Telemedicine Optimized Burn Intervention (TOBI)

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Pediatric ALL; Burns

Treatments: Procedure: Face-to-face burn care; Procedure: Telemedicine enhanced burn care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05019144

Pro00109037

K23HD098328-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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/caregivers 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.

Enrollment: 130 patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Caregiver parents and their children (patients) will be considered as participants and will be eligible for enrollment if:

1. the patient (child) is < 18 years of age; caregiver age >18 years of age
2. the patient is diagnosed with a partial thickness burn between <1% TBSA - 20% TBSA by a pediatric burn surgeon;
3. the patient's burn is being treated with advanced burn dressing therapy (e.g., Silvadene™, Polysporin™, Acticoat™, Mepilex™, or Mepitel™);
4. the patient's burn is evaluated by the MUSC burn team within 48 hours of injury;
5. the patient's caregiver (parent or legal guardian) is able to speak, hear, and understand English, as determined during study recruitment procedures;
6. the 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;
7. 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups

Face-to-face arm

Active Comparator group

Description:

Standard face-to-face burn care.

Treatment:

Procedure: Face-to-face burn care

TOBI arm

Experimental group

Description:

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.

Treatment:

Procedure: Telemedicine enhanced burn care