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临床试验/NCT05359575
NCT05359575已完成不适用

Measuring the Effectiveness of Three Instructional Interventions for Prehospital Cervical Spinal Immobilization by Laypeople: A Randomized Clinical Trial

University of Michigan2 个研究点 分布在 1 个国家目标入组 265 人开始时间: 2022年2月7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
265
试验地点
2
主要终点
Knowledge retention of correct c-collar application at follow up (2 months)

研究概览

简要总结

It is not known if bystanders equipped with point-of-care (POC) instruction are as effective as bystanders with in-person training for c-spine immobilization. Therefore, POC instructional interventions were developed during this study in response to the scalability challenges associated with in-person training to measure the comparative effectiveness and skill retention of POC instructions vs in-person training using a randomized clinical trial design.

详细描述

Road traffic injuries (RTIs) are the largest contributor to the global injury burden, which disproportionately affects low- and middle-income countries (LMICs). Traumatic spinal cord injury (TSCI) is the highest contributor to years lived disabled (YLDs) resulting from RTIs, accounting for 74.8% of YLDs from RTI. With a lack of robust emergency medical services (EMS), there has been increasing reliance on layperson bystanders to respond to RTIs in LMICs. Early spinal immobilization has the potential to limit neurological deficits secondary to TSCI and morbidity. Bystanders may be trained in-person or point-of-care (POC) instruction may be provided, as exists with automated external defibrillators and tourniquets. However, it is unknown if bystanders equipped with POC instruction are as effective as bystanders with in-person training for c-spine immobilization. Therefore, POC instructional interventions were developed in response to the scalability challenges associated with in-person training to measure the comparative effectiveness and skill retention of POC instructions vs in-person training using a randomized clinical trial design. The POC instructional flashcard was first piloted with an initial cohort of participants who were not assigned to any longitudinal follow-up date to pilot POC instructional interventions for c-spine immobilization and receive feedback for instructional flashcard revision prior to launching the "trial." Data from these participants is not considered part of the "trial" for analytic purposes. This entire testing process is with participants who are healthy volunteers and researchers simulating spinal injury victims to test which method of instruction is most effective and durable for understanding.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

The outcomes assessor only enters the laboratory after the participant has attempted to apply the cervical collar (c-collar). Therefore, the outcomes assessor is unaware of the instructional intervention that was employed. The outcomes assessor will collect cervical range of motion (CROM) measurements using a CROM device to verify correct c-collar placement by evaluating whether the c-collar was appropriately sized and if neck movement is restricted in five cardinal directions: flexion, extension, and bidirectional rotation.

入排标准

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

入选标准

  • Understand spoken and written English.

排除标准

  • 未提供

结局指标

主要结局

Knowledge retention of correct c-collar application at follow up (2 months)

时间窗: 2 months

Measurement: Number of participants who meet all 4 of the criteria for correct application of the c-collar.

Knowledge retention of correct c-collar application at follow up (1 month)

时间窗: 1 month

Measurement: Number of participants who meet all 4 of the criteria for correct application of the c-collar.

Correct c-collar application

时间窗: After initial intervention (up to 20 minutes)

Measurement: Number of participants who meet all 4 of the criteria for correct application of the c-collar.

次要结局

  • Level of Participant Confidence(After initial intervention (up to 20 minutes))
  • Level of Participant Confidence (2 months)(2 month)
  • Level of Participant Confidence (1 month)(1 month)

研究者

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

Jaimo Ahn

Harold W. and Helen L. Gehring Research Professor of Orthopedic Surgery

University of Michigan

研究点 (2)

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