The Educational ARDS Diagnosis Study

ARDS Clinical Trial

— READS  

Official title:

Randomized Educational ARDS Diagnosis Study (READS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02054611
• Other study ID #: READS1
• Status: Completed
• Phase: N/A
• First received: January 31, 2014
• Last updated: September 3, 2014
• Start date: February 2014
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No informed consent to participate

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• ARDS

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University of Toronto	St. Michael's Hospital, Toronto, Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Time	Amount of time spent completing the educational module	up to 4 weeks	No