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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 months, 20 months, 32 months, 36 months (i.e., post-implementation)
Awards & highlights
ENCOMPASS Trial 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.Check my eligibility
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.See study design
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.
ENCOMPASS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was given antibiotics and showed signs of infection when I arrived at the emergency department.
Select...
I might have an infection.
Select...
I am 18 years old or older.
Select...
My organs are not working properly due to infection.
ENCOMPASS Trial 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)
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
All-cause hospital readmission rate
All-cause mortality rate
Cause-specific hospital readmission rate
+3 moreOther outcome measures
Cost-Effectiveness
Number of eligible patients reached by STAR program
Number of providers included in STAR program adoption
+2 moreENCOMPASS 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.
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,239 Previous Clinical Trials
1,000,165 Total Patients Enrolled
8 Trials studying Sepsis
2,510 Patients Enrolled for Sepsis
National Institute of Nursing Research (NINR)NIH
579 Previous Clinical Trials
10,372,364 Total Patients Enrolled
2 Trials studying Sepsis
420 Patients Enrolled for Sepsis
Atrium HealthLead Sponsor
121 Previous Clinical Trials
30,836 Total Patients Enrolled
4 Trials studying Sepsis
770 Patients Enrolled for Sepsis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was given antibiotics and showed signs of infection when I arrived at the emergency department.I might have an infection.I am 18 years old or older.My organs are not working properly due to infection.My care instructions changed to not resuscitate or intubate after my infection started.I live more than 2.5 hours away from the hospital by car.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: Sepsis Transition and Recovery (STAR) Program
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have enrolled in this research endeavor?
"Indeed, the information sourced from clinicaltrials.gov states that this trial is actively seeking volunteers to join. This medical experiment was initially posted on July 1st 2020 and recently revised by April 19th 2022. As of now, 4032 individuals need to be enrolled between a single facility."
Answered by AI
Is enrollment currently available for this clinical experiment?
"Affirmative. Clinicaltrials.gov displays information regarding this trial's recruitment status; the study was first posted on July 1st 2020 and has been recently updated to April 19th 2022. The research team is seeking 4032 participants from one location."
Answered by AI
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