NIH/OMB) More than one race	1 Participants n=13 Participants	1 Participants n=23 Participants	0 Participants n=31 Participants	0 Participants n=32 Participants	0 Participants n=18 Participants	0 Participants n=16 Participants	2 Participants n=133 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=13 Participants	0 Participants n=23 Participants	0 Participants n=31 Participants	0 Participants n=32 Participants	0 Participants n=18 Participants	0 Participants n=16 Participants	0 Participants n=133 Participants
Education High school graduate or less	4 Participants n=11 Participants • number analyzed differs from overall due to missing data	12 Participants n=19 Participants • number analyzed differs from overall due to missing data	19 Participants n=31 Participants • number analyzed differs from overall due to missing data	13 Participants n=32 Participants • number analyzed differs from overall due to missing data	5 Participants n=18 Participants • number analyzed differs from overall due to missing data	5 Participants n=16 Participants • number analyzed differs from overall due to missing data	58 Participants n=127 Participants • number analyzed differs from overall due to missing data
Education Some college	7 Participants n=11 Participants • number analyzed differs from overall due to missing data	7 Participants n=19 Participants • number analyzed differs from overall due to missing data	12 Participants n=31 Participants • number analyzed differs from overall due to missing data	19 Participants n=32 Participants • number analyzed differs from overall due to missing data	13 Participants n=18 Participants • number analyzed differs from overall due to missing data	11 Participants n=16 Participants • number analyzed differs from overall due to missing data	69 Participants n=127 Participants • number analyzed differs from overall due to missing data
severity of illness	65.0 units on a scale STANDARD_DEVIATION 17.82 • n=11 Participants • not applicable to this arm Total analysis is limited to RCT Aim 3, n=63 patients. Pre-RCT data removed as not applicable.	72.8 units on a scale STANDARD_DEVIATION 26.55 • n=15 Participants • not applicable to this arm Total analysis is limited to RCT Aim 3, n=63 patients. Pre-RCT data removed as not applicable.	75.6 units on a scale STANDARD_DEVIATION 21.8 • n=31 Participants • not applicable to this arm Total analysis is limited to RCT Aim 3, n=63 patients. Pre-RCT data removed as not applicable.	77.0 units on a scale STANDARD_DEVIATION 27.2 • n=32 Participants • not applicable to this arm Total analysis is limited to RCT Aim 3, n=63 patients. Pre-RCT data removed as not applicable.	—	—	76.3 units on a scale STANDARD_DEVIATION 24.5 • n=89 Participants • not applicable to this arm Total analysis is limited to RCT Aim 3, n=63 patients. Pre-RCT data removed as not applicable.
Intubation Method oral intubation	—	8 Participants n=19 Participants • not applicable to extubated patients and family caregiver arm	15 Participants n=31 Participants • not applicable to extubated patients and family caregiver arm	16 Participants n=32 Participants • not applicable to extubated patients and family caregiver arm	—	—	39 Participants n=82 Participants • not applicable to extubated patients and family caregiver arm
Intubation Method tracheostomy	—	11 Participants n=19 Participants • not applicable to extubated patients and family caregiver arm	16 Participants n=31 Participants • not applicable to extubated patients and family caregiver arm	16 Participants n=32 Participants • not applicable to extubated patients and family caregiver arm	—	—	43 Participants n=82 Participants • not applicable to extubated patients and family caregiver arm
Physical Restraint	—	—	5 Participants n=31 Participants • Only measured for patients in the RCT, Aim 3	8 Participants n=32 Participants • Only measured for patients in the RCT, Aim 3	—	—	13 Participants n=63 Participants • Only measured for patients in the RCT, Aim 3
