CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,288 enrolled
Drug / intervention
Structured Telephone Support (STS) +4 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04829188
NCT04829188N/ACompleted

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

University of Pittsburgh·interventional·Posted Apr 2, 2021·Updated Jan 16, 2025

In Brief

A clinical study evaluating Structured Telephone Support (STS), Low-intensity Remote Patient Monitoring (RPM-Low), and 3 other interventions for Sepsis and 3 related conditions. Completed, enrolled 1,288 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedApr 2, 2021
Enrollment StartMar 30, 2021
Primary CompletionDec 15, 2024
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 5.3 years ago

Interventions

Structured Telephone Support (STS)behavioral

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.

Low-intensity Remote Patient Monitoring (RPM-Low)behavioral

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.

High-intensity Remote Patient Monitoring (RPM-High)behavioral

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.

Standard Response Teambehavioral

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.

Enhanced Response Teambehavioral

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.