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Comparison · NCT04495946-bbe3e44b

Sepsis Transition and Recovery (STAR) Program vs Usual Care: All-cause Mortality Rate

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Sepsis Transition and Recovery (STAR) Program vs Usual Care: All-cause Mortality Rate. Trial comparisons, record NCT04495946-bbe3e44b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04495946-bbe3e44b

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.1730.1570.19wilson
Risk in group 20.2050.1850.226wilson
Risk difference, group 1 minus group 2-0.0318-0.0585-0.00567newcombe hybrid score
Risk ratio, group 1 over group 20.8450.7360.97log
Odds ratio, group 1 over group 20.8120.6850.963log
Number needed to treat, for one fewer participant with the outcome on Sepsis Transition and Recovery (STAR) Program than on Usual Care31.417.1176from the risk difference interval

Groups2

Group 2 names the comparator: usual care.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Sepsis Transition and Recovery (STAR) Program
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.
3672,122OG000
Group 2Usual Care
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.
2921,426OG001

Outcome

Type
SECONDARY
Title
All-cause Mortality Rate
Description
Patients with date of death prior to 90 days post discharge documented in the electronic health record or in linked national death records
Time frame
90 days
Population

Source ClinicalTrials.gov

Trial

Title
Implementation and Effectiveness of Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship
NCT number
NCT04495946
Phases
NA
Conditions
Sepsis
Interventions
Sepsis Transition and Recovery (STAR) program, Usual care
Lead sponsor
Wake Forest University Health Sciences
Results first posted
2025-09-19

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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