Effect of Automated Real-Time Feedback on Early-Sepsis Care: A Pragmatic Clinical Trial.

OBJECTIVES: To determine if a real-time monitoring system with automated clinician alerts improves 3-hour sepsis bundle adherence. DESIGN: Prospective, pragmatic clinical trial. Allocation alternated every 7 days. SETTING: Quaternary hospital from December 1, 2020 to November 30, 2021. PATIENTS: Adult emergency department or inpatients meeting objective sepsis criteria triggered an electronic medical record (EMR)-embedded best practice advisory. Enrollment occurred when clinicians acknowledged the advisory indicating they felt sepsis was likely. INTERVENTION: Real-time automated EMR monitoring identified suspected sepsis patients with incomplete bundle measures within 1-hour of completion deadlines and generated reminder pages. Clinicians responsible for intervention group patients received reminder pages; no pages were sent for controls. The primary analysis cohort was the subset of enrolled patients at risk of bundle nonadherent care that had reminder pages generated. MEASUREMENTS AND MAIN RESULTS: The primary outcome was orders for all 3-hour bundle elements within guideline time limits. Secondary outcomes included guideline-adherent delivery of all 3-hour bundle elements, 28-day mortality, antibiotic discontinuation within 48-hours, and pathogen recovery from any culture within 7 days of time-zero. Among 3,269 enrolled patients, 1,377 had reminder pages generated and were included in the primary analysis. There were 670 (48.7%) at-risk patients randomized to paging alerts and 707 (51.3%) to control. Bundle-adherent orders were placed for 198 intervention patients (29.6%) versus 149 (21.1%) controls (difference: 8.5%; 95% CI, 3.9-13.1%; p = 0.0003). Bundle-adherent care was delivered for 152 (22.7%) intervention versus 121 (17.1%) control patients (difference: 5.6%; 95% CI, 1.4-9.8%; p = 0.0095). Mortality was similar between groups (8.4% vs 8.3%), as were early antibiotic discontinuation (35.1% vs 33.4%) and pan-culture negativity (69.0% vs 68.2%). CONCLUSIONS: Real-time monitoring and paging alerts significantly increased orders for and delivery of guideline-adherent care for suspected sepsis patients at risk of 3-hour bundle nonadherence. The trial was underpowered to determine whether adherence affected mortality. Despite enrolling patients with clinically suspected sepsis, early antibiotic discontinuation and pan-culture negativity were common, highlighting challenges in identifying appropriate patients for sepsis bundle application.

What Went Right? A Mixed-Methods Study of Positive Feedback Data in a Hospital-Wide Mortality Review Survey.

BACKGROUND: Toxic work culture contributes to healthcare worker burnout and attrition, but little is known about how healthcare organizations can systematically create and promote a culture of civility and collegiality. OBJECTIVE: To analyze peer-to-peer positive feedback collected as part of a systematized mortality review survey to identify themes and recognition dynamics that can inform positive organizational culture change. DESIGN: Convergent mixed-methods study design. PARTICIPANTS: A total of 388 physicians, 212 registered nurses, 64 advanced practice providers, and 1 respiratory therapist at four non-profit hospitals (2 academic and 2 community). INTERVENTION: Providing optional positive feedback in the mortality review survey. MAIN MEASURES: Key themes and subthemes that emerged from positive feedback data, associations between key themes and positive feedback respondent characteristics, and recognition dynamics between positive feedback respondents and recipients. KEY RESULTS: Approximately 20% of healthcare workers provided positive feedback. Three key themes emerged among responses with free text comments: (1) providing extraordinary patient and family-centered care; (2) demonstrating self-possession and mastery; and (3) exhibiting empathic peer support and effective team collaboration. Compared to other specialties, most positive feedback from medicine (70.2%), neurology (65.2%), hospice and palliative medicine (64.3%), and surgery (58.8%) focused on providing extraordinary patient and family-centered care (p = 0.02), whereas emergency medicine (59.1%) comments predominantly focused on demonstrating self-possession and mastery (p = 0.06). Registered nurses (40.2%) provided multidirectional positive feedback more often than other clinician types in the hospital hierarchy (p < 0.001). CONCLUSIONS: Analysis of positive feedback from a mortality review survey provided meaningful insights into a health system's culture of teamwork and values related to civility and collegiality when providing end-of-life care. Systematic collection and sharing of positive feedback is feasible and has the potential to promote positive culture change and improve healthcare worker well-being.

