Remote Monitoring Approaches to Reduce Readmissions After Infection and Sepsis: A Randomized Clinical Trial.

Importance: The Centers for Medicare & Medicaid Services reimburses remote monitoring to reduce hospital readmissions, yet its effectiveness remains uncertain. Objective: To evaluate effectiveness of remote monitoring in reducing readmissions following hospitalizations for serious infections overall and across prespecified subgroups. Design, Setting, and Participants: This randomized clinical trial was conducted from March 25, 2021, to December 9, 2024, using response adaptive randomization among postdischarge patients with sepsis or lower respiratory tract infection across 19 hospitals. Eligible patients were 21 years or older, lived in western Pennsylvania, were insured through the UPMC Health Plan or traditional fee-for-service Medicare, had a smartphone or other internet-connected device, had no cognitive impairment, and were at moderate or high risk for readmission at index hospitalization admission based on an internal predictive model. Analyses were based on intention to treat; data were analyzed from April to June 2025. Intervention: Four remote monitoring strategies combining questionnaire intensity (low vs high) and clinical response teams (standard vs enhanced) compared with usual care. Main Outcomes and Measures: The primary end point consisted of days at home at 90 days after discharge, assessed by posterior probability distribution for the cumulative odds ratios (CORs) in each study arm compared with usual care. Secondary end points included mortality, readmission, functional status, quality of life, and use of emergency department and hospice services. Results: Among the 1286 patients included in the analysis, the median age was 63 (IQR, 54-71) years; 665 patients (51.7%) were female. The median Charlson Comorbidity Index was 6 (IQR, 3-9), and 386 patients (32.6%) received intensive care. Patients were randomized to usual care (n = 399) or remote patient monitoring (RPM) with low- or high-intensity questionnaires and standard or enhanced clinical response team combinations: RPM-low standard response (n = 204), RPM-high standard response (n = 129), RPM-low enhanced response (n = 383), and RPM-high enhanced response (n = 171). Of 887 patients assigned to remote monitoring arms, 529 (59.6%) enrolled in the remote monitoring program. The median home days were similar across all study arms: 90 (IQR, 83-90) for usual care, 90 (IQR, 84-90) for RPM-low standard response, 90 (IQR, 85-90) for RPM-high standard response, 90 (IQR, 83-90) for RPM-low enhanced response, and 90 (IQR, 84-90) for RPM-high enhanced response. Compared with usual care, the CORs were 0.96 (credible interval [CrI], 0.70-1.32) for RPM-low standard response, 0.86 (95% CrI, 0.60-1.23) for RPM-high standard response, 1.01 (95% CrI, 0.76-1.33) for RPM-low enhanced response, and 0.96 (95% CrI, 0.69-1.36) for RPM-high enhanced response, and superiority probability was less than 55% for all comparisons. At least 1 readmission occurred in 151 of 399 patients (37.8%) in the usual care arm, 81 of 204 (39.7%) in the RPM-low standard response arm, 57 of 129 (44.2%) in the RPM-high standard response arm, 143 of 383 (37.3%) in the RPM-low enhanced response arm, and 62 of 171 (36.3%) in the RPM-high enhanced response arm. Among patients 65 years and older, standard and enhanced response arms had fewer home days compared with usual care (COR, 0.56 [95% CrI, 0.36-0.85] and 0.67 [95% CrI, 0.45-0.98], respectively; inferiority probability, 99.6% and 97.9%, respectively). Conclusions and Relevance: Among trial patients discharged after hospitalization for serious infections, remote monitoring did not increase time spent alive at home but reduced it in those 65 years and older. These findings support reevaluating and tailoring remote monitoring after acute care for sepsis and lower respiratory tract infection to support further alignment with patients' needs and desire for personalized monitoring. Trial Registration: ClinicalTrials.gov Identifier: NCT04829188.