Patient Anxiety	—	—	5.9 units on a scale STANDARD_DEVIATION 3 • n=31 Participants • not assessed in preclinical group	6.4 units on a scale STANDARD_DEVIATION 3.1 • n=32 Participants • not assessed in preclinical group	—	—	6.2 units on a scale STANDARD_DEVIATION 3.0 • n=63 Participants • not assessed in preclinical group
Patient Communication Difficulty	3.8 units on a scale STANDARD_DEVIATION 0.63 • n=11 Participants • Patient measure only. Not applicable in Aim 5 Total mean calculation limited to RCT Aim 3 only, n=63 patients. Pre-RCT data removed as not applicable	3.33 units on a scale STANDARD_DEVIATION 0.84 • n=18 Participants • Patient measure only. Not applicable in Aim 5 Total mean calculation limited to RCT Aim 3 only, n=63 patients. Pre-RCT data removed as not applicable	3.1 units on a scale STANDARD_DEVIATION 1.2 • n=31 Participants • Patient measure only. Not applicable in Aim 5 Total mean calculation limited to RCT Aim 3 only, n=63 patients. Pre-RCT data removed as not applicable	3.4 units on a scale STANDARD_DEVIATION 0.9 • n=32 Participants • Patient measure only. Not applicable in Aim 5 Total mean calculation limited to RCT Aim 3 only, n=63 patients. Pre-RCT data removed as not applicable	—	—	3.3 units on a scale STANDARD_DEVIATION 1.1 • n=92 Participants • Patient measure only. Not applicable in Aim 5 Total mean calculation limited to RCT Aim 3 only, n=63 patients. Pre-RCT data removed as not applicable
Patient Frustration with Communication	3.6 units on a scale STANDARD_DEVIATION 1.26 • n=11 Participants • Data missing on dropouts in Aim 1 and 2. Patient measure only, not applicable to Aim 5 Total mean calculation limited to RCT Aim 3 only, n=63 patients. Pre-RCT data removed as not applicable	2.94 units on a scale STANDARD_DEVIATION 1.35 • n=18 Participants • Data missing on dropouts in Aim 1 and 2. Patient measure only, not applicable to Aim 5 Total mean calculation limited to RCT Aim 3 only, n=63 patients. Pre-RCT data removed as not applicable	3.4 units on a scale STANDARD_DEVIATION 1.0 • n=31 Participants • Data missing on dropouts in Aim 1 and 2. Patient measure only, not applicable to Aim 5 Total mean calculation limited to RCT Aim 3 only, n=63 patients. Pre-RCT data removed as not applicable	3.9 units on a scale STANDARD_DEVIATION 0.3 • n=32 Participants • Data missing on dropouts in Aim 1 and 2. Patient measure only, not applicable to Aim 5 Total mean calculation limited to RCT Aim 3 only, n=63 patients. Pre-RCT data removed as not applicable	—	—	3.6 units on a scale STANDARD_DEVIATION 0.7 • n=92 Participants • Data missing on dropouts in Aim 1 and 2. Patient measure only, not applicable to Aim 5 Total mean calculation limited to RCT Aim 3 only, n=63 patients. Pre-RCT data removed as not applicable
Family Caregiver Anxiety	—	—	—	—	9.22 units on a scale STANDARD_DEVIATION 5.02 • n=18 Participants • not assessed in patient samples, only Aim 5	9.25 units on a scale STANDARD_DEVIATION 4.49 • n=16 Participants • not assessed in patient samples, only Aim 5	9.24 units on a scale STANDARD_DEVIATION 4.71 • n=34 Participants • not assessed in patient samples, only Aim 5
Family Caregiver Depression	—	—	—	—	5.89 units on a scale STANDARD_DEVIATION 3.85 • n=18 Participants • HADS not assessed in patient samples, only Aim 5	5.25 units on a scale STANDARD_DEVIATION 4.17 • n=16 Participants • HADS not assessed in patient samples, only Aim 5	5.59 units on a scale STANDARD_DEVIATION 3.96 • n=34 Participants • HADS not assessed in patient samples, only Aim 5
Family Communication Survey	—	—	—	—	25.94 units on a scale STANDARD_DEVIATION 6.24 • n=18 Participants • Measure is for Family caregivers only, Aim 5	24.93 units on a scale STANDARD_DEVIATION 5.57 • n=16 Participants • Measure is for Family caregivers only, Aim 5	25.47 units on a scale STANDARD_DEVIATION 5.87 • n=34 Participants • Measure is for Family caregivers only, Aim 5

