At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Improving Outcomes for Mechanically Ventilated Patients With the Digital EZ Board
In Brief
A clinical study evaluating Aim 1 - VidaTalk - post-extubation, Aim 2 - VidaTalk - intubated, and 2 other interventions for Nonverbal Communication and Critical Illness. Completed, enrolled 147 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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).
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.
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.