Distal Radius Buckle Fracture RCT

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Distal Radius Fracture

Treatments: Other: Monetary Cost of Immobilization Treatments; Other: Study Team; Other: Before Initial Treatment Decision; Other: Physician; Other: After Initial Treatment Decision

Study type: Interventional

Funder types: Other

Identifiers

NCT04032873

17-013965

Details and patient eligibility

About

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.

Full 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.

Enrollment: 129 patients

Sex: All

Ages: 4 to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

129 participants in 2 patient groups

Provider Cost

Other group

Description:

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.

Treatment:

Other: Before Initial Treatment Decision

Other: Physician

Other: Monetary Cost of Immobilization Treatments

Research Team Cost

Other group

Description:

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.

Treatment:

Other: After Initial Treatment Decision

Other: Study Team

Other: Monetary Cost of Immobilization Treatments