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临床试验/NCT04126837
NCT04126837已完成不适用

Accelerated Nursing Branch for the Diagnosis and Treatment of Ankle and Foot Injuries in Emergency Department: Preliminary Pilot Study

University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2020年3月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
2
主要终点
Percentage of patients who have received a diagnosis and treatment in accordance with medical recommendations.

研究概览

简要总结

The ankle and/or foot injuries incidence is high. Lateral ankle sprains are most common diagnosis, while fractures represent less than 15% of final diagnosis. Ankle and/or foot injuries are associated with significant morbidity in terms of pain and chronic instability. The societal cost of these injuries is significant mainly related to hospital care and sick-leave. In summary ankle and/or foot injuries are very frequent reason for emergency admission.

The study hypothesis is that an accelerated nursing care system for traumatized ankle and/or foot patients is feasible and allows patients to be cared for in accordance to current medical recommendations. Such a branch should be followed by a return to work and sports within a time frame consistent with the literature. The duration of patient management in emergency department should be short, less than that observed in a historical cohort. Finally patient satisfaction should be high. In the medium term, the implementation of an accelerated nursing branch for the diagnosis and treatment of ankle and/or foot injuries should contribute to effective care and reduction of over activity in emergency departments.

详细描述

The incidence of ankle and/or foot injuries is high. Lateral ankle sprains are the most common diagnosis, while fractures represent less than 15% of the final diagnosis. Ankle and/or foot injuries are associated with significant morbidity in terms of pain and chronic instability. The societal cost of these injuries is significant mainly related to hospital care and sick-leave. Ankle and/or foot injuries are very frequent reason for emergency admission.

The aim of this study is to assess the accelerated nursing branch for the diagnosis and treatment of ankle and/or foot injuries in emergency department.

Target Follow-Up duration: 1 month (30 days).

The study will be conducted in 3 phases:

  1. Training volunteer emergency department nurses. The training course of 10-hours session (2 hours e-learning and 8 hours attendance) will cover all aspects of management of ankle and/or foot injuries (from diagnosis to treatment). The nurses will have at least one year of clinical experience in emergency department. This training will be conducted by medical experts (emergency doctor, radiologist and orthopedist ). At the end of the training a formative assessment both theoretical and practical will be carried out with participants.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Isolated Ankle and/or foot Trauma out of dermabrasion
  • Admission to emergency department < 48 hours after the trauma
  • Written informed consent must be obtained
  • For women of childbearing age: effective contraception in place for at least 3 months

排除标准

  • X-ray performed before patient admission
  • Obvious open fracture
  • Ankle fracture or obvious deformation
  • Suspicion of polytrauma
  • Anterior surgery of the ankle and/or foot
  • Excessive alcoholization or intoxication by other psychoactive substances
  • Persons unable to communicate in french, with impaired comprehension skills and consciousness (problem with mental health)
  • Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of liberty
  • Non-affiliated to the french social security system (or equivalent)
  • Pregnant or nursing women
  • Patient participating in any interventional clinical reserach study

结局指标

主要结局

Percentage of patients who have received a diagnosis and treatment in accordance with medical recommendations.

时间窗: 30 days

Percentage of patients who have received a diagnosis and treatment by nurse in accordance with medical recommandation

次要结局

  • Description of pain intensity(1 day)
  • Deadline for return to work and /or sports(30 days)
  • Consummation of care (excluding medicines)(30 days)
  • Evaluate the time required to manage patients(30 days)
  • Percentage of patients with diagnosis in accordance with Ottawa rules(1 day)
  • Percentage of refusal in participation of the study(30 days)
  • Patient satisfaction assessed during discharge and in one month(1 and 30 days)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (2)

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