An Effectiveness-Implementation Trial of SPIRIT in ESRD

SPIRIT 在 ESRD 中的有效性实施试验

• 批准号: 10205754
• 负责人: MI-KYUNG SONG
• 金额: $ 15.6万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-06-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10205754
• 关键词: 2019-nCoV; Acute; Address; Admission activity; Advance Care Planning; Advance Directives; Affect; Anxiety; Area; Behavior; Belief System; COVID-19; COVID-19 pandemic; Caregivers; Caring; Cessation of life; Characteristics; Chronic Disease; Cluster randomized trial; Complex; Conflict (Psychology); Control Groups; Data; Decision Making; Disasters; Disease Outbreaks; Educational Background; End stage renal failure; Ethnic Origin; Exhibits; Family; Fright; Gender; Goals; Health; Healthcare; Hospitalization; Income; Individual; Infection; Intervention; Learning; Life; Literature; Longitudinal cohort study; Measures; Medical; Modeling; Natural Disasters; Outcome; Panic; Paper; Parents; Patient Recruitments; Patients; Perception; Questionnaires; Race; Readiness; Reflex action; Research; Resources; Risk; Social Change; Socioeconomic Status; Specific qualifier value; Stress; Time; Uncertainty; Update; Withdrawal; aggressive therapy; base; behavioral economics; behavioral/social science; care outcomes; care preference; cognitive performance; coronavirus disease; economic impact; effectiveness implementation trial; end of life; end of life care; end-of-life decision making; evidence base; experience; follow-up; group intervention; high risk; interest; multiple chronic conditions; novel; pandemic disease; post intervention; preference; psychologic; recruit; resilience; response; risk perception; sex; social; social health determinants; sociodemographics

ABSTRACT This R01 supplement submitted in response to NOT-OD-20-097, Research on the 2019 Novel Coronavirus and the Behavioral and Social Sciences, addresses one of the four focused areas specified in the notice: to examine “downstream health impacts resulting from social, behavioral, and economic impacts, including differences in risks and resiliency based on gender, race and ethnicity, socioeconomic status, and other social determinants of health.” The COVID pandemic has brought fear and uncertainty to all aspects of life and especially to medical care. Research has shown that after experiencing a natural disaster, people exhibit more risk averse behaviors, and that belief systems can change: people “update” their perception of background risk and perceive the world to be a much riskier place. Although studies have shown that values and preferences for end-of-life care are stable over time especially after individuals made an effort to actively think about their end-of-life preferences, another body of literature suggests that abrupt and disturbing social changes, such as disasters, can affect the psychological mechanisms underlying cognitive performance. The effects of a disaster may bring doubt to clinicians as well as to families regarding how to interpret an advance directive or end-of-life care preferences that were expressed some time prior to the pandemic. There is very little empirical data to guide advance care planning (ACP) with our sickest patients in the setting of a disaster and especially one that is so novel. Therefore, we seek to learn whether in the setting of this novel disaster patients with serious chronic illness are more or less likely to want aggressive treatment. This supplement research is to generate new empirical data on the impact of the COVIDE-19 pandemic on patients' end-of-life preferences, to address whether the stability of preferences is disrupted by the pandemic, and to identify patient characteristics, including race/ethnicity, associated with pre-/post-pandemic changes. We will leverage the parent study (R01NR017018), a cluster randomized trial of an evidence-based ACP intervention (SPIRIT), in which we are currently following 143 dyads (65% Blacks) who successfully completed both the baseline and 2- week post-intervention follow-up before the outbreak. In this new longitudinal cohort study, we will recruit 100 dyads from the pool of 143 to repeat the study assessment battery 2 more times along with new COVID-19 Stress Scales. The specific aims are to: 1) compare the stability of patients' goals-of-care preferences over time, from pre-outbreak to during-outbreak, by group (SPIRIT vs control) and estimate effect by race (Blacks and Whites); 2) assess the stability in the preparedness outcomes (dyad congruence, patient decisional conflict, and surrogate decision-making confidence) comparing pre-outbreak to during-outbreak by group, and estimate race effect; and 3) examine the associations of the COVID-19 Stress, sex, race/ethnicity, and other sociodemographic characteristics (e.g., education level, income) to change in the outcomes and the stability of patients' goals-of-care preferences after the COVID-19 outbreak.

摘要 本R 01补充文件是针对NOT-OD-20-097《2019年新型冠状病毒研究》提交的 以及行为和社会科学，涉及通知中指定的四个重点领域之一： 研究“社会、行为和经济影响对下游健康的影响，包括 基于性别、种族和民族、社会经济地位和其他社会因素的风险和弹性差异 健康的决定因素”。新型冠状病毒大流行给生活的各个方面带来了恐惧和不确定性， 特别是医疗保健。研究表明，在经历自然灾害后，人们表现出更多的 风险规避行为，以及信念系统可以改变：人们“更新”他们对背景风险的看法 并认为世界是一个更危险的地方。尽管研究表明价值观和偏好 随着时间的推移，特别是在个人努力积极思考他们的生活之后， 另一个文献表明，突然和令人不安的社会变化，如 灾难，可以影响认知表现的心理机制。的效果 灾难可能会给临床医生和家庭带来关于如何解释预先指示的疑问， 在大流行病爆发前一段时间就表达了对临终关怀的偏好。很少有经验的 数据，以指导我们的病情最严重的患者在灾难的设置，特别是 一个如此新奇的故事。因此，我们试图了解，在这种新的灾难设置的病人， 严重的慢性病或多或少需要积极的治疗。这项补充研究是为了 生成关于COVIDE-19大流行对患者临终偏好影响的新经验数据， 解决偏好的稳定性是否被大流行破坏，并确定患者 与大流行前/后变化相关的特征，包括种族/民族。我们将利用 母研究（R 01 NR 017018），一项基于证据的ACP干预（SPIRIT）的随机分组试验， 我们目前正在跟踪143对夫妇（65%的黑人），他们成功地完成了基线和2- 干预后一周的后续行动在爆发之前。在这项新的纵向队列研究中，我们将招募100名 从143个样本池中抽取二对样本，与新的COVID-19一起再重复2次研究评估组合沿着 压力量表。具体目标是：1）比较患者的护理目标偏好的稳定性， 按组（SPIRIT与对照组）列出的从爆发前到爆发期间的时间，以及按人种（黑人）列出的估计效应 和白人）; 2）评估准备结果的稳定性（二元一致性，患者决策 冲突和替代决策信心），按组比较爆发前和爆发期间，以及 估计种族效应;以及3）检查COVID-19压力，性别，种族/民族和其他 社会人口特征（例如，教育水平、收入）对结果的变化和 COVID-19爆发后患者的护理目标偏好。