Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up
The Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up (ASTROS) study is an effectiveness-implementation hybrid design. The effectiveness evaluation is designed as a multiple interrupted time series (mITS) analysis to test the impact of implementing an adapted Sepsis Transition and Recovery (STAR) program on enhancing post sepsis outcomes in new hospital settings.
Conditions:
🦠 Sepsis
🗓️ Study Start (Actual) 16 January 2024
🗓️ Primary Completion (Estimated) September 2025
✅ Study Completion (Estimated) September 2025
👥 Enrollment (Estimated) 1280
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Charlotte, North Carolina, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * adults 18 years of age and older;
    • * clinically suspected infection
    • 1. two or more markers of systemic inflammatory response syndrome within 24 h of presentation; AND
    • 2. antibiotics initiated within 24 hours and continued for at least one additional day
    • * organ dysfunction
    • 1. two or more points on admission Sequential Organ Failure Assessment (SOFA); OR
    • 2. two or more points on admission quick-SOFA
    • * deemed to be at high risk of hospital readmission within 90 days, defined as readmission risk probability of at least 25%
    • * not discharged from the hospital at the time of patient identification each morning.

    Exclusion Criteria:

    • * change in code status (i.e., initially full code followed by change to do not resuscitate and/or do not intubate) within 24 hours after index presentation due to presumed limitation of aggressive treatment and exposure to STAR program components;
    • * reside \> 2.5 hours drive time from the treating hospital due to the maximum reach of the community services leveraged within the STAR program and the general assumption that these patients may have less comprehensive utilization tracking within available electronic record systems for study outcomes;
    • * are actively participating in a different care management program (e.g., cancer care patient navigation) documented in the electronic health record (EHR) at time of hospital admission.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 10 August 2023
  • First Submitted that Met QC Criteria 16 August 2023
  • First Posted 18 August 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 January 2024
  • Last Update Posted 31 January 2024
  • Last Verified August 2023