PRIMARY outcome

Timeframe: Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU

Population: This outcome is only for the clinical trial. Applies only to Aim 3 arms.

Aim 3 - Mean item score of daily by patient self report using a single item Likert-type scale from the Ease of Communication Scale (ECS) where scores range from 0 "not hard at all" to 4 "extremely hard"

Outcome measures

Outcome measures
Measure	Aim 1- VidaTalk Post-extubation Preliminary to clinical trial. Grp1+ Grp2 will each consist of five previously mechanically ventilated patients recruited from the ICUs at the OSUWMC. Grp 1 will use an initial android prototype of VidaTalk tablet application assessed for functionality + usability on a series of scripted communication tasks. Grp 2 will use an improved alpha prototype of VidaTalk tablet application version engineered from observations made during Grp 1 sessions. Aim 1 - VidaTalk - post-extubation: Observation of task completion will be made while patients complete messages using the VidaTalk app: Tired, Pain - rating, location, quality, Ask for doctor, Finger writing, Keyboard phrase. Patients will also complete 1-item difficulty rating + 3-item After-Scenario Questionnaire after each task. Patients will rate the extent to which they would use the device if they were an ICU patient unable to speak. Grp 1 only: will be asked their preferences for customizing the app.	Aim 2 - VidaTalk Intubated 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 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 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-	Aim 3 - VidaTalk Tablet App n=25 Participants 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 min) 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. 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.	Aim 3 - Attention-control n=25 Participants 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 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.	Aim 5-VidaTalk Efficacy in Family Caregivers 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.	Aim-5 Control Group Aim - 5 Control Group
Mean Daily Patient-reported Communication Difficulty Rating Using Single Item 0-4 Rating Scale	—	—	3.10 score on a scale Standard Deviation 1.98	3.28 score on a scale Standard Deviation 1.90	—	—

SECONDARY outcome

Timeframe: Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU

Population: This Secondary Outcome is for participants in Aim 3 only.

Aim 3 - Calculated mean of daily measure by patient mark (x) or point on the Visual Analogue Scale for anxiety, a 100 mm vertical line ranging from 0 ("not anxious at all") to 10 ("most anxious I've ever been").

Outcome measures

Outcome measures
Measure	Aim 1- VidaTalk Post-extubation Preliminary to clinical trial. Grp1+ Grp2 will each consist of five previously mechanically ventilated patients recruited from the ICUs at the OSUWMC. Grp 1 will use an initial android prototype of VidaTalk tablet application assessed for functionality + usability on a series of scripted communication tasks. Grp 2 will use an improved alpha prototype of VidaTalk tablet application version engineered from observations made during Grp 1 sessions. Aim 1 - VidaTalk - post-extubation: Observation of task completion will be made while patients complete messages using the VidaTalk app: Tired, Pain - rating, location, quality, Ask for doctor, Finger writing, Keyboard phrase. Patients will also complete 1-item difficulty rating + 3-item After-Scenario Questionnaire after each task. Patients will rate the extent to which they would use the device if they were an ICU patient unable to speak. Grp 1 only: will be asked their preferences for customizing the app.	Aim 2 - VidaTalk Intubated 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 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 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-	Aim 3 - VidaTalk Tablet App n=25 Participants 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 min) 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. 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.	Aim 3 - Attention-control n=25 Participants 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 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.	Aim 5-VidaTalk Efficacy in Family Caregivers 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.	Aim-5 Control Group Aim - 5 Control Group
Mean Patient Reported Anxiety Score Using Visual Analogue Scale	—	—	5.55 score on a scale Standard Deviation 6.54	6.02 score on a scale Standard Deviation 6.07	—	—

SECONDARY outcome

Timeframe: Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU

Population: This information is for Aim 3 only.