The association of hospital research publications and clinical quality.

OBJECTIVE: To assess the quantity and impact of research publications among US acute care hospitals; to identify hospital characteristics associated with publication volumes; and to estimate the independent association of bibliometric indicators with Hospital Compare quality measures. DATA SOURCES: Hospital Compare; American Hospital Association Survey; Magnet Recognition Program; Science Citation Index Expanded. STUDY DESIGN: In cross-sectional studies using a 40% random sample of US Medicare-participating hospitals, we estimated associations of hospital characteristics with publication volumes and associations of hospital-linked bibliometric indicators with 19 Hospital Compare quality metrics. DATA COLLECTION/EXTRACTION METHODS: Using standardized search strategies, we identified all publications attributed to authors from these institutions from January 1, 2015 to December 31, 2016 and their subsequent citations through July 2020. PRINCIPAL FINDINGS: Only 647 of 1604 study hospitals (40.3%) had ≥1 publication. Council of Teaching Hospitals and Health Systems (COTH) hospitals had significantly more publications (average 599 vs. 11 for non-COTH teaching and 0.6 for nonteaching hospitals), and their publications were cited more frequently (average 22.6/publication) than those from non-COTH teaching (18.2 citations) or nonteaching hospitals (12.8 citations). In multivariable regression, teaching intensity, hospital beds, New England or Pacific region, and not-for-profit or government ownership were significant predictors of higher publication volumes; the percentage of Medicaid admissions was inversely associated. In multivariable linear regression, hospital publications were associated with significantly lower risk-adjusted mortality rates for acute myocardial infarction (coefficient -0.52, p = 0.01), heart failure (coefficient -0.74, p = 0.004), pneumonia (coefficient -1.02, p = 0.001), chronic obstructive pulmonary disease (coefficient -0.48, p = 0.005), and coronary artery bypass surgery (coefficient -0.73, p < 0.0001); higher overall Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) ratings (coefficient 2.37, p = 0.04); and greater patient willingness to recommend (coefficient 3.38, p = 0.01). CONCLUSIONS: A minority of US hospitals published in the biomedical literature. Publication quantity and impact indicators are independently associated with lower risk-adjusted mortality and higher HCAHPS scores.

Improving Allergy Documentation: A Retrospective Electronic Health Record System-Wide Patient Safety Initiative.

OBJECTIVES: Documentation of allergies in a coded, non-free-text format in the electronic health record (EHR) triggers clinical decision support to prevent adverse events. Health system-wide patient safety initiatives to improve EHR allergy documentation by specifically decreasing free-text allergy entries have not been reported. The goal of this initiative was to systematically reduce free-text allergen entries in the EHR allergy module. METHODS: We assessed free-text allergy entries in a commercial EHR used at a multihospital integrated health care system in the greater Boston area. Using both manual and automated methods, a multidisciplinary consensus group prioritized high-risk and frequently used free-text allergens for conversion to coded entries, added new allergen entries, and deleted duplicate allergen entries. Environmental allergies were moved to the patient problem list. RESULTS: We identified 242,330 free-text entries, which included a variety of environmental allergies (42%), food allergies (18%), contrast media allergies (13%), "no known allergy" (12%), drug allergies (2%), and "no contrast allergy" (2%). Most free-text entries were entered by medical assistants in ambulatory settings (34%) and registered nurses in perioperative settings (20%). We remediated a total of 52,206 free-text entries with automated methods and 79,578 free-text entries with manual methods. CONCLUSIONS: Through this multidisciplinary intervention, we identified and remediated 131,784 free-text entries in our EHR to improve clinical decision support and patient safety. Additional strategies are required to completely eliminate free-text allergy entry, and establish systematic, consistent, and safe guidelines for documenting allergies.

