Telemedicine Optimized Burn Intervention

Study Overview
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Brief Summary
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Because burn patients and their caregivers often live long distances from regional burn centers, access to expert burn care is limited, resulting in a negative effect on adherence to treatment and a higher risk of wound complication. A novel smartphone application synchronized with a web portal for providers, called the Telemedicine Optimized Burn Intervention (TOBI), was recently developed to enable burn experts to direct burn wound care while the patient and caregiver are home through text messaging, image transfer, and video-conferencing. The goal of the present study is evaluate TOBI compared to face-to-face care as usual for pediatric patients/caregivers visiting a burn center. This study will also assess the feasibility of conducting a larger-scale clinical trial in several burn centers. The app will allow the physician and patient to make instant decisions regarding treatment, allowing for turn on a dime treatment decisions, rather than having the patients and families wait for scheduled clinic appointments, often hours away from home. This on demand medical care takes an innovative approach to increasing access to burn experts through smartphone technology and addressing adherence to prescribed treatment by increasing communication between provider and patients.

Official Title
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A Novel Telemedicine Optimized Burn Intervention (TOBI) for Pediatric Burn-injured Patients and Their Caregivers

Conditions
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Burns, Pediatric ALL

Intervention / Treatment
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* Procedure: Face-to-face burn care
* Procedure: Telemedicine enhanced burn care


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Participants will be eligible for enrollment if: the patient (child) is < 18 years of age; the patient is diagnosed with a partial thickness burn between <1% TBSA - 20% TBSA by a pediatric burn surgeon; the burn is being treated with advanced burn dressing therapy (e.g., Silvadene™, Polysporin™, Acticoat™, Mepilex™, or Mepitel™); the burn is evaluated by the MUSC burn team within 48 hours of injury; the patient's caregiver (parent or legal guardian) is able to speak, hear, and understand English, as determined during study recruitment procedures; the patient/caregiver owns and is capable of using a smart device (an Android or iOS smartphone) with permission to download TOBI app from the Google Store or AppStore; able to comply with outpatient clinic visits. Exclusion Criteria: There are no exclusion criteria. All participants who meet inclusion criteria would be eligible to participate in the study.

