Distal Radius Buckle Fracture RCT

NCT04032873 | Completed

• 1 other identifier: 17-013965
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Radius Fracture

Keywords

Distal Radius Fracture; Cost; Buckle Fracture

Outcome Measures

Primary Outcomes (1)

• Monetary Cost of Immobilization's Influence on Treatment Decisions

  The outcome measure will evaluate whether monetary cost influenced payers' decisions to choose one immobilization treatment over the other (splinting vs. casting).

  1 to 5 minutes

Secondary Outcomes (1)

• Timing/Person Effect on Decision-Making

  1 to 5 minutes

Study Arms (2)

Provider Cost

OTHER

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.

Other: Monetary Cost of Immobilization Treatments; Other: Physician; Other: Before Initial Treatment Decision

Research Team Cost

OTHER

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.

Other: Monetary Cost of Immobilization Treatments; Other: Study Team; Other: After Initial Treatment Decision

Interventions

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.

Also known as: Cost Information

Provider Cost; Research Team Cost

Physician OTHER

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

Provider Cost

Study Team OTHER

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

Research Team Cost

Before Initial Treatment Decision OTHER

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

Also known as: Initial Consult

Provider Cost

After Initial Treatment Decision OTHER

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

Also known as: Post-Consult

Research Team Cost

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• Non-English speaking subjects.
• Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Wrist Fractures

Interventions

Physicians

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• John Todd R Lawrence, MD, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: July 25, 2019
• Study Start: May 31, 2017
• Primary Completion: October 9, 2019
• Study Completion: October 9, 2019
• Last Updated: February 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)