Reconciliation Payments in the Bundled Payments for Care Improvement Advanced Program and Reductions in Clinical Spending Needed for CMS to Avoid Financial Losses.

This study examines the magnitude of reconciliation payments and clinical spending reductions necessary for the Centers for Medicare & Medicaid Services to break even in the first 4 performance periods of the BPCI-A (Bundled Payments for Care Improvement Advanced) program.

Evaluating a co-designed care bundle to improve patient safety at discharge from adult and adolescent mental health services (SAFER-MH and SAFER-YMH): protocol for a non-randomised feasibility study.

INTRODUCTION: Patients being discharged from inpatient mental wards often describe safety risks in terms of inadequate information sharing and involvement in discharge decisions. Through stakeholder engagement, we co-designed, developed and adapted two versions of a care bundle intervention, the SAFER Mental Health care bundle for adult and youth inpatient mental health settings (SAFER-MH and SAFER-YMH, respectively), that look to address these concerns through the introduction of new or improved processes of care. METHODS AND ANALYSIS: Two uncontrolled before-and-after feasibility studies, where all participants will receive the intervention. We will examine the feasibility and acceptability of the SAFER-MH in inpatient mental health settings in patients aged 18 years or older who are being discharged and the feasibility and acceptability of the SAFER-YMH intervention in inpatient mental health settings in patients aged between 14 and 18 years who are being discharged. The baseline period and intervention periods are both 6 weeks. SAFER-MH will be implemented in three wards and SAFER-YMH in one or two wards, ideally across different trusts within England. We will use quantitative (eg, questionnaires, completion forms) and qualitative (eg, interviews, process evaluation) methods to assess the acceptability and feasibility of the two versions of the intervention. The findings will inform whether a main effectiveness trial is feasible and, if so, how it should be designed, and how many patients/wards should be included. ETHICS AND DISSEMINATION: Ethical approval was obtained from the National Health Service Cornwall and Plymouth Research Ethics Committee and Surrey Research Ethics Committee (reference: 22/SW/0096 and 22/LO/0404). Research findings will be disseminated with participating sites and shared in various ways to engage different audiences. We will present findings at international and national conferences, and publish in open-access, peer-reviewed journals.

Association of Hospital Participation in Bundled Payments for Care Improvement Advanced With Medicare Spending and Hospital Incentive Payments.

Importance: Bundled Payments for Care Improvement Advanced (BPCI-A) is a Centers for Medicare & Medicaid Services (CMS) initiative that aims to produce financial savings by incentivizing decreases in clinical spending. Incentives consist of financial bonuses from CMS to hospitals or penalties paid by hospitals to CMS. Objective: To investigate the association of hospital participation in BPCI-A with spending, and to characterize hospitals receiving financial bonuses vs penalties. Design, Setting, and Participants: Difference-in-differences and cross-sectional analyses of 4 754 139 patient episodes using 2013-2019 US Medicare claims at 694 participating and 2852 nonparticipating hospitals merged with hospital and market characteristics. Exposures: BPCI-A model years 1 and 2 (October 1, 2018, through December 31, 2019). Main Outcomes and Measures: Hospitals' per-episode spending, CMS gross and net spending, and the incentive allocated to each hospital. Results: The study identified 694 participating hospitals. The analysis observed a -$175 change in mean per-episode spending (95% CI, -$378 to $28) and an aggregate spending change of -$75.1 million (95% CI, -$162.1 million to $12.0 million) across the 428 670 episodes in BPCI-A model years 1 and 2. However, CMS disbursed $354.3 million (95% CI, $212.0 million to $496.0 million) more in bonuses than it received in penalties. Hospital participation in BPCI-A was associated with a net loss to CMS of $279.2 million (95% CI, $135.0 million to $423.0 million). Hospitals in the lowest quartile of Medicaid days received a mean penalty of $0.41 million; (95% CI, $0.09 million to $0.72 million), while those in the highest quartile received a mean bonus of $1.57 million; (95% CI, $1.09 million to $2.08 million). Similar patterns were observed for hospitals across increasing quartiles of Disproportionate Share Hospital percentage and of patients from racial and ethnic minority groups. Conclusions and Relevance: Among US hospitals measured between 2013 and 2019, participation in BPCI-A was significantly associated with an increase in net CMS spending. Bonuses accrued disproportionately to hospitals providing care for marginalized communities.

