STAR Program for Sepsis
(ASTROS Trial)
Recruiting in Palo Alto (17 mi)
Overseen byMarc A. Kowalkowski, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Wake Forest University Health Sciences
Disqualifiers: Change in code status, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the STAR Program for Sepsis treatment?
Research shows that patient-centered care transitions, which are part of the STAR Program, can improve patient outcomes and reduce hospital readmissions. Similar models have been effective in other conditions, like stroke and injury recovery, by enhancing care coordination and continuous management after hospital discharge.12345
Is the STAR Program for Sepsis safe for humans?
The available research on the STAR Program for Sepsis does not specifically address safety concerns, but it focuses on improving outcomes like reducing mortality and hospital readmissions for sepsis survivors. This suggests that the program is designed to enhance patient care without indicating any specific safety issues.678910
How is the STAR Program treatment different from usual care for sepsis?
Eligibility Criteria
This trial is for adults over 18 with suspected infection and signs of systemic inflammation, who've started antibiotics within 24 hours that continued for at least another day. They must have organ dysfunction indicated by SOFA scores or be at high risk of hospital readmission within 90 days.Inclusion Criteria
You present with two or more symptoms of systemic inflammatory response syndrome within 24 hours.
My organs are not functioning well according to a recent assessment.
I am 18 years old or older.
See 10 more
Exclusion Criteria
Actively participating in a different care management program documented in the electronic health record (EHR) at time of hospital admission
My treatment plan was changed within 24 hours of my initial assessment due to limitations in aggressive treatment and exposure to the STAR program.
I live more than 2.5 hours away from the hospital by car.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Pre-implementation
Qualitative evaluation to identify core functions necessary to maintain program effectiveness when implementing the STAR program in new settings
Varies
Treatment
Participants receive the Sepsis Transition and Recovery (STAR) program intervention, a 90-day, nurse-navigator-led program designed to facilitate transition/recovery after sepsis hospitalization
90 days
Virtual visits across the peri-hospital discharge interval
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of mortality and hospital readmission rates
90 days
Treatment Details
Interventions
- STAR Program (Behavioral Intervention)
- Usual Care (Behavioral Intervention)
Trial OverviewThe ASTROS study is testing the STAR Program against usual care to see if it improves recovery after sepsis in new hospital settings. It uses a multiple interrupted time series analysis to measure effectiveness as hospitals adopt the program.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Sepsis Transition and Recovery (STAR) programExperimental Treatment1 Intervention
Virtual sepsis navigation delivered across the peri-hospital discharge interval
Group II: Usual CareActive Control1 Intervention
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.
STAR Program is already approved in United States for the following indications:
🇺🇸 Approved in United States as Sepsis Transition and Recovery Program for:
- Post-sepsis care
- Sepsis recovery
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Atrium HealthCharlotte, NC
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Who Is Running the Clinical Trial?
Wake Forest University Health SciencesLead Sponsor
The Duke EndowmentCollaborator
References
Patient-Centered Care Transitions After Injury Hospitalization: A Comparative Effectiveness Trial. [2019]The investigation aimed to compare two approaches to the delivery of care for hospitalized injury survivors, a patient-centered care transition intervention versus enhanced usual care.
Effective Care Transitions: Reducing Readmissions to Improve Patient Care and Outcomes. [2023]Care transitions from one setting to another are vulnerable spaces where patients are susceptible to complications. Health systems, accountable care organizations, and payers recognize that care transition interventions are necessary to reduce unnecessary cost and utilization and improve patient outcomes following a hospitalization. Multiple care transition models exist, with varying degrees of intensity and success. This article describes a quality improvement project for a care transition model that incorporates key elements from the American Case Management Association's Transitions of Care Standards and the Transitional Care Management services as outlined by the Centers for Medicare & Medicaid Services.
The GeriPACT Initiative to Prevent All-Cause 30-Day Readmission in High Risk Elderly. [2021]Suboptimal care transitions increases the risk of adverse events resulting from poor care coordination among providers and healthcare facilities. The National Transition of Care Coalition recommends shifting the discharge paradigm from discharge from the hospital, to transfer with continuous management. The patient centered medical home is a promising model, which improves care coordination and may reduce hospital readmissions.
Methods guiding stakeholder engagement in planning a pragmatic study on changing stroke systems of care. [2020]The Comprehensive Post-Acute Stroke Services (COMPASS) Study is one of the first large pragmatic randomized-controlled clinical trials using comparative effectiveness research methods, funded by the Patient-Centered Outcomes Research Institute. In the COMPASS Study, we compare the effectiveness of a patient-centered, transitional care intervention versus usual care for stroke patients discharged home from acute care. Outcomes include stroke patient post-discharge functional status and caregiver strain 90 days after discharge, and hospital readmissions. A central tenet of Patient-Centered Outcomes Research Institute-funded research is stakeholder engagement throughout the research process. However, evidence on how to successfully implement a pragmatic trial that changes systems of care in combination with robust stakeholder engagement is limited. This combination is not without challenges.
Integrating patient care delivery. [2019]Concepts of coordinated care, case management, and continuous quality improvement were applied by a medical center nursing service to improve continuity and coordination of patient care between inpatient and outpatient programs. Quality and cost outcomes are presented for a pilot project with a total hip replacement population.
Passing the SNF Test: A Secondary Analysis of a Sepsis Transition Intervention Trial Among Patients Discharged to Post-Acute Care. [2023]Sepsis survivors discharged to post-acute care facilities experience high rates of mortality and hospital readmission. This study compared the effects of a Sepsis Transition and Recovery (STAR) program vs usual care (UC) on 30-day mortality and hospital readmission among sepsis survivors discharged to post-acute care.
Effect of a Multicomponent Sepsis Transition and Recovery Program on Mortality and Readmissions After Sepsis: The Improving Morbidity During Post-Acute Care Transitions for Sepsis Randomized Clinical Trial. [2023]To evaluate whether a nurse navigator-led, multicomponent Sepsis Transition And Recovery program improves 30-day mortality and readmission outcomes after sepsis hospitalization.
Protocol for a two-arm pragmatic stepped-wedge hybrid effectiveness-implementation trial evaluating Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship (ENCOMPASS). [2023]Sepsis survivors experience high morbidity and mortality, and healthcare systems lack effective strategies to address patient needs after hospital discharge. The Sepsis Transition and Recovery (STAR) program is a navigator-led, telehealth-based multicomponent strategy to provide proactive care coordination and monitoring of high-risk patients using evidence-driven, post-sepsis care tasks. The purpose of this study is to evaluate the effectiveness of STAR to improve outcomes for sepsis patients and to examine contextual factors that influence STAR implementation.
The effects of implementation of the Surviving Sepsis Campaign in the Netherlands. [2022]To reduce unintentional and avoidable adverse events in patients in hospitals in the Netherlands, a patient safety agency (VMS) programme was launched in 2008. Among the VMS topics, the programme 'optimal therapy in severe sepsis', according to the international Surviving Sepsis Campaign (SSC), aims to improve early diagnosis and treatment of sepsis to reduce sepsis mortality by 15% before the end of 2012. We analysed compliance data submitted to the international SSC database from the Netherlands and compared these data with published international SS C results. Data of 863 patients, representing 6% of the international data (n=14,209), were used for analysis. In the Netherlands, the resuscitation bundle compliance improved significantly from 7% at baseline to 27% after two years (p=0.002). Internationally, the resuscitation bundle compliance increased significantly from 11 to 31% (p.
Implementation of the Affordable Care Act: A Comparison of Outcomes in Patients With Severe Sepsis and Septic Shock Using the National Inpatient Sample. [2021]Sepsis is the most common and costly diagnosis in U.S.' hospitals. Despite quality improvement programs and heightened awareness, sepsis accounts for greater than 50% of all hospital deaths. A key modifier of outcomes is access to healthcare. The Affordable Care Act, passed in 2010, expanded access to health insurance coverage. The purpose of this study was to evaluate changes in insurance coverage and outcomes in patients with severe sepsis and septic shock as a result of the full implementation of the Affordable Care Act.
Evaluation of Adult Patients Readmitted for Severe Sepsis/Septic Shock Under the BPCI Advanced Program. [2023]Bundled Payments for Care Improvement-Advanced Program (BPCI-A) is designed to pay a single payment covering services provided during an episode of care. Sepsis is associated with increased readmissions, mortality, and health care costs. The purpose of the study was to evaluate the BPCI program patients with sepsis who were readmitted within 90 days versus not readmitted. This was a retrospective cohort study including 271 (110 readmitted) patients enrolled in the BPCI program with Diagnostic-Related Grouping codes of septicemia or severe sepsis. Skin/soft tissue infection was the most common infection. There was a significant difference between the groups for resource needs at discharge including wound care (25.45% versus 11.18%; P = 0.002) and physical therapy (74.55% versus 57.14%; P = 0.004). Mortality was higher among readmissions, 43.64% versus 26.71% no readmission ( P = 0.004). Identifying risk factors for readmission, providing appropriate resources, and follow-up may contribute to improved patient outcomes for patients with sepsis enrolled in the BPCI program.
Improving transitions and outcomes of sepsis survivors (I-TRANSFER): a type 1 hybrid protocol. [2023]This protocol is based on home health care (HHC) best practice evidence showing the value of coupling timely post-acute care visits by registered nurses and early outpatient provider follow-up for sepsis survivors. We found that 30-day rehospitalization rates were 7 percentage points lower (a 41% relative reduction) when sepsis survivors received a HHC nursing visit within 2 days of hospital discharge, at least 1 more nursing visit the first week, and an outpatient provider follow-up visit within 7 days compared to those without timely follow-up. However, nationwide, only 28% of sepsis survivors who transitioned to HHC received this timely visit protocol. The opportunity exists for many more sepsis survivors to benefit from timely home care and outpatient services. This protocol aims to achieve this goal. METHODS: Guided by the Consolidated Framework for Implementation Research, this Type 1 hybrid pragmatic study will test the effectiveness of the Improving Transitions and Outcomes of Sepsis Survivors (I-TRANSFER) intervention compared to usual care on 30-day rehospitalization and emergency department use among sepsis survivors receiving HHC. The study design includes a baseline period with no intervention, a six-month start-up period followed by a one-year intervention period in partnership with five dyads of acute and HHC sites. In addition to the usual care/control periods from the dyad sites, additional survivors from national data will serve as control observations for comparison, weighted to produce covariate balance. The hypotheses will be tested using generalized mixed models with covariates guided by the Andersen Behavioral Model of Health Services. We will produce insights and generalizable knowledge regarding the context, processes, strategies, and determinants of I-TRANSFER implementation.