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Patterns Of Survivors’ Recovery Trajectories in the ICECAP Trial
Documents
Advarra Approval Letter - January 11, 2024
Advarra ICF Approval Letter - February 29, 2024
ICF - Coming Soon
Master Consent Form - updated 3/13
Neuropsych Outcomes Training Certification Process
Participating Sites - Coming Soon
Regulatory Document Approval Parameters
Regulatory Document Management Training Certificate
Steps to be Released to Enroll
Study Abstract
Many patients now survive out-of-hospital cardiac arrest (OHCA), however gaps in knowledge about long-term outcomes result in a fragmented and underdeveloped continuum of care to achieve recovery. Recovery is defined as significant improvement in functional and cognitive outcomes and health-related quality of life. OHCA Survivors with favorable recovery patterns may potentially go back to work and/or social roles. Prior studies assessing recovery domains after OHCA are small, limited to single centers, and short-term outcomes i.e., 1-3 months. Identifying individual patient patterns of recovery over longer-term, and the ability to predict who will likely need more intensive support after discharge would allow interventions to be targeted more efficiently. We must also offer patients and their families the best information available about a patient’s prospects for continued recovery even in the absence of modifiable intervention targets. This study will be among the first to focus on a new equitable science of OHCA survivorship itself, seeking empirically derived targets for preserving or restoring recovery. To accomplish these goals, we propose an ancillary study- “Patterns Of Survivors’ Recovery Trajectories in the ICECAP trial (POST-ICECAP),” to the NINDS/NHLBI-funded ICECAP trial, conducted within the 60 sites of the NIH emergency care trials network, to describe recovery (functional outcome [primary], Cognition, and HRQoL outcomes [secondary]) in a large, well-characterized, racially/ethnically diverse, representative cohort of US OHCA patients. We will enroll n=1,000 who were screened for ICECAP and survived to hospital discharge. The parent ICECAP trial includes a telephone follow-up visit at 1 month and an in-person visit at 3 months. The ancillary study will add two telephone/videoconferencing visits at 6 and 9 months and an in-person visit at 12 months after OHCA.