Assessment of implementation methods in sepsis: study protocol for a cluster-randomized hybrid type 2 trial.

BACKGROUND: Sepsis is the leading cause of intensive care unit (ICU) admission and ICU death. In recognition of the burden of sepsis, the Surviving Sepsis Campaign (SSC) and the Institute for Healthcare Improvement developed sepsis "bundles" (goals to accomplish over a specific time period) to facilitate SSC guideline implementation in clinical practice. Using the SSC 3-h bundle as a base, the Centers for Medicare and Medicaid Services developed a 3-h sepsis bundle that has become the national standard for early management of sepsis. Emerging observational data, from an analysis conducted for the AIMS grant application, suggest there may be additional mortality benefit from even earlier implementation of the 3-h bundle, i.e., the 1-h bundle. METHOD: The primary aims of this randomized controlled trial are to: (1) examine the effect on clinical outcomes of Emergency Department initiation of the elements of the 3-h bundle within the traditional 3 h versus initiating within 1 h of sepsis recognition and (2) examine the extent to which a rigorous implementation strategy will improve implementation and compliance with both the 1-h bundle and the 3-h bundle. This study will be entirely conducted in the Emergency Department at 18 sites. A secondary aim is to identify clinical sepsis phenotypes and their impact on treatment outcomes. DISCUSSION: This cluster-randomized trial, employing implementation science methodology, is timely and important to the field. The hybrid effectiveness-implementation design is likely to have an impact on clinical practice in sepsis management by providing a rigorous evaluation of the 1- and 3-h bundles. FUNDING: NHLBI R01HL162954. TRIAL REGISTRATION: ClinicalTrials.gov NCT05491941. Registered on August 8, 2022.

Evaluation of Adult Patients Readmitted for Severe Sepsis/Septic Shock Under the BPCI Advanced Program.

Bundled Payments for Care Improvement-Advanced Program (BPCI-A) is designed to pay a single payment covering services provided during an episode of care. Sepsis is associated with increased readmissions, mortality, and health care costs. The purpose of the study was to evaluate the BPCI program patients with sepsis who were readmitted within 90 days versus not readmitted. This was a retrospective cohort study including 271 (110 readmitted) patients enrolled in the BPCI program with Diagnostic-Related Grouping codes of septicemia or severe sepsis. Skin/soft tissue infection was the most common infection. There was a significant difference between the groups for resource needs at discharge including wound care (25.45% versus 11.18%; P = 0.002) and physical therapy (74.55% versus 57.14%; P = 0.004). Mortality was higher among readmissions, 43.64% versus 26.71% no readmission ( P = 0.004). Identifying risk factors for readmission, providing appropriate resources, and follow-up may contribute to improved patient outcomes for patients with sepsis enrolled in the BPCI program.

Effects of Compliance With the Early Management Bundle (SEP-1) on Mortality Changes Among Medicare Beneficiaries With Sepsis: A Propensity Score Matched Cohort Study.

BACKGROUND: US hospitals have reported compliance with the SEP-1 quality measure to Medicare since 2015. Finding an association between compliance and outcomes is essential to gauge measure effectiveness. RESEARCH QUESTION: What is the association between compliance with SEP-1 and 30-day mortality among Medicare beneficiaries? STUDY DESIGN AND METHODS: Studying patient-level data reported to Medicare by 3,241 hospitals from October 1, 2015, to March 31, 2017, we used propensity score matching and a hierarchical general linear model (HGLM) to estimate the treatment effects associated with compliance with SEP-1. Compliance was defined as completion of all qualifying SEP-1 elements including lactate measurements, blood culture collection, broad-spectrum antibiotic administration, 30 mL/kg crystalloid fluid administration, application of vasopressors, and patient reassessment. The primary outcome was a change in 30-day mortality. Secondary outcomes included changes in length of stay. RESULTS: We completed two matches to evaluate population-level treatment effects. In standard match, 122,870 patients whose care was compliant were matched with the same number whose care was noncompliant. Compliance was associated with a reduction in 30-day mortality (21.81% vs 27.48%, respectively), yielding an absolute risk reduction (ARR) of 5.67% (95% CI, 5.33-6.00; P < .001). In stringent match, 107,016 patients whose care was compliant were matched with the same number whose care was noncompliant. Compliance was associated with a reduction in 30-day mortality (22.22% vs 26.28%, respectively), yielding an ARR of 4.06% (95% CI, 3.70-4.41; P < .001). At the subject level, our HGLM found compliance associated with lower 30-day risk-adjusted mortality (adjusted conditional OR, 0.829; 95% CI, 0.812-0.846; P < .001). Multiple elements correlated with lower mortality. Median length of stay was shorter among cases whose care was compliant (5 vs 6 days; interquartile range, 3-9 vs 4-10, respectively; P < .001). INTERPRETATION: Compliance with SEP-1 was associated with lower 30-day mortality. Rendering SEP-1 compliant care may reduce the incidence of avoidable deaths.

