An Effectiveness-Implementation Trial of SPIRIT in ESRD

摘要 本R01附录是为响应NOT-OD-20-097,2019年新型冠状病毒研究而提交的 以及行为和社会科学，涉及通知中规定的四个重点领域之一： 检查由社会、行为和经济影响造成的下游健康影响，包括 基于性别、种族和民族、社会经济地位和其他社会地位的风险和复原力差异 健康的决定因素。“COVID大流行给生活的方方面面带来了恐惧和不确定性 尤其是在医疗方面。研究表明，在经历了自然灾害之后，人们会表现出更多 厌恶风险的行为，以及信念系统可以改变：人们对背景风险的认知是“更新”的 并认为世界是一个风险更大的地方。尽管研究表明，价值观和偏好 临终关怀随着时间的推移是稳定的，特别是在个人努力积极考虑他们的 关于临终偏好，另一部文学作品表明，突然和令人不安的社会变化，如 灾难，会影响潜在的认知表现的心理机制。A的影响 灾难可能会给临床医生和家庭带来疑问，不知道如何解释预先指令或 在大流行之前的一段时间表达的临终关怀偏好。几乎没有经验主义的 在灾难背景下指导我们的重病患者的提前护理计划(ACP)的数据，尤其是 很新奇的一本书。因此，我们试图了解在这部小说的背景下，灾难患者是否 严重的慢性病或多或少可能需要积极的治疗。这项补充研究是为了 就柯维德-19大流行对患者临终偏好的影响产生新的经验数据，以 解决偏好的稳定性是否被大流行打乱的问题，并确定患者 与大流行前/大流行后变化有关的特征，包括种族/族裔。我们将利用 家长研究(R01NR017018)，循证ACP干预(SPIRIT)的整群随机试验，在 我们目前正在跟踪143名(65%的黑人)成功完成基线和2- 疾病暴发前干预后一周的随访。在这项新的纵向队列研究中，我们将招募100名 从143个人的池中选择重复学习评估电池2次以上的新新冠肺炎 压力标度。具体目的是：1)比较患者护理目标偏好的稳定性 从暴发前到暴发期间的时间，按组(白酒与对照)和按种族估计效果(黑人 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)按组比较暴发前和暴发中，以及 估计种族效应；3)检查新冠肺炎压力、性别、种族/民族和其他因素之间的关联 社会人口学特征(例如，教育水平、收入)对结果和稳定性的影响 新冠肺炎爆发后患者的护理目标偏好。

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.