Early recognition and response to increases in surgical site infections using optimised statistical process control charts-The early 2RIS trial: A multicentre stepped wedge cluster randomised controlled trial.

Background: Traditional approaches for surgical site infection (SSI) surveillance have deficiencies that delay detection of SSI outbreaks and other clinically important increases in SSI rates. We investigated whether use of optimised statistical process control (SPC) methods and feedback for SSI surveillance would decrease rates of SSI in a network of US community hospitals. Methods: We conducted a stepped wedge cluster randomised trial of patients who underwent any of 13 types of common surgical procedures across 29 community hospitals in the Southeastern United States. We divided the 13 procedures into six clusters; a cluster of procedures at a single hospital was the unit of randomisation and analysis. In total, 105 clusters were randomised to 12 groups of 8-10 clusters. All participating clusters began the trial in a 12-month baseline period of control or "traditional" SSI surveillance, including prospective analysis of SSI rates and consultative support for SSI outbreaks and investigations. Thereafter, a group of clusters transitioned from control to intervention surveillance every three months until all clusters received the intervention. Electronic randomisation by the study statistician determined the sequence by which clusters crossed over from control to intervention surveillance. The intervention was the addition of weekly application of optimised SPC methods and feedback to existing traditional SSI surveillance methods. Epidemiologists were blinded to hospital identity and randomisation status while adjudicating SPC signals of increased SSI rates, but blinding was not possible during SSI investigations. The primary outcome was the overall SSI prevalence rate (PR=SSIs/100 procedures), evaluated via generalised estimating equations with a Poisson regression model. Secondary outcomes compared traditional and optimised SPC signals that identified SSI rate increases, including the number of formal SSI investigations generated and deficiencies identified in best practices for SSI prevention. This trial was registered at ClinicalTrials.gov, NCT03075813. Findings: Between Mar 1, 2016, and Feb 29, 2020, 204,233 unique patients underwent 237,704 surgical procedures. 148,365 procedures received traditional SSI surveillance and feedback alone, and 89,339 procedures additionally received the intervention of optimised SPC surveillance. The primary outcome of SSI was assessed for all procedures performed within participating clusters. SSIs occurred after 1171 procedures assigned control surveillance (prevalence rate [PR] 0.79 per 100 procedures), compared to 781 procedures that received the intervention (PR 0·87 per 100 procedures; model-based PR ratio 1.10, 95% CI 0.94-1.30, p=0.25). Traditional surveillance generated 24 formal SSI investigations that identified 120 SSIs with deficiencies in two or more perioperative best practices for SSI prevention. In comparison, optimised SPC surveillance generated 74 formal investigations that identified 458 SSIs with multiple best practice deficiencies. Interpretation: The addition of optimised SPC methods and feedback to traditional methods for SSI surveillance led to greater detection of important SSI rate increases and best practice deficiencies but did not decrease SSI rates. Additional research is needed to determine how to best utilise SPC methods and feedback to improve adherence to SSI quality measures and prevent SSIs. Funding: Agency for Healthcare Research and Quality.

Systems engineering analysis of diagnostic referral closed-loop processes.

BACKGROUND: Closing loops to complete diagnostic referrals remains a significant patient safety problem in most health systems, with 65%-73% failure rates and significant delays common despite years of improvement efforts, suggesting new approaches may be useful. Systems engineering (SE) methods increasingly are advocated in healthcare for their value in studying and redesigning complex processes. OBJECTIVE: Conduct a formative SE analysis of process logic, variation, reliability and failures for completing diagnostic referrals originating in two primary care practices serving different demographics, using dermatology as an illustrating use case. METHODS: An interdisciplinary team of clinicians, systems engineers, quality improvement specialists, and patient representatives collaborated to understand processes of initiating and completing diagnostic referrals. Cross-functional process maps were developed through iterative group interviews with an urban community-based health centre and a teaching practice within a large academic medical centre. Results were used to conduct an engineering process analysis, assess variation within and between practices, and identify common failure modes and potential solutions. RESULTS: Processes to complete diagnostic referrals involve many sub-standard design constructs, with significant workflow variation between and within practices, statistical instability and special cause variation in completion rates and timeliness, and only 21% of all process activities estimated as value-add. Failure modes were similar between the two practices, with most process activities relying on low-reliability concepts (eg, reminders, workarounds, education and verification/inspection). Several opportunities were identified to incorporate higher reliability process constructs (eg, simplification, consolidation, standardisation, forcing functions, automation and opt-outs). CONCLUSION: From a systems science perspective, diagnostic referral processes perform poorly in part because their fundamental designs are fraught with low-reliability characteristics and mental models, including formalised workaround and rework activities, suggesting a need for different approaches versus incremental improvement of existing processes. SE perspectives and methods offer new ways of thinking about patient safety problems, failures and potential solutions.