The Impact of Antimicrobial Stewardship in Children in Low- and Middle-income Countries: A Systematic Review.

BACKGROUND: Antimicrobial stewardship (AMS) is central to the World Health Organisation Global Action Plan against antimicrobial resistance (AMR). If antibiotics are used without restraint, morbidity and mortality from AMR will continue to increase. In resource-rich settings, AMS can safely reduce antibiotic consumption. However, for children in low- and middle-income countries (LMIC), the impact of different AMS interventions is unknown. AIM: To determine the impact of different AMS interventions on antibiotic use and clinical and microbiologic outcomes in children in LMIC. METHODS: MEDLINE, Embase and PubMed were searched for studies of AMS interventions in pediatric population in LMIC settings. Controlled trials, controlled before-and-after studies and interrupted time series studies were included. Outcomes assessed were antibiotic use, multidrug-resistant organism (MDRO) rates, clinical outcomes and cost. RESULTS: Of 1462 studies, 34 met inclusion criteria including a total population of >5,000,000 in 17 countries. Twenty were in inpatients, 2 in ED, 10 in OPD and 2 in both. Seven studies were randomized controlled trials. All types of interventions reported a positive impact on antibiotic prescribing. AMS bundles with education, and clinical decision tools appeared more effective than guidelines alone. AMS interventions resulted in significantly decreased clinical infections (4/4 studies) and clinical failure (2/2) and reduced MDRO colonization rate (4/4). There was no concomitant increase in mortality (4/4 studies) or length of stay (2/2). CONCLUSION: Multiple effective strategies exist to reduce antibiotic consumption in LMIC. However, marked heterogeneity limit conclusions regarding the most effective approach, particularly regarding clinical outcomes. Overall, AMS strategies are important tools in the reduction of MDRO-related morbidity in children in LMIC.

Clinical decision support for severe trauma patients: Machine learning based definition of a bundle of care for hemorrhagic shock and traumatic brain injury.

BACKGROUND: Deviation from guidelines is frequent in emergency situations, and this may lead to increased mortality. Probably because of time constraints, 55% is the greatest reported guidelines compliance rate in severe trauma patients. This study aimed to identify among all available recommendations a reasonable bundle of items that should be followed to optimize the outcome of hemorrhagic shocks (HSs) and severe traumatic brain injuries (TBIs). METHODS: We first estimated the compliance with French and European guidelines using the data from the French TraumaBase registry. Then, we used a machine learning procedure to reduce the number of recommendations into a minimal set of items to be followed to minimize 7-day mortality. We evaluated the bundles using an external validation cohort. RESULTS: This study included 5,924 trauma patients (1,414 HS and 4,955 TBI) between 2011 and August 2019 and studied compliance to 36 recommendation items. Overall compliance rate to recommendation items was 71.6% and 66.9% for HS and TBI, respectively. In HS, compliance was significantly associated with 7-day decreased mortality in univariate analysis but not in multivariate analysis (risk ratio [RR], 0.91; 95% confidence interval [CI], 0.90-1.17; p = 0.06). In TBI, compliance was significantly associated with decreased mortality in univariate and multivariate analysis (RR, 0.85; 95% CI, 0.75-0.92; p = 0.01). For HS, the bundle included 13 recommendation items. In the validation cohort, when this bundle was applied, patients were found to have a lower 7-day mortality rate (RR, 0.46; 95% CI, 0.27-0.63; p = 0.01). In TBI, the bundle included seven items. In the validation cohort, when this bundle was applied, patients had a lower 7-day mortality rate (RR, 0.55; 95% CI, 0.34-0.71; p = 0.02). DISCUSSION: Using a machine-learning procedure, we were able to identify a subset of recommendations that minimizes 7-day mortality following traumatic HS and TBI. These two bundles remain to be evaluated in a prospective manner. LEVEL OF EVIDENCE: Care Management, level II.

