Home Management of Pediatric Buckle Fractures: Can Video Education Replace In-Person Visits?
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Patient-Reported Outcome Measurement Information System (PROMIS) Pediatric Short Form v2.0 - Physical Function Upper Extremity.
研究概览
简要总结
The goal of this clinical trial is to determine if a home management plan incorporating video education can effectively replace in-person visits for children aged 7-17 diagnosed with distal radius buckle fractures.
The main questions it aims to answer are:
Is a home management plan with video education non-inferior to in-person management for patient satisfaction? Is a home management plan superior to in-person management for reducing healthcare-related time, missed work/school, inappropriate care (e.g., rigid casting), and healthcare resource consumption? Researchers will compare the home management group to the in-person management group to see if video education can reduce healthcare costs and the burden on patients without compromising care quality.
Participants will:
Be randomized to either the in-person group or the video-based home management group.
Complete a pediatric PROMIS assessment at baseline and 6 weeks. Complete a satisfaction survey at the conclusion of the study.
详细描述
Pediatric buckle fractures of the wrist are extremely common. In the U.S., these are often referred to a pediatric orthopaedic specialist, despite evidence that specialty follow-up is unnecessary. These unnecessary visits add to healthcare costs, especially for patients living in rural areas who must travel long distances to see specialists. Our group has been successful with short video-based education in prior work. In this study, the investigators aim to reduce the burden of care for buckle fracture patients and their parents/guardians. Our objective is to determine whether a home management plan centered around video education can replace in-person visits. Here, the investigators propose a prospective, randomized controlled non-inferiority study to determine if a home management plan incorporating video education can replace in-person visits for pediatric buckle fractures. This study has the potential to reduce the burden on patients and families who may have to travel long distances and miss school/work. In addition, this method of treatment has the potential to reduce healthcare costs and increase access for other patients with higher acuity medical needs.
Our current objective is to determine whether a home management plan centered around video education can effectively replace in-person visits.
Hypothesis 1: A home management plan for pediatric buckle fractures incorporating video education is non-inferior to in-person management for patient satisfaction.
Hypothesis 2: A home management plan for pediatric buckle fractures incorporating video education is superior to in-person management for time spent on healthcare activities, missed time from work, missed time from school, rate of inappropriate care (rigid casting and follow-up x-ray), level of health care resource consumption as measured by provider time spent on delivering care.
The investigators plan to perform a prospective, randomized controlled non-inferiority study to examine the effectiveness of educational videos on validated patient-reported outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any incoming pediatric orthopaedic referral containing the phrase: "distal radius fracture" "wrist fracture" or "buckle fracture
- •A buckle fracture of the distal radius without opposite cortical break (an associated buckle fracture of the ulna is acceptable for inclusion)
- •Access to a smartphone, tablet, or computer
- •Access to internet to download or view videos
排除标准
- •Other fractures
- •Discontinuity of both cortices of the distal radius.
- •Metabolic bone disease
- •Developmental delay affecting assessment
- •Inability to utilize technology to view videos or follow instructions
- •Lack of internet or telephone access
- •Family/caregiver inability to speak or read English or Spanish
研究组 & 干预措施
In-person management
In-person group will be followed with standard-of-care clinic visits scheduled with an pediatric orthopaedic Surgeon at Carilion Clinic Institute for Orthopaedics and Neurosciences. Participants will complete a pediatric PROMIS assessment at baseline and 6 weeks for . Patients/guardians will complete a satisfaction survey.
Home management
Home-management group will be given access to an educational video explaining the nature of buckle fractures and treatment. all participants will enroll in MyChart to allow for asynchronous messages. Participants will complete a pediatric PROMIS assessment at baseline and 6 weeks. Patients/guardians will complete a satisfaction survey.
干预措施: Educational videos (Other)
结局指标
主要结局
Patient-Reported Outcome Measurement Information System (PROMIS) Pediatric Short Form v2.0 - Physical Function Upper Extremity.
时间窗: Baseline to 6 week follow-up
This pediatric PROMIS assessment will be filled out at baseline and 6 weeks. All responses will be recorded within the study's REDCap database. Responses for each question:
次要结局
- Parent Satisfaction Survey(Baseline to 6 week follow-up)
- Rigid Casting(Baseline to 6 week follow-up)
- Rate of follow-up X-rays(Baseline to 6 week follow-up)
- Provider time spent on delivering care(Baseline to 6 week follow-up)
研究者
Peter J Apel
Orthopedic Hand and Upper Extremity Surgeon
Carilion Clinic