Telemedicine Optimized Burn Intervention
- Conditions
- BurnsPediatric ALL
- Interventions
- Procedure: Face-to-face burn careProcedure: Telemedicine enhanced burn care
- Registration Number
- NCT05019144
- Lead Sponsor
- Medical University of South Carolina
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
Not provided
- There are no exclusion criteria. All participants who meet inclusion criteria would be eligible to participate in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Face-to-face arm Face-to-face burn care Standard face-to-face burn care. TOBI arm Telemedicine enhanced burn care 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.
- Primary Outcome Measures
Name Time Method Number of times problems with technology happened in the TOBI condition 24 months from the enrollment of the first participant or until the study number is reached Looking at the number of times providers or participants experienced technological problems with TOBI
Number of participants who agree to participate in the study 24 months from the enrollment of the first participant or until the study number is reached 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
Number of participants that experienced adverse events, serious adverse events, and unexpected problems 24 months from the enrollment of the first participant or until the study number is reached Looking at the number of participants in each condition that experienced AE, SEA, and UPs.
Percentage of participants retained in the study over time 24 months from the enrollment of the first participant or until the study number is reached Looking at the percentage or ratio of participants retained in the study versus those lost to attrition
TOBI treatment fidelity 24 months from the enrollment of the first participant or until the study number is reached Looking at the percentage of TOBI providers' adherence to the treatment protocol. Will use a fidelity checklist at each visit.
- Secondary Outcome Measures
Name Time Method Treatment adherence Measured during the treatment phase (2-4 weeks) Looking at the number of deviations from the prescribed treatment
Patient-Reported Outcomes Measurement Information System - Sleep (PROMIS-Sleep) (4-item form) scores Measured during the treatment phase (2-4 weeks) 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.
Caregiver's perception of child's pain scores Measured during the treatment phase (2-4 weeks) Looking at average pain scores between the two conditions using the caregivers' report (0-10 scale, with higher scores = more pain)
Number of days until wound is healed Measured during the treatment phase (2-4 weeks) Looking at the number of days it takes for wound to heal following burn injury in both conditions
Number of unscheduled ED/clinic and video visits Measured during the treatment phase (2-4 weeks) Looking at the number of days participants had unscheduled visits
Patient-reported pain scores Measured during the treatment phase (2-4 weeks) Looking at average pain scores between the two conditions using the Wong-Baker Scale (0-10, with higher scores = more pain)
Perception of Healthcare Access Measured at baseline and 1-month follow-up 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.
Patient-Reported Outcomes Measurement Information System - Self-Efficacy to Manage Emotions (PROMIS-Self-Efficacy-Manage-Emotions) (4-item form) scores Measured at baseline only 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.
Perceived Stress Scale (PSS) scores Measured at 1-month follow-up only 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.
Time to treatment of wound complication Measured during the treatment phase (2-4 weeks) 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
Attitudes Towards Technology and Telemedicine Questionnaire Measured at baseline and 1-month follow-up 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.
Positive And Negative Affect Schedule (PANAS) scores Measured at baseline and 1-month follow-up 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.
Posttraumatic Growth Inventory (PTGI) scores Measured at 1-month follow-up only Average scores on the Posttraumatic Growth Inventory (caregiver-reported). Scores range from 0-105, with higher scores = greater posttraumatic growth.
Total number of face-to-face visits 24 months from the enrollment of the first participant or until the study number is reached Looking at the total number of face-to-face visits
Direct cost to patient/caregiver 24 months from the enrollment of the first participant or until the study number is reached Looking at the direct cost to patient/caregiver
Time to return to work/school 24 months from the enrollment of the first participant or until the study number is reached Looking at the average time it took patient/caregiver to return to school/work
Patient-Reported Outcomes Measurement Information System - Depression (PROMIS-Depression) (4-item form) scores Measured at baseline and 1-month follow-up 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 - General Self-Efficacy (PROMIS-General-Self-Efficacy) (4-item form) scores Measured at baseline only 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.
Client Satisfaction Questionnaire-8 (CSQ-8) scores Measured at 1-month follow-up only Looking at average scores on the Client Satisfaction Questionnaire-8 scores (caregiver-reported). Scores range between 8-32, with higher scores = greater satisfaction.
mHealth App Usability Questionnaire (MAUQ) Scores Measured at 1-month follow-up only 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.
App metrics (TOBI condition only) 24 months from the enrollment of the first participant or until the study number is reached Looking at the TOBI app metrics (# of video-conferences, messages, \& photos)
Patient-Reported Outcomes Measurement Information System - Anxiety (PROMIS-Anxiety) (4-item form) scores Measured at baseline and 1-month follow-up 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.
Peritraumatic Distress Inventory (PDI) sores Measured at baseline only 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.
Total number of TOBI visits 24 months from the enrollment of the first participant or until the study number is reached Looking at the total number of TOBI visits
Total travel time 24 months from the enrollment of the first participant or until the study number is reached Looking at the total travel time in each condition
Trial Locations
- Locations (1)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States