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OpenTrials
Completed

NCT Number: NCT04032873

Distal Radius Buckle Fracture RCT

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.

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Key information

Age range

4 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Monetary Cost of Immobilization Treatments

Other

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

Other names: Cost Information

Physician

Other

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

Study Team

Other

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

Before Initial Treatment Decision

Other

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

Other names: Initial Consult

After Initial Treatment Decision

Other

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

Other names: Post-Consult

Primary outcomes

  1. 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

  1. Timing/Person Effect on Decision-Making

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 25, 2019
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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