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
- 2
- 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
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