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.

项目概述：现在许多患者在院外心脏骤停(UchA)中幸存下来，但在 对长期结果的了解导致要实现的连续护理支离破碎和不发达 恢复。康复被定义为功能和认知结果的显著改善，以及健康- 相关生活质量(HRQOL)。恢复模式良好的HC A幸存者可能会回到 工作和/或社会角色。先前评估uchA后恢复域的研究很少，仅限于单一研究。 中心和短期结果，即1-3个月。确定个别患者的康复模式 从长远来看，能够预测谁在出院后可能需要更密集的支持将 允许更有效地针对干预措施。同样重要的是，我们为患者及其家属提供 关于患者持续康复前景的最佳信息，即使在没有可修改的情况下也是如此 干预目标。这项研究将是第一批聚焦于一门新的公平科学的研究之一 生存本身，为保存或恢复复苏寻找经验派生的目标。 我们的单中心先导研究发现，近三分之一的uchA幸存者具有重要的临床意义 长期(12个月)和短期(3个月)功能结果之间的差异 恢复过程中的个体差异(即改善或恶化)。我们发现住院患者急性康复 与其他处理方式相比，在12个月时功能恢复模式更好，但Black 种族和西班牙裔/拉丁裔的复苏模式比非西班牙裔白人更差。 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，在 NIH紧急护理试验网络的60个地点，以描述恢复(功能结果[主要]， 认知和HRQOL结果[次要])在一个大的、特征良好的、种族/民族多样化的、 美国非霍奇金淋巴瘤患者的代表性队列。我们将招募n=1,000名接受ICECAP和 活到医院出院。家长ICECAP试验包括1个月后的电话随访和 3个月后亲自到访。辅助研究将在6点和9点增加两次电话/视频会议访问 两个月后进行一次面对面的访问，12个月后进行一次面谈。 对于目标1，我们将描述患者之间在恢复中的可变性(即，功能、认知、 和HRQOL结果)，并测试变化是否与疾病相关 在急性护理住院期间进行的严重程度评分和危重护理干预。Aim 2将测试 在1个月内接受急性住院康复治疗(VS门诊治疗/无治疗/熟练护理设施) 出院时间越长，3至12个月的康复效果越好。 最后，在目标3中，我们将测试非西班牙裔黑人和西班牙裔/拉丁裔患者是否对 3个月至12个月期间康复结果的变化，并探讨造成这种差异的机制。