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Behavioral Intervention

Sepsis Transition and Recovery (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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

ASTROS Trial 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.Check my eligibility

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.See study design

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.

ASTROS Trial 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.

ASTROS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

All-cause mortality and hospital readmission rate

Secondary outcome measures

Acute care-related costs

All-cause hospital readmission rate

All-cause mortality rate

+1 more

Other outcome measures

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

ASTROS 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 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,243 Previous Clinical Trials

1,003,450 Total Patients Enrolled

8 Trials studying Sepsis

5,248 Patients Enrolled for Sepsis

The Duke EndowmentOTHER

12 Previous Clinical Trials

38,662 Total Patients Enrolled

Marc A. Kowalkowski, PhDPrincipal InvestigatorWake Forest University Health Sciences

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential participants currently able to apply for this ongoing medical study?

"Indeed, the available information on clinicaltrials.gov confirms that this trial is currently actively seeking participants. The study was initially listed on January 16th, 2024 and most recently updated on January 29th, 2024. A total of 1280 patients will be enrolled in this trial across a single site or location."

Answered by AI

What is the current number of individuals being recruited for participation in this research investigation?

"Indeed, as indicated by clinicaltrials.gov, this clinical trial is actively seeking eligible participants. The initial posting of the trial was on January 16th, 2024 and it was most recently updated on January 29th, 2024. A total of 1280 individuals are being recruited at a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up

2024. "Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05997420.

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