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

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.

Conditions

• Sepsis
• Pneumonia
• Lower Resp Tract Infection
• Covid19

Interventions

BEHAVIORAL

Structured Telephone Support (STS)

Structured telephone support (STS) consists of post-discharge assessment, education, and medication reconciliation delivered telephonically by a health plan case manager, home care as needed, and follow-up with the primary care within seven days post-discharge.

BEHAVIORAL

Low-intensity Remote Patient Monitoring (RPM-Low)

Questions are pushed to members multiple times per week for up to 90 days post-discharge. Questions are limited to those checking vital signs that indicate worsening of infection. Patient answers to RPM questions trigger High or Medium alerts, which trigger a response by members of the intervention care team.

BEHAVIORAL

High-intensity Remote Patient Monitoring (RPM-High)

Questions are pushed to members multiple times per week for up to 90 days post-discharge. Questions include monitoring vital signs for worsening infection but also ask about factors that would indicate worsening of underlying heart or lung conditions, such as weight gain or shortness of breath. Patient answers to RPM questions trigger High or Medium alerts, which trigger a response by members of the intervention care team.

BEHAVIORAL

Standard Response Team

RPM alerts are screened by a nurse-staffed call center. Nurses determine whether emergency care is needed. If not, nurses contact the patient and/or the patients' PCP or specialist to coordinate care and ensure timely follow-up.

BEHAVIORAL

Enhanced Response Team

RPM alerts are screened by a nurse-staffed call center. Nurses determine whether emergency care is needed. If not, the call center alerts a multidisciplinary care team that is led by a certified registered nurse practitioner (CRNP). CRNPs, who operate in a palliative care role, have prescribing authority and can modify care plans. In addition to reacting to RPM triggers, team members (e.g., CRNP, social workers, nurses) meet with the patient in-person or virtually in the week after discharge and at least twice more in the next 90 days, conduct assessments and a pharmacy review, develop care plans, and discuss advance directives.

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• University of Pittsburgh

  lead OTHER

Principal Investigators

• Kalpana Char, MD · UPMC Health Plan

• Sachin Yende, MD · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-30

Primary Completion

2024-12-15

Completion

2024-12-15

Countries

• United States

Study Locations