Vidatalk Communication Application: Usability, Acceptability and Efficacy Study

Study Overview
=================
Brief Summary
-----------------
This Phase II Small Business Technology Transfer Research (STTR) will deliver a comprehensive patient communication solution for communication-impaired patients in the intensive care unit 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, 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. This study will use mixed methods including observations and interaction with hospitalized patients as they use the VidaTalk tool, surveys and medical record data extraction, product evaluation and brief interview, satisfaction surveys with family members of ICU patients, and focus groups with Registered Nurses. Specific Aim 1. 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. 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 significant reductions in patient-reported communication difficulty and frustration, anxiety, sedation exposure, delirium/coma-free days, and improved patient and family satisfaction with ICU care compared to MV patients receiving attention-control (i.e., tablets with health education application). Specific Aim 4. Validation of electronic visual analogue scale, versus current standard paper scale. Specific Aim 5 a, b and c. Test the effect of the communication tablet (VidaTalk) on psychological symptoms in family caregivers.

Detailed Description
-----------------
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.

Official Title
-----------------
Improving Outcomes for Mechanically Ventilated Patients With the Digital EZ Board

Conditions
-----------------
Nonverbal Communication, Critical Illness

Intervention / Treatment
-----------------
* Other: Aim 1 - VidaTalk - post-extubation
* Other: Aim 2 - VidaTalk - intubated
* Device: Aim 3 - VidaTalk tablet app
* Other: Aim 3 - attention-control with non-VidaTalk tablet


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aim 1- VidaTalk post-extubation<br>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. | Other: Aim 1 - VidaTalk - post-extubation<br>* Observation of task completion will be made while patients complete a series of messages using the VidaTalk app: Tell me you are tired Tell me you are having pain Rate this pain Tell me there is pain in your back Tell me your pain is sharp Ask to see the doctor Write your favorite color by drawing with your finger Type How are you? Patients will also complete a 1-item difficulty rating and a 3-item After-Scenario Questionnaire (ASQ) after each task. Patients will also be asked to (a) comment on the customization of the app and make suggestions; (b) rate the extent to which they would use the device if they were an ICU patient and unable to speak. Group 1 only: Patients will be asked about their preferences for customizing the VidaTalk app.<br>|
| Experimental: Aim 2 - VidaTalk intubated<br>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 | Other: Aim 2 - VidaTalk - intubated<br>* Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Data will be collected by a trained data collector as in Aim 1 with the addition of Ease of Communication and Frustration ratings before and after the testing sequence. To reduce burden, patients in this group will complete the 3-item ASQ one time after all tasks are completed. They will also complete a 13-item System Usability Scale (SUS).<br>|
| Experimental: Aim 3 - VidaTalk tablet app<br>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. | Device: Aim 3 - VidaTalk tablet app<br>* Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 minutes) each day to check user needs and concerns and will review or retrain on message options if needed.<br>|
| Other: Aim 3 - attention-control<br>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. | Other: Aim 3 - attention-control with non-VidaTalk tablet<br>* 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.<br>|
| No Intervention: Aim 5-VidaTalk Efficacy in Family caregivers<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Daily Patient-reported Communication Difficulty Rating Using Single Item 0-4 Rating Scale | 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 | Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Patient Reported Anxiety Score Using Visual Analogue Scale | 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). | Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU | 
| Mean Patient Frustration With Communication | 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 | Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU | 
| Mean Daily 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. | Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU daily in ICU | 
| Ease of Communication at Extubation /ICU Discharge | 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. | measured at Extubation /ICU Discharge | 
| Percentage of Patients Scoring in the Calm Range During Study Days on Richmond Agitation Sedation Score | 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. | Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU | 
| Delirium/Coma -Free 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. | Daily, from enrollment to 28 days post-enrollment | 
| Family Satisfaction With Care in the Intensive Care Unit FS-ICU | (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. | One 10 minute survey will be given at patient's ICU discharge or extubation | 
| Electronic Visual Analogue Scale-validation Measure | (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. | Only measured at baseline, order of administration randomized before or after paper version | 
| Patient Satisfaction With Care | A 24-item survey with lower scores indicating greater satisfaction with care. | Measured at extubation or discharge from ICU which ever comes first | 
| Family Member Anxiety | (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. | Baseline, patient extubation or discharge from ICU, 1-month, 3-month, 6-month post-discharge | 
| Family Member Depression | (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. | Baseline, patient extubation or discharge from ICU, 1-month, 3-month, 6-month post-discharge | 
| Post-traumatic Stress Symptoms: Impact of Events Scale-revised (IES-R) | (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. | 1-month, 3-month, 6-month post-discharge | 
| Family Communication Difficulty | 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. | baseline and extubation or discharge from the ICU | 
| Communication Task Error Rate | 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. | Measured during 30-60 minute usability testing visit which occurs at study completion. This outcome applies only to Aim 1 & 2 arms. | 
| Total Error Rate | 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. | Measured during 30-60 minute usability testing visit which occurs at study completion | 
| Patient Satisfaction With Communication Task Ease | 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. | Measured during 30-60 minute usability testing visit which occurs at study completion | 
| Observed Task Completion Time (in Seconds) | 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 | Measured during 30-60 minute usability testing visit which occurs at study completion | 
| After-Scenario Questionnaire (ASQ) Score | 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. | Measured during 30-60 minute usability testing visit which occurs at study completion | 
| System Usability Scale (SUS) -Adapted | 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. | Measured during 30-60 minute usability testing visit which occurs at study completion | 
| Number of Participants That Responded Yes to Having Communication Difficulty at Extubation or ICU Discharge | Measured as a single item : Question asked was - Presence of communication difficulty in the last few days? with answers being Yes or No | measured at Extubation /ICU Discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vidatalk, App, Augmentative and Alternative Communication, iPad, Android, Mechanical ventilation, Patient Communication, Critical Illness