Distal Radius Buckle Fracture RCT

Not Applicable

Completed

• Conditions: Distal Radius Fracture

• Registration Number: NCT04032873
• Lead Sponsor: Children's Hospital of Philadelphia

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.

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 Timeline

• Study Start: 2017-05-31
• Study First Submitted: 2019-07-23
• Study First Submitted QC: 2019-07-24
• Study First Posted: 2019-07-25
• Primary Completion: 2019-10-09
• Study Completion: 2019-10-09
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States