Distal Radius Buckle Fracture RCT

NCT ID: NCT04032873

Last Updated: 2021-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-31

Study Completion Date

2019-10-09

Brief Summary

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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

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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.

Conditions

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Distal Radius Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Provider Cost

The subject will be given information about the cost of casting and splinting for treatment of the buckle fracture by the orthopaedic surgeon before the decision for immobilization has been made.

Group Type OTHER

Monetary Cost of Immobilization Treatments

Intervention Type OTHER

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

Physician

Intervention Type OTHER

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

Before Initial Treatment Decision

Intervention Type OTHER

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

Research Team Cost

The subject will be given information about the cost of casting and splinting for treatment of the buckle fracture by a member of the study team after the decision for immobilization has been made.

Group Type OTHER

Monetary Cost of Immobilization Treatments

Intervention Type OTHER

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

Study Team

Intervention Type OTHER

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

After Initial Treatment Decision

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Physician

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

Intervention Type OTHER

Study Team

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

Intervention Type OTHER

Before Initial Treatment Decision

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

Intervention Type OTHER

After Initial Treatment Decision

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

Intervention Type OTHER

Other Intervention Names

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Cost Information Initial Consult Post-Consult

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Todd R Lawrence, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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17-013965

Identifier Type: -

Identifier Source: org_study_id

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