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Face-to-face arm<br>Standard face-to-face burn care. | Procedure: Face-to-face burn care<br>* If the participants are assigned to FTF care, they will receive standard burn care including a return follow-up in the burn clinic on a routine basis as prescribed by the clinical burn team (at least once per week) until the burn has healed.<br>|
| Experimental: TOBI arm<br>A novel smartphone application for burn wound care, called the Telemedicine Optimized Burn Intervention (TOBI), was recently developed to enable burn experts to direct burn wound care while the patient and caregiver are home through text messaging and video-conferencing. The app was designed to bring expert wound care directly to the patient's home to address barriers to healthcare, including high cost burden and time commitment (e.g., geographic limitations, transportation to burn centers, parking, lodging, meals, time away from school and work), particularly for patients/families in rural and medically underserved communities. TOBI is synced with a portal used by providers, as an adjunct to standard therapy. This burn app provides education through frequently asked questions, instructional burn dressing change videos in addition to direct communication between patient and burn expert through store-and-forward pictures and videoconferencing. | Procedure: Telemedicine enhanced burn care<br>* Participants assigned to TOBI will be given instructions how to download and use TOBI on a smartphone, including how to interface with burn clinicians using text-messaging, videoconferencing, and sending photos of the child's burn(s). The participants will have scheduled video visits with the care provider at least weekly until the burn has healed. The participants will be able to use other features of the app, such as text-messaging and sending photos of the burn(s), as needed. The participants will be able to use standard FTF burn care as well. They will be given instructions how to contact the burn team through the hospital paging operator if TOBI is unavailable or there is an emergency.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who agree to participate in the study | Looking at the number of participants who agree to enroll in the study versus the total number of participants who are approached to participate in the study | 24 months from the enrollment of the first participant or until the study number is reached | 
| Percentage of participants retained in the study over time | Looking at the percentage or ratio of participants retained in the study versus those lost to attrition | 24 months from the enrollment of the first participant or until the study number is reached | 
| TOBI treatment fidelity | Looking at the percentage of TOBI providers' adherence to the treatment protocol. Will use a fidelity checklist at each visit. | 24 months from the enrollment of the first participant or until the study number is reached | 
| Number of participants that experienced adverse events, serious adverse events, and unexpected problems | Looking at the number of participants in each condition that experienced AE, SEA, and UPs. | 24 months from the enrollment of the first participant or until the study number is reached | 
| Number of times problems with technology happened in the TOBI condition | Looking at the number of times providers or participants experienced technological problems with TOBI | 24 months from the enrollment of the first participant or until the study number is reached | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days until wound is healed | Looking at the number of days it takes for wound to heal following burn injury in both conditions | Measured during the treatment phase (2-4 weeks) | 
| Treatment adherence | Looking at the number of deviations from the prescribed treatment | Measured during the treatment phase (2-4 weeks) | 
| Number of unscheduled ED/clinic and video visits | Looking at the number of days participants had unscheduled visits | Measured during the treatment phase (2-4 weeks) | 
| Time to treatment of wound complication | Looking at the amount of time between a wound complication (e.g., infection, conversion to deeper burn requiring surgery, conversion to deeper burn requiring a change in therapy) until treatment is sought | Measured during the treatment phase (2-4 weeks) | 
| Patient-Reported Outcomes Measurement Information System - Sleep (PROMIS-Sleep) (4-item form) scores | Looking at average scores on the PROMIS-Sleep (4-item form) questionnaire (caregiver-reported) between the two conditions. Scores range from 4 to 20, with higher scores = greater sleep problems. | Measured during the treatment phase (2-4 weeks) | 
| Patient-reported pain scores | Looking at average pain scores between the two conditions using the Wong-Baker Scale (0-10, with higher scores = more pain) | Measured during the treatment phase (2-4 weeks) | 
| Caregiver's perception of child's pain scores | Looking at average pain scores between the two conditions using the caregivers' report (0-10 scale, with higher scores = more pain) | Measured during the treatment phase (2-4 weeks) | 
| Attitudes Towards Technology and Telemedicine Questionnaire | Looking at the change in group average scores on the Attitudes Towards Technology and Telemedicine Questionnaire (caregiver-reported) from baseline to 1 month follow-up. Scores may range between 26-130, with higher scores = more positive attitudes towards technology and telemedicine. | Measured at baseline and 1-month follow-up | 
| Perception of Healthcare Access | Looking at the change in group average scores on the Barriers to Care Questionnaire (BCQ), Pragmatics Subscale (caregiver-reported). Scores range from 0-100, with higher scores = fewer barriers and problems with access. | Measured at baseline and 1-month follow-up | 
| Positive And Negative Affect Schedule (PANAS) scores | Looking at the change in group average scores on the PANAS questionnaire measuring positive and negative affect (caregiver-reported). PANAS has two subscales - positive and negative affect. The scores on each subscale range between 10-50, with higher scores = higher levels of affect. | Measured at baseline and 1-month follow-up | 
| Patient-Reported Outcomes Measurement Information System - Depression (PROMIS-Depression) (4-item form) scores | Looking at the change in group average scores on the PROMIS-Depression (4-item form) questionnaire (caregiver-reported). Scores range between 4-20, with higher scores = more depression symptoms. | Measured at baseline and 1-month follow-up | 
| Patient-Reported Outcomes Measurement Information System - Anxiety (PROMIS-Anxiety) (4-item form) scores | Looking at the change in group average scores on the PROMIS-Anxiety (4-item form) questionnaire (caregiver-reported). Scores range between 4-20, with higher scores = more anxiety symptoms. | Measured at baseline and 1-month follow-up | 
| Patient-Reported Outcomes Measurement Information System - General Self-Efficacy (PROMIS-General-Self-Efficacy) (4-item form) scores | Looking at average scores on the PROMIS-General-Self-Efficacy (4-item form) questionnaire (caregiver-reported). Scores range between 4-20, with higher scores = greater general self-efficacy. | Measured at baseline only | 
| Patient-Reported Outcomes Measurement Information System - Self-Efficacy to Manage Emotions (PROMIS-Self-Efficacy-Manage-Emotions) (4-item form) scores | Looking at average scores on the PROMIS-Self-Efficacy-Manage-Emotions (4-item form) questionnaire (caregiver-reported). Scores range between 4-20, with higher scores = greater self-efficacy to manage emotions. | Measured at baseline only | 
| Peritraumatic Distress Inventory (PDI) sores | Looking at average scores on the Peritraumatic Distress Inventory (caregiver-reported). Scores range between 0-52, with higher scores = greater peritraumatic distress. An optimal cutoff score of 23 (sensitivity = 71%; specificity = 73%) is good for predicting clinically elevated PTSD 30-days post-injury. | Measured at baseline only | 
| Perceived Stress Scale (PSS) scores | Looking at average scores on the Perceived Stress Scale (caregiver-reported) between two conditions. Scores on the PSS can range from 0 to 40 with higher scores = higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. | Measured at 1-month follow-up only | 
| Posttraumatic Growth Inventory (PTGI) scores | Average scores on the Posttraumatic Growth Inventory (caregiver-reported). Scores range from 0-105, with higher scores = greater posttraumatic growth. | Measured at 1-month follow-up only | 
| Client Satisfaction Questionnaire-8 (CSQ-8) scores | Looking at average scores on the Client Satisfaction Questionnaire-8 scores (caregiver-reported). Scores range between 8-32, with higher scores = greater satisfaction. | Measured at 1-month follow-up only | 
| mHealth App Usability Questionnaire (MAUQ) Scores | Looking at average scores on the MAUQ questionnaire measuring app usability (caregiver-reported in TOBI condition only). Raw scores range between 21-147 and average scores range between 1-7, with higher overall average = higher usability of the app. | Measured at 1-month follow-up only | 
| Total number of face-to-face visits | Looking at the total number of face-to-face visits | 24 months from the enrollment of the first participant or until the study number is reached | 
| Total number of TOBI visits | Looking at the total number of TOBI visits | 24 months from the enrollment of the first participant or until the study number is reached | 
| Total travel time | Looking at the total travel time in each condition | 24 months from the enrollment of the first participant or until the study number is reached | 
| Direct cost to patient/caregiver | Looking at the direct cost to patient/caregiver | 24 months from the enrollment of the first participant or until the study number is reached | 
| Time to return to work/school | Looking at the average time it took patient/caregiver to return to school/work | 24 months from the enrollment of the first participant or until the study number is reached | 
| App metrics (TOBI condition only) | Looking at the TOBI app metrics (# of video-conferences, messages, & photos) | 24 months from the enrollment of the first participant or until the study number is reached | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatrics, Telemedicine, Mobile health, Burns