NCT03573492

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

June 4, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2018

Completed
Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

May 22, 2018

Last Update Submit

February 27, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Superior education technique

    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.

    30 days

Study Arms (2)

In-Person Education by Ultrasonographer

ACTIVE COMPARATOR

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

Other: Education

Online Education (EM Sono)

ACTIVE COMPARATOR

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

Other: Education

Interventions

Type of teaching being assigned to student arms

In-Person Education by UltrasonographerOnline Education (EM Sono)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mercy Health Youngstown

Youngstown, Ohio, 44501, United States

Location

MeSH Terms

Conditions

Venous ThrombosisPulmonary Embolism

Interventions

Educational Status

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolism

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 22, 2018

First Posted

June 29, 2018

Study Start

June 4, 2018

Primary Completion

December 5, 2018

Study Completion

December 5, 2018

Last Updated

March 1, 2019

Record last verified: 2019-02

Locations