An Effectiveness-Implementation Trial of SPIRIT in ESRD

ABSTRACTThis R01 supplement submitted in response to NOT-OD-20-097, Research on the 2019 Novel Coronavirusand the Behavioral and Social Sciences, addresses one of the four focused areas specified in the notice: toexamine "downstream health impacts resulting from social, behavioral, and economic impacts, includingdifferences in risks and resiliency based on gender, race and ethnicity, socioeconomic status, and other socialdeterminants of health." The COVID pandemic has brought fear and uncertainty to all aspects of life andespecially to medical care. Research has shown that after experiencing a natural disaster, people exhibit morerisk averse behaviors, and that belief systems can change: people "update" their perception of background riskand perceive the world to be a much riskier place. Although studies have shown that values and preferencesfor end-of-life care are stable over time especially after individuals made an effort to actively think about theirend-of-life preferences, another body of literature suggests that abrupt and disturbing social changes, such asdisasters, can affect the psychological mechanisms underlying cognitive performance. The effects of adisaster may bring doubt to clinicians as well as to families regarding how to interpret an advance directive orend-of-life care preferences that were expressed some time prior to the pandemic. There is very little empiricaldata to guide advance care planning (ACP) with our sickest patients in the setting of a disaster and especiallyone that is so novel. Therefore, we seek to learn whether in the setting of this novel disaster patients withserious chronic illness are more or less likely to want aggressive treatment. This supplement research is togenerate new empirical data on the impact of the COVIDE-19 pandemic on patients' end-of-life preferences, toaddress whether the stability of preferences is disrupted by the pandemic, and to identify patientcharacteristics, including race/ethnicity, associated with pre-/post-pandemic changes. We will leverage theparent study (R01NR017018), a cluster randomized trial of an evidence-based ACP intervention (SPIRIT), inwhich 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 100dyads from the pool of 143 to repeat the study assessment battery 2 more times along with new COVID-19Stress Scales. The specific aims are to: 1) compare the stability of patients' goals-of-care preferences overtime, from pre-outbreak to during-outbreak, by group (SPIRIT vs control) and estimate effect by race (Blacksand Whites); 2) assess the stability in the preparedness outcomes (dyad congruence, patient decisionalconflict, and surrogate decision-making confidence) comparing pre-outbreak to during-outbreak by group, andestimate race effect; and 3) examine the associations of the COVID-19 Stress, sex, race/ethnicity, and othersociodemographic characteristics (e.g., education level, income) to change in the outcomes and the stability ofpatients' goals-of-care preferences after the COVID-19 outbreak.