Aim 3 - This will be the calculated mean of the daily Communication Frustration scale - a single item scale reported by the patient, ranging from 0 "not frustrating" to 4 "extremely frustrating"

Outcome measures

Outcome measures
Measure	Aim 1- VidaTalk Post-extubation Preliminary to clinical trial. Grp1+ Grp2 will each consist of five previously mechanically ventilated patients recruited from the ICUs at the OSUWMC. Grp 1 will use an initial android prototype of VidaTalk tablet application assessed for functionality + usability on a series of scripted communication tasks. Grp 2 will use an improved alpha prototype of VidaTalk tablet application version engineered from observations made during Grp 1 sessions. Aim 1 - VidaTalk - post-extubation: Observation of task completion will be made while patients complete messages using the VidaTalk app: Tired, Pain - rating, location, quality, Ask for doctor, Finger writing, Keyboard phrase. Patients will also complete 1-item difficulty rating + 3-item After-Scenario Questionnaire after each task. Patients will rate the extent to which they would use the device if they were an ICU patient unable to speak. Grp 1 only: will be asked their preferences for customizing the app.	Aim 2 - VidaTalk Intubated 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 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 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-	Aim 3 - VidaTalk Tablet App n=25 Participants 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 min) 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. 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.	Aim 3 - Attention-control n=25 Participants 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 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.	Aim 5-VidaTalk Efficacy in Family Caregivers 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.	Aim-5 Control Group Aim - 5 Control Group
Mean Patient Frustration With Communication	—	—	3.14 units on a scale Standard Deviation 1.89	3.53 units on a scale Standard Deviation 0.17	—	—

SECONDARY outcome

Timeframe: Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU daily in ICU

Population: P-values were derived from mixed-effects regression using rank-based sedation exposure

Used in Aim 3 only. Calculation of benzodiazepine and morphine equivalents (for opiates) using hospital conversion charts (pharmacy conversion chart). All benzo IV doses were converted to Lorazepam IV doses. All opioid IV doses were converted to morphine IV doses. All benzo oral doses were converted to Lorazepam oral doses. All opioid oral doses were converted to morphine oral doses. Oral doses were converted to IV equivalents. Summed doses of Lorazepam IV and morphine IV were calculated for each study day for each patient. Doses were converted to milligrams per kilogram based on the patient's body weight. Higher numbers indicate greater sedation and/or opiate exposure.

Outcome measures

Outcome measures
Measure	Aim 1- VidaTalk Post-extubation Preliminary to clinical trial. Grp1+ Grp2 will each consist of five previously mechanically ventilated patients recruited from the ICUs at the OSUWMC. Grp 1 will use an initial android prototype of VidaTalk tablet application assessed for functionality + usability on a series of scripted communication tasks. Grp 2 will use an improved alpha prototype of VidaTalk tablet application version engineered from observations made during Grp 1 sessions. Aim 1 - VidaTalk - post-extubation: Observation of task completion will be made while patients complete messages using the VidaTalk app: Tired, Pain - rating, location, quality, Ask for doctor, Finger writing, Keyboard phrase. Patients will also complete 1-item difficulty rating + 3-item After-Scenario Questionnaire after each task. Patients will rate the extent to which they would use the device if they were an ICU patient unable to speak. Grp 1 only: will be asked their preferences for customizing the app.	Aim 2 - VidaTalk Intubated 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 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 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-	Aim 3 - VidaTalk Tablet App n=29 Participants 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 min) 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. 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.	Aim 3 - Attention-control n=27 Participants 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 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.	Aim 5-VidaTalk Efficacy in Family Caregivers 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.	Aim-5 Control Group Aim - 5 Control Group
Mean Daily Sedation Exposure Morphine (mg/kg)	—	—	.84 mg/kg Standard Deviation 2.10	.24 mg/kg Standard Deviation .50	—	—
Mean Daily Sedation Exposure Benzo (mg/kg)	—	—	.01 mg/kg Standard Deviation .05	.008 mg/kg Standard Deviation .02	—	—

SECONDARY outcome

Timeframe: measured at Extubation /ICU Discharge

Population: Extubated ICU patients

Ease of Communication Scale -10-item likert scale total score ranging from 0-40. Each item is 0-4 likert scale, total score is sum of all items with higher scores indicating greater communication difficulty.