The association of hospital teaching intensity with 30-day postdischarge heart failure readmission and mortality rates.

OBJECTIVE: To investigate risk-adjusted, 30-day postdischarge heart failure mortality and readmission rates stratified by hospital teaching intensity. DATA SOURCES AND STUDY SETTING: A total of 709 221 Medicare fee-for-service beneficiaries discharged from 3135 US hospitals between 1/1/2013 and 11/30/2014 with a principal diagnosis of heart failure. STUDY DESIGN: Hospitals were classified as Council of Teaching Hospitals and Health Systems (COTH) major teaching hospitals, non-COTH teaching hospitals, and nonteaching hospitals. Hospital teaching status was linked with MedPAR patient data and FY2016 Hospital Readmission Reduction Program penalties. Index hospitalization survival probabilities were estimated with hierarchical logistic regression and used to stratify index hospitalization survivors into severity deciles. Decile-specific models were estimated for 30-day postdischarge readmission and mortality. Thirty-day postdischarge outcomes were estimated by teaching intensity and penalty categories. PRINCIPAL FINDINGS: Averaged across deciles, adjusted 30-day COTH hospital readmission rates were, on a relative scale ([COTH minus nonteaching] ÷ nonteaching), 1.63 percent higher (95% CI: 0.89 percent, 2.25 percent) than at nonteaching hospitals, but their average adjusted 30-day postdischarge mortality rates were 11.55 percent lower (95% CI: -13.78 percent, -9.37 percent). Penalized COTH hospitals had the highest readmission rates of all categories (23.99 percent [95% CI: 23.50 percent, 24.49 percent]) but the lowest 30-day postdischarge mortality (8.30 percent [95% CI: 7.99 percent, 8.57 percent] vs 9.84 percent [95% CI: 9.69 percent, 9.99 percent] for nonpenalized, nonteaching hospitals). CONCLUSIONS: Heart failure readmission penalties disproportionately impact major teaching hospitals and inadequately credit their better postdischarge survival.

Colorectal Surgical Site Infection Prevention Kits Prior to Elective Colectomy Improve Outcomes.

INTRODUCTION: Patient compliance with preoperative mechanical and antibiotic bowel preparation, skin washes, carbohydrate loading, and avoidance of fasting are key components of successful colorectal ERAS and surgical site infection (SSI)-reduction programs. In July 2016, we began a quality improvement project distributing a free SSI Prevention Kit (SSIPK) containing patient instructions, mechanical and oral bowel preparation, chlorhexidine washes, and carbohydrate drink to all patients scheduled for elective colectomy, with the goal of improving patient compliance and rates of SSI. METHODS: This was a prospective data audit of our first 221 SSIPK+ patients, who were compared to historical controls (SSIPK-) of 1760 patients undergoing elective colectomy from January 2013 to March 2017. A 1:1 propensity score system accounted for nonrandom treatment assignment. Matched patients' complications, particularly postoperative infection and ileus, were compared. RESULTS: SSIPK+ (n = 219) and SSIPK- (n = 219) matched patients were statistically identical on demographics, comorbidities, BMI, surgical indication, and procedure. SSIPK+ patients had higher compliance with mechanical (95% vs 71%, P < 0.001) and oral antibiotic (94% vs 27%, P < 0.001) bowel preparation. This translated into lower overall SSI rates (5.9% vs 11.4%, P = 0.04). SSIPK+ patients also had lower rates of anastomotic leak (2.7% vs 6.8%, P = 0.04), prolonged postoperative ileus (5.9% vs 14.2%, P < 0.01), and unplanned intubation (0% vs 2.3%, P = 0.02). Furthermore, SSIPK+ patients had shorter mean hospital length of stay (3.1 vs 5.4 d, P < 0.01) and had fewer unplanned readmissions (5.9% vs 14.6%, P < 0.001). There were no differences in rates of postoperative pneumonia, urinary tract infection, Clostridium difficile colitis, sepsis, or death. CONCLUSION: Provision of a free-of-charge SSIPK is associated with higher patient compliance with preoperative instructions and significantly lower rates of surgical site infections, lower rates of prolonged postoperative ileus, and shorter hospital stays with fewer readmissions. Widespread utilization of such a bundle could therefore lead to significantly improved outcomes.

