SepsisASTROSNCT05997420
Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up
A study testing STAR Program in people with Sepsis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- STAR Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,820 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up (ASTROS)
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.
Read the detailed description
Approximately 1.4 million survivors of sepsis (life-threatening organ dysfunction due to infection) are discharged from U.S. hospitals annually, facing high rates of long-term mortality and morbidity as well as incurring high costs to healthcare systems. To improve outcomes and address disparities, this study developed a multicomponent Sepsis Transition and Recovery (STAR) intervention that leverages real-time advanced analytics to identify high-risk patients who are most likely to benefit from sepsis-specific transitional support. STAR is a 90-day, nurse-navigator-led program designed to facilitate transition/recovery after sepsis hospitalization. Navigators provide disease education, help patients overcome medical-system barriers to recommended care, and bridge gaps in service that serve as points of failure for complex sepsis patients. STAR specifically targets delivery of best-practice post-sepsis care including: i) medication optimization, ii) screening for new impairments, iii) anticipation/mitigation of risk for health deterioration, and iv) palliative care when appropriate. STAR is the only intervention to date supported by randomized, controlled trial evidence to improve outcomes for sepsis survivors.
Despite rigorous data supporting STAR program effectiveness in its initial context, there are significant differences in healthcare infrastructure and resources at different sites that require careful adaptation prior to implementation to retain effectiveness. More research is needed to identify STAR's core functions (i.e., the subset of an intervention's features that are causally related to outcomes; to be distinguished from features that may be adapted without compromising intervention's effectiveness and may enhance effectiveness by promoting proficient/consistent use in new contexts), study the implementation process, and evaluate STAR performance in new contexts. The goal of this project is to examine strategies to optimize the STAR program to fit well in other settings.
- Conditions
- Sepsis
- Being tested
- STAR Program, Usual Care
- Keywords
- critical illness recovery, care transitions, survivorship, mortality, hospital readmission
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAR ProgramBehavioural
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.
Usual CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis Transition and Recovery (STAR) program | Experimental | Virtual sepsis navigation delivered across the peri-hospital discharge interval Receives: 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. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality and hospital readmission rate
Binary composite endpoint of mortality and hospital readmission assessed 90 days post index hospital discharge
Measured: day 90
Secondary outcomes (4)
Number of hospital free days
Continuous composite endpoint of days alive and outside of the hospital assessed 90 days post index hospital discharge
Measured: day 90
All-cause mortality rate
Binary endpoint of all-cause mortality rate assessed 90 days post index hospital discharge
Measured: day 90
All-cause hospital readmission rate
Binary endpoint of all-cause readmission rate assessed 90 days post index hospital discharge
Measured: day 90
Acute care-related costs
Healthcare costs attributed to care received at emergency department, observation, and inpatient encounters during follow-up
Measured: day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start16 Jan 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,820 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The Duke Endowment
- Responsible party
- Sponsor
- Investigators
- Marc A. Kowalkowski, PhD, Principal investigator, Wake Forest University Health SciencesSarah Birken, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997420
- Sponsor's protocol ID
- IRB00087673
- Other IDs
- 7056-SP
- Acronym
- ASTROS
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2023
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up (ASTROS)
- ClinicalTrials.gov ID
- NCT05997420
- Acronym / sponsor ID
- ASTROS / IRB00087673
- Conditions
- Sepsis
- Keywords
- critical illness recovery, care transitions, survivorship, mortality, hospital readmission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,820 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- The Duke Endowment
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately 1.4 million survivors of sepsis (life-threatening organ dysfunction due to infection) are discharged from U.S. hospitals annually, facing high rates of long-term mortality and morbidity as well as incurring high costs to healthcare systems. To improve outcomes and address disparities, this study developed a multicomponent Sepsis Transition and Recovery (STAR) intervention that leverages real-time advanced analytics to identify high-risk patients who are most likely to benefit from sepsis-specific transitional support. STAR is a 90-day, nurse-navigator-led program designed to facilitate transition/recovery after sepsis hospitalization. Navigators provide disease education, help patients overcome medical-system barriers to recommended care, and bridge gaps in service that serve as points of failure for complex sepsis patients. STAR specifically targets delivery of best-practice post-sepsis care including: i) medication optimization, ii) screening for new impairments, iii) anticipation/mitigation of risk for health deterioration, and iv) palliative care when appropriate. STAR is the only intervention to date supported by randomized, controlled trial evidence to improve outcomes for sepsis survivors.
Despite rigorous data supporting STAR program effectiveness in its initial context, there are significant differences in healthcare infrastructure and resources at different sites that require careful adaptation prior to implementation to retain effectiveness. More research is needed to identify STAR's core functions (i.e., the subset of an intervention's features that are causally related to outcomes; to be distinguished from features that may be adapted without compromising intervention's effectiveness and may enhance effectiveness by promoting proficient/consistent use in new contexts), study the implementation process, and evaluate STAR performance in new contexts. The goal of this project is to examine strategies to optimize the STAR program to fit well in other settings.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sepsis Transition and Recovery (STAR) program | Experimental | Behavioral: STAR ProgramVirtual sepsis navigation delivered across the peri-hospital discharge interval |
| Usual Care | Active comparator | Behavioral: Usual CareStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- adults 18 years of age and older;
- clinically suspected infection
- organ dysfunction
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STAR ProgramIn 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. | Behavioural | Sepsis Transition and Recovery (STAR) program |
| Usual CareHospitals 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. | Behavioural | Usual Care |
Primary outcome
All-cause mortality and hospital readmission rate
Time frame: day 90
Binary composite endpoint of mortality and hospital readmission assessed 90 days post index hospital discharge
4 secondary outcomes
Number of hospital free days
Time frame: day 90
All-cause mortality rate
Time frame: day 90
All-cause hospital readmission rate
Time frame: day 90
Acute care-related costs
Time frame: day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc A. Kowalkowski, PhD principal investigator
Wake Forest University Health Sciences
Sarah Birken, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STAR Program in people with Sepsis, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality and hospital readmission rate (time frame: day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.