Educational Videos for Broken Bones

(HM-PBF Trial)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Carilion Clinic

Disqualifiers: Other fractures, Metabolic bone disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

46 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Peter J Apel, MD, PhD

Principal Investigator

Carilion Clinic Orthopaedic Surgery

Eligibility Criteria

This trial is for children aged 7-17 with distal radius buckle fractures. It's designed to see if managing their treatment at home with educational videos is as good as in-person care. Kids must be able to follow the video instructions and have a caregiver who can help them.

Inclusion Criteria

I have a specific type of wrist fracture without a break on the opposite side.

My child has a broken wrist or forearm.

Access to internet to download or view videos

Exclusion Criteria

Family/caregiver inability to speak or read English or Spanish

I have a metabolic bone disease.

Inability to utilize technology to view videos or follow instructions

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Randomization

Participants are randomized to either the in-person management group or the video-based home management group

1 day

Treatment

Participants receive either in-person management or video-based home management for buckle fractures

6 weeks

In-person group: multiple visits; Home management group: video education

Follow-up

Participants are monitored for safety and effectiveness after treatment, including completion of a satisfaction survey and PROMIS assessment

6 weeks

Asynchronous communication via MyChart

Treatment Details

Interventions

• Home Management with Video Education

Trial Overview Researchers are testing whether a home management plan using educational videos for kids' broken bones is just as satisfying for patients and more efficient than visiting doctors. They're checking if it saves time, reduces missed school or work, prevents unnecessary treatments, and cuts healthcare costs.

Participant Groups

Group I: Home management Experimental Treatment 1 Intervention

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.

Group II: In-person management Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Carilion Clinic

Lead Sponsor

Trials

85

Recruited

15,400+

Virginia Polytechnic Institute and State University

Collaborator

Trials

162

Recruited

26,900+