Conducting an rct in the COVID-19 pandemic: Targeting vulnerability to seasonal and acute weather changes to keep australians with cardiovascular disease out of hospital-the res

ABSTRACT

Objective: Australia is experiencing ever more frequent/provocative weather and environmental challenges, including more extreme heatwaves and catastrophic bushfires. Concurrently, the annual challenge of wintry conditions to a population adapted to warmer conditions persists. Remarkably, however, there are no proven interventions to reduce seasonal challenges to the cardiovascular health of vulnerable individuals. In a world-first, the REsilience to Seasonal ILlness and Increased Emergency admissioNs CarE (RESILIENCE) Trial will test the hypothesis that an individually tailored, intervention program will reduce the risk of re-hospitalisation and mortality in vulnerable individuals. Design and method: 300 adult patients admitted to the Austin Hospital in Melbourne, Australia with heart disease and multimorbidity will be recruited and randomised (11) to standard care (SC) or the RESILIENCE program (RP) over 12-months. Applying a COVID-19 adapted protocol, the RP group will have their bio-behavioural profile and home environment assessed post-discharge, to determine their vulnerability to seasonal events. An individualised case-management program, including a virtual clinic review with a dedicated RP cardiac nurse and physician, will be applied to promote seasonal resilience. The primary end-point is all-cause days alive out of hospital (DAOH) during 12-month follow-up. Results: With study recruitment delayed due to COVID-19 restrictions, virtual screening of medical in-patients has confirmed the need and potential for the RP. Of 630 potential participants identified over a 6 week period, 196 patients (31%) met eligibility criteria-85 women and 79 men, mean (±SD) age 79 ± 11 years. Non-eligibility was largely due to non-chronic form of heart disease (34%), no comorbidity (23 %), and inability to give informed consent (15%). Conclusions: Preliminary data suggest that once commenced, we will rapidly recruit the requisite number of trial participants and depending on the results, we will be able to determine the cost-effectiveness of the RP to reduce seasonallyinduced admissions and mortality.