STAR Program for Sepsis

(ASTROS Trial)

Overseen By Marc Kowalkowski, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Change in code status, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 90 days

1280 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well the STAR (Sepsis Transition and Recovery) program aids recovery from sepsis after hospital discharge. Sepsis is a serious infection that can lead to organ failure, and the STAR program provides virtual support during the transition from hospital to home. Participants will either receive this specialized support or continue with the usual care provided by their hospitals. Individuals who have experienced a serious infection leading to hospitalization and are at risk of returning to the hospital soon may be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to understanding the role of virtual support in sepsis recovery.

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 prior data suggests that the STAR Program is safe for sepsis patients?

Research has shown that the Sepsis Transition and Recovery (STAR) program is generally well-received by participants. One study found that this program, which offers virtual support after a hospital stay for sepsis, helps people live longer. It significantly reduced deaths within 30 and 90 days after leaving the hospital. This suggests the program is likely safe, as better survival rates usually indicate fewer serious side effects. Another study confirmed that the STAR program lowers the risk of dying soon after hospital discharge. Reports of major negative effects were absent, which is a positive sign for safety. Overall, the STAR program seems to be a safe choice for those recovering from sepsis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The STAR Program for sepsis is unique because it offers a virtual sepsis navigation system that supports patients during the critical transition period from hospital to home. Unlike the standard care, which varies by facility and is determined by individual clinicians, the STAR Program provides a consistent and structured approach to managing recovery. Researchers are excited about this trial because it could improve patient outcomes by ensuring continuity of care and reducing the risk of complications after discharge. This innovative method leverages technology to provide personalized support, potentially transforming the recovery process for sepsis patients.

What evidence suggests that the STAR Program is effective for enhancing post sepsis outcomes?

Research has shown that the Sepsis Transition and Recovery (STAR) program, which participants in this trial may receive, can significantly aid sepsis recovery. Studies have found that patients in the STAR program had lower chances of dying or being readmitted to the hospital within 30 days compared to those who received usual care, another treatment arm in this trial. One study also found that the program reduced the risk of dying within 90 days. The STAR program includes a nurse who guides patients and uses telehealth, providing remote healthcare to support recovery. This approach has successfully improved long-term health for sepsis survivors. ^{1 3 4 6 7}

Who Is on the Research Team?

Marc A. Kowalkowski, PhD

Principal Investigator

Wake Forest University Health Sciences

Sarah Birken, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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 started antibiotics within a day and took them for at least another day.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• STAR Program
• Usual Care

Trial Overview The 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.

How Is the Trial Designed?

Group I: Sepsis Transition and Recovery (STAR) program Experimental Treatment 1 Intervention

Virtual sepsis navigation delivered across the peri-hospital discharge interval

Group II: Usual Care Active Control 1 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

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

The Duke Endowment

Collaborator

Trials

17

Recruited

48,100+

Published Research Related to This Trial

Implementing a proactive telehealth follow-up system for geriatric patients at the Tennessee Valley Healthcare System led to a significant reduction in 30-day all-cause readmissions, decreasing from 21% to 13% during the intervention period.

The use of Plan, Do, Study, Act (PDSA) cycles and data sharing among care teams improved care coordination and accountability, contributing to better management of high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The GeriPACT Initiative to Prevent All-Cause 30-Day Readmission in High Risk Elderly. Powers, JS., Abraham, L., Parker, R., et al.[2021]

The COMPASS Study is a large pragmatic randomized-controlled trial that aims to compare a patient-centered transitional care intervention with usual care for stroke patients, focusing on outcomes like functional status and caregiver strain 90 days post-discharge.

The study emphasizes robust stakeholder engagement, involving patients, caregivers, and community stakeholders, to enhance the effectiveness of the trial and address gaps in existing literature on stakeholder involvement in pragmatic research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methods guiding stakeholder engagement in planning a pragmatic study on changing stroke systems of care. Gesell, SB., Klein, KP., Halladay, J., et al.[2020]

The STAR program, a telehealth-based strategy for sepsis survivors, aims to improve post-discharge outcomes by providing proactive care coordination and monitoring, with a planned enrollment of 4032 patients over 36 months.

This study will evaluate the effectiveness of STAR in reducing hospital readmissions and mortality within 90 days of discharge, while also examining factors that influence its implementation across eight hospitals in North Carolina.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a two-arm pragmatic stepped-wedge hybrid effectiveness-implementation trial evaluating Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship (ENCOMPASS). Kowalkowski, M., Eaton, T., McWilliams, A., et al.[2023]

In a study of 271 patients with sepsis enrolled in the Bundled Payments for Care Improvement-Advanced Program, those who were readmitted within 90 days had a significantly higher mortality rate (43.64%) compared to those who were not readmitted (26.71%).

Patients who were readmitted also had greater resource needs at discharge, such as wound care (25.45% vs. 11.18%) and physical therapy (74.55% vs. 57.14%), highlighting the importance of identifying risk factors and providing adequate resources to improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Adult Patients Readmitted for Severe Sepsis/Septic Shock Under the BPCI Advanced Program. Crabtree, PA., Bach, H., Del Fierro, E., et al.[2023]

A pilot project at a medical center focused on improving patient care continuity and coordination for total hip replacement patients through coordinated care and case management.

The project aimed to enhance quality and cost outcomes, demonstrating the potential benefits of applying continuous quality improvement strategies in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating patient care delivery. Holle, ML., Rick, C., Sliefert, MK., et al.[2019]

A nurse navigator-led Sepsis Transition And Recovery program significantly reduced the combined rate of 30-day mortality and hospital readmissions among high-risk sepsis patients, with 28.7% of participants in the program experiencing these outcomes compared to 33.3% in the usual care group.

The program also resulted in fewer deaths (9.5% vs 12.0%) and rehospitalizations (20.3% vs 24.6%), indicating that structured postsepsis care can improve patient outcomes after hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Taylor, SP., Murphy, S., Rios, A., et al.[2023]

A quality improvement project demonstrated that a collaborative care transition model, involving a nurse care manager and primary care provider, can enhance patient outcomes and reduce complications after hospitalization.

Key interventions such as medication reconciliation, addressing social needs, and coordinated follow-up are crucial for effective care transitions, particularly for patients at high risk of readmission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective Care Transitions: Reducing Readmissions to Improve Patient Care and Outcomes. Kinard, T., Brennan-Cook, J., Johnson, S., et al.[2023]

A patient-centered care transition intervention for hospitalized injury survivors led to significant reductions in severe postinjury concerns compared to enhanced usual care, with 53% of intervention patients reporting severe concerns at six months versus 74% in the control group.

The intervention also resulted in lower emergency department visits within three to six months (16.5% for intervention vs. 30.2% for control), suggesting improved care management, although it did not significantly affect symptomatic or functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered Care Transitions After Injury Hospitalization: A Comparative Effectiveness Trial. Zatzick, D., Russo, J., Thomas, P., et al.[2019]

The STAR program, a nurse-navigator-led intervention, showed a potential reduction in 30-day mortality and hospital readmission rates among sepsis survivors discharged to post-acute care, with 20.5% readmission in the STAR group compared to 29.9% in usual care.

In the study of 175 sepsis survivors, the STAR program resulted in lower all-cause mortality (5.7% vs. 8.1%) and readmission rates (17.1% vs. 26.4%) compared to usual care, suggesting it may be an effective strategy for improving outcomes in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Passing the SNF Test: A Secondary Analysis of a Sepsis Transition Intervention Trial Among Patients Discharged to Post-Acute Care. Colucciello, NA., Kowalkowski, MA., Kooken, M., et al.[2023]

Timely home health care (HHC) visits for sepsis survivors, including a nursing visit within 2 days of discharge and follow-up within 7 days, can significantly reduce 30-day rehospitalization rates by 41%.

The I-TRANSFER study aims to evaluate the effectiveness of this timely care protocol compared to usual care, potentially improving health outcomes for sepsis survivors, as only 28% currently receive such timely follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving transitions and outcomes of sepsis survivors (I-TRANSFER): a type 1 hybrid protocol. O'Connor, M., Kennedy, EE., Hirschman, KB., et al.[2023]

A patient safety program in the Netherlands aimed at improving the early diagnosis and treatment of severe sepsis led to a significant increase in compliance with the resuscitation bundle from 7% to 27% over two years, indicating improved patient care.

The Netherlands' compliance improvement was notable compared to international data, which showed an increase from 11% to 31%, suggesting that targeted programs can enhance adherence to sepsis treatment protocols and potentially reduce mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of implementation of the Surviving Sepsis Campaign in the Netherlands. Tromp, M., Tjan, DH., van Zanten, AR., et al.[2022]

The implementation of the Affordable Care Act led to a significant increase in Medicaid coverage (4.75%) and a decrease in uninsured patients (1.91%), which correlated with improved outcomes for patients with severe sepsis and septic shock.

In-hospital mortality rates for severe sepsis decreased from 22.90% to 18.59% after the Affordable Care Act, with the greatest reduction seen in Medicaid patients, who also experienced shorter hospital stays by an average of 2.45 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of the Affordable Care Act: A Comparison of Outcomes in Patients With Severe Sepsis and Septic Shock Using the National Inpatient Sample. Chinai, B., Gaughan, J., Schorr, C.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10229099/

Effect of a Multicomponent Sepsis Transition and Recovery ... A nurse navigator-led, multicomponent Sepsis Transition And Recovery program improves 30-day mortality and readmission outcomes after sepsis hospitalization.

2. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/article-abstract/2837200

Proactive Telehealth-Based Sepsis Transition and ... Objective To evaluate the effect of a sepsis transition and recovery (STAR) program compared with usual care on postdischarge outcomes.

3. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-025-05585-3

Effectiveness of targeted post-acute interventions and follow ... In total, seven studies evaluated the effect of care coordination and bundle approaches on sepsis long-term outcome including 171,550 patients.

4. mcknights.com mcknights.com/news/sepsis-recovery-program-saves-lives-but-doesnt-prevent-hospital-returns/

Sepsis recovery program saves lives but doesn't prevent ... When the outcomes were examined separately, however, the study found a significant drop in deaths among STAR participants. The 90-day mortality ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12060418/

Leveraging inter-organizational networks to scale up a sepsis ... We demonstrated improved outcomes following discharge among sepsis survivors who participated in the Sepsis Transition And Recovery (STAR) ...

6. researchgate.net researchgate.net/figure/Sepsis-Transition-and-Recovery-STAR-program-description-The-scheduled-touchpoints-for_fig2_337639319

Sepsis Transition and Recovery (STAR) program ... This systematic review aims to compile the present evidence on the effectiveness of post-acute interventions and follow-up services on patient-relevant long- ...

7. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-021-06521-1

Protocol for a two-arm pragmatic stepped-wedge hybrid ... We developed the Sepsis Transition and Recovery (STAR) program to address persistent morbidity and mortality for sepsis survivors. The STAR ...