Clinical trial NCT02921776: Vidatalk Communication Application: Usability, Acceptability and Efficacy Study
Official title: Improving Outcomes for Mechanically Ventilated Patients With the Digital EZ Board
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonverbal Communication
Critical Illness
Keywords: Vidatalk
App
Augmentative and Alternative Communication
iPad
Android
Mechanical ventilation
Patient Communication
Critical Illness
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Vidatak, LLC
First posted: 2016-10-03
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Aim 1:

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)

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:

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

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 3:

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

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 5

Inclusion Criteria:

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. 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

Primary outcomes:
measure: Mean Daily Patient-reported Communication Difficulty Rating Using Single Item 0-4 Rating Scale
timeFrame: Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU
Secondary outcomes:
measure: Mean Patient Reported Anxiety Score Using Visual Analogue Scale
timeFrame: Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU
measure: Mean Patient Frustration With Communication
timeFrame: Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU
measure: Mean Daily Sedation Exposure
timeFrame: Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU daily in ICU
measure: Ease of Communication at Extubation /ICU Discharge
timeFrame: measured at Extubation /ICU Discharge
measure: Percentage of Patients Scoring in the "Calm" Range During Study Days on Richmond Agitation Sedation Score
timeFrame: Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU
measure: Delirium/Coma -Free Days
timeFrame: Daily, from enrollment to 28 days post-enrollment
measure: Family Satisfaction With Care in the Intensive Care Unit FS-ICU
timeFrame: One 10 minute survey will be given at patient's ICU discharge or extubation
measure: Electronic Visual Analogue Scale-validation Measure
timeFrame: Only measured at baseline, order of administration randomized before or after paper version
measure: Patient Satisfaction With Care
timeFrame: Measured at extubation or discharge from ICU which ever comes first
measure: Family Member Anxiety
timeFrame: Baseline, patient extubation or discharge from ICU, 1-month, 3-month, 6-month post-discharge
measure: Family Member Depression
timeFrame: Baseline, patient extubation or discharge from ICU, 1-month, 3-month, 6-month post-discharge
measure: Post-traumatic Stress Symptoms: Impact of Events Scale-revised (IES-R)
timeFrame: 1-month, 3-month, 6-month post-discharge
measure: Family Communication Difficulty
timeFrame: baseline and extubation or discharge from the ICU
measure: Communication Task Error Rate
timeFrame: Measured during 30-60 minute usability testing visit which occurs at study completion. This outcome applies only to Aim 1 & 2 arms.
measure: Total Error Rate
timeFrame: Measured during 30-60 minute usability testing visit which occurs at study completion
measure: Patient Satisfaction With Communication Task Ease
timeFrame: Measured during 30-60 minute usability testing visit which occurs at study completion
measure: Observed Task Completion Time (in Seconds)
timeFrame: Measured during 30-60 minute usability testing visit which occurs at study completion
measure: After-Scenario Questionnaire (ASQ) Score
timeFrame: Measured during 30-60 minute usability testing visit which occurs at study completion
measure: System Usability Scale (SUS) -Adapted
timeFrame: Measured during 30-60 minute usability testing visit which occurs at study completion
measure: Number of Participants That Responded "Yes" to Having Communication Difficulty at Extubation or ICU Discharge
timeFrame: measured at Extubation /ICU Discharge
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Mary Beth Happ, PhD
role: PRINCIPAL_INVESTIGATOR
References: