Patient Safety Indicators During the Initial COVID-19 Pandemic Surge in the United States.

OBJECTIVE: The COVID-19 pandemic presented a challenge to inpatient safety. It is unknown whether there were spillover effects due to COVID-19 into non-COVID-19 care and safety. We sought to evaluate the changes in inpatient Agency for Healthcare Research and Quality patient safety indicators (PSIs) in the United States before and during the first surge of the pandemic among patients admitted without COVID-19. METHODS: We analyzed trends in PSIs from January 2019 to June 2020 in patients without COVID-19 using data from IBM MarketScan Commercial Database. We included members of employer-sponsored or Medicare supplemental health plans with inpatient, non-COVID-19 admissions. The primary outcomes were risk-adjusted composite and individual PSIs. RESULTS: We analyzed 1,869,430 patients admitted without COVID-19. Among patients without COVID-19, the composite PSI score was not significantly different when comparing the first surge (Q2 2020) to the prepandemic period (e.g., Q2 2020 score of 2.46 [95% confidence interval {CI}, 2.34-2.58] versus Q1 2020 score of 2.37 [95% CI, 2.27-2.46]; P = 0.22). Individual PSIs for these patients during Q2 2020 were also not significantly different, except in-hospital fall with hip fracture (e.g., Q2 2020 was 3.42 [95% CI, 3.34-3.49] versus Q4 2019 was 2.45 [95% CI, 2.40-2.50]; P = 0.01). CONCLUSIONS: The first surge of COVID-19 was not associated with worse inpatient safety for patients without COVID-19, highlighting the ability of the healthcare system to respond to the initial surge of the pandemic.

Clinical Decision Support for Hypertension Management in Chronic Kidney Disease: A Randomized Clinical Trial.

Importance: Chronic kidney disease (CKD) affects 37 million adults in the United States, and for patients with CKD, hypertension is a key risk factor for adverse outcomes, such as kidney failure, cardiovascular events, and death. Objective: To evaluate a computerized clinical decision support (CDS) system for the management of uncontrolled hypertension in patients with CKD. Design, Setting, and Participants: This multiclinic, randomized clinical trial randomized primary care practitioners (PCPs) at a primary care network, including 15 hospital-based, ambulatory, and community health center-based clinics, through a stratified, matched-pair randomization approach February 2021 to February 2022. All adult patients with a visit to a PCP in the last 2 years were eligible and those with evidence of CKD and hypertension were included. Intervention: The intervention consisted of a CDS system based on behavioral economic principles and human-centered design methods that delivered tailored, evidence-based recommendations, including initiation or titration of renin-angiotensin-aldosterone system inhibitors. The patients in the control group received usual care from PCPs with the CDS system operating in silent mode. Main Outcomes and Measures: The primary outcome was the change in mean systolic blood pressure (SBP) between baseline and 180 days compared between groups. The primary analysis was a repeated measures linear mixed model, using SBP at baseline, 90 days, and 180 days in an intention-to-treat repeated measures model to account for missing data. Secondary outcomes included blood pressure (BP) control and outcomes such as percentage of patients who received an action that aligned with the CDS recommendations. Results: The study included 174 PCPs and 2026 patients (mean [SD] age, 75.3 [0.3] years; 1223 [60.4%] female; mean [SD] SBP at baseline, 154.0 [14.3] mm Hg), with 87 PCPs and 1029 patients randomized to the intervention and 87 PCPs and 997 patients randomized to usual care. Overall, 1714 patients (84.6%) were treated for hypertension at baseline. There were 1623 patients (80.1%) with an SBP measurement at 180 days. From the linear mixed model, there was a statistically significant difference in mean SBP change in the intervention group compared with the usual care group (change, -14.6 [95% CI, -13.1 to -16.0] mm Hg vs -11.7 [-10.2 to -13.1] mm Hg; P = .005). There was no difference in the percentage of patients who achieved BP control in the intervention group compared with the control group (50.4% [95% CI, 46.5% to 54.3%] vs 47.1% [95% CI, 43.3% to 51.0%]). More patients received an action aligned with the CDS recommendations in the intervention group than in the usual care group (49.9% [95% CI, 45.1% to 54.8%] vs 34.6% [95% CI, 29.8% to 39.4%]; P < .001). Conclusions and Relevance: These findings suggest that implementing this computerized CDS system could lead to improved management of uncontrolled hypertension and potentially improved clinical outcomes at the population level for patients with CKD. Trial Registration: ClinicalTrials.gov Identifier: NCT03679247.

