Distal Radius Buckle Fracture RCT

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Distal Radius Fracture

Intervention / Treatment
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* Other: Monetary Cost of Immobilization Treatments
* Other: Physician
* Other: Study Team
* Other: Before Initial Treatment Decision
* Other: After Initial Treatment Decision


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Provider Cost<br>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<br>* Information regarding the monetary cost of casting and splinting patient's buckle fracture to be presented to adult subject/payer.<br>* Other names: Cost Information;Other: Physician<br>* The monetary cost information is relayed by the patient's physician<br>Other: Before Initial Treatment Decision<br>* Monetary cost information is relayed during the initial consult, before the treatment decision is made.<br>* Other names: Initial Consult;|
| Other: Research Team Cost<br>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<br>* Information regarding the monetary cost of casting and splinting patient's buckle fracture to be presented to adult subject/payer.<br>* Other names: Cost Information;Other: Study Team<br>* The monetary cost information is relayed by a member of the study team<br>Other: After Initial Treatment Decision<br>* Monetary cost information is relayed after the initial consult with the treating physician, after the treatment decision is made.<br>* Other names: Post-Consult;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Distal Radius Fracture, Cost, Buckle Fracture