Using Design Thinking to Improve Patient-Provider Communication in the Emergency Department.

QUALITY ISSUE: Emergency department overcrowding has been identified as a quality and patient safety concern. INITIAL ASSESSMENT: The need for a project focused on mitigating risk in the setting of overcrowding was identified. CHOICE OF SOLUTION: Design thinking is an improvement methodology that uses a process that prioritizes empathy for end users and is optimal for abstract problems. IMPLEMENTATION: The team leveraged design thinking to walk through a 5-step process. In the empathize phase, inputs were collected and safety themes identified. In the define phase, optimal communication was identified as the focus area of the project. During the ideate phase, the team looked both internally and externally to identify tactics that existed to improve communication. Next, the team prototyped different solutions. In the testing phase, 33 trainings with 289 clinicians were conducted. EVALUATION: The evaluation of this program demonstrated that it was positively received by clinicians. Although only 72% of clinicians believed the course would be a valuable use of their time before taking it, 97% reported it was a valuable use of their time following completion (P < .001). Precourse self-evaluation of knowledge, skill, and ability was high. Despite this, postcourse self-efficacy improved significantly in all 4 domains studied. LESSONS LEARNED: Design thinking offers an agile method for process improvement that was ideal for our relatively abstract problem. Although likely not an optimal method for a problem that is well understood, design thinking holds promise for many of the increasingly patient-centered initiatives that are underway in health care.

Adopting RCA2: The Interrater Reliability of Safety Assessment Codes.

Safety assessment codes (SACs) are one method to evaluate adverse events and determine the need for a root cause analysis. Few facilities currently use SACs, and there is no literature examining their interrater reliability. Two independent raters assigned frequency, actual harm, and potential harm ratings to a sample of patient safety reports. An actual and potential SAC were determined. Percent agreement and Cohen's κ were calculated. Substantial agreement existed for the actual SAC (κ = 0.626, P < .001), fair agreement for the potential SAC (κ = 0.266, P < .001), and low agreement for potential harm (κ = 0.171, P = .002). Although there is subjectivity in all aspects of assigning SACs, the greatest is in potential severity. This presents a problem when using the potential SAC and is in agreement with previous literature showing significant subjectivity in determining potential harm. An operational framework is needed to strengthen reliability.

Safety Culture and Mortality after Acute Myocardial Infarction: A Study of Medicare Beneficiaries at 171 Hospitals.

OBJECTIVES: To investigate the association between hospital safety culture and 30-day risk-adjusted mortality for Medicare patients with acute myocardial infarction (AMI) in a large, diverse hospital cohort. SUBJECTS: The final analytic cohort consisted of 19,357 Medicare AMI discharges (MedPAR data) linked to 257 AHRQ Hospital Survey on Patient Safety Culture surveys from 171 hospitals between 2008 and 2013. STUDY DESIGN: Observational, cross-sectional study using hierarchical logistic models to estimate the association between hospital safety scores and 30-day risk-adjusted patient mortality. Odds ratios of 30-day, all-cause mortality, adjusting for patient covariates, hospital characteristics (size and teaching status), and several different types of safety culture scores (composite, average, and overall) were determined. PRINCIPAL FINDINGS: No significant association was found between any measure of hospital safety culture and adjusted AMI mortality. CONCLUSIONS: In a large cross-sectional study from a diverse hospital cohort, AHRQ safety culture scores were not associated with AMI mortality. Our study adds to a growing body of investigations that have failed to conclusively demonstrate a safety culture-outcome association in health care, at least with widely used national survey instruments.

New Mandated Centers for Medicare and Medicaid Services Requirements for Sepsis Reporting: Caution from the Field.

