Q: Who is eligible for POST-ICECAP?
A:
- Age ≥ 18 years
- Coma after resuscitation from OHCA
- Patients who were either screened or enrolled in the ICECAP trial
- Received targeted temperature management
- Patient survived to 1 month
- Signed ICF by a patient or an authorized representative
Q: What is the definition of “Received targeted temperature management” in the inclusion criteria?
A: Any definitive temperature control device either initiated or ordered within 24 hours of cardiac arrest. All target temperatures including fever control and durations are acceptable (for example, an order during the first 24 hours to turn on a cooling device if temperature > 37.5℃ would be “active fever control” even if turning on the device was never required.) Fever control using medications alone is not a sufficient eligibility criterion (for example, an order to administer acetaminophen for temperature >37.5 ℃ or even scheduled acetaminophen would not be considered “active” temperature management). Please reach out to us for any clarifications at POST-ICECAP-contact@umich.edu
Q: Does the NOA need to be blinded?
A: No, the NOA does not need to be blinded in POST-ICECAP. If the 3-month assessment is being done for ICECAP, follow the ICECAP rules that the NOA is blinded
Q: What is the time commitment for NOA training including Modified Rankin, NIH-Toolbox, Neuro-Qol, and BTACT?
A: Approximately 8 hours i.e. one business day
Q: How long do the NOA assessments take during each visit?
A: Approximately 60 minutes for telephone visits and 90 minutes for in-person visits
Q: Do subjects need to be re-consented when they regain the capacity to consent?
A: No. If the subject is cognitively impaired at the time of consent, enrollment will be based on obtaining consent from a legally authorized representative (LAR). Subjects will not need to be consented when they gain the capacity to consent. However, participation is voluntary therefore subjects may withdraw from the study at any time.
Q: If a subject needs to end the telephone interview before completion, can the remaining interview be completed at a later time?
A: Yes. However, any neuropsych test should be completed in its entirety and not as 2 separate interviews. Letting the person take a break, and completing some other instruments on a separate call or day is okay. And best to keep these calls close together in time.
Q:If the interview needs to be divided into two separate interviews, which measures should be prioritized?
A:The Modified Rankin Scale (F144) is a ‘must have’ measure for all participants and should be collected first. If the subject has a MRS less than 5, in order of priority collect:
- follow-up form (F516)
- neuropsychological outcomes applicable to the visit type (F509, F512, F513)
- psychological patient-reported outcomes (F507, F508, F510)
- physical and social patient-reported outcomes applicable to the visit type (F511, F514, F515, F517, F518, F519)
Q: Can the outcomes questionnaires be printed/completed on paper and then transcribed to WebDCU?
A: Yes, except NIH Toolbox and Neuro QoL - these are administered on iPads.
Q: Can a subject co-enroll in another trial?
A: Yes. Please contact us and we can assist in the coordination of visits and selection of study assessments.
Q: Can a site participate in POST-ICECAP if not participating in ICECAP?
A: No, not at this time.
Q: What is the time commitment for chart review after consent is obtained?
A: Approximately 2 hours
Q: What is the time commitment for the Intake Questionnaire after consent is obtained?
A: Approximately 30 minutes.
Q: Can I consent and enroll a patient between 30 and 45 days (in the window for 30-day follow-up)?
A: Yes. This patient is in the window for the 30-day assessment, and you will be able to obtain the consent and first assessment. The goal is to capture the first assessment at 30 days; therefore, you should not intentionally wait until after 30 days. However, some patients might still be hospitalized at this time, and other patients may return to the clinic after 4-5 weeks providing an opportunity.
Q: Can I enroll a current prisoner into POST-ICECAP?
A: Being a prisoner is an exclusion criterion for both the ICECAP trial and the POST-ICECAP study.
Q: What happens if the patient is screened but dies before the official 1-month enrollment date for entry into the study? Will that effort be reimbursed?
A: If a participant dies before 30 days, they are technically never enrolled and do not contribute to the study. There will be no payment for that participant. It would be fine to never complete anything except the enrollment form for such a person. In some cases, you might only complete a consent form and never add them to WebDCU at all. The latter would be the least work.
From a practical standpoint, you often know who is likely to survive and who is less certain. It is often easier to complete all those intake forms right away rather than waiting till after 30 days if you have high expectations, but you do not have to complete them. This is something we trust the team to use their judgment and incorporate into their workflow.
Q: if a patient is enrolled but dies before the 3-month visit, will there be any reimbursement to the site?
A: Yes, if someone dies between 1 month and 3 months, you will get paid the full $400 once the End of Study form is complete. We hope mortality in this time window is low.
Q: When completing the NIH Toolbox assessments, what should we enter as the patient identifier to distinguish between an ICECAP assessment an POST-ICECAP assessment?
A: To differentiate the files from the i-Pad we are asking the POST-ICECAP sites to use a unique naming convention when entering the Subject ID in the i-Pad. Please see the below scenarios:
- Subjects ONLY enrolled in ICECAP – Please use just the assigned ICECAP subject ID (####)
- Subjects enrolled in ICECAP and POST-ICECAP – For the Day 90/3 Month visit, please use the ICECAP assigned ID only (####). This assessment is not uploaded to both databases but will be linked to the ICECAP uploaded file at the end of the study. For the POST-ICECAP 12 month visit, please use the POST-ICECAP ID with a unique identifier (POST####).
- ICECAP screen failures, but enrolled in POST-ICECAP – Please use the POST-ICECAP assigned ID with the unique identifier (POST####)