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临床试验/NCT03573492
NCT03573492已完成不适用

Bedside Ultrasound in the Assessment of Deep Venous Thrombosis: Effectiveness of In-Person Versus Online Instruction

Mercy Health Ohio1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2018年6月4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
发起方
入组人数
18
试验地点
1
主要终点
Superior education technique

研究概览

简要总结

This study will examine the effectiveness of pre-recorded instructional videos in the use of bedside ultrasonography to ascertain the presence of a lower extremity deep venous thrombosis (DVT) as compared to in-person lectures and hands-on training.

详细描述

This will be a single site prospective pilot study analyzing the agreement between the results of ED student bedside ultrasonography and radiology-performed ultrasonography. Medical students rotating at St Elizabeth Boardman Hospital in the emergency department from any U.S. medical school will be considered for enrollment. Once a rotation has been set up by the medical student and the medical student coordinator, they will be given information on the study being performed and asked if they will be interested. The medical student coordinator will provide them this information. They will be instructed to reply to the co-P.I. if they are interested in participating in the project and given the formal consent to review upon receipt of their affirmative response.

Potential study participants will be provided envelopes by the co-P.I. containing both the formal written consent to participate in the study as well as a short knowledge test of ultrasound technology and the DVT study itself. The student will be required to first sign the consent form, then take the examination and receive a failing score in order to participate in the study. This pre-test will be based heavily on the quizzes from the EMSono learning modules. Permission has been obtained by Dr. Robert Jones to use these questions as the basis for the pre-test examination. A passing score on the pre-test assessment will be considered to be 80% or higher. The assignment list will be computer-generated using the website www.randomizer.org. Students will be given their numeric randomization assignments based on the order in which they finish their exam, after those that pass are excluded. The exact methodology is described in https://www.randomizer.org/tutorial/lesson2.html. Utilizing this methodology, a randomly-generated value of 1 shall be online training, and 2 shall be in-person training.

The study itself shall consist of two arms separated by training. The patient inclusion criteria will not vary between the two arms, only the level of student training. Additional data will be obtained regarding study participants prior to the start of the study, including: training level, approximate number of lower extremity ultrasound studies performed by the participant in the past, overall ultrasound experience, and any formal sonographic education or credentialing.

In the first arm, participating students must have completed the "Practical Scanning" and "Lower Extremity DVT Ultrasound" modules contained within the EMSono online ultrasound instruction. In the second arm, participating student must have attended the in-person training that will be provided by an RDMS-certified ultrasonographer, Kathryn Gentile. The training will last approximately 4 hours in each training method and will include instruction on performing a B-mode compression test of the deep veins of the lower extremities to assess for presence or absence of DVT. There will be no significant difference in the approximate content covered in each training method. Each arm must pass a practical examination in which they must demonstrate basic proficiency in the use of the ultrasound device as well as the ability to obtain all views necessary for their examinations. Failure of the practical exam will result in exclusion from the remainder of the study. They will also be required to repeat the pre-test assessment which will be tracked for improvement from their first pre-test assessment. Both arms will have their pre-test assessment, training, and post-test practical examination monitored by the P.I., co-P.I., ultrasonographer, or another suitable proctor.

Emergency department patients whom the physician has a clinical suspicion for lower extremity DVT or PE and have intention of ordering formal radiology department performed ultrasound will be consented to also have a bedside ultrasound performed by study participant. This consent will be obtained by either the resident or attending physician providing the care of the patient; at which point, the physician will inform whatever student study participant is currently on shift in the department. If there are multiple student study participants present and on shift in the department, the physician must inform a student in an appropriate manner. If a student has already begun to see the patient that is to receive the DVT assessment, then they shall be the study participant selected. If no student has begun to see the patient, then the student with the fewest number of US DVT scans performed in the course of this study will be the study participant selected. If neither of these factors are definitive, then the ED physician shall decide the student to perform the examination via coin toss. If a physical coin is unavailable, then a smartphone coin toss app will be considered an acceptable alternative. The device utilized to obtain these exams shall be a Philips Lumify linear 12-4 MHz probe attached to a Samsung Galaxy View 19" tablet.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Care Provider)

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •of students:
  • •Voluntary participation in the study
  • •Signed written informed consent
  • •Completion of all requirements for their respective arm of the study

排除标准

  • •of students:
  • •Passing preliminary ultrasound knowledge test
  • •Prior education by EMSono or by an RDMS-certified ultrasonographer for the assessment of lower extremity DVT
  • •Rotation period less than 4 weeks
  • •Inclusion Criteria of patients:
  • •Age 18 or greater
  • •Clinical suspicion of DVT or PE
  • •Hemodynamic stability
  • •Intact decision-making capacity
  • •Voluntary presentation to the ED
  • •Formal radiological lower extremity DVT study ordered by appropriate provider.
  • •Exclusion Criteria of patients:
  • •Trauma or other anatomic abnormality
  • •Known DVT diagnosis within 48 hours
  • •History of chronic DVT
  • •Indwelling catheter or hemodialysis access in the extremity to be studied
  • •Refusal to participate in the study.

研究组 & 干预措施

In-Person Education by Ultrasonographer

Active Comparator

In-person education of the DVT scanning technique by an RDMS-certified ultrasonographer

干预措施: Education (Other)

Online Education (EM Sono)

Active Comparator

Online lectures of DVT scanning technique by an Emergency Ultrasound fellowship director

干预措施: Education (Other)

结局指标

主要结局

Superior education technique

时间窗: 30 days

Whether pre-recorded instruction is capable of providing sufficient education to ED medical students to obtain accurate diagnosis of DVT via ultrasonography or if in-person education should continue to be considered the standard of training. This will be assessed by calculating the sensitivity and specificity of each education technique compared to the "gold standard" of the formal DVT ultrasound by radiology.

次要结局

未报告次要终点

研究者

发起方
Mercy Health Ohio
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alex Daves

Principal Investigator

Mercy Health Ohio

研究点 (1)

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