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.

项目总结 因急性神经系统疾病(ANI，如中风、肿瘤、脑外伤)进入神经科学重症监护病房(NICU) 通常是突如其来的和痛苦的。大约20%-40%的幸存者和他们的照顾者认可具有临床意义 住院时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的和消极的 影响复苏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 这些患者和照顾者的慢性情绪困扰。在NINR的资助下，我们的多学科团队最近 进行了一项试验性研究，考察了简短的6次会议(2次面对面，4次通过视频直播)的双向恢复能力 干预(共同康复)，以预防高危幸存者和照顾者的慢性情绪困扰。在一首歌中 一起康复的随机对照试验与时间、剂量和注意力匹配的教育对照，我们遇到了一个先验集合 是可行性、可接受性、可信度和坚持性的标志。我们还观察到了统计学和临床意义 积极干预对减轻情绪困扰症状和PTS的影响研究结果已发表在 JAMA网络。对于拟议的项目，我们寻求在先前积极发现的基础上，进行全面的、 大样本ANI患者干预效果的单盲随机对照试验(RCT) 和他们的照顾者。本研究的目的是：1)证明共同康复对提高自我的有效性。 报告的二元情绪困扰(主要结果)，以及PTS、正念、应对和人际交往变量 (二次结果)；以及2)评估干预后改善的机制(调解人和主持人)。我们会 登记并随机分配194名有风险的二元组(每组97人)，接受一起康复或接受关注 安慰剂教育控制。试验将在马萨诸塞州综合医院NICU进行，使用我们建立的 在R21期间成功实施了方法。研究临床医生将提供6，30分钟的会议(2次在床边 和4通过出院后的现场视频)发送到每个患者-护理者二人组。所有参与者都将在基线上完成测量， 在计划完成后(6周)和3个月后。本次R01的数据最终将作为申请的基础 为大规模、多站点混合有效性提供资金--实施研究，随后是恢复的可扩展性 一起发送给美国各地的其他NICU。