ABCDEF Bundle Practices for Critically Ill Children: An International Survey of 161 PICUs in 18 Countries.

OBJECTIVES: To evaluate current international practice in PICUs regarding components of the "Assessing Pain, Both Spontaneous Awakening and Breathing Trials, Choice of Sedation, Delirium Monitoring/Management, Early Exercise/Mobility, and Family Engagement/Empowerment" (ABCDEF) bundle. DESIGN: Online surveys conducted between 2017 and 2019. SETTING: One-hundred sixty-one PICUs across the United States (n = 82), Canada (n = 14), Brazil (n = 27), and Europe (n = 38) participating in the Prevalence of Acute Rehabilitation for Kids in the PICU study. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Of the 161 participating PICUs, 83% were in academic teaching hospitals and 42% were in free-standing children's hospitals. Median size was 16 beds (interquartile range, 10-24 beds). Only 15 PICUs (9%) had incorporated all six ABCDEF bundle components into routine practice. Standardized pain assessment (A) was the most common (91%), followed by family engagement (F, 88%) and routine sedation assessment (C) with validated scales (84%). Protocols for testing extubation readiness or conducting spontaneous breathing trials (B) were reported in 57%, with 34% reporting a ventilator weaning protocol. Routine delirium monitoring with a validated screening tool (D) was reported by 44% of PICUs, and 26% had a guideline, protocol, or policy for early exercise/mobility (E). Practices for spontaneous breathing trials were variable in 29% of Canadian PICUs versus greater than 50% in the other regions. Delirium monitoring was lowest in Brazilian PICUs (18%) versus greater than 40% in other regions, and family engagement was reported in 55% of European PICUs versus greater than 90% in other regions. CONCLUSIONS: ABCDEF bundle components have been adopted with substantial variability across regions. Additional research must rigorously evaluate the efficacy of specific elements with a focus on B, D, E, and full ABCDEF bundle implementation. Implementation science is needed to facilitate an understanding of the barriers to ABCDEF implementation and sustainability with a focus on specific cultural and regional differences.

Effect of a Quality Improvement Bundle to Standardize the Use of Intravenous Fluids for Hospitalized Pediatric Patients: A Stepped-Wedge, Cluster Randomized Clinical Trial.

