FAQ
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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 and durations are acceptable.
For example, an order during the first 24 hours to turn on a cooling device if the temperature exceeds 37.5°C qualifies as “active fever control,” even if the device was never turned on.
However, fever control using medications alone (e.g., acetaminophen orders) is not sufficient. For clarifications, contact POST-ICECAP-contact@umich.edu.
Q: Can a site participate in POST-ICECAP if not participating in ICECAP?
A: No, not at this time.
Q: Can a subject co-enroll in another trial?
A: Yes. Contact us for assistance in coordinating visits and study assessments.
Q: Do subjects need to be re-consented when they regain the capacity to consent?
A: No. If a subject is cognitively impaired at the time of consent, the LAR provides consent. Subjects do not need to re-consent once they regain capacity, but they may withdraw at any time.
Q: Can I consent and enroll a patient between 30 and 45 days (in the window for 30-day follow-up)?
A: Yes. The goal is to conduct the first assessment at 30 days, but some patients may still be hospitalized or return to the clinic after 4-5 weeks.
Q: Can I enroll a current prisoner into POST-ICECAP?
A: No. Being a prisoner is an exclusion criterion for both ICECAP and POST-ICECAP.
Q: What is the time commitment for NOA training, including Modified Rankin, NIH Toolbox, Neuro-QoL, and BTACT?
A: Approximately 8 hours (one business day).
Q: How long do the NOA assessments take during each visit?
A:
- Telephone visits: ~60 minutes
- In-person visits: ~90 minutes
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: If a subject needs to end a telephone interview before completion, can the remaining interview be completed later?
A: Yes. However, neuropsych tests should be completed in one sitting. Other instruments can be completed in a separate call, but it is best to keep them close together in time.
Q: If an interview is divided into two separate sessions, which measures should be prioritized?
A: Collect in the following priority order:
- Modified Rankin Scale (F144) (must-have measure for all participants).
- If MRS < 5, collect in this order:
- Follow-up form (F516)
- Neuropsychological outcomes (F509, F512, F513)
- Psychological patient-reported outcomes (F507, F508, F510)
- Physical and social patient-reported outcomes (F511, F514, F515, F517, F518, F519).
Q: Can the outcomes questionnaires be printed/completed on paper and then transcribed to WebDCU?
A: Yes, except for NIH Toolbox and Neuro-QoL, which must be administered on iPads.
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 conducted for ICECAP, follow ICECAP blinding rules.
Q: What happens if a patient is screened but dies before the 1-month enrollment date? Will the site be reimbursed?
A: No. If a participant dies before 30 days, they are never officially enrolled and do not contribute to the study, so no payment will be made. You may complete an enrollment form, but it is not required to enter the patient into WebDCU.
Q: If a patient is enrolled but dies before the 3-month visit, will there be reimbursement?
A: Yes. If a participant dies between 1 month and 3 months, the site will receive the full $400 once the End of Study form is completed.
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:
ICECAP screen failures, but enrolled in POST-ICECAP – Please use the POST-ICECAP assigned ID with the unique identifier (POST####)
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####).