Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
46 participants
INTERVENTIONAL
2022-06-01
2024-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
No interventions assigned to this group
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.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
5 Years
17 Years
ALL
Yes
Sponsors
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Virginia Polytechnic Institute and State University
OTHER
Carilion Clinic
OTHER
Responsible Party
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Peter J Apel
Orthopedic Hand and Upper Extremity Surgeon
Principal Investigators
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Peter J Apel, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Carilion Clinic Orthopaedic Surgery
Locations
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Carilion Clinic Orthopaedic Surgery
Roanoke, Virginia, United States
Countries
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References
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Landin LA. Epidemiology of children's fractures. J Pediatr Orthop B. 1997 Apr;6(2):79-83. doi: 10.1097/01202412-199704000-00002.
Bae DS, Howard AW. Distal radius fractures: what is the evidence? J Pediatr Orthop. 2012 Sep;32 Suppl 2:S128-30. doi: 10.1097/BPO.0b013e31824b2545.
Baig MN, Egan C. Improving Management of Paediatric Buckle Fracture in Orthopaedic Outpatients: A Completed Audit Loop. Cureus. 2017 Nov 8;9(11):e1829. doi: 10.7759/cureus.1829.
Koelink E, Boutis K. Paediatrician office follow-up of common minor fractures. Paediatr Child Health. 2014 Oct;19(8):407-12. doi: 10.1093/pch/19.8.407.
Symons S, Rowsell M, Bhowal B, Dias JJ. Hospital versus home management of children with buckle fractures of the distal radius. A prospective, randomised trial. J Bone Joint Surg Br. 2001 May;83(4):556-60. doi: 10.1302/0301-620x.83b4.11211.
Firmin F, Crouch R. Splinting versus casting of "torus" fractures to the distal radius in the paediatric patient presenting at the emergency department (ED): a literature review. Int Emerg Nurs. 2009 Jul;17(3):173-8. doi: 10.1016/j.ienj.2009.03.006. Epub 2009 May 7.
Boutis K. Common pediatric fractures treated with minimal intervention. Pediatr Emerg Care. 2010 Feb;26(2):152-7; quiz 158-62. doi: 10.1097/PEC.0b013e3181ce310c.
Koelink E, Schuh S, Howard A, Stimec J, Barra L, Boutis K. Primary Care Physician Follow-up of Distal Radius Buckle Fractures. Pediatrics. 2016 Jan;137(1). doi: 10.1542/peds.2015-2262. Epub 2015 Dec 10.
Plint AC, Perry JJ, Correll R, Gaboury I, Lawton L. A randomized, controlled trial of removable splinting versus casting for wrist buckle fractures in children. Pediatrics. 2006 Mar;117(3):691-7. doi: 10.1542/peds.2005-0801.
Davidson JS, Brown DJ, Barnes SN, Bruce CE. Simple treatment for torus fractures of the distal radius. J Bone Joint Surg Br. 2001 Nov;83(8):1173-5. doi: 10.1302/0301-620x.83b8.11451.
Williams BA, Palumbo NE, Phillips SA, Blakemore LC. What They Want - Caregiver and Patient Immobilization Preferences for Pediatric Buckle Fractures of the Wrist. Iowa Orthop J. 2020;40(1):83-90.
Heikkinen K, Helena LK, Taina N, Anne K, Sanna S. A comparison of two educational interventions for the cognitive empowerment of ambulatory orthopaedic surgery patients. Patient Educ Couns. 2008 Nov;73(2):272-9. doi: 10.1016/j.pec.2008.06.015.
Wright JE, Brown RR, Chadwick C, Karadaglis D. The use of the Internet by orthopaedic outpatients. J Bone Joint Surg Br. 2001 Nov;83(8):1096-7. doi: 10.1302/0301-620x.83b8.12390. No abstract available.
Yi PH, Ganta A, Hussein KI, Frank RM, Jawa A. Readability of arthroscopy-related patient education materials from the American Academy of Orthopaedic Surgeons and Arthroscopy Association of North America Web sites. Arthroscopy. 2013 Jun;29(6):1108-12. doi: 10.1016/j.arthro.2013.03.003.
Cotugna N, Vickery CE, Carpenter-Haefele KM. Evaluation of literacy level of patient education pages in health-related journals. J Community Health. 2005 Jun;30(3):213-9. doi: 10.1007/s10900-004-1959-x.
Bini SA, Schilling PL, Patel SP, Kalore NV, Ast MP, Maratt JD, Schuett DJ, Lawrie CM, Chung CC, Steele GD. Digital Orthopaedics: A Glimpse Into the Future in the Midst of a Pandemic. J Arthroplasty. 2020 Jul;35(7S):S68-S73. doi: 10.1016/j.arth.2020.04.048. Epub 2020 Apr 22.
Colaco K, Willan A, Stimec J, Barra L, Davis A, Howard A, Boutis K. Home Management Versus Primary Care Physician Follow-up of Patients With Distal Radius Buckle Fractures: A Randomized Controlled Trial. Ann Emerg Med. 2021 Feb;77(2):163-173. doi: 10.1016/j.annemergmed.2020.07.039. Epub 2020 Oct 21.
Other Identifiers
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21-1491
Identifier Type: -
Identifier Source: org_study_id
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