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The Educational ARDS Diagnosis Study (READS)

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ClinicalTrials.gov Identifier: NCT02054611
Recruitment Status : Completed
First Posted : February 4, 2014
Last Update Posted : September 4, 2014
Sponsor:
Collaborators:
St. Michael's Hospital, Toronto
Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
Eddy Fan, University of Toronto

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) Not Applicable

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:

  1. Educational module completion followed by evaluation
  2. 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.

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Study Type : Interventional  (Clinical Trial)
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 : February 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : September 2014

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.




Primary Outcome Measures :
  1. ARDS Diagnosis [ Time Frame: 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 :
  1. ARDS Diagnosis [ Time Frame: 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)

  2. Time [ Time Frame: up to 4 weeks ]
    Amount of time spent completing the educational module



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No informed consent to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054611


Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Sponsors and Collaborators
University of Toronto
St. Michael's Hospital, Toronto
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Eddy Fan, MD, PhD University Health Network and Mount Sinai Hospital
Principal Investigator: Gordon Rubenfeld, MD, MSc Sunnybrook Health Sciences Centre

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Responsible Party: Eddy Fan, Assistant Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT02054611    
Other Study ID Numbers: READS1
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: September 4, 2014
Last Verified: September 2014
Keywords provided by Eddy Fan, University of Toronto:
ARDS
Chest radiographs
Vignettes
Online educational video