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Clinical Trials/NCT04032873
NCT04032873CompletedNot Applicable

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

Children's Hospital of Philadelphia2 sites in 1 country129 target enrollmentStarted: May 31, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
129
Locations
2
Primary Endpoint
Monetary Cost of Immobilization's Influence on Treatment Decisions

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
4 Years to 14 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Monetary Cost of Immobilization's Influence on Treatment Decisions

Time Frame: 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 Outcomes

  • Timing/Person Effect on Decision-Making(1 to 5 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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