Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • COVID-19
  • Lower Resp Tract Infection
  • Pneumonia
  • Sepsis
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Investigator, Outcomes Assessor)Primary Purpose: Health Services Research

Participation Requirements

Age
Between 21 years and 125 years
Gender
Both males and females

Description

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...

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.

Tracking Information

NCT #
NCT04829188
Collaborators
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Namita Ahuja Yende, MD UPMC Health Plan Principal Investigator: Sachin Yende, MD University of Pittsburgh