Importance: Given that hypotonic maintenance intravenous fluids (IVF) may cause hospital-acquired harm, in November 2018, the American Academy of Pediatrics released a clinical practice guideline recommending the use of isotonic IVF for patients aged 28 days to 18 years without contraindications. No recommendations were made regarding laboratory monitoring; however, unnecessary laboratory tests may contribute to health care waste and harm patients. Objective: To examine the effect of a quality improvement intervention bundle on (1) increasing the mean proportion of hours per hospital day with exclusive isotonic IVF use to at least 80% and (2) decreasing the mean proportion of hospital days with laboratory tests obtained. Design, Setting, and Participants: This stepped-wedge, cluster randomized clinical trial (Standardization of Fluids in Inpatient Settings [SOFI]) was sponsored by a national quality improvement collaborative and was conducted across 106 US pediatric hospitals. The SOFI intervention period was from September 2019 to March 2020. Interventions: Hospital sites were exposed to educational materials, a clinical algorithm and order set for IVF use, electronic medical record interventions to reduce laboratory testing, and "harms of overtesting" cards. Main Outcomes and Measures: Primary outcomes were mean proportion of hours per hospital day receiving exclusive isotonic IVF and mean proportion of hospital days with laboratory test values obtained. Secondary measures included total IVF duration per hospital day, daily patient weight measurement while receiving IVF, serum sodium testing, and adverse events. Baseline data were collected for 2 months; intervention period data, 7 months. Outcomes were analyzed using linear mixed-effects regression models. Results: A total of 106 hospitals were randomly assigned to 1 of 3 intervention start dates (wedges), and 100 hospitals (94%) completed the study. In total, 5215 hospitalizations were reviewed before the intervention, and 6724 hospitalizations were reviewed after the intervention. Prior to interventions, the mean (SD) proportion of hours per day with exclusive isotonic IVF use was 88.5% (31.7%). Interventions led to an absolute increase of 5.4% (95% CI, 3.9%-6.9%) above baseline in exclusive isotonic IVF use but did not change the proportion of hospital days during which a laboratory test value was obtained (estimated difference, 0.1%; 95% CI, -1.5% to 1.7%; P = .90), IVF use duration (estimated difference, -1.2%; 95% CI, -2.9% to 0.4%), serum sodium testing, or adverse events. There was an absolute increase of 4.4% (95% CI, 2.6%-6.2%) in the mean proportion of hospital days with a patient weight measurement while receiving IVF. Conclusions and Relevance: In this stepped-wedge, cluster randomized clinical trial, an intervention bundle significantly improved the use of isotonic maintenance IVF without a concomitant increase in adverse events or electrolyte testing. Further work is required to deimplement laboratory testing. Trial Registration: ClinicalTrials.gov Identifier: NCT03924674.

Implementation and evaluation of sepsis surveillance and decision support in medical ICU and emergency department.

OBJECTIVE: To improve the timely diagnosis and treatment of sepsis many institutions implemented automated sepsis alerts. Poor specificity, time delays, and a lack of actionable information lead to limited adoption by bedside clinicians and no change in practice or clinical outcomes. We aimed to compare sepsis care compliance before and after a multi-year implementation of a sepsis surveillance coupled with decision support in a tertiary care center. DESIGN: Single center before and after study. SETTING: Large academic Medical Intensive Care Unit (MICU) and Emergency Department (ED). POPULATION: Patients 18 years of age or older admitted to *** Hospital MICU and ED from 09/4/2011 to 05/01/2018 with severe sepsis or septic shock. INTERVENTIONS: Electronic medical record-based sepsis surveillance system augmented by clinical decision support and completion feedback. MEASUREMENTS AND MAIN RESULTS: There were 1950 patients admitted to the MICU with the diagnosis of severe sepsis or septic shock during the study period. The baseline characteristics were similar before (N = 854) and after (N = 1096) implementation of sepsis surveillance. The performance of the alert was modest with a sensitivity of 79.9%, specificity of 76.9%, positive predictive value (PPV) 27.9%, and negative predictive value (NPV) 97.2%. There were 3424 unique alerts and 1131 confirmed sepsis patients after the sniffer implementation. During the study period average care bundle compliance was higher; however after taking into account improvements in compliance leading up to the intervention, there was no association between intervention and improved care bundle compliance (Odds ratio: 1.16; 95% CI: 0.71 to 1.89; p-value 0.554). Similarly, the intervention was not associated with improvement in hospital mortality (Odds ratio: 1.55; 95% CI: 0.95 to 2.52; p-value: 0.078). CONCLUSIONS: A sepsis surveillance system incorporating decision support or completion feedback was not associated with improved sepsis care and patient outcomes.

Prognostic Values of the Timing of Antibiotic Administration and the Sepsis Bundle Component in Elderly Patients With Septic Shock: A Retrospective Study.

