Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633094
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
Home Management of Pediatric Buckle Fractures
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Home Management of Pediatric Buckle Fractures Can Video Education Replace In-Person Visits
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HM-PBF
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 workschool inappropriate care eg 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
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 workschool inappropriate care eg 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 US 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 parentsguardians 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 schoolwork 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 CoordinatorClinical Research Assistant Parentguardians 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 Patientsguardians will complete a satisfaction survey
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 CoordinatorClinical Research Assistant Parentguardians 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 Patientsguardians will complete a satisfaction survey
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None