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临床试验/NCT04032873
NCT04032873已完成不适用

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

Children's Hospital of Philadelphia1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2017年5月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
129
试验地点
1
主要终点
Monetary Cost of Immobilization's Influence on Treatment Decisions

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
4 Years 至 14 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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).

排除标准

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

研究组 & 干预措施

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.

干预措施: Monetary Cost of Immobilization Treatments (Other)

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.

干预措施: Physician (Other)

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.

干预措施: Before Initial Treatment Decision (Other)

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.

干预措施: Monetary Cost of Immobilization Treatments (Other)

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.

干预措施: Study Team (Other)

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.

干预措施: After Initial Treatment Decision (Other)

结局指标

主要结局

Monetary Cost of Immobilization's Influence on Treatment Decisions

时间窗: 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).

次要结局

  • Timing/Person Effect on Decision-Making(1 to 5 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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