INTRODUCTION: Elderly patients are more susceptible to sepsis and septic shock. Early administration of broad-spectrum antibiotics is a key element of the sepsis management of bundle. Our study aimed to investigate the association between the timing of antibiotics administration and the risk of adverse outcomes in elderly patients with septic shock, and to examine the prognostic value of other bundle elements. METHOD: This is a single-center, retrospective, case-control study including elderly patients (aged ≥ 65 years) diagnosed with septic shock in the emergency department between October 1, 2018, and December 31, 2019. Eligible patients were divided into early (within 1 h) and late (beyond 1 h) groups according to the time interval between septic shock recognition and initial antibiotic administration. The characteristics, sepsis-related severity scores, management strategy, and outcomes were recorded. A multivariate logistic regression model was used to identify the independent prognostic factors. RESULTS: A total of 331 patients were included in the study. The overall 90-day mortality rate was 43.8% (145/331). There were no significant differences in baseline characteristics, sepsis-related severity scores, and management strategy between the two groups. There was no significant difference between the early and late groups in the rate of intensive care unit transfer (46.4% vs. 46.6%, P = 0.96), endotracheal intubation (28.3% vs. 27.5%, P = 0.87), renal replacement therapy (21.7% vs. 21.8%, P = 1.00), or 90-day mortality (44.2% vs. 43.5%, P = 0.90). Serum lactate level (hazard ratio [HR] = 1.15, P < 0.01) and source control (HR = 0.56, P = 0.03) were identified as independent factors associated with 90-day mortality. CONCLUSION: The timing of antibiotic administration was not associated with adverse outcomes in elderly patients with septic shock. Serum lactate level and source control implementation were independent prognostic factors in these patients.

Prevention of Central-Line Associated Bloodstream Infections: 2021 Update.

Despite a large volume of research in prevention, central line-associated bloodstream infections and catheter-related bloodstream infections continue to cause significant morbidity, mortality, and increased health care costs. Strategies in prevention, including decision about catheter placement, insertion bundles, adherence to standard of care guidelines, and technologic innovations, shown to decrease rates of catheter-related bloodstream infections and central line-associated bloodstream infections are described in this update. The coronavirus disease 2019 pandemic has resulted in increased health care-acquired infections, including central line-associated bloodstream infections.

Dissecting the Perioperative Care Bundle.

Enhanced recovery after surgery (ERAS) protocols are comprehensive perioperative care pathways designed to mitigate the physiologic stressors associated with surgery and, in turn, improve clinical outcomes and lead to health care cost savings. Although individual components may differ, ERAS protocols are typically organized as multimodal care "bundles" that, when followed closely and in their entirety, are meant to generate amplified cumulative benefits. This manuscript examines some of the critical components, describes some areas where the science is weak (but dogma may be strong), and provides some of the evidence or lack thereof behind components of a standard ERAS protocol.

Effect of an Obstetric Hemorrhage Bundle on Clinical Outcomes and Clinician Perceptions.

OBJECTIVE: To examine the effect of an obstetric hemorrhage (OBH) safety bundle on health outcomes and to explore nurses' and physicians' perceptions of using the bundle. DESIGN: Descriptive longitudinal study, including review of electronic health records for 79,509 births, and clinician surveys. SETTING: Nine hospitals in the southwestern United States. PARTICIPANTS: 685 maternity nurses and 210 obstetricians. INTERVENTIONS/MEASUREMENTS: Retrospective and prospective data collection over 3.5 years to examine selected health outcomes before and after implementing an OBH bundle. A 10-item questionnaire was used to survey clinicians for their perceptions of bundle use. The Hospital Survey on Patient Safety Culture was used to explore nurses' views of the safety climate before and after bundle implementation. RESULTS: Statistically significant decreases in mean documented blood loss were observed with bundle use. Blood loss rates of less than 500 ml and greater than 1,000 ml increased, and blood loss rates of 500 to 1,000 ml decreased. Use of postpartum hemorrhage medications increased. When adjusted for multiple tests, there was no statistically significant difference in the rates of postpartum hysterectomies or ICU admissions or in length of stay. Clinicians' perceptions of bundle use were positive, with scores ranging from 6 to 8 on a scale of 1 to 10. However, Hospital Survey on Patient Safety Culture results indicated a decrease in nurses' perceptions of safety after bundle implementation. CONCLUSION: OBH bundles provide tools and guidance to improve perinatal care and outcomes. Our findings of lower mean blood loss, increased use of postpartum hemorrhage medications, and positive perceptions of the bundle differed from findings of previous studies. Nurses' perceptions of safety decreased, yet clinicians reported that care was safer with the OBH bundle. Nurses' commitment and collaboration are vital to the success of bundle implementation.

