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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04032873
Other study ID # 17-013965
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 31, 2017
Est. completion date October 9, 2019

Study information

Verified date February 2021
Source Children's Hospital of Philadelphia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 129
Est. completion date October 9, 2019
Est. primary completion date October 9, 2019
Accepts healthy volunteers No
Gender All
Age group 4 Years to 14 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.
Physician
The monetary cost information is relayed by the patient's physician
Study Team
The monetary cost information is relayed by a member of the study team
Before Initial Treatment Decision
Monetary cost information is relayed during the initial consult, before the treatment decision is made.
After Initial Treatment Decision
Monetary cost information is relayed after the initial consult with the treating physician, after the treatment decision is made.

Locations

Country Name City State
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 1 to 5 minutes
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