Patterns Of Survivors' recovery Trajectories in the ICECAP trial (POST-ICECAP)

ICECAP 试验中幸存者的康复轨迹模式 (POST-ICECAP)

• 批准号: 10660518
• 负责人: Sachin Agarwal
• 金额: $ 259.64万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-01 至 2028-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10660518
• 关键词: Acute; Ancillary Study; Back; Black race; Brain; Caring; Characteristics; Clinical; Cognition; Cognitive; Cognitive deficits; Coma; Consciousness Disorders; Continuity of Patient Care; Coronary Angiography; Critical Care; Data; Dependence; Deterioration; Discrimination; Disparity; Eligibility Determination; Emergency Care; Employment; Enrollment; Environmental Risk Factor; Equity; Ethnic Origin; Event; Family; Funding; Guidelines; Health; Heart Arrest; Hispanic; Home; Hospitalization; Hospitals; Hour; Impaired cognition; Impairment; Individual; Inpatients; Insurance; Intervention; Knowledge; Latinx; Length of Stay; National Heart, Lung, and Blood Institute; National Institute of Neurological Disorders and Stroke; Neurologic; Not Hispanic or Latino; Outcome; Outcome Assessment; Outpatients; Parents; Patient Self-Report; Patients; Pattern; Persons; Physiological; Pilot Projects; Public Health; Quality of life; Race; Randomized; Recovery; Recovery of Function; Rehabilitation therapy; Reporting; Resuscitation; Role; Science; Severities; Severity of illness; Site; Skilled Nursing Facilities; Socioeconomic Factors; Survivors; Telephone; Testing; United States National Institutes of Health; Videoconferencing; Visit; Work; acute care; clinical practice; cognitive recovery; cohort; comorbidity; disability; ethnic disparity; ethnic diversity; experience; follow-up; functional outcomes; health care availability; health related quality of life; hospital care; hypoxic ischemic injury; improved; indexing; individual patient; individual variation; long term recovery; natural hypothermia; out-of-hospital cardiac arrest; patient variability; performance based measurement; preservation; primary outcome; psychological distress; racial disparity; racial diversity; racism; recruit; secondary outcome; social factors; social health determinants; survivorship; treatment as usual

Project Summary: 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 (HRQoL). 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 be likely to need more intensive support after discharge would allow interventions to be targeted more efficiently. It is also crucial that we 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. Our single-center pilot study has found that nearly one-third of the OHCA survivors had clinically important differences between long-term (12 months) and short-term (3 months) functional outcomes with large between- individual variability in recovery (i.e., improvement or worsening). We found that inpatient acute rehabilitation was associated with better functional recovery patterns at 12 months compared to other dispositions, but Black race and Hispanic/Latinx had worse recovery patterns than non-Hispanic Whites. To fill this gap, we propose an ancillary study 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 survive 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. For Aim 1, we will describe between-patient variability in recovery (i.e., improvement in functional, cognitive, and HRQoL outcomes) from 3 to 12 months after OHCA, and test whether changes are associated with illness severity scores, and critical care interventions performed during the acute care stay. Aim 2 will test whether receipt of acute inpatient rehabilitation (vs outpatient therapy/no therapy/skilled nursing facility) within 1 month of hospital discharge is associated with greater improvement in recovery outcomes from 3 to 12 months. Finally, in Aim 3, we will test whether non-Hispanic Black and Hispanic/Latinx patients have less favorable changes in recovery outcomes between 3 and 12 months and explore mechanisms for such disparities.

项目摘要：现在许多患者在院外心脏骤停（OHCA）中存活，但 关于长期结果知识导致了一种支离破碎和不发达的连续护理， 复苏恢复的定义是功能和认知结果的显著改善，以及健康- 相关生活质量（HRQoL）。具有良好恢复模式的OHCA幸存者可能会回到 工作或社会角色。先前评估OHCA后恢复域的研究规模较小，仅限于单个 中心和短期结果，即，1-3个月确定个体患者的恢复模式， 长期而言，预测谁在出院后可能需要更密集的支持的能力， 使干预措施更有针对性。同样重要的是，我们为患者及其家属提供 即使在没有可改变的情况下，关于患者持续康复前景的最佳信息 干预目标。这项研究将是第一个集中在一个新的公平科学的OHCA 生存本身，寻求经验得出的目标，以保持或恢复复苏。 我们的单中心试点研究发现，近三分之一的OHCA幸存者有临床重要的 长期（12个月）和短期（3个月）功能结局之间存在差异， 回收率的个体变异性（即，改善或恶化）。我们发现住院病人的急性康复 与其他处置相比，在12个月时与更好的功能恢复模式相关，但黑色 种族和西班牙裔/拉丁裔的恢复模式比非西班牙裔白人差。 为了填补这一空白，我们建议对NINDS/NHLBI资助的ICECAP试验进行一项辅助研究， NIH急诊护理试验网络的60个站点，用于描述恢复（功能结局[主要]， 认知和HRQoL结局[次要]），在一个大型的、特征良好的、种族/民族多样的， 美国OHCA患者的代表性队列。我们将入组n=1,000名接受ICECAP筛选的患者， 活到出院。ICECAP母试验包括1个月时的电话随访访视和 3个月时进行实地考察。辅助研究将在6点和9点增加两次电话/视频会议访视 在OHCA后12个月进行一次亲自访问。 对于目标1，我们将描述患者间恢复的变异性（即，功能、认知 和HRQoL结果），并测试变化是否与疾病相关 严重程度评分和在急性护理停留期间进行的重症护理干预。目标2将测试是否 1个月内接受急性住院康复治疗（vs门诊治疗/无治疗/专业护理机构） 出院率与3 - 12个月恢复结局的改善相关。 最后，在目标3中，我们将测试非西班牙裔黑人和西班牙裔/拉丁裔患者是否具有较不利的 在3和12个月之间的恢复结果的变化，并探讨这种差异的机制。