Systems Analysis of a Dedicated Ambulatory Respiratory Unit for Seeing and Ensuring Follow-up of Patients With COVID-19 Symptoms.

COVID-19 necessitated significant care redesign, including new ambulatory workflows to handle surge volumes, protect patients and staff, and ensure timely reliable care. Opportunities also exist to harvest lessons from workflow innovations to benefit routine care. We describe a dedicated COVID-19 ambulatory unit for closing testing and follow-up loops characterized by standardized workflows and electronic communication, documentation, and order placement. More than 85% of follow-ups were completed within 24 hours, with no observed staff, nor patient infections associated with unit operations. Identified issues include role confusion, staffing and gatekeeping bottlenecks, and patient reluctance to visit in person or discuss concerns with phone screeners.

Community and Campus COVID-19 Risk Uncertainty Under University Reopening Scenarios: Model-Based Analysis.

BACKGROUND: Significant uncertainty has existed about the safety of reopening college and university campuses before the COVID-19 pandemic is better controlled. Moreover, little is known about the effects that on-campus students may have on local higher-risk communities. OBJECTIVE: We aimed to estimate the range of potential community and campus COVID-19 exposures, infections, and mortality under various university reopening plans and uncertainties. METHODS: We developed campus-only, community-only, and campus × community epidemic differential equations and agent-based models, with inputs estimated via published and grey literature, expert opinion, and parameter search algorithms. Campus opening plans (spanning fully open, hybrid, and fully virtual approaches) were identified from websites and publications. Additional student and community exposures, infections, and mortality over 16-week semesters were estimated under each scenario, with 10% trimmed medians, standard deviations, and probability intervals computed to omit extreme outliers. Sensitivity analyses were conducted to inform potential effective interventions. RESULTS: Predicted 16-week campus and additional community exposures, infections, and mortality for the base case with no precautions (or negligible compliance) varied significantly from their medians (4- to 10-fold). Over 5% of on-campus students were infected after a mean of 76 (SD 17) days, with the greatest increase (first inflection point) occurring on average on day 84 (SD 10.2 days) of the semester and with total additional community exposures, infections, and mortality ranging from 1-187, 13-820, and 1-21 per 10,000 residents, respectively. Reopening precautions reduced infections by 24%-26% and mortality by 36%-50% in both populations. Beyond campus and community reproductive numbers, sensitivity analysis indicated no dominant factors that interventions could primarily target to reduce the magnitude and variability in outcomes, suggesting the importance of comprehensive public health measures and surveillance. CONCLUSIONS: Community and campus COVID-19 exposures, infections, and mortality resulting from reopening campuses are highly unpredictable regardless of precautions. Public health implications include the need for effective surveillance and flexible campus operations.

Early recognition and response to increases in surgical site infections using optimized statistical process control charts-the Early 2RIS Trial: a multicenter cluster randomized controlled trial with stepped wedge design.

