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STAR Program for Sepsis (ENCOMPASS Trial)

N/A

Waitlist Available

Led By Marc Kowalkowski, PhD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Suspected infection

Must not have

Patients who reside > 2.5 hours drive time from the treating hospital

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 months, 20 months, 32 months, 36 months (i.e., post-implementation)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether the Sepsis Transition and Recovery (STAR) program, which uses a nurse navigator to help with things like meds and chronic conditions, will help reduce mortality and hospital readmissions for people who have sepsis.

Who is the study for?

This trial is for adults with suspected sepsis who are at high risk of readmission within 90 days. They must have signs of organ dysfunction, received antibiotics or had a bacterial culture ordered, and show evidence of an inflammatory response. It's not for those with limited treatment plans due to code status changes, living far from the hospital, enrolled in another care program, or previously randomized.

What is being tested?

The study compares usual sepsis care against the STAR program which includes a nurse navigator and post-sepsis care bundle focusing on physical, mental recovery; medication review; chronic condition surveillance; and palliative care when needed. The effectiveness will be measured by mortality and readmission rates after 90 days.

What are the potential side effects?

Since this trial compares different management programs rather than medications, side effects are not typical as seen with drug interventions. However, there may be differences in experiences related to the quality and type of healthcare services received.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was given antibiotics and showed signs of infection when I arrived at the emergency department.

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I might have an infection.

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I am 18 years old or older.

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My organs are not working properly due to infection.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I live more than 2.5 hours away from the hospital by car.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 months, 20 months, 32 months, 36 months (i.e., post-implementation)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 months, 20 months, 32 months, 36 months (i.e., post-implementation)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 months, 20 months, 32 months, 36 months (i.e., post-implementation) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

All-cause mortality and hospital readmission rate

Secondary study objectives

All-cause hospital readmission rate

All-cause mortality rate

Cause-specific hospital readmission rate

+3 more

Other study objectives

Cost-Effectiveness

Number of eligible patients reached by STAR program

Number of providers included in STAR program adoption

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sepsis Transition and Recovery (STAR) ProgramExperimental Treatment1 Intervention

Virtual sepsis navigation delivered across the peri-hospital discharge interval

Group II: Usual CareActive Control1 Intervention

Standard of care received through Atrium Health facilities for patients hospitalized with sepsis. Aspects of usual care will be determined by treating clinicians independent of trial assignment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sepsis Transition and Recovery (STAR) program

2020

N/A

~4020

0 / 5Eligibility criteria met