Atrium Health
Charlotte, North Carolina, 28203, United States
NCT Number: NCT05997420
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.
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All sexes
Interventional
Not applicable
Charlotte, North Carolina, 28203, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In the STAR program intervention, a centrally located nurse navigator facilitates the application of four evidence-based core components of post-sepsis care (i.e., review of medications, new impairments, comorbidities, and palliative care) to patients prior to and during the 90 days after hospital discharge. The STAR navigator will provide telephone and EHR-based support within the hospitalization and to patients across all discharge settings with remote monitoring at specified intervals following hospital discharge. Patients will continue to receive STAR directed services for 90 days following their discharge and then will be transitioned back to the next appropriate care location.
Hospitals and their patients will not have access to the STAR program. Patients will continue to receive usual care throughout their stay and discharge, consisting of: patient education and follow-up instructions at discharge, which are not specific to sepsis; routine recommendations for follow-up visits with primary care providers; arrangements for home health services or care management follow-up based on each patient's needs but not specifically tailored to the sepsis population; discharge to post-acute setting with no sepsis-specific follow-up. All aspects of usual care will be determined by treating clinicians independent of trial assignment.
Time frame: day 90
Binary composite endpoint of mortality and hospital readmission assessed 90 days post index hospital discharge
Time frame: day 90
Continuous composite endpoint of days alive and outside of the hospital assessed 90 days post index hospital discharge
Time frame: day 90
Binary endpoint of all-cause mortality rate assessed 90 days post index hospital discharge
Time frame: day 90
Binary endpoint of all-cause readmission rate assessed 90 days post index hospital discharge
Time frame: day 90
Healthcare costs attributed to care received at emergency department, observation, and inpatient encounters during follow-up
Time frame: Pre-implementation
Open-ended, qualitative evaluation to identify core functions necessary to maintain program effectiveness when implementing the STAR program in new settings
Time frame: Pre-implementation
Open-ended, qualitative evaluation to identify potential adaptations that are important to implementing the STAR program in new settings
Time frame: Up to 2 years
Number of hospital attending providers with patients enrolled in STAR
Time frame: Up to 2 years
Total number of patients who received the intervention
Time frame: Up to 2 years
Quantitative assessment of fidelity to completion of key intervention components (e.g., medication reconciliation, physical and mental health screenings, goals-of-care documentation)
Wake Forest University Health Sciences
Other
Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up (ASTROS)
Acronym: ASTROS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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