Redcap data collection form questions:
Q1: How to access Redcap data collection site and fill in patient data?
A: Go to the Redcap access link > enter your log in ID and Password > click on ‘My Projects’ > click on ‘The Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN)’ > click on ‘Data Entry’ > Click on box named ‘ Add new record’
Q2: In Redcap data collection site if you see this NOTICE: “This project is currently in Development status. Real data should NOT be entered until the project has been moved to Production status.” What to do?
A: Just ignore the notice. You can enter the real patient data. We plan to keep it that way to incorporate changes. Don’t worry, data won’t be lost.
Q3: What is Day-0 and Day-1?
A: Day 0 = Admission day and time to the next day at 8 a.m. Example:
- If a patient is admitted to the ICU at 11 a.m. today until the next morning at 8 a.m. is Day 0 (Day 0 data will be 21 hours of duration)
- If a patient is admitted to the ICU at 9 p.m. today until the next morning at 8 a.m. is Day 0 (Day 0 data will be 11 hours of duration)
- If a patient is admitted to the ICU at 1 a.m. today until the next morning at 8 a.m. is Day 0 (Day 0 data will be 7 hours of duration)
Day 1 = Next 8 a.m. to 8 a.m. the following day. Example:
- Day 0 = 10 a.m. November 1 at 10 a.m. to 8 a.m. November 2.
- Day 1 = 8 a.m. November 2 to 8 a.m. November 3.
- Day 2 = 8 a.m. November 3 to 8 a.m. November 4
Q4: Specific ventilator settings and data?
A: Fill pertinent data, leave other columns blank, and write details in comment box below.
Q5: For investigations that are not available every 24 hours, how do we account for that?
A: For any unavailable data, you leave it blank and write a comment at the end.
Q6: When we have the word ‘documented’ in CRF- as for SBT or need for continuation of antibiotics or central lines/ catheter infection etc.- is it acceptable if they are discussed during rounds or do you need a specific note of it made in the daily patient notes?
A: Discussions at rounds are okay.
Q7: How about patients have long ICU stays (>28 days)?
A: For those patients with long ICU stay (more than 28 days), please collect the variables on these days : Day 0, day 1, day 2, day 3, day 7, day 14 , day 21, day 28. On day 28, you choose ” alive” for these patients, and write down at ” comment” section like this ” Patient is still in ICU”.
For other patient with shorter ICU stay ( less than 28 days), you record Day 0, day 1, day 2, day 3, day 7, day 14 , or day 21. It depends on real situation. For example, if patient is discharged from ICU on day 7, you don’t have to record day 14 and 21. HOWEVER , Day 28 is “a must” to all the patients unless it is really hard to get the data.
Technical/ Software Questions:
Q1. Do we need to install new software on our fixed computing devices?
A: No, you should be able to access it online with Wi-Fi, otherwise we have paper version, installing on 1-2 portable laptops would be last resort during study period, which we can send link and can be downloaded.
Q2. Do we need training on this software? If so, who provides this training?
A: yes, there is a structured training, will be given via google hangout in two 3-3 hours session in 4th-6th month of study.
Q3. Is the software supported?
A: yes, by study IT personnel and CERTAIN steering committee members.
Q4. What happens to the software at the end of the study?
A: You can keep using both the paper version and the original computer version; however no maintenance and support will be guaranteed after the study completion. Mayo Clinic holds the copyright and we will be working on both commercial and open-source options for further development, maintenance and support beyond the study period.
Q5. Who will administer and support the system-is this done locally or remotely?
A: Remotely by study IT personnel,
Time Frame questions:
Q1. What is the anticipated time requirement per patient?
A: 1 hour per patient in retrospective, variable given days in ICU for post interventions period (average 1-2 hour per patient)
Q2. What is the anticipated time requirement (hours) for the study?
A: (pre – 50 patients = 50-75 hours, training first 3 clinicians=3+15+3=20 hours, then 20-50 hours for those 3 to train others locally, post-100 patients=~200 hours, total= 350 maximum over 12 month period)