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.

A Public Health Critical Race Praxis Informed Congestive Heart Failure Quality Improvement Initiative on Inpatient General Medicine.

BACKGROUND: Prior evaluation at our hospital demonstrated that, compared to White patients, Black and Latinx patients with congestive heart failure (CHF) were less likely to be admitted to the cardiology service rather than the general medicine service (GMS). Patients admitted to GMS (compared to cardiology) had inferior rates of cardiology follow-up and 30-day readmission. OBJECTIVE: To develop and test the feasibility and impacts of using quality improvement (QI) methods, in combination with the Public Health Critical Race Praxis (PHCRP) framework, to engage stakeholders in developing an intervention for ensuring guideline-concordant inpatient CHF care across all patient groups. METHODS: We compared measures for all patients admitted with CHF to GMS between September 2019 and March 2020 (intervention group) to CHF patients admitted to GMS in the previous year (pre-intervention group) and those admitted to cardiology during the pre-intervention and intervention periods (cardiology group). Our primary measures were 30-day readmissions and 14- and 30-day post-discharge cardiology follow-up. RESULTS: There were 79 patients admitted with CHF to GMS during the intervention period, all of whom received the intervention. There were similar rates of Black and Latinx patients across the three groups. Compared to pre-intervention, intervention patients had a significantly lower 30-day readmission rate (18.9% vs. 24.8%; p=0.024), though the cardiology group also had a decrease in 30-day readmissions from the pre-intervention to intervention period. Compared to pre-intervention, intervention patients had significantly higher 14-day and 30-day post-discharge follow-up visits scheduled with cardiology (36.7% vs. 24.8%, p=0.005; 55.7% vs. 42.3%, p=0.0029), but no improvement in appointment attendance. CONCLUSION: This study provides a first test of applying the PHCRP framework within a stakeholder-engaged QI initiative for improving CHF care across races and ethnicities. Our study design cannot evaluate causation. However, the improvements in 30-day readmission, as well as in processes of care that may affect it, provide optimism that inclusion of a racism-conscious framework in QI initiatives is feasible and may enhance QI measures.

Cost of Inpatient Falls and Cost-Benefit Analysis of Implementation of an Evidence-Based Fall Prevention Program.

Importance: There is insufficient research on the costs of patient falls in health care systems, a leading source of nonreimbursable adverse events. Objective: To report the costs of inpatient falls and the cost savings associated with implementation of an evidence-based fall prevention program. Design, Setting, and Participants: In this economic evaluation, a matched case-control study used the findings from an interrupted time series analysis that assessed changes in fall rates following implementation of an evidence-based fall prevention program to understand the cost of inpatient falls. An economic analysis was then performed to assess the cost benefits associated with program implementation across 2 US health care systems from June 1, 2013, to August 31, 2019, in New York, New York, and Boston, Massachusetts. All adults hospitalized in participating units were included in the analysis. Data analysis was performed from October 2021 to November 2022. Interventions: Evidence-based fall prevention program implemented in 33 medical and surgical units in 8 hospitals. Main Outcomes and Measures: Primary outcome was cost of inpatient falls. Secondary outcome was the costs and cost savings associated with the evidence-based fall prevention program. Results: A total of 10 176 patients who had a fall event (injurious or noninjurious) with 29 161 matched controls (no fall event) were included in the case-control study and the economic analysis (51.9% were 65-74 years of age, 67.1% were White, and 53.6% were male). Before the intervention, there were 2503 falls and 900 injuries; after the intervention, there were 2078 falls and 758 injuries. Based on a 19% reduction in falls and 20% reduction in injurious falls from the beginning to the end of the postintervention period, the economic analysis demonstrated that noninjurious and injurious falls were associated with cost increases of $35 365 and $36 776, respectively. The implementation of the evidence-based fall prevention program was associated with $14 600 in net avoided costs per 1000 patient-days. Conclusions and Relevance: This economic evaluation found that fall-related adverse events represented a clinical and financial burden to health care systems and that the current Medicare policy limits reimbursement. In this study, costs of falls only differed marginally by injury level. Policies that incentivize organizations to implement evidence-based strategies that reduce the incidence of all falls may be effective in reducing both harm and costs.

Patient Characteristics Associated With Reactions to Mrgprx2-Activating Drugs in an Electronic Health Record-Linked Biobank.

