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

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.

<strong></strong>The Effect of Cluster Nursing in ICU on Treatment Compliance and Intestinal Barrier Function in Patients with Refractory Septic Shock

“…⑥ Nutritional care: The patient's nasogastric tube was set in advance during the patient's treatment, and the nutrient was injected into the patient through the nasogastric tube. The infusion speed and flow rate were strictly controlled to prevent food backflow and stress caused by cold nutrients [10]. ⑦ Complication care: Prompt replacement of catheters and urine bags was performed to avoid bacterial infections, and timely sputum aspiration was conducted to avoid or prevent pneumonia.…”

Health system approaches to providing posthospital care for survivors of sepsis and critical illness

“…Successful dissemination of postcritical illness nurse navigator programs will likely require tailoring to local health system context. Key implementation factors for this care delivery model are being studied [39].…”

“…Although there is some optimism that reimbursement for recovery care will improve [49], the majority of critical illness recovery care programs will need to be supported by demonstration of return on investment through improved health outcomes and avoidance of downstream complications and healthcare utilization. Currently, data are mixed on the cost-effectiveness of postcritical illness programs [50][51][52], although additional cost evaluations are ongoing [39,53].…”

Conceptualizing Transitional Care After Critical Illness Using Stakeholder Perspectives: A Qualitative Content Analysis

“…Although studies of critical illness survivorship draw on the concept of transitions [5][6][7][8][9][10], none has evaluated evidence-based models of transitional care delivery. The rationale for doing so is strong.…”