Outcome measures

Outcome measures
Measure	Aim 1- VidaTalk Post-extubation Preliminary to clinical trial. Grp1+ Grp2 will each consist of five previously mechanically ventilated patients recruited from the ICUs at the OSUWMC. Grp 1 will use an initial android prototype of VidaTalk tablet application assessed for functionality + usability on a series of scripted communication tasks. Grp 2 will use an improved alpha prototype of VidaTalk tablet application version engineered from observations made during Grp 1 sessions. Aim 1 - VidaTalk - post-extubation: Observation of task completion will be made while patients complete messages using the VidaTalk app: Tired, Pain - rating, location, quality, Ask for doctor, Finger writing, Keyboard phrase. Patients will also complete 1-item difficulty rating + 3-item After-Scenario Questionnaire after each task. Patients will rate the extent to which they would use the device if they were an ICU patient unable to speak. Grp 1 only: will be asked their preferences for customizing the app.	Aim 2 - VidaTalk Intubated 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 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 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-	Aim 3 - VidaTalk Tablet App n=16 Participants 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 min) 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. 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.	Aim 3 - Attention-control n=26 Participants 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 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.	Aim 5-VidaTalk Efficacy in Family Caregivers 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.	Aim-5 Control Group Aim - 5 Control Group
Ease of Communication at Extubation /ICU Discharge	—	—	23.19 score on a scale Standard Deviation 11.31	27.23 score on a scale Standard Deviation 10.46	—	—

SECONDARY outcome

Timeframe: Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU

Population: Since this is a categorical measure, we compared percentage of patients with RASS in -1 to +1 (calm) range during study days.

The Richmond Agitation Sedation Scale, a 10-level observational rating of agitation-sedation motor activity ranging from +4 'combative' to -5 unresponsive, with 0 as calm. Since this is a categorical measure, we compared proportion of patients with RASS in -1 to +1 (calm) range during study days.

Outcome measures

Outcome measures
Measure	Aim 1- VidaTalk Post-extubation Preliminary to clinical trial. Grp1+ Grp2 will each consist of five previously mechanically ventilated patients recruited from the ICUs at the OSUWMC. Grp 1 will use an initial android prototype of VidaTalk tablet application assessed for functionality + usability on a series of scripted communication tasks. Grp 2 will use an improved alpha prototype of VidaTalk tablet application version engineered from observations made during Grp 1 sessions. Aim 1 - VidaTalk - post-extubation: Observation of task completion will be made while patients complete messages using the VidaTalk app: Tired, Pain - rating, location, quality, Ask for doctor, Finger writing, Keyboard phrase. Patients will also complete 1-item difficulty rating + 3-item After-Scenario Questionnaire after each task. Patients will rate the extent to which they would use the device if they were an ICU patient unable to speak. Grp 1 only: will be asked their preferences for customizing the app.	Aim 2 - VidaTalk Intubated 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 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 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-	Aim 3 - VidaTalk Tablet App n=27 Participants 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 min) 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. 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.	Aim 3 - Attention-control n=27 Participants 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 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.	Aim 5-VidaTalk Efficacy in Family Caregivers 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.	Aim-5 Control Group Aim - 5 Control Group
Percentage of Patients Scoring in the "Calm" Range During Study Days on Richmond Agitation Sedation Score	—	—	81.48 percentage of participants in calm range	77.78 percentage of participants in calm range	—	—

SECONDARY outcome

Timeframe: Daily, from enrollment to 28 days post-enrollment

Population: Calculated as % days with delirium/total ICU days.

Aim 3 -Delirium/coma-free days is defined as the number of days alive and free of delirium and coma during the 28-day study period. Delirium will be coded as present when a patient displays both features 1 and 2, and either 3 or 4 of the CAM-ICU (Confusion Assessment Method). Coma is defined as a RASS (Richmond Agitation-Sedation Scale ) assessment score of -4 or -5.