BACKGROUND: The release of the Center for Medicare and Medicaid Service's (CMS) latest quality measure, Severe Sepsis/Septic Shock Early Management Bundle (SEP-1), has intensified the long-standing debate over optimal care for severe sepsis and septic shock. Although the last decade of research has demonstrated the importance of comprehensive bundled care in conjunction with compliance mechanisms to reduce patient mortality, it is not clear that SEP-1 achieves this aim. The heterogeneous and often cryptic presentation of severe sepsis and septic shock, along with the multifaceted criteria for the definition of this clinical syndrome, pose a particular challenge for fitting requirements to this disease, and implementation could have unintended consequences. OBJECTIVE: Following a simulated reporting exercise, in which 50 charts underwent expert review, we aimed to detail the challenges of, and offer suggestions on how to rethink, measuring performance in severe sepsis and septic shock care. DISCUSSION: There were several challenges associated with the design and implementation of this measure. The ambiguous definition of severe sepsis and septic shock, prescriptive fluid volume requirements, rigid reassessment, and complex abstraction logic all raise significant concern. CONCLUSIONS: Although SEP-1 represents an important first step in requiring hospitals to improve outcomes for patients with severe sepsis and septic shock, the current approach must be revisited. The volume and complexity of the currently required SEP-1 reporting elements deserve serious consideration and revision before they are used as measures of accountability and tied to reimbursement.

Reporting trends and outcomes in ST-segment-elevation myocardial infarction national hospital quality assessment programs.

BACKGROUND: For patients who undergo primary percutaneous coronary intervention (PCI) for ST-segment-elevation myocardial infarction, the door-to-balloon time is an important performance measure reported to the Centers for Medicare & Medicaid Services (CMS) and tied to hospital quality assessment and reimbursement. We sought to assess the use and impact of exclusion criteria associated with the CMS measure of door-to-balloon time in primary PCI. METHODS AND RESULTS: All primary PCI-eligible patients at 3 Massachusetts hospitals (Brigham and Women's, Massachusetts General, and North Shore Medical Center) were evaluated for CMS reporting status. Rates of CMS reporting exclusion were the primary end points of interest. Key secondary end points were between-group differences in patient characteristics, door-to-balloon times, and 1-year mortality rates. From 2005 to 2011, 26% (408) of the 1548 primary PCI cases were excluded from CMS reporting. This percentage increased over the study period from 13.9% in 2005 to 36.7% in the first 3 quarters of 2011 (P<0.001). The most frequent cause of exclusion was for a diagnostic dilemma such as a nondiagnostic initial ECG, accounting for 31.2% of excluded patients. Although 95% of CMS-reported cases met door-to-balloon time goals in 2011, this was true of only 61% of CMS-excluded cases and consequently 82.6% of all primary PCI cases performed that year. The 1-year mortality for CMS-excluded patients was double that of CMS-included patients (13.5% versus 6.6%; P<0.001). CONCLUSIONS: More than a quarter of patients who underwent primary PCI were excluded from hospital quality reports collected by CMS, and this percentage has grown substantially over time. These findings may have significant implications for our understanding of process improvement in primary PCI and mechanisms for reimbursement through Medicare.

Setting quality and safety priorities in a target-rich environment: an academic medical center's challenge.

Hospitals are continually challenged to provide safer and higher-quality patient care despite resource constraints. With an ever-increasing range of quality and safety targets at the national, state, and local levels, prioritization is crucial in effective institutional quality goal setting and resource allocation.Organizational goal-setting theory is a performance improvement methodology with strong results across many industries. The authors describe a structured goal-setting process they have established at Massachusetts General Hospital for setting annual institutional quality and safety goals. Begun in 2008, this process has been conducted on an annual basis. Quality and safety data are gathered from many sources, both internal and external to the hospital. These data are collated and classified, and multiple approaches are used to identify the most pressing quality issues facing the institution. The conclusions are subject to stringent internal review, and then the top quality goals of the institution are chosen. Specific tactical initiatives and executive owners are assigned to each goal, and metrics are selected to track performance. A reporting tool based on these tactics and metrics is used to deliver progress updates to senior hospital leadership.The hospital has experienced excellent results and strong organizational buy-in using this effective, low-cost, and replicable goal-setting process. It has led to improvements in structural, process, and outcomes aspects of quality.

