An Effectiveness-Implementation Trial of SPIRIT in ESRD

摘要

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.