Rapid Development and Deployment of an Intensivist-Led Venovenous Extracorporeal Membrane Oxygenation Cannulation Program.

OBJECTIVES: To determine the safety and efficacy of a rapidly deployed intensivist-led venovenous extracorporeal membrane oxygenation cannulation program in a preexisting extracorporeal membrane oxygenation program. DESIGN: A retrospective observational before-and-after study of 40 patients undergoing percutaneous cannulation for venovenous extracorporeal membrane oxygenation in an established cannulation program by cardiothoracic surgeons versus a rapidly deployed medical intensivist cannulation program. SETTING: An adult ICU in a tertiary academic medical center in Camden, NJ. PATIENTS: Critically ill adult subjects with severe respiratory failure undergoing percutaneous cannulation for venovenous extracorporeal membrane oxygenation. INTERVENTIONS: Percutaneous cannulation for venovenous extracorporeal membrane oxygenation performed by cardiothoracic surgeons compared with cannulations performed by medical intensivists. MEASUREMENTS AND MAIN RESULTS: Venovenous extracorporeal membrane oxygenation cannulation site attempts were retrospectively reviewed. Subject demographics, specialty of physician performing cannulation, type of support, cannulation configuration, cannula size, imaging guidance, success rate, and complications were recorded and summarized. Twenty-two cannulations were performed by three cardiothoracic surgeons in 11 subjects between September 2019 and February 2020. The cannulation program rapidly transitioned to an intensivist-led and performed program in March 2020. Fifty-seven cannulations were performed by eight intensivists in 29 subjects between March 2020 and December 2020. Mean body mass index for subjects did not differ between groups (33.86 vs 35.89; p = 0.775). There was no difference in days on mechanical ventilation prior to cannulation, configuration, cannula size, or discharge condition. There was no difference in success rate of cannulation on first attempt per cannulation site (95.5 vs 96.7; p = 0.483) or major complication rate per cannulation site (4.5 vs 3.5; p = 1). CONCLUSIONS: There is no difference between success and complication rates of percutaneous venovenous extracorporeal membrane oxygenation canulation when performed by cardiothoracic surgeons versus medical intensivist in an already established extracorporeal membrane oxygenation program. A rapidly deployed cannulation program by intensivists for venovenous extracorporeal membrane oxygenation can be performed with high success and low complication rates.

Implementation of the Affordable Care Act: A Comparison of Outcomes in Patients With Severe Sepsis and Septic Shock Using the National Inpatient Sample.

