Implementation and Effectiveness of Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship: A Hybrid Effectiveness-Implementation Randomized Controlled Trial

BACKGROUND

Sepsis is a common and life-threatening condition defined by organ dysfunction due to a dysregulated response to infection (Fleischmann, 2016). Aggressive early sepsis identification and treatment initiatives have decreased hospital mortality for patients with sepsis (Rhodes, 2017; Kaukonen, 2014). However, sepsis survivors continue to face challenges after the acute illness episode, experiencing new functional, cognitive, and psychological deficits, and high rates of hospital readmission and mortality in the 90-days after hospital discharge (Iwashyna, 2010; Borges, 2015; Annane, 2015; Prescott, 2015; Mayr, 2017). To address persistent morbidity and mortality for sepsis survivors, Atrium Health developed the Sepsis Treatment and Recovery (STAR) program which uses a nurse navigator to deliver a bundle of best-practice care elements for the delivery of longitudinal post-sepsis care for up to 90 days. These care elements are directed towards the specific challenges and sequelae following a sepsis hospitalization and include: 1) identification and treatment of new physical, mental, and cognitive deficits; 2) review and adjustment of medications; 3) surveillance of treatable conditions that commonly lead to poor outcomes including chronic conditions that may destabilize during sepsis and recovery; and 4) focus on palliative care when appropriate (Prescott, 2018) These care elements have good face-validity and have shown to be associated with improved outcomes for sepsis survivors in observational data (Taylor, 2020). However, they are not widely applied in real-world settings for this vulnerable population, likely hindered by a gap in understanding key contextual factors underlying how to best integrate this bundle of care elements into the complex and fragmented post-discharge setting (Brownson, 2012; Bodenheimer, 2008; Coleman, 2004; Kim, 2013)

RATIONALE

In randomized controlled trials (RCTs), successfully implemented care transition programs using nurse navigators have been shown to reduce hospital readmission and costs. To better enhance transitions of care for the highest risk, complex patients with suspected sepsis, the investigators propose extending this evidence using a nurse-facilitated care transition program for patients in the post-sepsis transition period to improve the implementation of recommended care practices and bridge care gaps. This approach, called the Sepsis Transition and Recovery (STAR) program, is the next step in the progression of the investigator team's work on improving discharge transitions and sepsis processes of care. A key aspect of this initiative includes the ability to identify sepsis survivors at the greatest risk for poor outcomes. For example, one-quarter of sepsis survivors account for three-quarters of hospital readmission and costs, indicating that identifying high-risk sepsis patients for targeted facilitation of best-practice care could efficiently impact quality and cost.

The STAR program uses near real-time risk modeling to identify high-risk patients and a centrally located nurse, virtually connected to participating hospitals, to coordinate the application of evidence-based recommendations for post-sepsis care, overcome barriers to recommended care, and bridge gaps in service that can serve as points of failure for complex patients. During hospitalization, high-risk patients enter into a transition pathway integrated within Atrium Health Hospital Medicine's Transition Services program and includes the following core components: i) Introduction to STAR process prior to discharge (confirm provider consults e.g., PT, ID, palliative); ii) Disease-specific education and discharge "playbook"; iii) Virtual hospital follow-up evaluation within 48 hours including medication reconciliation; iv) Second, post-acute virtual follow-up within 72-96 hours (symptom monitoring, confirm provider follow-up); v) Weekly contact with STAR team; vi) Referral to provider follow-up (e.g., primary care provider, transition clinic) as appropriate; vii) Coordinated transition to the next appropriate care location after 90 days from time of discharge. The STAR navigator also meets weekly with the Medical Director of the Atrium Health Transition Services program who provides additional clinical oversight of ongoing cases.