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

Wake Forest University (WFU)

Status: Enrolling

Conditions: Sepsis

Treatments: Behavioral: Usual Care; Behavioral: STAR Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05997420

7056-SP (Other Grant/Funding Number)

IRB00087673

Details and patient eligibility

About

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.

Full description

Approximately 1.4 million survivors of sepsis (life-threatening organ dysfunction due to infection) are discharged from U.S. hospitals annually, facing high rates of long-term mortality and morbidity as well as incurring high costs to healthcare systems. To improve outcomes and address disparities, this study developed a multicomponent Sepsis Transition and Recovery (STAR) intervention that leverages real-time advanced analytics to identify high-risk patients who are most likely to benefit from sepsis-specific transitional support. STAR is a 90-day, nurse-navigator-led program designed to facilitate transition/recovery after sepsis hospitalization. Navigators provide disease education, help patients overcome medical-system barriers to recommended care, and bridge gaps in service that serve as points of failure for complex sepsis patients. STAR specifically targets delivery of best-practice post-sepsis care including: i) medication optimization, ii) screening for new impairments, iii) anticipation/mitigation of risk for health deterioration, and iv) palliative care when appropriate. STAR is the only intervention to date supported by randomized, controlled trial evidence to improve outcomes for sepsis survivors.

Despite rigorous data supporting STAR program effectiveness in its initial context, there are significant differences in healthcare infrastructure and resources at different sites that require careful adaptation prior to implementation to retain effectiveness. More research is needed to identify STAR's core functions (i.e., the subset of an intervention's features that are causally related to outcomes; to be distinguished from features that may be adapted without compromising intervention's effectiveness and may enhance effectiveness by promoting proficient/consistent use in new contexts), study the implementation process, and evaluate STAR performance in new contexts. The goal of this project is to examine strategies to optimize the STAR program to fit well in other settings.

Enrollment: 1,280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1,280 participants in 2 patient groups

Sepsis Transition and Recovery (STAR) program

Experimental group

Description:

Virtual sepsis navigation delivered across the peri-hospital discharge interval

Treatment:

Behavioral: STAR Program

Usual Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Usual Care