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A recent investigation led by the Center for Sepsis Epidemiology and Prevention Studies (SEPSIS) at the Harvard Pilgrim Health Care Institute opens a dialogue on the efficacy of the Centers for Medicare and Medicaid Services’ (CMS) sepsis quality measure, the Severe Sepsis/Septic Shock Management Bundle (SEP-1).
Sepsis is a critical condition that emerges from an inappropriate response to infection, necessitating prompt intervention to boost survival rates. In 2015, CMS introduced the SEP-1 measure to encourage timely treatment for sepsis. This framework mandates that healthcare providers perform a series of specific actions within three hours of diagnosing sepsis, which include monitoring lactate levels, obtaining blood cultures, administering antibiotics, and, in certain scenarios, providing substantial fluid resuscitation. Originally functioning as a pay-for-reporting initiative, SEP-1 has evolved into a pay-for-performance system.
The application of SEP-1 has sparked debate, particularly regarding its rigid protocols that may not adequately address the diverse presentations of sepsis. Various conditions may resemble sepsis, which raises concerns that overwhelming pressure on healthcare professionals to act swiftly and aggressively could inadvertently lead to treatments for patients who do not have an infection, potentially causing adverse outcomes.
Data from CMS indicates that patients who receive care in accordance with SEP-1 guidelines experience lower mortality rates compared to those who do not. However, the underlying reasons for this disparity remain uncertain; it is unclear whether the reduced mortality is a direct result of the SEP-1 bundle’s effectiveness or if it simply reflects the fact that patients receiving compliant care may generally be less ill and less complicated than those who receive non-compliant care.
The study, published in JAMA Network Open and entitled “Complex Sepsis Presentations, SEP-1 Bundle Compliance, and Outcomes,” sought to clarify the relative contributions of SEP-1 compliance versus patient characteristics in determining outcomes. Researchers conducted extensive medical record analyses of 590 sepsis patients from four academic medical centers between 2019 and 2022. They meticulously documented and compared the profiles of patients who did and did not receive SEP-1 compliant care, placing special emphasis on clinical factors that may influence treatment decisions yet have often been overlooked in previous studies. These factors included patients’ primary languages, mental status, requirements for urgent procedures, and the presence of concurrent non-infectious issues.
The findings revealed that patients who received SEP-1 compliant care had distinct differences from those who did not. The latter group was found to have more complicated medical profiles, often presenting with atypical symptoms, concurrently significant non-infectious conditions, and a greater likelihood of requiring urgent interventions. Notably, after adjusting for these complexities, the initial correlation between SEP-1 compliance and decreased mortality rates dissipated, challenging the prevailing assumption of a straightforward benefit from SEP-1 adherence.
“Our findings indicate that not all non-compliance with SEP-1 equates to inferior care; rather, it often mirrors the intricacies of sepsis presentations and the competing clinical priorities that healthcare providers face,” stated Chanu Rhee, MD, MPH, the study’s lead author and an Associate Professor of Population Medicine at Harvard Medical School. He further emphasized that the absence of a mortality association following adjustments raises significant doubts about the effectiveness of CMS’s transition of SEP-1 to a pay-for-performance model in significantly enhancing sepsis survival rates.
The results align with calls from prominent professional organizations, such as the Infectious Diseases Society of America, advocating for a reevaluation of rigid process-based sepsis mandates like SEP-1, suggesting that a shift toward risk-adjusted outcome measures is necessary.
“These insights highlight the urgent need for quality measures that encourage hospitals to enhance all aspects of sepsis care—from early detection to recovery after hospitalization—while allowing for clinical judgment in treatment decisions,” remarked Michael Klompas, MD, MPH, the study’s senior author and a Professor of Medicine and Population Medicine at Harvard Medical School. “To genuinely improve outcomes for sepsis patients, our focus must extend beyond simplistic admission bundles and encompass comprehensive strategies that consider the entirety of sepsis management.”
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