Distal Radius Buckle Fracture RCT
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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:
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:
|
| 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:
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:
|
Outcome Measures
Primary Outcome Measures
- Monetary Cost of Immobilization's Influence on Treatment Decisions [1 to 5 minutes]
The outcome measure will evaluate whether monetary cost influenced payers' decisions to choose one immobilization treatment over the other (splinting vs. casting).
Secondary Outcome Measures
- Timing/Person Effect on Decision-Making [1 to 5 minutes]
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
Eligibility Criteria
Criteria
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.
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Parent of a child ages 4 to 14 years with a buckle fracture that requires treatment with either a cast or a splint.
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Parental/guardian permission (informed consent).
Exclusion Criteria:
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Non-English speaking subjects.
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Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Children's Hospital of Philadelphia
Investigators
- Principal Investigator: John Todd R Lawrence, MD, PhD, Children's Hospital of Philadelphia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17-013965