Clinical trial NCT06633094: Home Management of Pediatric Buckle Fractures
Official title: Home Management of Pediatric Buckle Fractures: Can Video Education Replace In-Person Visits?
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Buckle Fracture
Patient Satisfaction
Keywords: Pediatric orthopedics
Distal radius fractures
Pediatric fractures
Fracture management
Patient education
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
Collaborators: name: Virginia Polytechnic Institute and State University
First posted: 2024-10-09
Enrollment: 46
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Our study population will be composed of children who are diagnosed with a distal radius buckle fracture at Carilion Clinic. Subjects will be randomized to one of two groups: in-person management or home management through video education.

Incoming pediatric referrals containing the phrase: "distal radius fracture" "wrist fracture" or "buckle fracture" will be flagged and the x-rays will be reviewed within 4 business hours by one of the three pediatric orthopaedic surgeons on this study. If the fracture pattern meets inclusion criteria, the family will be offered the opportunity to enroll by the Clinical Research Coordinator/Clinical Research Assistant. Parent/guardians will acknowledge consent by secure electronic signature on REDCap. Children 7-17 years of age will be asked to assent.

Those randomized to the in-person group will meet with an Orthopaedic Surgeon at Carilion Clinic Institute for Orthopaedics and Neurosciences. the 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 from both groups will complete a pediatric PROMIS assessment at baseline and 6 weeks. Patients/guardians will complete a satisfaction survey.

Eligibility criteria: Inclusion Criteria:

* 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)
* Age 5-17
* Access to a smartphone, tablet, or computer
* Access to internet to download or view videos

Exclusion Criteria:

* 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

Primary outcomes:
measure: Patient-Reported Outcome Measurement Information System (PROMIS) Pediatric Short Form v2.0 - Physical Function Upper Extremity.
timeFrame: Baseline to 6 week follow-up
Secondary outcomes:
measure: Parent Satisfaction Survey
timeFrame: Baseline to 6 week follow-up
measure: Rigid Casting
timeFrame: Baseline to 6 week follow-up
measure: Rate of follow-up X-rays
timeFrame: Baseline to 6 week follow-up
measure: Provider time spent on delivering care
timeFrame: Baseline to 6 week follow-up
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Carilion Clinic Orthopaedic Surgery
state: Virginia
Study officials:
affiliation: Carilion Clinic Orthopaedic Surgery
name: Peter J Apel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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