Distal Radius Buckle Fracture RCT

Influence of Cost Information on Cast vs. Splint Decision-Making After Pediatric Buckle Fractures: A Randomized Controlled Trial

This study evaluates the influence of cost information on decision-making for immobilization for treatment of distal radial buckle fractures. Half of the participants will receive cost information from an orthopaedic surgeon prior to making their decision for treatment, while the other half will receive cost information from another member of the study team after they had made their decision treatment.

Study Overview

• Status: Completed
• Conditions: Distal Radius Fracture
• Intervention / Treatment: Other: Monetary Cost of Immobilization Treatments; Other: Physician; Other: Before Initial Treatment Decision; Other: Study Team; Other: After Initial Treatment Decision

Detailed Description

Research has shown equipoise in treatment outcomes after casting and splinting for pediatric buckle fractures. Despite the similarly favorable treatment outcomes associated with both casting and splinting these fractures, there is wide disparities in cost between the two types of immobilization. However, cost information is not routinely presented to families during the discussion of immobilization types.

The primary objective of this study is to determine if cost information influences family decision-making about immobilization type after pediatric buckle fractures. A secondary objective is to determine if the timing of and person disseminating the cost information changes the influence it has on families' decision-making.

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males or females ages 4 to 14 years with a buckle fracture for which they will be treated with a cast or a splint.
• Parental/guardian permission (informed consent) and, if appropriate, child assent.
• Parent of a child ages 4 to 14 years with a buckle fracture that requires treatment with either a cast or a splint.
• Parental/guardian permission (informed consent).

Exclusion Criteria:

• Non-English speaking subjects.
• Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Provider Cost; The subject will be given information about the cost of casting and splinting for treatment of the buckle fracture by the orthopaedic surgeon before the decision for immobilization has been made.	Other: Monetary Cost of Immobilization Treatments; Information regarding the monetary cost of casting and splinting patient's buckle fracture to be presented to adult subject/payer.; Other Names: Cost Information; Other: Physician; The monetary cost information is relayed by the patient's physician; Other: Before Initial Treatment Decision; Monetary cost information is relayed during the initial consult, before the treatment decision is made.; Other Names: Initial Consult
Other: Research Team Cost; The subject will be given information about the cost of casting and splinting for treatment of the buckle fracture by a member of the study team after the decision for immobilization has been made.	Other: Monetary Cost of Immobilization Treatments; Information regarding the monetary cost of casting and splinting patient's buckle fracture to be presented to adult subject/payer.; Other Names: Cost Information; Other: Study Team; The monetary cost information is relayed by a member of the study team; Other: After Initial Treatment Decision; Monetary cost information is relayed after the initial consult with the treating physician, after the treatment decision is made.; Other Names: Post-Consult

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monetary Cost of Immobilization's Influence on Treatment Decisions	The outcome measure will evaluate whether monetary cost influenced payers' decisions to choose one immobilization treatment over the other (splinting vs. casting).	1 to 5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timing/Person Effect on Decision-Making	A secondary objective is to determine if the timing of and person disseminating the cost information changes the influence it has on families' decision-making	1 to 5 minutes

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: John Todd R Lawrence, MD, PhD, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2017
• Primary Completion (Actual): October 9, 2019
• Study Completion (Actual): October 9, 2019

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: July 24, 2019
• First Posted (Actual): July 25, 2019

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Cost; Distal Radius Fracture; Buckle Fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: 17-013965

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The IPD will not be shared with researchers outside of the research team for this clinical trial.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No