Protocol for a two-arm pragmatic stepped-wedge hybrid effectiveness-implementation trial evaluating Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship (ENCOMPASS)

Marc Kowalkowski, Tara Eaton, Andrew McWilliams, Hazel Tapp, Aleta Rios, Stephanie Murphy, Ryan Burns, Bella Gutnik, Katherine O'Hare, Lewis McCurdy, Michael Dulin, Christopher Blanchette, Shih-Hsiung Chou, Scott Halpern, Derek C Angus, Stephanie P Taylor, Marc Kowalkowski, Tara Eaton, Andrew McWilliams, Hazel Tapp, Aleta Rios, Stephanie Murphy, Ryan Burns, Bella Gutnik, Katherine O'Hare, Lewis McCurdy, Michael Dulin, Christopher Blanchette, Shih-Hsiung Chou, Scott Halpern, Derek C Angus, Stephanie P Taylor

Abstract

Background: Sepsis survivors experience high morbidity and mortality, and healthcare systems lack effective strategies to address patient needs after hospital discharge. The Sepsis Transition and Recovery (STAR) program is a navigator-led, telehealth-based multicomponent strategy to provide proactive care coordination and monitoring of high-risk patients using evidence-driven, post-sepsis care tasks. The purpose of this study is to evaluate the effectiveness of STAR to improve outcomes for sepsis patients and to examine contextual factors that influence STAR implementation.

Methods: This study uses a hybrid type I effectiveness-implementation design to concurrently test clinical effectiveness and gather implementation data. The effectiveness evaluation is a two-arm, pragmatic, stepped-wedge cluster randomized controlled trial at eight hospitals in North Carolina comparing clinical outcomes between sepsis survivors who receive Usual Care versus care delivered through STAR. Each hospital begins in a Usual Care control phase and transitions to STAR in a randomly assigned sequence (one every 4 months). During months that a hospital is allocated to Usual Care, all eligible patients will receive usual care. Once a hospital transitions to STAR, all eligible patients will receive STAR during their hospitalization and extending through 90 days from discharge. STAR includes centrally located nurse navigators using telephonic counseling and electronic health record-based support to facilitate best-practice post-sepsis care strategies including post-discharge review of medications, evaluation for new impairments or symptoms, monitoring existing comorbidities, and palliative care referral when appropriate. Adults admitted with suspected sepsis, defined by clinical criteria for infection and organ failure, are included. Planned enrollment is 4032 patients during a 36-month period. The primary effectiveness outcome is the composite of all-cause hospital readmission or mortality within 90 days of discharge. A mixed-methods implementation evaluation will be conducted before, during, and after STAR implementation.

Discussion: This pragmatic evaluation will test the effectiveness of STAR to reduce combined hospital readmissions and mortality, while identifying key implementation factors. Results will provide practical information to advance understanding of how to integrate post-sepsis management across care settings and facilitate implementation, dissemination, and sustained utilization of best-practice post-sepsis management strategies in other heterogeneous healthcare delivery systems.

Trial registration: NCT04495946 . Submitted July 7, 2020; Posted August 3, 2020.

Keywords: Continuity of patient care; Health services; Infection; Patient navigator; Pragmatic clinical trial; Sepsis.

Conflict of interest statement

Dr. Blanchette reports receiving salary from Novo Nordisk. No other disclosures were reported.

Figures

Fig. 1
Fig. 1
Overview of ENCOMPASS Stepped-Wedge Trial Design and Timeline. The ENCOMPASS trial design is depicted. Each study hospital begins in the Usual Care condition. Every 4 months, one study hospital transitions from Usual Care to the Sepsis Transition and Recovery (STAR) Program for the remainder of the trial. The sequence and timing of the transition for each hospital is randomly assigned. The total ENCOMPASS trial enrollment interval is 36 months. Implementation is evaluated before, during, and after the patient enrollment interval
Fig. 2
Fig. 2
Conceptual model describing the integration of STAR to improve post-sepsis care and outcomes. The elements of the Sepsis Transition and Recovery (STAR) program are shown mapped onto the Chronic Care Model framework. Adapted from Wagner EH, Chronic disease management: what will it take to improve care for chronic illness? Eff Clin Pract. 1998
Fig. 3
Fig. 3
Sepsis Transition and Recovery (STAR) Program Description. The scheduled touchpoints for patients in the Sepsis Transition and Recovery (STAR) program are depicted. Patients and caregivers are first introduced to the STAR program during hospitalization at a participating Atrium Health (AH) facility. Specific STAR program tasks to be performed during the acute care (1, 2), discharge readiness (3), early post-acute transition (4), and 90-day post-acute (5, 6) intervals are summarized

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Source: PubMed

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