Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up

NCT05997420 | Completed

• 2 other identifiers: IRB000876737056-SP
• Study Type: interventional
• Target: 1,820
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

critical illness recovery; care transitions; survivorship; mortality; hospital readmission

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of hospital free days

  day 90

• All-cause mortality rate

  day 90

• All-cause hospital readmission rate

  day 90

• Acute care-related costs

  day 90

Other Outcomes (5)

• Qualitative assessment of the core functions of the STAR program

  Pre-implementation

• Qualitative assessment of the adaptable "forms" for implementing the STAR program

  Pre-implementation

• Number of providers included in STAR program adoption

  Up to 2 years

Study Arms (2)

Sepsis Transition and Recovery (STAR) program

EXPERIMENTAL

Virtual sepsis navigation delivered across the peri-hospital discharge interval

Behavioral: STAR Program

Usual Care

ACTIVE COMPARATOR

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

Interventions

STAR Program BEHAVIORAL

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.

Sepsis Transition and Recovery (STAR) program

Usual Care BEHAVIORAL

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.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults 18 years of age and older;
• clinically suspected infection
• two or more markers of systemic inflammatory response syndrome within 24 h of presentation; AND
• antibiotics initiated within 24 hours and continued for at least one additional day
• organ dysfunction
• two or more points on admission Sequential Organ Failure Assessment (SOFA); OR
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• The Duke Endowment: collaborator

Study Sites (1)

Atrium Health

Charlotte, North Carolina, 28203, United States

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc A. Kowalkowski, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Sarah Birken, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All hospitals begin the study under the usual care condition. The STAR intervention will be introduced to groups of hospitals at two separate time points approximately six months apart. The sequence of intervention introduction will not be randomized. Once STAR has been introduced at a study hospital, eligible patients will receive STAR during their index hospitalization and extending through 90 days from discharge or date of death.

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 18, 2023
• Study Start: January 16, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 29, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)