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: 10463667
• 负责人: Ana-Maria Vranceanu
• 金额: $ 63.99万
• 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/10463667
• 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.

项目摘要 急性神经系统疾病的神经科学重症监护病房（NICU）（ANI;例如，中风，肿瘤，TBI） 通常是突然而创伤。大约20-40％的幸存者及其护理人员认可临床意义 住院时的情绪困扰和创伤后压力症状（PTS），往往会慢性且负面 影响恢复轨迹和整体生活质量。不幸的是，没有有效的干预措施可以防止 这些患者和看护人的慢性情绪困扰。借助Ninr的资助，我们的多学科团队 进行了一项试点研究，研究了短暂的6节（亲自2，通过实时视频）的交付 干预（共同恢复），以防止在风险幸存者和看护人中慢性情绪困扰。在一个 盲目的恢复与时间，剂量和注意力与教育控制相匹配的RCT，我们遇到了先验集 可行性，可接受性，信誉和依从性的标记。我们还观察到统计和临床意义 主动干预对减少情绪困扰和PT症状的影响。调查结果已在 JAMA网络。对于拟议的项目，我们试图通过进行完全动力的， 疗效，干预措施的单一盲随机对照试验（RCT）在较大的ANI患者的二元组样本中 和他们的照顾者。这项研究的目标是：1）证明共同恢复以改善自我的功效 报告的二元情绪困扰（主要结果）以及PT，正念，应对和人际交互变量 （次要结果）； 2）评估干预后改善的机制（调解人和主持人）。我们将 注册并随机分配194个处于风险二元组（每个研究组97）以接收恢复或注意力 安慰剂教育控制。该试验将使用我们的已建立 方法论在R21期间成功实施。研究临床医生将进行6，30分钟的会议（床边2次 和4通过现场视频出院后）到每个患者保养者二元组。所有参与者将在基线时完成措施， 完成计划后（6周）和3个月后。该R01的数据最终将作为申请的基础 用于大规模的多站点混合有效性研究的资金，然后进行可恢复的可伸缩性 一起到美国各地的其他NICU。