CompletedNot Applicable

Implementation and Effectiveness of Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship

United States3,894 participantsStarted 2020-07-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

All-cause Mortality and Hospital Readmission Rate

Timeframe: 90 days

Trial details

NCT IDNCT04495946

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-01

Results submitted2025-07-07

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