BACKGROUND: Mas-related G protein-couple receptor x2 (Mrgprx2) activation underlies many common non-IgE-mediated adverse drug reactions (ADRs), yet the features of patients with reactions to Mrgprx2-activating drugs are unknown. OBJECTIVE: To characterize the patient-specific comorbidities and laboratory characteristics associated with listed reactions to Mrgprx2-activating drugs, including fluoroquinolones, morphine, neuromuscular blockade agents, vancomycin, and leuprolide. METHODS: We used a retrospective, observational cohort study design using electronic health record data from adults with an Mrgprx2-activating drug exposure recorded within a hospital system clinical Biobank. Odds ratios (ORs) and incidence rate ratios for clinical characteristics associated with ADRs, including immediate hypersensitivity reactions, were calculated using multivariable logistic regression. RESULTS: Among 59,763 patients exposed to Mrgprx2-activating drugs, 4846 had a listed ADR. Female sex, White race, asthma (OR: 1.81, 95% confidence interval [CI]: 1.68-1.94), chronic urticaria (OR: 1.73, 95% CI: 1.46-2.05), and mastocytosis (OR: 12.79, 95% CI: 5.98-27.02) were associated with increased odds of a reaction. Overall, patients with allergic disease had 1.21 times the rate of an ADR compared with patients without allergic disease. Elevated absolute eosinophil count was inversely associated with reactions, and there was no association with elevated total IgE. Observed associations were similar in a patient subgroup with immediate-type hypersensitivity reactions. CONCLUSION: Specific allergic diseases and common allergic biomarkers are differentially associated with ADRs to Mrgprx2-activating drugs. These findings from a large, "real world" drug-exposed population highlight clinical factors that may contribute to non-IgE-mediated drug allergy.

The Association of the First Surge of the COVID-19 Pandemic with the High- and Low-Value Outpatient Care Delivered to Adults in the USA.

BACKGROUND: The first surge of the COVID-19 pandemic entirely altered healthcare delivery. Whether this also altered the receipt of high- and low-value care is unknown. OBJECTIVE: To test the association between the April through June 2020 surge of COVID-19 and various high- and low-value care measures to determine how the delivery of care changed. DESIGN: Difference in differences analysis, examining the difference in quality measures between the April through June 2020 surge quarter and the January through March 2020 quarter with the same 2 quarters' difference the year prior. PARTICIPANTS: Adults in the MarketScan® Commercial Database and Medicare Supplemental Database. MAIN MEASURES: Fifteen low-value and 16 high-value quality measures aggregated into 8 clinical quality composites (4 of these low-value). KEY RESULTS: We analyzed 9,352,569 adults. Mean age was 44 years (SD, 15.03), 52% were female, and 75% were employed. Receipt of nearly every type of low-value care decreased during the surge. For example, low-value cancer screening decreased 0.86% (95% CI, -1.03 to -0.69). Use of opioid medications for back and neck pain (DiD +0.94 [95% CI, +0.82 to +1.07]) and use of opioid medications for headache (DiD +0.38 [95% CI, 0.07 to 0.69]) were the only two measures to increase. Nearly all high-value care measures also decreased. For example, high-value diabetes care decreased 9.75% (95% CI, -10.79 to -8.71). CONCLUSIONS: The first COVID-19 surge was associated with receipt of less low-value care and substantially less high-value care for most measures, with the notable exception of increases in low-value opioid use.

Effect of an Online Weight Management Program Integrated With Population Health Management on Weight Change: A Randomized Clinical Trial.

