Home Management of Pediatric Buckle Fractures (HM-PBF)

October 7, 2024 updated by: Peter J Apel, Carilion Clinic

Home Management of Pediatric Buckle Fractures: Can Video Education Replace In-Person Visits?

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Carilion Clinic Orthopaedic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
Other: Educational videos
Internet will be used to deliver educational videos to subjects enrolled in the home management arm of the study which will be available on the Carilion Clinic Orthopaedic Education YouTube Channel. This will consist of a prerecorded video made by the three pediatric orthopaedic surgeons on this study explaining the nature of buckle fractures and treatment. Participants will be sent a link to the video over email (an example of a similar video in clinical use at Carilion Orthopaedics and the script of the video can be found in the study document attached).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Reported Outcome Measurement Information System (PROMIS) Pediatric Short Form v2.0 - Physical Function Upper Extremity.
Time Frame: 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:
Baseline to 6 week follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent Satisfaction Survey
Time Frame: Baseline to 6 week follow-up

4 Questions:

A survey will be sent to the parents/guardians to obtain the following information:

1) Satisfaction with their care, measures on a 5-point Likert scale:

  • Participants will select: Strongly Disagree, Disagree, Neither Agree or Disagree, Agree, or Strongly Agree 2) Time spent on healthcare activities
  • Recorded in minutes 3) Time missed from work
  • Recorded in minutes 4) Time missed time from school.
  • Recorded in minutes
Baseline to 6 week follow-up
Rigid Casting
Time Frame: Baseline to 6 week follow-up

Electronic medical record chart review will be performed to determine:

Rate of rigid casting

- Yes or No
Baseline to 6 week follow-up
Rate of follow-up X-rays
Time Frame: Baseline to 6 week follow-up
Electronic medical record chart review will be performed to determine: Number of x-rays ordered during follow-up care
Baseline to 6 week follow-up
Provider time spent on delivering care
Time Frame: Baseline to 6 week follow-up
Electronic medical record chart review will be performed to determine: Number of follow-up visits (minutes per session)
Baseline to 6 week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carilion Clinic

Collaborators

Virginia Polytechnic Institute and State University

Investigators

  • Principal Investigator: Peter J Apel, MD, PhD, Carilion Clinic Orthopaedic Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

October 4, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Estimated)

October 9, 2024

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-1491

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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