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Developing Evidence-Based Sepsis Time Zero Criteria and Quality Metrics Using Electronic Health Record Data

Award Number: R01HS027170
ORGANIZATION: AGENCY FOR HEALTH CARE RESEARCH AND QUALITY
OPDIV: AHRQ
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/03/2020
PERIOD OF PERFORMANCE END DATE: 11/30/2025

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Developing Evidence-Based Sepsis Time Zero Criteria and Quality Metrics Using Electronic Health Record Data - PROJECT ABSTRACT Sepsis is a leading cause of death. It is also a major driver of antibiotic utilization, in large part because current guidelines and mandates compel clinicians to administer antibiotics immediately for all patients with possible sepsis even though more than a third of patients initially suspected to have sepsis turn out to have viral or non-infectious conditions. The Centers for Medicare & Medicaid Services (CMS) “SEP-1” measure, for example, requires hospitals to give broad-spectrum antibiotics within 3 hours of to all patients with suspected sepsis as well as measure lactate levels, draw blood cultures, and administer at least 30cc/kg of fluids for hypotension. Newer guidelines are pushing for even faster antibiotic administration and bundle completion. Aggressive, rigid, and reflexive sepsis care may therefore benefit some patients but also unnecessarily risks promoting antibiotic resistance, drug adverse events, C.difficile infections, and fluid overload in others. A major barrier to providing appropriate sepsis care to the right patients is our limited understanding of which specific clinical presentations are most likely to benefit from immediate antibiotics and which can safely be managed more conservatively. Similarly, we have imperfect understanding of which specific processes of care are critical to optimize outcomes and which are not. To address these gaps, we need a better way to define sepsis “time zero,” a concept that embodies both the criteria that should trigger immediate interventions when infection is suspected and the point from which timeliness of care is measured. The current definition of sepsis includes a heterogeneous mix of clinical signs, some of which are clearly urgent and some that may tolerate more time for investigation before administering antibiotics. The problem is compounded by the fact that SEP-1's time zero definition is subjective and labor-intensive to abstract, undermining its credibility and utility for benchmarking hospitals' quality of care. In this project, we propose to leverage detailed electronic health record data from millions of encounters from 167 hospitals in two datasets to develop more evidence-based sepsis time zero criteria and quality metrics. These goals are reflected our Specific Aims: 1) Develop evidence-based, objective, and electronically computable definitions of sepsis time zero by using electronic health record data to identify the clinical signs that are associated with higher mortality when antibiotics are delayed, 2) Systematically evaluate the associations between each sepsis bundle component and mortality and compare the full bundle to simpler, streamlined versions, and 3) Assess whether and how optimal treatment strategies differ for commonly encountered and easily recognizable sepsis phenotypes based on infection site, comorbidities, and clinical signs. This proposal directly addresses the antibiotic stewardship focus of AHRQ's HAI Prevention Portfolio and AHRQ's mission to improve health care safety and quality by providing new insights into identifying and treating sepsis, informing more rational antibiotic use, and facilitating better measurement of quality-of-care. 1


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	HARVARD PILGRIM HEALTH CARE INC	1 WELLNESS WAY	CANTON	MA	02021	NORFOLK	USA	Research on Healthcare Costs, Quality and Outcomes	000	5	3/11/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $462,347 )
2024	2024	HARVARD PILGRIM HEALTH CARE INC	1 WELLNESS WAY	CANTON	MA	02021	NORFOLK	USA	Research on Healthcare Costs, Quality and Outcomes	000	5	5/13/2024	NON-COMPETING CONTINUATION	$462,347
														Subtotal = $462,347

Issue Date FY: 2023 ( Subtotal = $470,988 )
2023	2023	HARVARD PILGRIM HEALTH CARE INC	1 WELLNESS WAY	CANTON	MA	02021	NORFOLK	USA	Research on Healthcare Costs, Quality and Outcomes	000	4	5/11/2023	NON-COMPETING CONTINUATION	$470,988
														Subtotal = $470,988

Issue Date FY: 2022 ( Subtotal = $479,709 )
2022	2022	HARVARD PILGRIM HEALTH CARE INC	93 WORCESTER ST	WELLESLEY	MA	02481	NORFOLK	USA	Research on Healthcare Costs, Quality and Outcomes	000	3	4/25/2022	NON-COMPETING CONTINUATION	$479,709
														Subtotal = $479,709

Issue Date FY: 2021 ( Subtotal = $488,771 )
2021	2021	HARVARD PILGRIM HEALTH CARE INC	93 WORCESTER ST	WELLESLEY	MA	02481	NORFOLK	USA	Research on Healthcare Costs, Quality and Outcomes	001	2	4/15/2021	NON-COMPETING CONTINUATION	$488,771
2021	2020	HARVARD PILGRIM HEALTH CARE INC	93 WORCESTER ST	WELLESLEY	MA	02481	NORFOLK	USA	Research on Healthcare Costs, Quality and Outcomes	000	1	10/28/2020	NEW	$0
														Subtotal = $488,771

Issue Date FY: 2020 ( Subtotal = $497,867 )
2020	2020	HARVARD PILGRIM HEALTH CARE INC	93 WORCESTER ST	WELLESLEY	MA	02481	NORFOLK	USA	Research on Healthcare Costs, Quality and Outcomes	000	1	8/3/2020	NEW	$497,867
														Subtotal = $497,867

Grand Total All Awards = $2,399,682

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Developing Evidence-Based Sepsis Time Zero Criteria and Quality Metrics Using Electronic Health Record Data

Award Number: R01HS027170

ORGANIZATION: AGENCY FOR HEALTH CARE RESEARCH AND QUALITY

OPDIV: AHRQ

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/03/2020

PERIOD OF PERFORMANCE END DATE: 11/30/2025

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