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POST-ICECAP

In-a-nutshell

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Participant Eligibility

  • ICECAP Participants are eligible
    • Must survive to 30 days after cardiac arrest

  • ICECAP Screen Failures are eligible
    • Must survive to 30 days after cardiac arrest
    • Coma
    • Received some form of targeted temperature management (include fever prevention)

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Participant Screening

  • Approach anyone who is expected to survive their hospitalization after cardiac arrest-
    • Transferred to the inpatient floor after the ICU
    • Headed to LTAC or rehab or nursing home directly from ICU
    • Discharged from hospital, but still <30 days after cardiac arrest

  • Link to the POST-ICECAP study Flyer

  • Best to get consent before their hospital discharge
    • Get consent well in advance of 30 days
    • Note: The participant is not “officially” enrolled until they survive to 30 days

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Consent

  • Eligible participants may provide informed consent at any time before the first POST-ICECAP evaluation at 1 month
  • Please use electronic version of the consent form; it is the preferred way
  • The consent is also available in Spanish
  • In POST-ICECAP majority of the consents will be obtained from the patients, however certain patients with severe brain injury will be unable to follow commands at the time of consent. In those cases, the consent will be acquired from the LAR of the patient.

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Participant Screening

  • After consent, complete the baseline information
    • Chart review
    • Intake questionnaire

  • Many of these data can be provided by caregiver or family
    • It may be easier to get when the participant is comatose or impaired

  • Many of these data are stable over time
    • OK to ask questions over multiple visits
    • OK to get more complete data on follow-up visits if data are missing initially

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Participant Screening – Chart Review

  • EMS Code Review
  • Medical History
  • Laboratory Tests
  • Pittsburgh Cardiac Arrest Category
    • Illness severity
  • Hospital Discharge
  • Hospital Summary
    • Treatment and TTM
    • Hospital procedures

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Participant Screening – Questions

  • Intake Questionnaire
    • Self-reported Demographics
    • Gender, Race, other minority status
    • Socioeconomic Status
    • Insurance Resources
  • Experience of Discrimination Scale
  • Premorbid PTSD Screening

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Keeping Track of the Participant

  • Get multiple points of contact
    • Participant Phone number
    • Participant Home address
    • Partner/spouse/roommate phone number
    • Phone numbers of other caregivers
    • Another family or friend who would know the whereabouts
    • Facebook or other social media�
  • Institutionalized participants
    • Partner/spouse/caregiver informant phone numbers and address

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Keeping Track of Participant’s Upcoming Visit

  • WebDCU will send “Visit Due” notifications
  • Create your Calendar reminders
    • Start arranging a visit 1 week or more in advance
    • Call the day before a visit
  • Central Outcomes Team Tracking
    • The ICECAP team will remind you about 1 and 3-month ICECAP follow-up
    • The POST-ICECAP team will remind you about all non-ICECAP participants and all 6, 9, and 12-month follow-up

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Visit – 1 month

Domains

Measures

Functional Status

Modified Rankin Scale

Neuropsychological Outcomes

BTACT

Psychological Deficits

Generalized Anxiety Disorder-2 (GAD-2)

Patient Health Questionnaire-8 (PHQ-8)

PTSD Checklist for DSM-V (PCL-5)

Interval Medical Events

Rehabilitation, Hospitalizations, Outpatients

If, Disorders of Consciousness

Disability Rating Scale

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In-person Visits – 3 and 12 month

Domains

Measures

Functional Status

Modified Rankin Scale

Neuropsychological Outcomes

NIH Toolbox, BTACT

Health-related Quality of Life, IADL

Neuro QoL, Modified Lawton-Brody IADL

Psychological Deficits

Generalized Anxiety Disorder-2 (GAD-2)

Patient Health Questionnaire-8 (PHQ-8)

PTSD Checklist for DSM-V (PCL-5)

Interval Medical Events

Rehabilitation, Hospitalizations, Outpatients

Cardiac Function

Kansas City cardiomyopathy

Social Support

ENRICHD Social Support

If, Disorders of Consciousness

Disability Rating Scale

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Phone Visits – 6 and 9 month

Domains

Measures

Functional Status

Modified Rankin Scale

Neuropsychological Outcomes

BTACT

Psychological Deficits

Generalized Anxiety Disorder-2 (GAD-2)

Patient Health Questionnaire-8 (PHQ-8)

PTSD Checklist for DSM-V (PCL-5)

Interval Medical Events

Rehabilitation, Hospitalizations, Outpatients

ADL, Fatigue, IADL

Neuro-QoL Short Forms, Modified Lawton-Brody IADL

Cardiac Function

Kansas City cardiomyopathy

Social Support

ENRICHD Social Support

If, Disorders of Consciousness

Disability Rating Scale

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End of Study

  • End of Study Form
    • Death
    • Withdraws from study
    • Finishes 12-month visit
    • Lost to follow-up – must discuss this during Operations call

  • Vital Status Search
    • Participants with whom we lose contact before 12-months

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Paying Participants

  • We encourage to reimburse participants for time, inconvenience, parking, and travel
    • Use your institutional methods to arrange it
  • The rate per visit should not exceed GSA per diem for your location
  • Note: Reimbursement $ come from your per-subject payments
  • Template for Participant Compensation Plan

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Questions or Problems

  • For all issues related to eligibility, questionnaires or Instruments, and outcomes assessment, email is the preferred option POST-ICECAP-contact@umich.edu
  • Education (training, website access, material development): Courtney Miller coraymon@med.umich.edu
  • WebDCU Support (user account requests, technical support, CRF completion): Sara Meyer (843) 792-1599 butlers@musc.edu Liz O’Donohue (843) 876-1129 odonohue@musc.edu
  • Site Management: Natalie Fisher brownnat@med.umich.edu
  • Finances: Harney, Deneil dkolk@med.umich.edu Valerie Stevenson vwillis@umich.edu