Telemedicine Optimized Burn Intervention (TOBI)

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

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.

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.

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.

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.

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

Looking at the percentage or ratio of participants retained in the study versus those lost to attrition

Looking at the percentage of TOBI providers' adherence to the treatment protocol. Will use a fidelity checklist at each visit.

Number of participants that experienced adverse events, serious adverse events, and unexpected problems

Looking at the number of times providers or participants experienced technological problems with TOBI

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

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.

Looking at average pain scores between the two conditions using the Wong-Baker Scale (0-10, with higher scores = more pain)

Looking at average pain scores between the two conditions using the caregivers' report (0-10 scale, with higher scores = more pain)

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.

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.

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.

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.

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.

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.

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.

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.

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.

Average scores on the Posttraumatic Growth Inventory (caregiver-reported). Scores range from 0-105, with higher scores = greater posttraumatic growth.

Looking at average scores on the Client Satisfaction Questionnaire-8 scores (caregiver-reported). Scores range between 8-32, with higher scores = greater satisfaction.

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.

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.