N/A
N=147
Vidatalk Communication Application: Usability, Acceptability and Efficacy Study
Nonverbal Communication · Critical Illness
Bottom Line
View on ClinicalTrials.gov: NCT02921776 ↗Enrolled (actual)
147
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Mean Daily Patient-reported Communication Difficulty Rating Using Single Item 0-4 Rating Scale — 3.10; 3.28 score on a scale — p=0.45
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Aim 1 - VidaTalk - post-extubation (Other); Aim 2 - VidaTalk - intubated (Other); Aim 3 - VidaTalk tablet app (Device); Aim 3 - attention-control with non-VidaTalk tablet (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Daily Patient-reported Communication Difficulty Rating Using Single Item 0-4 Rating Scale |
3.10; 3.28 | 0.45 |
| SECONDARY Mean Patient Reported Anxiety Score Using Visual Analogue Scale |
5.55; 6.02 | 0.55 |
| SECONDARY Mean Patient Frustration With Communication |
3.14; 3.53 | 0.10 |
| SECONDARY Mean Daily Sedation Exposure |
.01; .008; .84; .24 | 0.02 sig |
| SECONDARY Ease of Communication at Extubation /ICU Discharge |
23.19; 27.23 | 0.38 |
| SECONDARY Percentage of Patients Scoring in the "Calm" Range During Study Days on Richmond Agitation Sedation Score |
81.48; 77.78 | 0.32 |
| SECONDARY Delirium/Coma -Free Days |
8.26; 8.54 | 0.93 |
| SECONDARY Family Satisfaction With Care in the Intensive Care Unit FS-ICU |
81.8; 92.4 | 0.07 |
| SECONDARY Electronic Visual Analogue Scale-validation Measure |
— | — |
| SECONDARY Patient Satisfaction With Care |
4.45; 4.56 | 0.71 |
| SECONDARY Family Member Anxiety |
9.14; 9.29; 8.67; 9.62; 4.86; 9.17 | 0.94 |
| SECONDARY Family Member Depression |
5.86; 5.50; 5.78; 5.15; 7.43; 6.20 | 0.82 |
| SECONDARY Post-traumatic Stress Symptoms: Impact of Events Scale-revised (IES-R) |
21.5; 30.5; 21; 27.5; 23; 26 | 0.26 |
| SECONDARY Family Communication Difficulty |
28.67; 25.62; 33.67; 29.46 | — |
| SECONDARY Communication Task Error Rate |
.45; 1.09; .09; 1.0; .273; 1.0 | — |
| SECONDARY Total Error Rate |
0.30; 0.87 | — |
| SECONDARY Patient Satisfaction With Communication Task Ease |
5.7; 6.7; 6.7; 6.7; 6.9; 5.8 | — |
| SECONDARY Observed Task Completion Time (in Seconds) |
64.27; 117.45; 16.73; 80.0; 26.6; 74.0 | — |
| SECONDARY After-Scenario Questionnaire (ASQ) Score |
18.2; 19.5; 20.3; 20.1; 20.7; 18.1 | — |
| SECONDARY System Usability Scale (SUS) -Adapted |
82.5; 68.5 | — |
| SECONDARY Number of Participants That Responded "Yes" to Having Communication Difficulty at Extubation or ICU Discharge |
0; 0; 14; 23; 0 | 0.05 |
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.
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
Data sourced from ClinicalTrials.gov (NCT02921776). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.