Comparison · NCT04495946-sae
Sepsis Transition and Recovery (STAR) Program vs Usual Care: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Sepsis Transition and Recovery (STAR) Program vs Usual Care: serious adverse events. Trial comparisons, record NCT04495946-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04495946-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.36 | 0.339 | 0.38 | wilson | |
| Risk in group 2 | 0.335 | 0.311 | 0.36 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0244 | -0.00768 | 0.056 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.07 | 0.978 | 1.18 | log | |
| Odds ratio, group 1 over group 2 | 1.11 | 0.967 | 1.28 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Sepsis Transition and Recovery (STAR) Program than on Usual Care | 41 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: usual care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Sepsis 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. | 763 | 2,122 | EG000 |
| Group 2 | Usual 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. | 478 | 1,426 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From enrollment until end of follow up, up to 90 days after hospital discharge
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
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04495946?tab=results
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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