Importance: Online programs may help with weight loss but have not been widely implemented in routine primary care. Objective: To compare the effectiveness of a combined intervention, including an online weight management program plus population health management, with the online program only and with usual care. Design, Setting, and Participants: Cluster randomized trial with enrollment from July 19, 2016, through August 10, 2017, at 15 primary care practices in the US. Eligible participants had a scheduled primary care visit and were aged 20 to 70 years, had a body mass index between 27 and less than 40, and had a diagnosis of hypertension or type 2 diabetes. Follow-up ended on May 8, 2019. Interventions: Participants in the usual care group (n = 326) were mailed general information about weight management. Participants in the online program only group (n = 216) and the combined intervention group (n = 298) were registered for the online program. The participants in the combined intervention group also received weight-related population health management, which included additional support from nonclinical staff who monitored their progress in the online program and conducted periodic outreach. Main Outcomes and Measures: The primary outcome was weight change at 12 months based on measured weights recorded in the electronic health record. Weight change at 18 months was a secondary outcome. Results: Among the 840 participants who enrolled (mean age, 59.3 years [SD, 8.6 years]; 60% female; 76.8% White), 732 (87.1%) had a recorded weight at 12 months and the missing weights for the remaining participants were imputed. There was a significant difference in weight change at 12 months by group with a mean weight change of -1.2 kg (95% CI, -2.1 to -0.3 kg) in the usual care group, -1.9 kg (95% CI, -2.6 to -1.1 kg) in the online program only group, and -3.1 kg (95% CI, -3.7 to -2.5 kg) in the combined intervention group (P < .001). The difference in weight change between the combined intervention group and the usual care group was -1.9 kg (97.5% CI, -2.9 to -0.9 kg; P < .001) and the difference between the combined intervention group and the online program only group was -1.2 kg (95% CI, -2.2 to -0.3 kg; P = .01). At 18 months, the mean weight change was -1.9 kg (95% CI, -2.8 to -1.0 kg) in the usual care group, -1.1 kg (95% CI, -2.0 to -0.3 kg) in the online program only group, and -2.8 kg (95% CI, -3.5 to -2.0 kg) in the combined intervention group (P < .001). Conclusions and Relevance: Among primary care patients with overweight or obesity and hypertension or type 2 diabetes, combining population health management with an online program resulted in a small but statistically significant greater weight loss at 12 months compared with usual care or the online program only. Further research is needed to understand the generalizability, scalability, and durability of these findings. Trial Registration: ClinicalTrials.gov Identifier: NCT02656693.

Assessing information system readiness for mitigating malpractice risk through simulation: results of a multi-site study.

OBJECTIVE: To develop and test an instrument for assessing a healthcare organization's ability to mitigate malpractice risk through clinical decision support (CDS). MATERIALS AND METHODS: Based on a previously collected malpractice data set, we identified common types of CDS and the number and cost of malpractice cases that might have been prevented through this CDS. We then designed clinical vignettes and questions that test an organization's CDS capabilities through simulation. Seven healthcare organizations completed the simulation. RESULTS: All seven organizations successfully completed the self-assessment. The proportion of potentially preventable indemnity loss for which CDS was available ranged from 16.5% to 73.2%. DISCUSSION: There is a wide range in organizational ability to mitigate malpractice risk through CDS, with many organizations' electronic health records only being able to prevent a small portion of malpractice events seen in a real-world dataset. CONCLUSION: The simulation approach to assessing malpractice risk mitigation through CDS was effective. Organizations should consider using malpractice claims experience to facilitate prioritizing CDS development.

Changes in medical errors after implementation of a handoff program.

BACKGROUND: Miscommunications are a leading cause of serious medical errors. Data from multicenter studies assessing programs designed to improve handoff of information about patient care are lacking. METHODS: We conducted a prospective intervention study of a resident handoff-improvement program in nine hospitals, measuring rates of medical errors, preventable adverse events, and miscommunications, as well as resident workflow. The intervention included a mnemonic to standardize oral and written handoffs, handoff and communication training, a faculty development and observation program, and a sustainability campaign. Error rates were measured through active surveillance. Handoffs were assessed by means of evaluation of printed handoff documents and audio recordings. Workflow was assessed through time-motion observations. The primary outcome had two components: medical errors and preventable adverse events. RESULTS: In 10,740 patient admissions, the medical-error rate decreased by 23% from the preintervention period to the postintervention period (24.5 vs. 18.8 per 100 admissions, P<0.001), and the rate of preventable adverse events decreased by 30% (4.7 vs. 3.3 events per 100 admissions, P<0.001). The rate of nonpreventable adverse events did not change significantly (3.0 and 2.8 events per 100 admissions, P=0.79). Site-level analyses showed significant error reductions at six of nine sites. Across sites, significant increases were observed in the inclusion of all prespecified key elements in written documents and oral communication during handoff (nine written and five oral elements; P<0.001 for all 14 comparisons). There were no significant changes from the preintervention period to the postintervention period in the duration of oral handoffs (2.4 and 2.5 minutes per patient, respectively; P=0.55) or in resident workflow, including patient-family contact and computer time. CONCLUSIONS: Implementation of the handoff program was associated with reductions in medical errors and in preventable adverse events and with improvements in communication, without a negative effect on workflow. (Funded by the Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services, and others.).