Outcome measures

Outcome measures
Measure	Aim 1- VidaTalk Post-extubation Preliminary to clinical trial. Grp1+ Grp2 will each consist of five previously mechanically ventilated patients recruited from the ICUs at the OSUWMC. Grp 1 will use an initial android prototype of VidaTalk tablet application assessed for functionality + usability on a series of scripted communication tasks. Grp 2 will use an improved alpha prototype of VidaTalk tablet application version engineered from observations made during Grp 1 sessions. Aim 1 - VidaTalk - post-extubation: Observation of task completion will be made while patients complete messages using the VidaTalk app: Tired, Pain - rating, location, quality, Ask for doctor, Finger writing, Keyboard phrase. Patients will also complete 1-item difficulty rating + 3-item After-Scenario Questionnaire after each task. Patients will rate the extent to which they would use the device if they were an ICU patient unable to speak. Grp 1 only: will be asked their preferences for customizing the app.	Aim 2 - VidaTalk Intubated 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 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 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-	Aim 3 - VidaTalk Tablet App n=27 Participants 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 min) 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. 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.	Aim 3 - Attention-control n=27 Participants 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 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.	Aim 5-VidaTalk Efficacy in Family Caregivers 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.	Aim-5 Control Group Aim - 5 Control Group
Delirium/Coma -Free Days	—	—	8.26 percent days with delirium/total ICU day	8.54 percent days with delirium/total ICU day	—	—

SECONDARY outcome

Timeframe: One 10 minute survey will be given at patient's ICU discharge or extubation

Population: Total score on the Family Satisfaction in the Intensive Care Unit Survey (FS-ICU) completed by designated family caregiver-support person.

(Aim3 )The Family Satisfaction with ICU Care (FS-ICU 24R) questionnaire overall satisfaction score is derived from questions 1 through 24 (26 items) and combines two subscale summary scores. The satisfaction with care summary score is derived from the questions numbered 1 through 14 (which consists of 16 questions because question 2 has parts a, b and c). The satisfaction with decision making summary score is derived from questions 15 through 24 (10 questions). All questions are coded as integers from 1 (worst) to 5 (best). Rescale the summary scores from 1 through 5 to 0 through 100 by subtracting 1 from the scores (so they can range from 0 to 4) and then multiplying each score by 25.

Outcome measures

Outcome measures
Measure	Aim 1- VidaTalk Post-extubation Preliminary to clinical trial. Grp1+ Grp2 will each consist of five previously mechanically ventilated patients recruited from the ICUs at the OSUWMC. Grp 1 will use an initial android prototype of VidaTalk tablet application assessed for functionality + usability on a series of scripted communication tasks. Grp 2 will use an improved alpha prototype of VidaTalk tablet application version engineered from observations made during Grp 1 sessions. Aim 1 - VidaTalk - post-extubation: Observation of task completion will be made while patients complete messages using the VidaTalk app: Tired, Pain - rating, location, quality, Ask for doctor, Finger writing, Keyboard phrase. Patients will also complete 1-item difficulty rating + 3-item After-Scenario Questionnaire after each task. Patients will rate the extent to which they would use the device if they were an ICU patient unable to speak. Grp 1 only: will be asked their preferences for customizing the app.	Aim 2 - VidaTalk Intubated 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 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 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-	Aim 3 - VidaTalk Tablet App n=8 Participants 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 min) 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. 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.	Aim 3 - Attention-control n=8 Participants 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 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.	Aim 5-VidaTalk Efficacy in Family Caregivers 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.	Aim-5 Control Group Aim - 5 Control Group
Family Satisfaction With Care in the Intensive Care Unit FS-ICU	—	—	81.8 score on a scale Standard Deviation 13.8	92.4 score on a scale Standard Deviation 7.2	—	—

Adverse Events

Additional Information

Mary Beth Happ, PhD, RN

The Ohio State University

Phone: 614-292-8336

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place