Vidatalk Communication Application: Usability, Acceptability and Efficacy Study

NCT ID: NCT02921776

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-19
• Study Completion Date: 2019-06-11

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.

Conditions

Nonverbal Communication; Critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Aim 1- VidaTalk post-extubation

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.

Group Type: EXPERIMENTAL

Aim 1 - VidaTalk - post-extubation

Intervention Type: OTHER

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.

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 (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

Group Type: EXPERIMENTAL

Aim 2 - VidaTalk - intubated

Intervention Type: OTHER

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).

Aim 3 - VidaTalk tablet app

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.

Group Type: EXPERIMENTAL

Aim 3 - VidaTalk tablet app

Intervention Type: DEVICE

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.

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.

Group Type: OTHER

Aim 3 - attention-control with non-VidaTalk tablet

Intervention Type: OTHER

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 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.

Intervention Type: OTHER

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-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).

Intervention Type: OTHER

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 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 Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. ≥18 years old

2. Able to communicate in English

3. Awake alert, responding appropriately to commands.

4. Normal (aided or unaided) hearing and vision

5. Able to control head, arm and hand movements

6. Physiologically stable and in no acute distress (per nurse report)

1. ≥18 years old

2. Able to communicate in English

3. Awake alert, responding appropriately to commands.

4. Normal (aided or unaided) hearing and vision

5. Able to control head, arm and hand movements

6. Physiologically stable and in no acute distress (per nurse report)

7. Intubated via oral endotracheal or tracheal tube without speaking valve, receiving mechanical ventilation

1. ≥18 years old

2. Able to communicate in English

3. Awake alert, responding appropriately to commands.

4. Normal (aided or unaided) hearing and vision

5. Able to control head, arm and hand movements

6. Physiologically stable and in no acute distress (per nurse report)

7. Intubated via oral endotracheal or tracheal tube without speaking valve, received mechanical ventilation during past 48 hours

1. Family caregivers of patient participants enrolled in Aim 3 as identified by the patient or self

2. >/=18 years old

3. Able to read and speak English

4. Non-professional, unpaid caregiver

5. Plans to visit at least 3 days/ week during ICU stay

6. Reliable telephone access (for follow-up assessment)

Exclusion Criteria

1. Pre-existing communication impairments

2. Diagnosis of severe dementia or brain injury

3. CAM-ICU positive for delirium

4. unresponsiveness or inattention

Aim 2:

1. Pre-existing communication impairments

2. Diagnosis of severe dementia or brain injury

3. CAM-ICU positive for delirium

4. unresponsiveness or inattention

Aim 3:

1. Pre-existing communication impairments

2. Diagnosis of severe dementia or brain injury

3. CAM-ICU positive for delirium

4. unresponsiveness or inattention

Aim 5

1. Age under 18 years

2. Unable to read and speak English

3. Severe uncorrected hearing loss

4. Self-reported diagnosis of dementia or Alzheimer's

5. Self-reported psychiatric disorder (bipolar disorder, schizophrenia) or substance abuse requiring inpatient treatment within the last 12 months

6. Unreliable telephone access

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vidatak, LLC

INDUSTRY

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Mary Beth Happ

Associate Dean for Research and Innovation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Beth Happ, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Ohio State University Medical Center

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2016H0006

Identifier Type: -

Identifier Source: org_study_id