Rates of Bronchopulmonary Dysplasia Following Implementation of a Novel Prevention Bundle.

Importance: Bronchopulmonary dysplasia (BPD) rates in the United States remain high and have changed little in the last decade. Objective: To develop a consistent BPD prevention bundle in a systematic approach to decrease BPD. Design, Setting, and Participants: This quality improvement study included 484 infants with birth weights from 501 to 1500 g admitted to a level 3 neonatal intensive care unit in the Kaiser Permanente Southern California system from 2009 through 2019. The study period was divided into 3 periods: 1, baseline (2009); 2, initial changes based on ongoing cycles of Plan-Do-Study-Act (2010-2014); and 3, full implementation of successive Plan-Do-Study-Act results (2015-2019). Interventions: A BPD prevention system of care bundle evolved with a shared mental model that BPD is avoidable. Main Outcomes and Measures: The primary outcome was BPD in infants with less than 33 weeks' gestational age (hereafter referred to as BPD <33). Other measures included adjusted BPD <33, BPD severity grade, and adjusted median postmenstrual age (PMA) at hospital discharge. Balancing measures were adjusted mortality and adjusted mortality or specified morbidities. Results: The study population included 484 infants with a mean (SD) birth weight of 1070 (277) g; a mean (SD) gestational age of 28.6 (2.9) weeks; 252 female infants (52.1%); and 61 Black infants (12.6%). During the 3 study periods, BPD <33 decreased from 9 of 29 patients (31.0%) to 3 of 184 patients (1.6%) (P < .001 for trend); special cause variation was observed. The standardized morbidity ratio for the adjusted BPD <33 decreased from 1.2 (95% CI, 0.7-1.9) in 2009 to 0.4 (95% CI, 0.2-0.8) in 2019. The rates of combined grades 1, 2, and 3 BPD decreased from 7 of 29 patients (24.1%) to 17 of 183 patients (9.3%) (P < .008 for trend). Grade 2 BPD rates decreased from 3 of 29 patients (10.3%) to 5 of 183 patients (2.7%) (P = .02 for trend). Adjusted median PMA at home discharge decreased by 2 weeks, from 38.2 (95% CI, 37.3-39.1) weeks in 2009 to 36.8 (95% CI, 36.6-37.1) weeks during the last 3 years (2017-2019) of the full implementation period. Adjusted mortality was unchanged, whereas adjusted mortality or specified morbidities decreased significantly. Conclusions and Relevance: A sustained low rate of BPD was observed in infants after the implementation of a detailed BPD system of care.

Implementing a Safety Bundle to Improve Screening and Care for Perinatal Mood and Anxiety Disorders.

