Clinical trial NCT05997420: Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up
Official title: Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up (ASTROS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sepsis
Keywords: critical illness recovery
care transitions
survivorship
mortality
hospital readmission
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: The Duke Endowment
First posted: 2023-08-18
Enrollment: 1280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All hospitals begin the study under the usual care condition. The STAR intervention will be introduced to groups of hospitals at two separate time points approximately six months apart. The sequence of intervention introduction will not be randomized. Once STAR has been introduced at a study hospital, eligible patients will receive STAR during their index hospitalization and extending through 90 days from discharge or date of death.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: All-cause mortality and hospital readmission rate
timeFrame: day 90
Secondary outcomes:
measure: Number of hospital free days
timeFrame: day 90
measure: All-cause mortality rate
timeFrame: day 90
measure: All-cause hospital readmission rate
timeFrame: day 90
measure: Acute care-related costs
timeFrame: day 90
Other outcomes:
measure: Qualitative assessment of the core functions of the STAR program
timeFrame: Pre-implementation
measure: Qualitative assessment of the adaptable "forms" for implementing the STAR program
timeFrame: Pre-implementation
measure: Number of providers included in STAR program adoption
timeFrame: Up to 2 years
measure: Number of eligible patients reached by STAR program
timeFrame: Up to 2 years
measure: Proportion of patients with STAR program intervention delivered as intended
timeFrame: Up to 2 years
Locations:
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Marc A. Kowalkowski, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Sarah Birken, PhD
role: PRINCIPAL_INVESTIGATOR
References: