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: 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: What is the definition of “Received targeted temperature management” in the inclusion criteria?
A: Yes. 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: 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.