OBJECTIVE: To improve screening and care of individuals with perinatal mood and anxiety disorders (PMAD) through the implementation of a perinatal mental health safety bundle. DESIGN: Rapid-cycle quality improvement model using four plan-do-study-act cycles over the course of 90 days. Individuals between 28 and 32 weeks gestation and at their 6-week postpartum follow-up visit were screened and offered stage-based care for PMAD. SETTING/LOCAL PROBLEM: At baseline, only 15% of clients of a suburban, private-practice women's health clinic were receiving PMAD screening with a validated tool, and the site lacked standardized PMAD care practices among health care providers. PARTICIPANTS: Health care providers (n = 2), staff (n = 4), and eligible patients (n = 78) at a private-practice women's health clinic. INTERVENTION/MEASUREMENTS: A screening, brief intervention, referral, and treatment/follow-up (SBIRT) model was used to screen eligible patients, provide treatment options, and appropriately refer for follow-up to mental health services. Team engagement occurred via weekly meetings. Measurements included pre-post maternal and team engagement survey results, biweekly chart review, and run chart analysis. RESULTS: Effective PMAD screening and right care were achieved for 85% of eligible individuals; this included receiving screening, referral to treatment, a scheduled mental health appointment, and clinic follow-up to ensure mental health care uptake. CONCLUSION: Use of the SBIRT model to implement a safety bundle may contribute to improved mental health outcomes for individuals receiving perinatal care in a private-practice outpatient health care setting. Education and engagement among clinicians, staff, and patients are key to successful implementation of a safety bundle.

Bundle to care for newborn children of mothers with suspected or confirmed diagnosis of COVID-19.

OBJECTIVE: To build and validate the contents of a bundle for the care of newborn children of mothers with suspected or confirmed diagnosis of COVID-19 in the delivery room and in the rooming-in care. METHOD: Methodological research, developed in 2020 in three stages: bibliographic survey, construction of the instrument in Google Forms® and content validation by seven judges. The initial instrument consisted of seven nursing care. The content validity index above 80% was used to assess the agreement between the judges. RESULTS: All items in the bundle reached agreement among judges above 80% after the third round of evaluation. The final version consisted of six items. CONCLUSION: This study allowed the construction and content validation of the proposed bundle. The content proved to be valid and may contribute to the quality of nursing care in the face of the care of these newborns.

Treatment Patterns and Clinical Outcomes After the Introduction of the Medicare Sepsis Performance Measure (SEP-1).

BACKGROUND: Medicare requires that hospitals report on their adherence to the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1). OBJECTIVE: To evaluate the effect of SEP-1 on treatment patterns and patient outcomes. DESIGN: Longitudinal study of hospitals using repeated cross-sectional cohorts of patients. SETTING: 11 hospitals within an integrated health system. PATIENTS: 54 225 encounters between January 2013 and December 2017 for adults with sepsis who were hospitalized through the emergency department. INTERVENTION: Onset of the SEP-1 reporting requirement in October 2015. MEASUREMENTS: Changes in SEP-1-targeted processes, including antibiotic administration, lactate measurement, and fluid administration at 3 hours from sepsis onset; repeated lactate and vasopressor administration for hypotension within 6 hours of sepsis onset; and sepsis outcomes, including risk-adjusted intensive care unit (ICU) admission, in-hospital mortality, and home discharge among survivors. RESULTS: Two years after its implementation, SEP-1 was associated with variable changes in process measures, with the greatest effect being an increase in lactate measurement within 3 hours of sepsis onset (absolute increase, 23.7 percentage points [95% CI, 20.7 to 26.7 percentage points]; P < 0.001). There were small increases in antibiotic administration (absolute increase, 4.7 percentage points [CI, 1.9 to 7.6 percentage points]; P = 0.001) and fluid administration of 30 mL/kg of body weight within 3 hours of sepsis onset (absolute increase, 3.4 percentage points [CI, 1.5 to 5.2 percentage points]; P < 0.001). There was no change in vasopressor administration. There was a small increase in ICU admissions (absolute increase, 2.0 percentage points [CI, 0 to 4.0 percentage points]; P = 0.055) and no changes in mortality (absolute change, 0.1 percentage points [CI, -0.9 to 1.1 percentage points]; P = 0.87) or discharge to home. LIMITATION: Data are from a single health system. CONCLUSION: Implementation of the SEP-1 mandatory reporting program was associated with variable changes in process measures, without improvements in clinical outcomes. Revising the measure may optimize its future effect. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Prospective Observational Multisite Study of Handover in the Emergency Department: Theory versus Practice.

