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New program aims to help sepsis patients recover at home

NCT ID NCT05997420

Knowledge-focused Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a program called STAR, where a nurse helps sepsis patients manage medications, new health problems, and follow-up care for 90 days after leaving the hospital. Researchers wanted to see if this support reduces deaths and hospital readmissions. Over 1,800 adults at high risk of readmission took part. The goal is to find out if this program can be used in other hospitals to improve recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
STAR Program (behavioral intervention with nurse navigator)
What this could lead to
If successful, this could show that a simple nurse-led support program improves recovery and reduces hospital returns for sepsis survivors.
What could go wrong
This is an implementation study, not a test of a new drug. Results may not apply to all hospitals, and the program may not reduce deaths or readmissions as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

1,820 people

The number who actually took part.

Started

Jan 2024

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * adults 18 years of age and older; * clinically suspected infection 1. two or more markers of systemic inflammatory response syndrome within 24 h of presentation; AND 2. antibiotics initiated within 24 hours and continued for at least one additional day * organ dysfunction 1. two or more points on admission Sequential Organ Failure Assessment (SOFA); OR 2. two or more points on admission quick-SOFA * deemed to be at high risk of hospital readmission within 90 days, defined as readmission risk probability of at least 25% * not discharged from the hospital at the time of patient identification each morning. Exclusion Criteria: * change in code status (i.e., initially full code followed by change to do not resuscitate and/or do not intubate) within 24 hours after index presentation due to presumed limitation of aggressive treatment and exposure to STAR program components; * reside \> 2.5 hours drive time from the treating hospital due to the maximum reach of the community services leveraged within the STAR program and the general assumption that these patients may have less comprehensive utilization tracking within available electronic record systems for study outcomes; * are actively participating in a different care management program (e.g., cancer care patient navigation) documented in the electronic health record (EHR) at time of hospital admission.

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Conditions

The condition(s) this trial relates to.

infectious disease with sepsis Sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sepsis

Contacts and locations

Locations

  • Atrium Health

    Charlotte, North Carolina, 28203, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.