A Novel Telemedicine Optimized Burn Intervention (TOBI) for Pediatric Burn-injured Patients and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Number of Participants Who Agree to Participate in the Study
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •There are no exclusion criteria. All participants who meet inclusion criteria would be eligible to participate in the study.
研究组 & 干预措施
Face-to-face arm
Standard face-to-face burn care.
干预措施: Face-to-face burn care (Procedure)
TOBI arm
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.
干预措施: Telemedicine enhanced burn care (Procedure)
结局指标
主要结局
Number of Participants Who Agree to Participate in the Study
时间窗: At enrollment
Looking at the number of participants (parents and children) who agree to enroll in the study at the time of burn injury versus the total number of participants who were approached to participate in the study.
Number of Participants Retained in the Study Over Time
时间窗: From enrollment to 30 days after burn wound has healed (up to 35 days after enrollment).
Looking at the number of participants retained in the study versus those lost to attrition
Wound Care Treatment Adherence
时间窗: Assessed weekly at clinic/telemedicine visit until burn wound was healed, up to 35 days after injury
Looking at the percentage of patient/caregiver dyads who adhered to prescribed burn wound care treatment protocol. A wound care fidelity checklist was used at each visit to determine the percentage of wound care adherence per visit. These percentages were then averaged for each weekly visit to give the value below.
Number of Child Participants That Experienced Adverse Events, Serious Adverse Events, and Unexpected Problems
时间窗: Assessed weekly until burn wound was healed, up to 35 days
Looking at the number of child participants in each condition that experienced adverse events, serious adverse events, and unexpected problems. Adverse events in this study included infection, delay in wound care or non-healing wound. Adult caregivers are not included in this as they did not have burn wounds that were assesssed.
Number of Times Problems With Technology Happened in the TOBI Condition
时间窗: Assessed weekly until burn wound was healed, up to 35 days
Looking at the number of times providers or participants experienced and reported technological problems with TOBI
次要结局
- Number of Unscheduled ED or Clinic Visits(Measured during the treatment phase (2-4 weeks))
- Number of Days Until Wound is Healed(Measured during the treatment phase (2-4 weeks))
- Number of Wound Complications(Measured during the treatment phase (2-4 weeks))
- Patient-reported Pain Scores(Measured during the treatment phase (week 1 clinic visit))
- Caregiver's Perception of Child's Pain Scores(Measured during the treatment phase (week 1 clinic visit))
- Perception of Healthcare Access(Measured at baseline and 1-month follow-up)
- Attitudes Towards Technology and Telemedicine Questionnaire(Measured at baseline and 1-month follow-up)
- Positive And Negative Affect Schedule (PANAS) Scores(Measured at baseline/enrollment and 1-month follow-up.)
- Patient-Reported Outcomes Measurement Information System - Depression (PROMIS-Depression) Scores(Measured at baseline and 1-month follow-up)
- Patient-Reported Outcomes Measurement Information System - Anxiety (PROMIS-Anxiety) Scores(Measured at baseline and 1-month follow-up)
- Total Number of Face-to-face Visits(Treatment phase (weeks 2-4))
- Total Number of TOBI Visits(Treatment phase (weeks 2-4))
- Total Travel Time(From enrollment through treatment phase (weeks 1-4))
- Direct Cost to Patient/Caregiver(From enrollment through treatment phase (weeks 1-4))
- Time to Return to Work(From enrollment through the treatment phase (weeks 1-4). This included any time that the parent had was out of work because of the injury at time of occurrence or due to clinic follow up.)
- Patient-Reported Outcomes Measurement Information System - General Self-Efficacy (PROMIS-General-Self-Efficacy) Scores(Measured at baseline only)
- Patient-Reported Outcomes Measurement Information System - Self-Efficacy to Manage Emotions (PROMIS-Self-Efficacy-Manage-Emotions) Scores(Measured at baseline only)
- Peritraumatic Distress Inventory (PDI) Sores(Measured at baseline only)
- Perceived Stress Scale (PSS) Scores(Measured at 1-month follow-up only)
- Posttraumatic Growth Inventory (PTGI) Scores(Measured at 1-month follow-up only)
- Client Satisfaction Questionnaire-8 (CSQ-8) Scores(Measured at 1-month follow-up only)
- mHealth App Usability Questionnaire (MAUQ) Scores(Measured at 1-month follow-up only)
- Attitudes Towards Technology and Telemedicine Questionnaire(Measured at baseline and 1-month follow-up)
- Perception of Healthcare Access(Measured at baseline and 1-month follow-up)
- mHealth App Usability Questionnaire (MAUQ) Scores(Measured at 1-month follow-up only)