跳至主要内容
临床试验/NCT03248687
NCT03248687已完成不适用

Home Management Versus Primary Care Physician Follow up in Children With Distal Radius Fractures: A Randomized Control Trial

The Hospital for Sick Children2 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
149
试验地点
2
主要终点
Activity Scales for Kids - Performance Version, which is a validated activity scale that measures the ability of a child's physical function

研究概览

简要总结

The investigators will be enrolling children with distal radius buckle fractures, treating them with a removable splint and randomizing them to follow up as needed vs required follow up with a primary care physician 1-2 weeks after the ED visit.

详细描述

Buckle fractures of the distal forearm that include the radius are the most common fracture in childhood, and the risk of this fracture occurring is about 1 in every 25 children.Despite the high frequency of this fracture, it is a very stable injury and thus can be safely treated with a removable wrist splint while the fracture heals. Furthermore, authors have concluded that since orthopedic intervention is exceedingly rare, this type of fracture may safely be followed by a primary care physician (PCP) or managed at home.

In Canada, about 50% of these injuries are routinely discharged from the ED for follow up with the PCP, instead of an orthopedic clinic. The investigators' work examined the management outcomes of 180 children with a distal radius buckle fractures who were treated in an ED with a removable splint, given anticipatory guidance, and advised to follow up in two weeks with their PCP. We demonstrated that PCP follow up was safe and effective, with about 90% of patients completing their care at the PCP without additional visits to an ED or orthopedic surgeon. All patients recovered as expected without complications. However, about 50% of these patients did not receive additional anticipatory guidance from their PCPs on duration of splint use or expected timing of return to usual activities at the PCP visit. Nevertheless, patients with and without this additional anticipatory guidance reported a similar duration of splint use and timing for return to usual activities, largely based on what was recommended at the ED visit. Since these injuries are inherently stable, carry an excellent prognosis, and are treated with a splint that can be removed at home in accordance with anticipatory guidance provided in the ED, it calls into question the need for any routine physician follow up of these common minor fractures.

If home management of distal radius buckle fracture after ED discharge demonstrated safety and effectiveness in a methodologically robust study, it would have clear advantages for patients and families, physicians, and the health care system. The frustrations of lengthy clinic visits and transport difficulties would be avoided. Parents would miss less time away from work or other priorities, and the patients themselves would not miss school. In medically under-serviced communities in particular, patients would avoid long travel distances to see a physician for this minor injury where physician intervention after the ED visit is rarely required. Furthermore, it will obviate the need to shift the care of these common minor fractures from the orthopedic surgeon to the PCP, relieving some pressure on health care practitioners and increase availability for other patients more in need of physician services. Importantly, the potential for reduced use of superfluous health care services for this common injury is also likely to result in health care cost savings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

The outcomes assessor will not know if the patient was followed at home or by a primary care provider.

入排标准

年龄范围
5 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Otherwise healthy children aged 5 to 17 years who present to the study ED within three days of a wrist injury that is diagnosed in the ED as a distal radius buckle fracture will be eligible for enrolment. Furthermore, approximately 15% of children with this fracture have an associated ulnar buckle or ulnar styloid fracture. In previous similar research, children with these associated ulnar fractures were included in the study population. Thus, distal radius buckle fractures with or without an associated buckle/styloid fracture of the distal ulna will be eligible for participation.

排除标准

  • Children at risk for pathologic fractures such as those with congenital or acquired bony disease (Appendix I).
  • Congenital anomalies of the extremities which may complicate clinical or radiographic assessment.
  • Multisystem trauma and multiple fractures of the same limb since these patients would require additional management and follow-up beyond that of an isolated buckle fracture.
  • Patients cognitively and developmentally delayed such that they are unable to communicate pain or have limited performance in activities of daily living at baseline.
  • Past history of ipsilateral distal radius/ulna fracture within 3 months of enrollment.
  • Patients who do not have phone or electronic mail access. This will preclude follow up of these patients.
  • Patients in whom the English language is so limited that consent and/or follow up is not possible.

结局指标

主要结局

Activity Scales for Kids - Performance Version, which is a validated activity scale that measures the ability of a child's physical function

时间窗: Three weeks post injury

The Activity Scales for Kids is a validated activity scale that measures a child's physical function

次要结局

  • Proportion of parents who rated the satisfaction with their care as "very satisfied/satisfied."(4 weeks)
  • Health Economic Evaluation - dollar values will be obtained for patient and health care costs and compared between the groups.(12 weeks)
  • Proportion of children with splint use "almost all of the time" > 3 weeks duration(12 weeks)
  • Proportion of children who received unscheduled visits to a physician for the index wrist injury, obtained by parental report and Canadian Institute of Health Information data(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathy Boutis

Staff Physician and Sr. Associate Scientist

The Hospital for Sick Children

研究点 (2)

Loading locations...

相似试验