Proactive Telehealth-Based Sepsis Transition and Recovery Support, Hospital Readmission, and Mortality: A Randomized Clinical Trial.

Abstract

Sepsis survivors experience high morbidity and mortality after discharge, but health systems lack effective approaches to improve recovery. To evaluate the effect of a sepsis transition and recovery (STAR) program compared with usual care on postdischarge outcomes. The ENCOMPASS (Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship) stepped-wedge cluster randomized clinical trial was conducted among adults hospitalized with sepsis at 7 US hospitals in a single health care system from July 2020 to June 2023. Each hospital was a cluster, with 1 randomly transitioning to STAR every 4 months. Follow-up ended in December 2023. The STAR program was a navigator-led, telehealth-based strategy to proactively deliver evidence-driven postsepsis care to high-risk patients for 90 days after discharge. The primary outcome was the composite of all-cause hospital readmission or mortality within 90 days of discharge. Of 3548 patients enrolled, 1843 (52%) were women, and the median (IQR) age was 68 (57-77) years; 1160 (33%) were admitted to the intensive care unit. A total of 1426 patients were randomized to the usual care group and 2122 patients were randomized to the STAR group. In the STAR group, 1393 patients (66%) engaged with the STAR program at least once after discharge. The composite all-cause readmission or mortality at 90 days did not differ between the STAR and usual care groups (1023 [48.2%] vs 684 [48.0%]; adjusted odds ratio, 1.05; 95% CI, 0.90-1.24; P = .53). Analysis of the outcomes separately demonstrated a lower frequency of death among patients in the STAR group compared with those in the usual care group (367 [17.3%] vs 292 [20.5%]; adjusted odds ratio, 0.88; 95% CI, 0.77-0.99; P = .04) and a higher frequency of readmission among patients in the STAR group (763 [35.9%] vs 478 [33.5%]; adjusted odds ratio, 1.13; 95% CI, 0.92-1.38; P = .24). In this randomized clinical trial, a multicomponent, navigator-led STAR program did not reduce the composite of all-cause readmission and mortality at 90 days after discharge. ClinicalTrials.gov Identifier: NCT04495946.