INTRODUCTION: The handover process in the emergency department (ED) is relevant for patient outcomes and lays the foundation for adequate patient care. The aim of this study was to examine the current prehospital to ED handover practice with regard to content, structure, and scope. METHODS: We carried out a prospective, multicenter observational study using a specifically developed checklist. The steps of the handover process in the ED were documented in relation to qualification of the emergency medical services (EMS) staff, disease severity, injury patterns, and treatment priority. RESULTS: We documented and evaluated 721 handovers based on the checklist. According to ISBAR (Identification, Situation, Background, Assessment, Recommendation), MIST (Mechanism, Injuries, Signs/Symptoms, Treatment), and BAUM (Situation [German: Bestand], Anamnesis, Examination [German: Untersuchung], Measures), almost all handovers showed a deficit in structure and scope (99.4%). The age of the patient was reported 339 times (47.0%) at the time of handover. The time of the emergency onset was reported in 272 cases (37.7%). The following vital signs were transferred more frequently for resuscitation room patients than for treatment room patients: blood pressure (BP)/(all comparisons p < 0.05), heart rate (HR), oxygen saturation (SpO2) and Glasgow Coma Scale (GCS). Physicians transmitted these vital signs more frequently than paramedics BP, HR, SpO2, and GCS. A handover with a complete ABCDE algorithm (Airway, Breathing, Circulation, Disability, Environment/Exposure) took place only 31 times (4.3%). There was a significant difference between the occupational groups (p < 0.05). CONCLUSION: Despite many studies on handover standardization, there is a remarkable inconsistency in the transfer of information. A "hand-off bundle" must be created to standardize the handover process, consisting of a uniform mnemonic accompanied by education of staff, training, and an audit process.

Prevention of Cardiac Surgery-Associated Acute Kidney Injury by Implementing the KDIGO Guidelines in High-Risk Patients Identified by Biomarkers: The PrevAKI-Multicenter Randomized Controlled Trial.

BACKGROUND: Prospective, single-center trials have shown that the implementation of the Kidney Disease: Improving Global Outcomes (KDIGO) recommendations in high-risk patients significantly reduced the development of acute kidney injury (AKI) after surgery. We sought to evaluate the feasibility of implementing a bundle of supportive measures based on the KDIGO guideline in high-risk patients undergoing cardiac surgery in a multicenter setting in preparation for a large definitive trial. METHODS: In this multicenter, multinational, randomized controlled trial, we examined the adherence to the KDIGO bundle consisting of optimization of volume status and hemodynamics, functional hemodynamic monitoring, avoidance of nephrotoxic drugs, and prevention of hyperglycemia in high-risk patients identified by the urinary biomarkers tissue inhibitor of metalloproteinases-2 [TIMP-2] and insulin growth factor-binding protein 7 [IGFBP7] after cardiac surgery. The primary end point was the adherence to the bundle protocol and was evaluated by the percentage of compliant patients with a 95% confidence interval (CI) according to Clopper-Pearson. Secondary end points included the development and severity of AKI. RESULTS: In total, 278 patients were included in the final analysis. In the intervention group, 65.4% of patients received the complete bundle as compared to 4.2% in the control group (absolute risk reduction [ARR] 61.2 [95% CI, 52.6-69.9]; P < .001). AKI rates were statistically not different in both groups (46.3% intervention versus 41.5% control group; ARR -4.8% [95% CI, -16.4 to 6.9]; P = .423). However, the occurrence of moderate and severe AKI was significantly lower in the intervention group as compared to the control group (14.0% vs 23.9%; ARR 10.0% [95% CI, 0.9-19.1]; P = .034). There were no significant effects on other specified secondary outcomes. CONCLUSIONS: Implementation of a KDIGO-derived treatment bundle is feasible in a multinational setting. Furthermore, moderate to severe AKI was significantly reduced in the intervention group.