Comparative Effectiveness of Readmission Reduction Interventions for Individuals with Sepsis or Pneumonia

Last updated: January 14, 2025
Sponsor: University of Pittsburgh
Overall Status: Completed

Phase

N/A

Condition

Pneumonia

Soft Tissue Infections

Treatment

High-intensity Remote Patient Monitoring (RPM-High)

Structured Telephone Support (STS)

Standard Response Team

Clinical Study ID

NCT04829188
STUDY20080130
  • Ages > 21
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • UPMC Health Plan members

  • Medicare Fee-for-Service enrollees

  • Age 21+ -Hospitalized with a primary diagnosis of sepsis or lower respiratory tractinfection, --

  • Discharged to home, independent living facility, or skilled nursing facility

  • Readmission risk is moderate or high

Exclusion

Exclusion Criteria:

  • Admitted from hospice;

  • Discharged to hospice, inpatient rehabilitation, or a long term acute care facility;

  • Known to be pregnant;

  • Current enrollment in another remote patient monitoring program;

  • Failure of the Callahan 6 item cognitive screen and do not have a proxy to consent;

  • No access to a technological device required to participate in remote patientmonitoring program;

  • Current enrollment in UPMC Advanced Illness Care program;

  • Severe, persistent cognitive impairment;

  • No documented PCP;

  • PCP disapproves of the patient being enrolled in remote patient monitoring;

  • Discharged from hospital to skilled nursing facility and stay at the skilled nursingfacility for greater than 28 days

Study Design

Total Participants: 1288
Treatment Group(s): 5
Primary Treatment: High-intensity Remote Patient Monitoring (RPM-High)
Phase:
Study Start date:
March 30, 2021
Estimated Completion Date:
December 15, 2024

Study 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): 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.

Connect with a study center

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

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