Distal Radius Buckle Fracture RCT

Distal Radius Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04032873
• Other study ID #: 17-013965
• Status: Completed
• Phase: N/A
• Start date: May 31, 2017
• Est. completion date: October 9, 2019

Study information

• Verified date: February 2021
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: October 9, 2019
• Est. primary completion date: October 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

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.
• Physician
The monetary cost information is relayed by the patient's physician
• Study Team
The monetary cost information is relayed by a member of the study team
• Before Initial Treatment Decision
Monetary cost information is relayed during the initial consult, before the treatment decision is made.
• After Initial Treatment Decision
Monetary cost information is relayed after the initial consult with the treating physician, after the treatment decision is made.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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