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Distal Radius Buckle Fracture RCT

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04032873
Enrollment
129
Registered
2019-07-25
Start date
2017-05-31
Completion date
2019-10-09
Last updated
2021-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Radius Fracture

Keywords

Distal Radius Fracture, Cost, Buckle Fracture

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.

Interventions

OTHERMonetary Cost of Immobilization Treatments

Information regarding the monetary cost of casting and splinting patient's buckle fracture to be presented to adult subject/payer.

The monetary cost information is relayed by the patient's physician

OTHERStudy Team

The monetary cost information is relayed by a member of the study team

OTHERBefore Initial Treatment Decision

Monetary cost information is relayed during the initial consult, before the treatment decision is made.

OTHERAfter Initial Treatment Decision

Monetary cost information is relayed after the initial consult with the treating physician, after the treatment decision is made.

Sponsors

Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 14 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Monetary Cost of Immobilization's Influence on Treatment Decisions1 to 5 minutesThe outcome measure will evaluate whether monetary cost influenced payers' decisions to choose one immobilization treatment over the other (splinting vs. casting).

Secondary

MeasureTime frameDescription
Timing/Person Effect on Decision-Making1 to 5 minutesA secondary objective is to determine if the timing of and person disseminating the cost information changes the influence it has on families' decision-making

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026