N/A
N=468
Implementation and Effectiveness of Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship
Sepsis
Bottom Line
View on ClinicalTrials.gov: NCT04495946 ↗Enrolled (actual)
468
Serious AEs
35.0%
Results posted
Sep 2025
Primary outcome: Primary: All-cause Mortality and Hospital Readmission Rate — 1023; 684 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sepsis Transition and Recovery (STAR) program (Behavioral); Usual care (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause Mortality and Hospital Readmission Rate |
1023; 684 | — |
| SECONDARY Number of Days Alive and Outside the Hospital |
72.2; 71.9 | — |
| SECONDARY All-cause Mortality Rate |
367; 292 | — |
| SECONDARY All-cause Hospital Readmission Rate |
763; 478 | — |
| SECONDARY Number of Outpatient Provider Visits |
3.0; 3.6 | — |
| SECONDARY Number of Emergency Department Visits |
0.50; 0.46 | — |
| SECONDARY Cause-specific Hospital Readmission Rate |
370; 222 | — |
| SECONDARY Inpatient Functional Assessment or Physical Therapy Consult |
1768; 1196 | — |
| SECONDARY Inpatient Mental Health Assessment |
2048; 1385 | — |
| SECONDARY Count of Participants With Support Service Referrals |
594; 374 | — |
| SECONDARY Early Outpatient Provider Follow up |
468; 348 | — |
| SECONDARY Outpatient Medication Reconciliation |
1590; 866 | — |
| SECONDARY Palliative Care Consultation |
430; 234 | — |
| SECONDARY Completed Care Preferences |
526; 309 | — |
| SECONDARY Discharge to Hospice Care |
97; 69 | — |
| SECONDARY Place of Death |
204; 150; 69; 67; 94; 75 | — |
Summary
The purpose of this study is to evaluate if implementation of the Sepsis Transition and Recovery (STAR) program within a large healthcare system will improve outcomes for high-risk patients with suspected sepsis, while concurrently examining contextual factors related to STAR program delivery within routine care to generate knowledge of best practices for implementation and dissemination of post sepsis transitions of care. To address persistent morbidity and mortality for sepsis survivors, Atrium Health developed the Sepsis Treatment and Recovery (STAR) program which uses a nurse navigator to deliver a bundle of best-practice care elements for the delivery of longitudinal post-sepsis care for up to 90 days. These care elements are directed towards the specific challenges and sequelae following a sepsis hospitalization and include: 1) identification and treatment of new physical, mental, and cognitive deficits; 2) review and adjustment of medications; 3) surveillance of treatable conditions that commonly lead to poor outcomes including chronic conditions that may de-stabilize during sepsis and recovery; and 4) focus on palliative care when appropriate. ENCOMPASS (Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship) is an effectiveness-implementation hybrid type I trial, with the evaluation designed as a two-arm, pragmatic, stepped-wedge cluster randomized controlled trial conducted at eight regional hospitals in which each participating hospital begins in a usual care control phase and transitions to the STAR program intervention in a randomly assigned sequence. Patients are allocated to receive the treatment condition (i.e., usual care or STAR) assigned to their admission hospital at time of enrollment. ENCOMPASS will test the hypothesis that patients who receive care through the STAR program will have reduced mortality and hospital readmission assessed 90 days post index hospital discharge compared to patients who receive usual care.
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age upon admission
- Suspected infection
- Oral/parenteral antibiotic or bacterial culture order within 24 hours of emergency department presentation; and
- Evidence of systemic inflammatory response (i.e., at least two abnormal of temperature; heart rate; respiratory rate; and WBC count or bands)
- Evidence of organ dysfunction (i.e., at least two points on either Quick Sepsis-related Organ Failure Assessment or Sepsis-related Organ Failure Assessment risk tools)
- Deemed as high risk for 90-day readmission using risk-scoring models
- Not discharged at the time of patient list generation
Exclusion Criteria
- Patients with a change in code status (i.e., do not resuscitate, do not intubate) within 24 hours after infection onset due to presumed limitation of aggressive treatment
- Patients who reside > 2.5 hours drive time from the treating hospital
- Patients actively enrolled in a different care management program at time of admission
- Patient has been randomized previously.
Data sourced from ClinicalTrials.gov (NCT04495946). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.