The Educational ARDS Diagnosis Study (READS)

Randomized Educational ARDS Diagnosis Study (READS)

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.

Study Overview

• Status: Completed
• Conditions: ARDS
• Intervention / Treatment: Other: Online Educational Module; Other: Evaluation First (Placebo)

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.

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • SunnyBrook Health Sciences Centre
    • Toronto, Ontario, Canada
      • University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• No informed consent to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Toronto
• Collaborators: Sunnybrook Health Sciences Centre; Unity Health Toronto
• Investigators: Principal Investigator: Eddy Fan, MD, PhD, University Health Network and Mount Sinai Hospital; Principal Investigator: Gordon Rubenfeld, MD, MSc, SunnyBrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: January 31, 2014
• First Submitted That Met QC Criteria: February 3, 2014
• First Posted (Estimate): February 4, 2014

Study Record Updates

• Last Update Posted (Estimate): September 4, 2014
• Last Update Submitted That Met QC Criteria: September 3, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: ARDS; Chest radiographs; Vignettes; Online educational video
• Other Study ID Numbers: READS1