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Distal Radius Buckle Fracture RCT

Primary Purpose

Distal Radius Fracture

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Monetary Cost of Immobilization Treatments
Physician
Study Team
Before Initial Treatment Decision
After Initial Treatment Decision
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture focused on measuring Distal Radius Fracture, Cost, Buckle Fracture

Eligibility Criteria

4 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Provider Cost

Research Team Cost

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Timing/Person Effect on Decision-Making
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

Full Information

First Posted
July 23, 2019
Last Updated
February 1, 2021
Sponsor
Children's Hospital of Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT04032873
Brief Title
Distal Radius Buckle Fracture RCT
Official Title
Influence of Cost Information on Cast vs. Splint Decision-Making After Pediatric Buckle Fractures: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 31, 2017 (Actual)
Primary Completion Date
October 9, 2019 (Actual)
Study Completion Date
October 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture
Keywords
Distal Radius Fracture, Cost, Buckle Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Provider Cost
Arm Type
Other
Arm Description
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.
Arm Title
Research Team Cost
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Monetary Cost of Immobilization Treatments
Other Intervention Name(s)
Cost Information
Intervention Description
Information regarding the monetary cost of casting and splinting patient's buckle fracture to be presented to adult subject/payer.
Intervention Type
Other
Intervention Name(s)
Physician
Intervention Description
The monetary cost information is relayed by the patient's physician
Intervention Type
Other
Intervention Name(s)
Study Team
Intervention Description
The monetary cost information is relayed by a member of the study team
Intervention Type
Other
Intervention Name(s)
Before Initial Treatment Decision
Other Intervention Name(s)
Initial Consult
Intervention Description
Monetary cost information is relayed during the initial consult, before the treatment decision is made.
Intervention Type
Other
Intervention Name(s)
After Initial Treatment Decision
Other Intervention Name(s)
Post-Consult
Intervention Description
Monetary cost information is relayed after the initial consult with the treating physician, after the treatment decision is made.
Primary Outcome Measure Information:
Title
Monetary Cost of Immobilization's Influence on Treatment Decisions
Description
The outcome measure will evaluate whether monetary cost influenced payers' decisions to choose one immobilization treatment over the other (splinting vs. casting).
Time Frame
1 to 5 minutes
Secondary Outcome Measure Information:
Title
Timing/Person Effect on Decision-Making
Description
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
Time Frame
1 to 5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Todd R Lawrence, MD, PhD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The IPD will not be shared with researchers outside of the research team for this clinical trial.

Learn more about this trial

Distal Radius Buckle Fracture RCT

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