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New program aims to keep sepsis survivors out of the hospital

NCT ID NCT04495946

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a program called STAR, where a nurse navigator helps sepsis patients for 90 days after they leave the hospital. The nurse checks medications, new health problems, and offers support by phone. Researchers wanted to see if this program lowers the chance of death or another hospital stay. Over 3,800 adults from eight hospitals took part.

What this could mean

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

Active substance
Sepsis Transition and Recovery (STAR) program (behavioral intervention with nurse navigator)
What this could lead to
If successful, this program could become a standard way to help sepsis survivors recover at home, reducing deaths and return trips to the hospital.
What could go wrong
This is a completed pragmatic trial, so results are available. However, the program may not work equally well in all hospitals or for all patients, and it requires extra staff and resources to run.

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

3,894 people

The number who actually took part.

Started

Jul 2020

Finished

Apr 2024

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: 1. At least 18 years of age upon admission 2. Suspected infection 1. Oral/parenteral antibiotic or bacterial culture order within 24 hours of emergency department presentation; and 2. Evidence of systemic inflammatory response (i.e., at least two abnormal of temperature; heart rate; respiratory rate; and WBC count or bands) 3. 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) 4. Deemed as high risk for 90-day readmission using risk-scoring models 5. Not discharged at the time of patient list generation Exclusion Criteria: 1. 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 2. Patients who reside \> 2.5 hours drive time from the treating hospital 3. Patients actively enrolled in a different care management program at time of admission 4. Patient has been randomized previously.

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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.