READS: The Educational ARDS Diagnosis Study

Sponsor

University of Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT02054611

Collaborator

Unity Health Toronto (Other), Sunnybrook Health Sciences Centre (Other)

600

Enrollment

Locations

Arms

Duration (Months)

300

Patients Per Site

43.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ARDS	Other: Online Educational Module Other: Evaluation First (Placebo)	N/A

Detailed Description

In this LUNG-SAFE sub-study, the investigators will evaluate the effect of a brief online educational module on correctly identifying patients (i.e., standardized cases) with ARDS according to the Berlin Definition.

The investigators hypothesize that the training from the educational module will allow more accurate diagnosis of ARDS according to the Berlin Definition by participating data collectors/study coordinators.

Data collectors and study coordinators from ICUs participating in LUNG-SAFE would be randomized (by simple random number generator) to one of the following online educational streams:

Educational module completion followed by evaluation
Evaluation followed by educational module completion

Limited demographic data will be collected from the respondents, along with their responses to the 15 multiple choice test questions. Time spent viewing the educational module will also be collected.

Study Design

Study Type:

Interventional

Actual Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Randomized Educational ARDS Diagnosis Study (READS)

Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Educational Module First Respondents will complete the online educational module first, followed by the evaluation	Other: Online Educational Module A descriptive video detailing the diagnosis of ARDS according to the Berlin Definition, along with online educational materials available for review.
Placebo Comparator: Evaluation First Respondents will complete the the evaluation first, followed by the online educational module	Other: Evaluation First (Placebo) 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.

Arm

Intervention/Treatment

Active Comparator: Educational Module First

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

Other: Online Educational Module

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

Placebo Comparator: Evaluation First

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

Other: Evaluation First (Placebo)

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.

Outcome Measures

Primary Outcome Measures

ARDS Diagnosis [up to 4 weeks]
The number of correct responses to the evaluation component (15 multiple choice questions) of the educational module (in aggregate).

Secondary Outcome Measures

ARDS Diagnosis [up to 4 weeks]
Number of correct responses to the evaluation component of the educational modules, separated by question type (vignettes vs. chest x-rays)
Time [up to 4 weeks]
Amount of time spent completing the educational module

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Study coordinators/data collectors for the LUNG-SAFE study

Exclusion Criteria:

No informed consent to participate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada
2	University Health Network	Toronto	Ontario	Canada

Sponsors and Collaborators

University of Toronto
Unity Health Toronto
Sunnybrook Health Sciences Centre

Investigators

Principal Investigator: Eddy Fan, MD, PhD, University Health Network and Mount Sinai Hospital
Principal Investigator: Gordon Rubenfeld, MD, MSc, Sunnybrook Health Sciences Centre