Recovering Together: Building resiliency in dyads of patients with an acute brain injury admitted to the Neuroscience Intensive Care Unit and their informal caregivers

共同康复：为神经科学重症监护室收治的急性脑损伤患者及其非正式护理人员建立复原力

• 批准号: 10273202
• 负责人: Ana-Maria Vranceanu
• 金额: $ 70.17万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-06 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10273202
• 关键词: Acute; Acute Brain Injuries; Adherence; Admission activity; Adult; Adverse effects; Anxiety; Attention; Caregivers; Chronic; Clinical; Clinical Data; Cognitive; Data; Diagnosis; Distress; Dose; Educational process of instructing; Electronic Health Record; Emotional; Enrollment; Event; Funding; General Hospitals; Geography; Goals; Home; Hospitalization; Hospitals; Individual; Infrastructure; Intensive Care Units; Interpersonal Relations; Intervention; Intervention Trial; Investigation; Lead; Manuscripts; Massachusetts; Measures; Mediating; Mediation; Mediator of activation protein; Medical; Mental Depression; Methodology; Neurologic; Neurosciences; Outcome; Participant; Patient Self-Report; Patients; Personal Satisfaction; Persons; Pilot Projects; Placebos; Population; Psychologist; Publishing; Quality of life; Randomized; Randomized Controlled Trials; Recovery; Recovery of Function; Research; Risk; Sample Size; Sampling; Severities; Single-Blind Study; Stress; Stroke; Surveys; Survivors; Team Nursing; Testing; Time; base; clinical predictors; clinically relevant; clinically significant; coping; demographics; effectiveness implementation study; efficacious intervention; efficacy outcomes; efficacy testing; efficacy trial; emotional distress; emotional functioning; emotional symptom; ethnic diversity; experience; follow-up; improved; individual patient; informal caregiver; medical complication; member; mindfulness; multidisciplinary; new technology; novel; post-traumatic stress; post-traumatic symptoms; predicting response; prevent; primary caregiver; primary outcome; programs; psychosocial; racial diversity; recruit; resilience; response; satisfaction; secondary outcome; skills; tumor

PROJECT SUMMARY Admission to the Neuroscience Intensive Care Unit (NICU) for an acute neurological illness (ANI; e.g., stroke, tumor, TBI) is often sudden and traumatic. Approximately 20-40% of survivors and their caregivers endorse clinically significant emotional distress and posttraumatic stress symptoms (PTS) at hospitalization, which tend to become chronic and negatively impact the recovery trajectory and overall quality of life. Unfortunately, there are no efficacious interventions to prevent chronic emotional distress in these patients and caregivers. With funding from NINR, our multidisciplinary team recently conducted a pilot study examining the delivery of a brief, 6-session ( 2 in person, 4 via live video) dyadic resiliency intervention (Recovering Together) to prevent chronic emotional distress in at risk survivors and caregivers. In a single blind RCT of Recovering Together versus a time, dose and attention matched educational control, we met a priori set markers of feasibility, acceptability, credibility and adherence. We also observed statistically and clinically significant effects of the active intervention on reduction in symptoms of emotional distress and PTS. Findings have been published in JAMA Network. For the proposed project, we seek to build on our prior positive findings by conducting a fully powered, efficacy, single blind randomized controlled trial (RCT) of the intervention in a larger sample of dyads of patients with ANI and their caregivers. The goals of this study are to:1) demonstrate the efficacy of Recovering Together for improving self- reported dyadic emotional distress (primary outcome), and PTS, mindfulness, coping, and interpersonal interaction variables (secondary outcomes); and 2) assess mechanisms (mediators and moderators) of improvement after intervention. We will enroll and randomly assign 194 at risk dyads (97 per study group) to receive either Recovering Together or the attention placebo educational control. The trial will take place at the Massachusetts General Hospital NICU using our established methodology successfully implemented during the R21. Study clinicians will deliver 6, 30 minute sessions (2 at bedside and 4 via live video after discharge) to each patient-caregiver dyad. All participants will complete measures at baseline, after completion of program (6 weeks) and 3 months later. Data from this R01 will ultimately serve as the basis to apply for funding for a large-scale, multisite hybrid effectiveness-implementation study followed by scalability of Recovering Together to other NICUs from across USA.

项目概要 因急性神经系统疾病（ANI；例如中风、肿瘤、TBI）入住神经科学重症监护室 (NICU) 往往是突然的和创伤性的。大约 20-40% 的幸存者及其护理人员认可具有临床意义 住院期间的情绪困扰和创伤后应激症状 (PTS)，这些症状往往会变成慢性且负面的 影响康复轨迹和整体生活质量。不幸的是，没有有效的干预措施来预防 这些患者和护理人员的长期情绪困扰。在 NINR 的资助下，我们的多学科团队最近 进行了一项试点研究，检查了简短的 6 次会议（2 次面对面，4 次通过现场视频）二元弹性的交付 干预（一起康复），以防止高危幸存者和护理人员出现慢性情绪困扰。在一个单一的 一起恢复的盲目随机对照试验与时间、剂量和注意力匹配的教育控制相比，我们遇到了先验集 可行性、可接受性、可信度和遵守性的标志。我们还观察到具有统计学意义和临床意义的 积极干预对减少情绪困扰和 PTS 症状的影响。研究结果发表于 贾玛网络。对于拟议的项目，我们力求在我们之前的积极发现的基础上，进行一次全面的、 对更大样本的 ANI 患者进行干预的单盲随机对照试验 (RCT) 的有效性 和他们的照顾者。本研究的目标是：1) 证明“一起康复”对于改善自我的功效 报告的二元情绪困扰（主要结果）以及 PTS、正念、应对和人际互动变量 （次要结果）； 2）评估干预后改善的机制（中介者和调节者）。我们将 招募并随机分配 194 名处于危险中的二人组（每个研究组 97 名）接受“共同康复”或“关注” 安慰剂教育控制。该试验将在马萨诸塞州总医院新生儿重症监护病房（NICU）进行，使用我们既定的设备 在 R21 期间成功实施了方法。研究临床医生将提供 6 次 30 分钟的疗程（2 次在床边） 4 出院后通过实时视频）发送给每位患者-护理人员二人组。所有参与者都将完成基线测量， 课程完成后（6周）和3个月后。此R01的数据最终将作为申请的依据 为大规模、多地点混合有效性实施研究提供资金，然后进行恢复的可扩展性 与美国各地的其他新生儿重症监护室 (NICU) 一起。