OBJECTIVES: Sepsis is the most common and costly diagnosis in U.S.' hospitals. Despite quality improvement programs and heightened awareness, sepsis accounts for greater than 50% of all hospital deaths. A key modifier of outcomes is access to healthcare. The Affordable Care Act, passed in 2010, expanded access to health insurance coverage. The purpose of this study was to evaluate changes in insurance coverage and outcomes in patients with severe sepsis and septic shock as a result of the full implementation of the Affordable Care Act. DESIGN: This retrospective study uses data from the Healthcare Cost and Utilization Project National Inpatient Sample during 2011-2016. Data were divided into two groups: 2011-2013 (pre Affordable Care Act) and 2014-2016 (post Affordable Care Act). Outcomes were in-hospital mortality, mortality rates based on insurance type, and hospital length of stay. PATIENTS: Hospitalized adults between the ages 18 and 64. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: A total of 361,323 severe sepsis or septic shock hospital discharges were included. Comparing pre-Affordable Care Act with post-Affordable Care Act, there was a 4.75% increase in medicaid coverage and a 1.91% decrease in the uninsured. Overall in-hospital mortality decreased from 22.90% pre-Affordable Care Act to 18.59% post-Affordable Care Act. Pre-Affordable Care Act uninsured patients had the highest mortality (25.68%). Patients with medicaid had the greatest reduction in mortality (5.71%) and length of stay (2.45 d). The mean (SD) length of stay pre Affordable Care Act was 13.92 (17.42) days, compared with 12.35 (15.76) days post Affordable Care Act. All results were statistically significant (p < 0.0001). CONCLUSIONS: In this cohort, there was an increase in insured patients with severe sepsis and septic shock post Affordable Care Act. Mortality and length of stay decreased in the post-Affordable Care Act period with the greatest reduction identified in the medicaid population. The improvement in outcomes could be attributed to advances in management, earlier presentation, patients being less severely ill and receiving treatment sooner.

The Association of Increasing Hospice Use With Decreasing Hospital Mortality: An Analysis of the National Inpatient Sample.

EXECUTIVE SUMMARY: Usage of hospice services for patients facing life-limiting illness has steadily increased. In these services, hospitals discharge patients to various hospice settings, including the inpatient model, where a patient may remain in the discharging hospital to receive hospice services. In this discharge practice, the patient is considered a hospital survivor and subsequent hospice death. The purpose of the study was to determine if the decline of in-hospital mortality for six common high-volume admission diagnoses could be attributed in part to an increase in discharges to a hospice setting for end-of-life care. In this retrospective study using the National Inpatient Sample database from 2007 to 2011, we identified patients ≥18 years for six acute and chronic diagnoses: heart failure, chronic obstructive pulmonary disease, acute myocardial infarction, acute myocardial infarction with cardiogenic shock, septic shock, and lung neoplasm (cancer). We categorized patients according to their hospital discharge disposition as hospice or in-hospital mortality. A total of 10,458,728 patients met our criteria, of which 2.72% were discharged to hospice and 6.38% died. Compared to patients who died in the hospital, hospice patients were older, had a shorter length of stay, and experienced more comorbidities. Hospice use was more common in Medicare patients, in nonteaching hospitals, and in the South. White individuals were more likely to be discharged to hospice compared to nonwhites. Among the six selected diagnoses over the 5-year period, hospice use rose as observed mortality decreased. Our findings suggest that variability among hospitals in hospice use will affect benchmarked hospital mortality comparisons and could inappropriately reward or penalize hospitals in their public reporting.

Prevention of central venous catheter-related bloodstream infections: is it time to add simulation training to the prevention bundle?

STUDY OBJECTIVE: To study the impact of adding simulation-based education to the pre-intervention mandatory hospital efforts aimed at decreasing central venous catheter-related blood stream infections (CRBSI) in intensive care units (ICU). DESIGN: Pre- and post-intervention retrospective observational investigation. SETTING: 24-bed ICU and a 562-bed university-affiliated, urban teaching hospital. PATIENTS: ICU patients July 2004-June 2008 were studied for the development of central venous catheter related blood stream infections (CRBSI). MEASUREMENTS: ICU patients from July 2004-June 2008 were studied for the development of central venous catheter-related blood stream infections (CRBSI). PRE-INTERVENTION: mandatory staff and physician education began in 2004 to reduce CRBSI. The CRBSI-prevention program included online and didactic courses, and a pre- and post-test. Elements in the pre-intervention efforts included hand hygiene, full barrier precautions, use of Chlorhexidine skin preparation, and mask, gown, gloves, and hat protection for operators. A catheter-insertion cart containing all supplies and checklist were was a mandatory element of this program; a nurse was empowered to stop the procedure for non-performance of checklist items. INTERVENTION: As of July 1, 2006, a mandatory simulation-based program for all intern, resident, and fellow physicians was added to teach central venous catheter (CVC) insertion. MEASUREMENTS: Data collected pre- and post-intervention were CRBSI incidence, number of ICU catheter days, mortality, laboratory pathogen results, and costs. MAIN RESULTS: The pre-intervention CRBSI incidence of 6.47/1,000 catheter days was reduced significantly to 2.44/1,000 catheter days post-intervention (58%; P < 0.05), resulting in a $539,902 savings (USD; 47%), and was attributed to shorter ICU and hospital lengths of stay. CONCLUSIONS: Following simulation-based CVC program implementation, CRBSI incidence and costs were significantly reduced for two years post-intervention.

