Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up (ASTROS)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up (ASTROS) study is an effectiveness-implementation hybrid design. The effectiveness evaluation is designed as a multiple interrupted time series (mITS) analysis to test the impact of implementing an adapted Sepsis Transition and Recovery (STAR) program on enhancing post sepsis outcomes in new hospital settings.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• adults 18 years of age and older;

• clinically suspected infection

‣ two or more markers of systemic inflammatory response syndrome within 24 h of presentation; AND

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

• organ dysfunction

‣ two or more points on admission Sequential Organ Failure Assessment (SOFA); OR

⁃ 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.

Locations
United States
North Carolina
Atrium Health
RECRUITING
Charlotte
Contact Information
Primary
Marc Kowalkowski, PhD
Marc.Kowalkowski@AtriumHealth.org
(704) 355-9902
Time Frame
Start Date: 2024-01-16
Estimated Completion Date: 2025-12
Participants
Target number of participants: 1280
Treatments
Experimental: Sepsis Transition and Recovery (STAR) program
Virtual sepsis navigation delivered across the peri-hospital discharge interval
Active_comparator: Usual Care
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.
Related Therapeutic Areas
Sponsors
Collaborators: The Duke Endowment
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov

Similar Clinical Trials