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Behavioral Intervention

STAR Program for Sepsis (ASTROS Trial)

N/A

Recruiting

Led By Marc A. 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

Organ dysfunction with two or more points on admission Sequential Organ Failure Assessment (SOFA) or two or more points on admission quick-SOFA

antibiotics initiated within 24 hours and continued for at least one additional day

Must not have

Reside > 2.5 hours drive time from the treating hospital

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial, called the ASTROS study, is testing the effectiveness of a program designed to improve outcomes for patients recovering from sepsis in new hospitals. The study will use a method called multiple interrupted

Who is the study for?

This trial is for adults over 18 with suspected infection and signs of systemic inflammation, who've started antibiotics within 24 hours that continued for at least another day. They must have organ dysfunction indicated by SOFA scores or be at high risk of hospital readmission within 90 days.

What is being tested?

The ASTROS study is testing the STAR Program against usual care to see if it improves recovery after sepsis in new hospital settings. It uses a multiple interrupted time series analysis to measure effectiveness as hospitals adopt the program.

What are the potential side effects?

Since this trial compares standard post-sepsis care with the STAR Program, side effects are not drug-related but may include potential risks associated with changes in healthcare delivery methods.

Eligibility Criteria

Inclusion Criteria

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

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My organs are not functioning well according to a recent assessment.

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I started antibiotics within a day and took them for at least another day.

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I started antibiotics within a day of showing infection signs and continued for at least another day.

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I might have an infection based on my symptoms.

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I am currently hospitalized.

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I am currently hospitalized.

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My organs are not working properly.

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 ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years 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

Acute care-related costs

All-cause hospital readmission rate

All-cause mortality rate

+1 more

Other study objectives

Number of eligible patients reached by STAR program

Number of providers included in STAR program adoption

Proportion of patients with STAR program intervention delivered as intended

+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 each facility for patients hospitalized with sepsis. Aspects of usual care will be determined by treating clinicians independent of trial assignment.

0 / 8Eligibility criteria met