Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up (ASTROS)

Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up (ASTROS)

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.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Behavioral: STAR Program; Behavioral: Usual Care

Detailed Description

Approximately 1.4 million survivors of sepsis (life-threatening organ dysfunction due to infection) are discharged from U.S. hospitals annually, facing high rates of long-term mortality and morbidity as well as incurring high costs to healthcare systems. To improve outcomes and address disparities, this study developed a multicomponent Sepsis Transition and Recovery (STAR) intervention that leverages real-time advanced analytics to identify high-risk patients who are most likely to benefit from sepsis-specific transitional support. STAR is a 90-day, nurse-navigator-led program designed to facilitate transition/recovery after sepsis hospitalization. Navigators provide disease education, help patients overcome medical-system barriers to recommended care, and bridge gaps in service that serve as points of failure for complex sepsis patients. STAR specifically targets delivery of best-practice post-sepsis care including: i) medication optimization, ii) screening for new impairments, iii) anticipation/mitigation of risk for health deterioration, and iv) palliative care when appropriate. STAR is the only intervention to date supported by randomized, controlled trial evidence to improve outcomes for sepsis survivors.

Despite rigorous data supporting STAR program effectiveness in its initial context, there are significant differences in healthcare infrastructure and resources at different sites that require careful adaptation prior to implementation to retain effectiveness. More research is needed to identify STAR's core functions (i.e., the subset of an intervention's features that are causally related to outcomes; to be distinguished from features that may be adapted without compromising intervention's effectiveness and may enhance effectiveness by promoting proficient/consistent use in new contexts), study the implementation process, and evaluate STAR performance in new contexts. The goal of this project is to examine strategies to optimize the STAR program to fit well in other settings.

• Study Type: Interventional
• Enrollment (Actual): 1820
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Atrium Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sepsis Transition and Recovery (STAR) program; Virtual sepsis navigation delivered across the peri-hospital discharge interval	Behavioral: STAR Program; In the STAR program intervention, a centrally located nurse navigator facilitates the application of four evidence-based core components of post-sepsis care (i.e., review of medications, new impairments, comorbidities, and palliative care) to patients prior to and during the 90 days after hospital discharge. The STAR navigator will provide telephone and EHR-based support within the hospitalization and to patients across all discharge settings with remote monitoring at specified intervals following hospital discharge. Patients will continue to receive STAR directed services for 90 days following their discharge and then will be transitioned back to the next appropriate care location.
Active Comparator: Usual Care; Standard of care received through each facility for patients hospitalized with sepsis. Aspects of usual care will be determined by treating clinicians independent of trial assignment.	Behavioral: Usual Care; Hospitals and their patients will not have access to the STAR program. Patients will continue to receive usual care throughout their stay and discharge, consisting of: patient education and follow-up instructions at discharge, which are not specific to sepsis; routine recommendations for follow-up visits with primary care providers; arrangements for home health services or care management follow-up based on each patient's needs but not specifically tailored to the sepsis population; discharge to post-acute setting with no sepsis-specific follow-up. All aspects of usual care will be determined by treating clinicians independent of trial assignment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality and hospital readmission rate	Binary composite endpoint of mortality and hospital readmission assessed 90 days post index hospital discharge	day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of hospital free days	Continuous composite endpoint of days alive and outside of the hospital assessed 90 days post index hospital discharge	day 90
All-cause mortality rate	Binary endpoint of all-cause mortality rate assessed 90 days post index hospital discharge	day 90
All-cause hospital readmission rate	Binary endpoint of all-cause readmission rate assessed 90 days post index hospital discharge	day 90
Acute care-related costs	Healthcare costs attributed to care received at emergency department, observation, and inpatient encounters during follow-up	day 90

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative assessment of the core functions of the STAR program	Open-ended, qualitative evaluation to identify core functions necessary to maintain program effectiveness when implementing the STAR program in new settings	Pre-implementation
Qualitative assessment of the adaptable "forms" for implementing the STAR program	Open-ended, qualitative evaluation to identify potential adaptations that are important to implementing the STAR program in new settings	Pre-implementation
Number of providers included in STAR program adoption	Number of hospital attending providers with patients enrolled in STAR	Up to 2 years
Number of eligible patients reached by STAR program	Total number of patients who received the intervention	Up to 2 years
Proportion of patients with STAR program intervention delivered as intended	Quantitative assessment of fidelity to completion of key intervention components (e.g., medication reconciliation, physical and mental health screenings, goals-of-care documentation)	Up to 2 years

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: The Duke Endowment
• Investigators: Principal Investigator: Marc A. Kowalkowski, PhD, Wake Forest University Health Sciences; Principal Investigator: Sarah Birken, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2024
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: August 10, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: mortality; survivorship; care transitions; hospital readmission; critical illness recovery
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis
• Other Study ID Numbers: IRB00087673; 7056-SP (Other Grant/Funding Number: The Duke Endowment)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No