ARDSREADSNCT02054611
The Educational ARDS Diagnosis Study
A study testing Online Educational Module in people with ARDS, run by University of Toronto at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- ARDS
- What is being tested?
- Online Educational Module
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 2 sitesCanada
- Study dates
- Feb 2014to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Study coordinators/data collectors for the LUNG-SAFE study
Who cannot join
- No informed consent to participate
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Sunnybrook Health Sciences Centre
Toronto, Ontario
University Health Network
Toronto, Ontario
About this study
Official title: 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.
Read the 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.
- Conditions
- ARDS
- Being tested
- Online Educational Module, Evaluation First (Placebo)
- Keywords
- ARDS, Chest radiographs, Vignettes, Online educational video
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Educational ModuleOther
A descriptive video detailing the diagnosis of ARDS according to the Berlin Definition, along with online educational materials available for review.
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.
| Study group | Role | What they receive |
|---|---|---|
| Educational Module First | Active comparator | Respondents will complete the online educational module first, followed by the evaluation Receives: Other: Online Educational Module |
| Evaluation First | Placebo comparator | Respondents will complete the the evaluation first, followed by the online educational module Receives: Other: Evaluation First (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ARDS Diagnosis
The number of correct responses to the evaluation component (15 multiple choice questions) of the educational module (in aggregate).
Measured: up to 4 weeks
Secondary outcomes (2)
ARDS Diagnosis
Number of correct responses to the evaluation component of the educational modules, separated by question type (vignettes vs. chest x-rays)
Measured: up to 4 weeks
Time
Amount of time spent completing the educational module
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto, Sunnybrook Health Sciences Centre
- Responsible party
- Principal investigator, Eddy Fan, University of Toronto
- Investigators
- Eddy Fan, MD, PhD, Principal investigator, University Health Network and Mount Sinai HospitalGordon Rubenfeld, MD, MSc, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054611
- Sponsor's protocol ID
- READS1
- Acronym
- READS
- Status last verified
- Sep 2014
- First submitted
- 31 Jan 2014
- Last updated
- 4 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Educational ARDS Diagnosis Study (READS)
- ClinicalTrials.gov ID
- NCT02054611
- Acronym / sponsor ID
- READS / READS1
- Conditions
- ARDS
- Keywords
- ARDS, Chest radiographs, Vignettes, Online educational video
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Unity Health Toronto, Sunnybrook Health Sciences Centre
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 4 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Module First | Active comparator | Other: Online Educational ModuleRespondents will complete the online educational module first, followed by the evaluation |
| Evaluation First | Placebo comparator | Other: Evaluation First (Placebo)Respondents will complete the the evaluation first, followed by the online educational module |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Study coordinators/data collectors for the LUNG-SAFE study
Key exclusion criteria (1 listed)
- No informed consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Educational ModuleA descriptive video detailing the diagnosis of ARDS according to the Berlin Definition, along with online educational materials available for review. | Other | Educational Module First |
| 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. | Other | Evaluation First |
Primary outcome
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).
2 secondary outcomes
ARDS Diagnosis
Time frame: up to 4 weeks
Time
Time frame: up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eddy Fan, MD, PhD principal investigator
University Health Network and Mount Sinai Hospital
Gordon Rubenfeld, MD, MSc principal investigator
Sunnybrook Health Sciences Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Educational Module in people with ARDS, run by University of Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ARDS Diagnosis (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2014.