BACKGROUND: Surgical site infections (SSIs) cause significant patient suffering. Surveillance and feedback of SSI rates is an evidence-based strategy to reduce SSIs, but traditional surveillance methods are slow and prone to bias. The objective of this cluster randomized controlled trial (RCT) is to determine if using optimized statistical process control (SPC) charts for SSI surveillance and feedback lead to a reduction in SSI rates compared to traditional surveillance. METHODS: The Early 2RIS Trial is a prospective, multicenter cluster RCT using a stepped wedge design. The trial will be performed in 29 hospitals in the Duke Infection Control Outreach Network (DICON) and 105 clusters over 4 years, from March 2016 through February 2020; year one represents a baseline period; thereafter, 8-9 clusters will be randomized to intervention every 3 months over a 3-year period using a stepped wedge randomization design. All patients who undergo one of 13 targeted procedures at study hospitals will be included in the analysis; these procedures will be included in one of six clusters: cardiac, orthopedic, gastrointestinal, OB-GYN, vascular, and spinal. All clusters will undergo traditional surveillance for SSIs; once randomized to intervention, clusters will also undergo surveillance and feedback using optimized SPC charts. Feedback on surveillance data will be provided to all clusters, regardless of allocation or type of surveillance. The primary endpoint is the difference in rates of SSI between the SPC intervention compared to traditional surveillance and feedback alone. DISCUSSION: The traditional approach for SSI surveillance and feedback has several major deficiencies because SSIs are rare events. First, traditional statistical methods require aggregation of measurements over time, which delays analysis until enough data accumulate. Second, traditional statistical tests and resulting p values are difficult to interpret. Third, analyses based on average SSI rates during predefined time periods have limited ability to rapidly identify important, real-time trends. Thus, standard analytic methods that compare average SSI rates between arbitrarily designated time intervals may not identify an important SSI rate increase on time unless the "signal" is very strong. Therefore, novel strategies for early identification and investigation of SSI rate increases are needed to decrease SSI rates. While SPC charts are used throughout industry and healthcare to improve and optimize processes, including other types of healthcare-associated infections, they have not been evaluated as a tool for SSI surveillance and feedback in a randomized trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT03075813 , Registered March 9, 2017.

Potential Community and Campus Covid-19 Outcomes Under University and College Reopening Scenarios.

BACKGROUND: Significant uncertainty exists in many countries about the safety of, and best strategies for, reopening college and university campuses until the Covid-19 pandemic is better controlled. Little also is known about the effects on-campus students may have on local higher-risk communities. We aimed to estimate potential community and campus Covid-19 exposures, infections, and mortality due to various university reopening and precaution plans under current ranges of assumptions and uncertainties. METHODS: We developed and calibrated campus-only, community-only, and campus-x-community epidemic differential equation and agent-based models. Input parameters for campus and surrounding communities were estimated via published and grey literature, scenario development, expert opinion, accuracy optimization algorithms, and Monte Carlo simulation; models were cross-validated against each other using February-June 2020 data from heterogeneous U.S. counties and states. Campus opening plans (spanning various fully open, hybrid, and fully virtual approaches) were identified from websites and publications. All scenarios were simulated assuming 16-week semesters and estimated ranges for Covid-19 prevalence among community residents and arriving students, precaution compliance, contact frequency, virus attack rates, and tracing and isolation effectiveness. Additional student and community exposures, infections, and mortality were estimated under each scenario, with 10% trimmed medians, standard deviations, and probability intervals computed to omit extreme outlier scenarios. Factorial analyses were conducted to identify intervention inputs with largest and smallest effects. RESULTS: As a base case with no precautions (or no compliance), predicted 16-week student infections and mortality under normal operations ranged significantly from 471 to 9,495 (median: 2,286, SD: 2,627) and 0 to 123 (median: 9, SD: 14) per 10,000 students, respectively. The maximum active exposures across a semester was 15.76% of all students warranting tracing. Total additional community exposures, infections, and mortality ranged from 1 to 187, 13 to 820, and 1 to 21 per 10,000 residents, respectively. 1% and 5% of on-campus students were infected after a mean (SD) of 11 (3) and 76 (17) days, respectively; >10% students infected by the end of a semester in 34.8% of scenarios, with the greatest increase (first inflection point) occurring on aver-age on day 84 (SD: 10.2 days). Common reopening precautions reduced infections by 24% to 26% and mortality by 36% to 50% in both populations. Uncertainties in many factors, however, produced tremendous variability in all results, ranging from medians by -67% to +342%. CONCLUSIONS: Consequences on community and student Covid-19 exposures, infections, and mortality of reopening physical campuses are very highly unpredictable, depending on a combination of random chance, controllable (e.g. physical layouts), and uncontrollable (e.g. human behavior) factors. Implications include needs for criteria to adapt campus operations mid-semester, methods to detect when necessary, and contingency plans for doing so.