Contemporary performance of U.S. teaching and nonteaching hospitals.

PURPOSE: To compare the performance of U.S. teaching and nonteaching hospitals using a portfolio of contemporary, publicly reported metrics. METHOD: The authors classified acute care general hospitals filing a Medicare Institutional Cost Report according to teaching intensity: nonteaching, teaching, or Council of Teaching Hospitals member. They compared aggregate results across categories for Hospital Compare process compliance, mortality, and readmission rates (acute myocardial infarction [AMI], heart failure, pneumonia); Surgical Care Improvement Project (SCIP) performance; compliance with Leapfrog standards; patient experience; patient services and key technologies; safety (computerized physician order entry, intensive care unit staffing, National Quality Forum safe practices, hospital-acquired conditions); and cost/resource utilization (Medicare-adjusted expense per case; Leapfrog efficiency and resource use standards). RESULTS: Availability of patient services and advanced technologies were associated with teaching intensity (P < .0001), as were most hospital safety metrics. Teaching intensity was favorably associated with SCIP performance, AMI and heart failure process scores, and mortality (P < .0001). It was unfavorably associated with higher AMI and pneumonia readmission rates (P < .0001) and lower scores for individual patient satisfaction measures. Costs per case were similar (P = .4194) across hospital categories after correction for federally allowed adjustments (case mix, wages, and low-income patient care). CONCLUSIONS: Teaching hospitals offer advanced clinical capabilities, educate the next generation of providers, care for disadvantaged urban populations, and are leaders in health care research and innovation. However, many stakeholders may be unaware of an additional value-relatively higher quality and safety in many areas, with similar adjusted costs.

Documentation of decision-making capacity, informed consent, and health care proxies: a study of surrogate consent.

BACKGROUND: Patients in the general hospital are routinely asked to make decisions about their medical care. However, some of them are unable to express a choice, understand the information provided, weigh the options, or make a decision for themselves; when this occurs, the task of making an appropriate medical decision is left to another-a substitute decision-maker (SDM). OBJECTIVE: We sought to understand the practice patterns surrounding surrogate consent. We hypothesized that SDMs would be used frequently for patients with an altered mental status (AMS) but that there would be insufficient documentation of health care proxies (HCP) and of clinician assessment of a patient's decision-making capacity. METHODS: A retrospective chart review was conducted on inpatients who underwent a lumbar puncture. The review assessed whether patients had a HCP in the record, if the patient's mental status was evaluated prior to obtaining informed consent, if the patient's capacity was addressed in this assessment, and whether a SDM was asked to provide the informed consent. RESULTS: Consistent with our hypotheses, we found that the majority of patients did not have documentation of a HCP in the record. We found that the mental status of all patients was assessed prior to the procedure, but that documentation regarding assessment of decision-making capacity was lacking. CONCLUSIONS: Our pilot investigation suggests that there is need for improvement in our evaluation and documentation of altered mental status and a patient's ability to make informed decisions. To this end, several quality-improvement suggestions are discussed.

Restructuring within an academic health center to support quality and safety: the development of the Center for Quality and Safety at the Massachusetts General Hospital.

Recent focus on the need to improve the quality and safety of health care has created new challenges for academic health centers (AHCs). Whereas previously quality was largely assumed, today it is increasingly quantifiable and requires organized systems for improvement. Traditional structures and cultures within AHCs, although well suited to the tripartite missions of teaching, research, and clinical care, are not easily adaptable to the tasks of measuring, reporting, and improving quality. Here, the authors use a case study of Massachusetts General Hospital's efforts to restructure quality and safety to illustrate the value of beginning with a focus on organizational culture, using a systematic process of engaging clinical leadership, developing an organizational framework dependent on proven business principles, leveraging focus events, and maintaining executive dedication to execution of the initiative. The case provides a generalizable example for AHCs of how applying explicit management design can foster robust organizational change with relatively modest incremental financial resources.