NCT02054611

Brief Summary

Without rigorous, high-quality training materials, the results of the LUNG-SAFE study examining the global incidence and outcomes of severe lung failure (acute respiratory distress syndrome \[ARDS\]) could be confused by either under-recognition of patients with, or misclassification of patients without, ARDS. This problem has been previously identified with the use of the prior ARDS definitions, particularly in patients with milder severity of illness. Importantly, the chest x-ray criteria in the ARDS definition has demonstrated only moderate reliability when applied by experts, although this can be improved through the use of training radiographs (as will be used in this educational module). The investigators hypothesize that the training from the educational module will allow more accurate diagnosis of ARDS by data collectors/study coordinators participating in the LUNG-SAFE study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

January 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 4, 2014

Status Verified

September 1, 2014

Enrollment Period

6 months

First QC Date

January 31, 2014

Last Update Submit

September 3, 2014

Conditions

ARDS

Keywords

ARDSChest radiographsVignettesOnline educational video

Outcome Measures

Primary Outcomes (1)

  • ARDS Diagnosis

    The number of correct responses to the evaluation component (15 multiple choice questions) of the educational module (in aggregate).

    up to 4 weeks

Secondary Outcomes (2)

  • ARDS Diagnosis

    up to 4 weeks

  • Time

    up to 4 weeks

Study Arms (2)

Educational Module First

ACTIVE COMPARATOR

Respondents will complete the online educational module first, followed by the evaluation

Other: Online Educational Module

Evaluation First

PLACEBO COMPARATOR

Respondents will complete the the evaluation first, followed by the online educational module

Other: Evaluation First (Placebo)

Interventions

Online Educational ModuleOTHER

A descriptive video detailing the diagnosis of ARDS according to the Berlin Definition, along with online educational materials available for review.

Educational Module First
Evaluation First (Placebo)OTHER

The respondents will view the descriptive video detailing the diagnosis of ARDS according to the Berlin Definition, along with online educational materials available for review only after they have completed the evaluation.

Evaluation First

Eligibility Criteria

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

You may qualify if:

  • Study coordinators/data collectors for the LUNG-SAFE study

You may not qualify if:

  • No informed consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

University Health Network

Toronto, Ontario, Canada

Location

Study Officials

  • Eddy Fan, MD, PhD

    University Health Network and Mount Sinai Hospital

    PRINCIPAL INVESTIGATOR

  • Gordon Rubenfeld, MD, MSc

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 31, 2014

First Posted

February 4, 2014

Study Start

February 1, 2014

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

September 4, 2014

Record last verified: 2014-09

Locations

CA(2)