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 (1:1) 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 seasonally-induced admissions and mortality.