Covid19 Clinical Trial
Official title:
Comparative Effectiveness of Readmission Reduction Interventions for Individuals With Sepsis or Pneumonia
An adaptive platform trial to compare effectiveness of different care models to prevent readmissions for patients hospitalized with sepsis or lower respiratory tract infection. The primary outcome is number of days spent at home within 90 days after hospital discharge.
This study implements an adaptive platform trial to compare effectiveness of different care models to prevent readmissions for patients hospitalized with sepsis or lower respiratory tract infection and discharged to home (with or without a short stay in a skilled nursing facility prior to going home): structured telephone support (STS); low-intensity remote patient monitoring (RPM-Low); and high-intensity remote patient monitoring (RPM-High). The remote patient monitoring models will be staffed by a physician or a nurse (Standard Team) or by a dedicated nurse-practitioner (NP)-led multidisciplinary team (Enhanced Team). Patients will be randomized to one of five arms: STS, RPM-Low + Standard Team, RPM-Low + Enhanced Team, RPM-High + Standard Team, and RPM-High + Enhanced Team. Using response adaptive randomization (RAR), interim outcome results will be used to modify the random allocation of patients to each study arm. The primary outcome is number of days spent at home within 90 days after hospital discharge. Patient-reported functional status and quality of life data will be collected in addition to electronic health record (EHR) and claims-based data to measure health care utilization. Qualitative interviews with patients and providers will provide insight into the effectiveness of the implementation process. ;
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