Multicenter clinical trials in sepsis: understanding the big picture and building a successful operation at your hospital.

Only through adequately designed and adequately conducted clinical trials can new treatments be found for the benefit of the septic patient. Over the past 20 years, tens of thousands of patients have been enrolled in sepsis clinical trials with little success. These efforts, however, have not been without worth. Much has been learned and the knowledge gained has changed our approach to trial design in this very difficult field. Animal studies are better designed to match the clinical picture of severe sepsis. Phase II studies are more carefully engineered to answer questions about the most suitable target population and end points. Trial conduct likely benefits from use of CROs and a CCC. The future of clinical trials may include more standardization of sepsis management across investigative sites. Before the decision is made to become an investigative site in a multicenter industry-sponsored clinical trial in sepsis or severe sepsis, it is important to recognize what is required to succeed. Once these key-to-success elements are in place, members of the investigative team are more likely to realize the satisfaction and career growth from becoming a successful site. The most professional satisfaction comes from the knowledge of contributing to original science in the field of the sepsis.

Multicenter clinical trials in sepsis: understanding the big picture and building a successful operation at your hospital.

The environment for clinical trials in sepsis has long been identified as challenging and full of road blocks and land mines. Unlike many other diagnoses (ie, cancer, acute myocardial infarction) relevance of animal studies and predictive capability of phase II trials for dose generation is less clear. The members of the investigative team must realize the essentials for success in a multicenter clinical trial. It is also useful and important to understand the big picture of clinical trial development as well as properly functioning interfaces among sponsor, contract research organizations, and investigative sites. Because early enrollment into sepsis clinical trials is usually required, collaboration between emergency medicine and critical care is needed.

Location of patients before transfer to a tertiary care intensive care unit: impact on outcome.

OBJECTIVE: To evaluate the impact of the source of patients transferred to a tertiary care intensive care unit (ICU) (referring hospital ICU vs referring hospital emergency department [ED]) on outcomes of transferred patients. DESIGN AND SETTING: We performed a retrospective review of data contained in the Project Impact database of a medical-surgical ICU at a university hospital. PATIENTS AND PARTICIPANTS: A total of 503 patients transferred from local community hospitals, 283 from EDs and 220 from ICUs, were identified and included. In addition to comparing all ED transfers with all ICU transfers, comparisons between the 2 populations were made for the subgroups of patients with intracranial hemorrhage (group 1), nonhemorrhagic stroke (group 2), and all other patients (group 3). MEASUREMENTS AND RESULTS: Patients were evaluated for a variety of outcome parameters, including mortality and ICU and hospital length of stay (LOS) according to their location at the referring hospital at the time of transfer: ICU (ICUtx) or ED (EDtx). Mortality was significantly lower among EDtx in all transferred patients as well as in groups 2 and 3 with no difference in mortality identified in group 1. Intensive care unit LOS was shorter for EDtx and the 3 groups, and hospital LOS was shorter among all EDtx and those in group 3. Group 3 EDtx also had lower than predicted mortality. CONCLUSIONS: Transfer of patients to a tertiary care ICU from the ED of a referring hospital is associated with significantly better outcomes than transfers from referring hospital ICUs.