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

Trial Summary

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

How is the STAR Program treatment different from usual care for sepsis?

The STAR Program is unique because it is a nurse navigator-led, telehealth-based strategy that focuses on proactive care coordination and monitoring of high-risk sepsis patients after hospital discharge, aiming to improve outcomes like mortality and readmission rates. ^{6 7 8 11 12}

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.

Research Team

Marc A. Kowalkowski, PhD

Principal Investigator

Wake Forest University Health Sciences

Sarah Birken, PhD

Principal Investigator

Wake Forest University Health Sciences

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 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

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
• 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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Patient-Centered Care Transitions After Injury Hospitalization: A Comparative Effectiveness Trial. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Effective Care Transitions: Reducing Readmissions to Improve Patient Care and Outcomes. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The GeriPACT Initiative to Prevent All-Cause 30-Day Readmission in High Risk Elderly. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Methods guiding stakeholder engagement in planning a pragmatic study on changing stroke systems of care. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Integrating patient care delivery. [2019]

6. United States 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. [2023]

7. United States 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. [2023]

8. England 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). [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

The effects of implementation of the Surviving Sepsis Campaign in the Netherlands. [2022]

10. United States 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. [2021]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of Adult Patients Readmitted for Severe Sepsis/Septic Shock Under the BPCI Advanced Program. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Improving transitions and outcomes of sepsis survivors (I-TRANSFER): a type 1 hybrid protocol. [2023]