Improving recovery for sepsis patients after hospital discharge
Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up (ASTROS)
This study is testing a new support program for people recovering from sepsis after leaving the hospital to see if it helps them stay healthier and live longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1280 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Charlotte, North Carolina) |
| Trial ID | NCT05997420 on ClinicalTrials.gov |
What this trial studies
The ASTROS study aims to enhance post-sepsis outcomes by implementing an adapted Sepsis Transition and Recovery (STAR) program in new hospital settings. This program utilizes real-time analytics to identify high-risk patients and provides a 90-day, nurse-navigator-led intervention that includes disease education, medication optimization, and support for overcoming barriers to care. The study employs a multiple interrupted time series analysis to evaluate the effectiveness of the STAR program compared to usual care, addressing the unique healthcare infrastructure at different sites. By focusing on best-practice post-sepsis care, the program seeks to reduce long-term mortality and morbidity among sepsis survivors.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with sepsis and are at high risk for hospital readmission.
Not a fit: Patients who have a change in code status shortly after presentation or live more than 2.5 hours from the treating hospital may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve recovery outcomes and reduce hospital readmissions for sepsis survivors.
How similar studies have performed: Previous studies have shown success with similar transitional care programs for sepsis survivors, indicating a promising approach to improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Charlotte, North Carolina
- Atrium Health — Charlotte, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Marc A. Kowalkowski, PhD — Wake Forest University Health Sciences
- Study coordinator: Marc Kowalkowski, PhD
- Email: Marc.Kowalkowski@AtriumHealth.org
- Phone: (704) 355-9902
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.