Vidatalk Communication Application: Usability, Acceptability and Efficacy Study

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

Time frame: 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.

Aims 1 & 2. The After-Scenario Questionnaire (ASQ) is a 3-item likert-type scale used to assess how difficult a user perceived a task in a usability test. Responses range from 1-strongly disagree to 7- strongly agree. Total score is the sum of the 3 items, possible scores range from 3 to 21. Higher scores indicated better outcomes. This was not measured for each task as that was too burdensome for intubated patients. We measured once as an overall rating at the end of the session- 3-item ASQ.

Time frame: Measured during 30-60 minute usability testing visit which occurs at study completion

Population: After Scenario Questionnaire is a 3-item patient rating of the usability of the VidaTalk communication application for each communication feature on ease, time, and support information

Aims 1 & 2 - count of the number of errors recorded by video screen capture for each of 8 communication tasks. Individual patients ranged from 0 to 9 errors, however this measure contains no upper range per task as it is a count of actual observed errors committed by patients.

Time frame: Measured during 30-60 minute usability testing visit which occurs at study completion. This outcome applies only to Aim 1 & 2 arms.

Population: Aim 1 extubated patients. Using group 1 and group 2 summary data, 11 patients completed 82 tasks (6 were abandoned, 5 of these by one patient). Removing abandonments.

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.

Time frame: Daily, from enrollment to 28 days post-enrollment

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

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.

Time frame: measured at Extubation /ICU Discharge

Population: Extubated ICU patients

(Aim4) visual analogue touch screen scale via android tablet with REDCap link. Not able to calculate because the touch screen scale was unreliable. Patients often needed assistance with the touch screen cursor for this experimental measure. We determined that pencil and paper analogue scale was superior for this patient population.

Time frame: Only measured at baseline, order of administration randomized before or after paper version

Population: Not able to calculate because the touch screen scale was unreliable. Patients often needed assistance with the touch screen cursor for this experimental measure. We determined that pencil and paper analogue scale was superior for this patient population.

Family Communication Survey administered to participant families. Sum of 9-items with each item rating 0 (not at all) to 4 (extremely difficult), resulting in a total summed score from 0 - 36. Higher scores indicate greater difficulty.

Time frame: baseline and extubation or discharge from the ICU

Population: Family Communication Survey baseline and extubation or discharge from the ICU

(Aim 5) Hospital Anxiety and Depression Scale (HADS) Anxiety sub scale including 7 items each scored from 0-3 with total scores ranging from 0 - 21 with higher scores indicating higher levels of anxiety.

Time frame: Baseline, patient extubation or discharge from ICU, 1-month, 3-month, 6-month post-discharge

Population: Baseline

(Aim 5). Hospital Anxiety and Depression Scale (HADS-D)- Depression Subscale including 7 items each scored from 0-3 with total scores ranging from 0 - 21 with higher scores indicating higher levels of depression symptoms.

Time frame: Baseline, patient extubation or discharge from ICU, 1-month, 3-month, 6-month post-discharge

Population: Aim 5 Family member depression HADS-D subscale

(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.

Time frame: 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.

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.

Time frame: 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

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

Time frame: 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 - 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).

Time frame: 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.

Measured as a single item : Question asked was - Presence of communication difficulty in the last few days? with answers being Yes or No

Time frame: measured at Extubation /ICU Discharge

Population: Extubated ICU patients

Aims 1 & 2 - This is the time, measured in seconds, on the screen capture recording beginning with the communication task command to patient completion of the communication task or message to patient completion of each of the 8 communication tasks on the usability test, calculated from the screen capture recordings

Time frame: Measured during 30-60 minute usability testing visit which occurs at study completion

Population: This is the time, measured in seconds, on the screen capture recording beginning with the communication task command to patient completion of the communication task or message to patient completion of each of the 8 communication tasks on the usability test, calculated from the screen capture recordings

A 24-item survey with lower scores indicating greater satisfaction with care.

Time frame: Measured at extubation or discharge from ICU which ever comes first

Population: Patient Satisfaction with Care at extubation /ICU discharge single item likert type scale 1 (very dissatisfied) to 5 (very satisfied)

Aims 1 & 2 - a single item from the After Scenario Questionnaire (ASQ) of patient's self rating of satisfaction with the ease of completing each of 8 communication tasks on the usability test. Question asked of patients was Overall, I am satisfied with the ease of completing this task. 1-strongly disagree 7-strongly agree. Higher scores indicated greater satisfaction with the ease of completing the task.

Time frame: Measured during 30-60 minute usability testing visit which occurs at study completion

Population: Aim 1 Extubated patients - mean Task Ease Rating Aim 2 Intubated patients - mean Task Ease Rating

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.

Time frame: 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.

(Aim 5) Impact of Events Scale-revised. The IES-R is a 22-item self-report instrument with three subscales including intrusion (8 items), avoidance (8 items), and hyperarousal (6 items). The respondent is asked to report the degree of distress experienced for each item in the past 7 days. Each item is scored on a five-point Likert scale (0, not at all; 1, rarely; 2, occasionally; 3, fairly often; and 4, often) and total scores range from 0 to 88. Higher scores are representative of greater distress.

Time frame: 1-month, 3-month, 6-month post-discharge

Population: Impact of events scale median/IQR

Aims 1 & 2, System Usability Scale is 13-item likert type scale with item ratings of 1 'strongly agree' to 7 'strongly disagree' to obtain the patient's rating of overall usability of the VidaTalk application, total scores range from 13 to 91 Note: This is different from the standard 10-item SUS that uses a 5-point scale, with scores ranging 0-100.

Time frame: Measured during 30-60 minute usability testing visit which occurs at study completion

Population: Note: This is different from the standard 10-item SUS that uses a 5-point scale, with scores ranging 0-100.~Aim 3 and 5 were not addressed with this question.

Aims 1 & 2 - calculated mean of the total number of errors recorded by video screen capture divided by the number of communication tasks completed (8 maximum) Aim 1 extubated patients. Using group 1 and group 2 summary data, 11 patients completed 82 tasks (6 were abandoned, 5 of these by one patient). Removing abandonments, total number of errors = 25/ 82 tasks = 0.30 error rate. Aim 2 intubated patients. 11 patients completed 69 tasks (18 were abandoned; 1 task was refused). Removing abandonments, total number of errors = 60/ 69 tasks = 0.87error rate.

Time frame: Measured during 30-60 minute usability testing visit which occurs at study completion

Population: Aim 1 extubated patients. Using group 1 and group 2 summary data, 11 patients completed 82 tasks (6 were abandoned, 5 of these by one patient).~Aim 2 intubated patients. 11 patients completed 69 tasks (18 were abandoned; 1 task was refused).