Background Neutralizing monoclonal antibodies (MAb) are a promising therapy for early COVID-19, but effectiveness has not been confirmed in a real-world setting. Methods In this quasi-experimental pre-/post-implementation study, we estimated the effectiveness of MAb treatment within 7 days of symptom onset in high-risk ambulatory adults with COVID-19. The primary outcome was a composite of emergency department visit or hospitalization within 14 days of positive test. Secondary outcomes included adverse events and 14-day mortality. The average treatment effect in the treated for MAb therapy was estimated using inverse probability of treatment weighting and the impact of MAb implementation using propensity-weighted interrupted time series analysis. Results Pre-implementation (July-November, 2020), 7404 qualifying patients were identified. Post-implementation (December 2020-January 2021), 594 patients received MAb treatment and 5536 did not. The primary outcome occurred in 75 (12.6%) MAb recipients, 1018 (18.4%) contemporaneous controls and 1525 (20.6%) historical controls. MAb treatment was associated with decreased likelihood of emergency care or hospitalization, odds ratio 0.69 (95% CI 0.60-0.79). After implementation, the weighted probability that a given patient would require an emergency department visit or hospitalization decreased significantly (0.7% per day, 95% CI 0.03%-0.10%). Mortality was 0.2% (n=1) in the MAb group compared to 1.0% (n=71) and 1.0% (n=57) in pre- and post-implementation controls, respectively. Adverse events occurred in 7 (1.2%); 2 (0.3%) were considered serious. Conclusions MAb treatment of high-risk ambulatory patients with early COVID-19 was well-tolerated and likely effective at preventing the need for subsequent emergency department or hospital care.
Improving antibiotic prescribing in outpatient settings is a public health priority. In the United States, urgent care (UC) encounters are increasing and have high rates of inappropriate antibiotic prescribing. Our objective was to characterize antibiotic prescribing practices during UC encounters, with a focus on respiratory tract conditions. This was a retrospective cohort study of UC encounters in the Intermountain Healthcare network. Among 1.16 million UC encounters, antibiotics were prescribed during 34% of UC encounters and respiratory conditions accounted for 61% of all antibiotics prescribed. Of respiratory encounters, 50% resulted in antibiotic prescriptions, yet the variability at the level of the provider ranged from 3% to 94%. Similar variability between providers was observed for respiratory conditions where antibiotics were not indicated and in first-line antibiotic selection for sinusitis, otitis media, and pharyngitis. These findings support the importance of developing antibiotic stewardship interventions specifically targeting UC settings.
Importance: Interventions to reduce hospitalization of patients with COVID-19 are urgently needed. Randomized trials for efficacy suggest that anti-SARS-CoV2 neutralizing monoclonal antibodies (MAb) may reduce medically-attended visits and hospitalization but effectiveness has not been confirmed in a real-world setting. Objective: Estimate the effectiveness of MAb infusion in a real-world cohort of ambulatory patients with early symptomatic COVID-19 at high risk for hospitalization. Design: Quasi-experimental observational cohort study using target trial emulation and causal inference methodology in pre-and post-implementation groups. Setting: Infusion centers and urgent care clinics within an integrated healthcare system in the United States Participants: 13,534 high-risk adult outpatients with symptomatic, laboratory-confirmed COVID-19 within 7 days of symptom onset. Exposures: A single intravenous infusion of either bamlanivimab 700 mg or casirivimab/imdevimab 1200 mg/1200 mg. Main Outcomes and Measures: The primary outcome was emergency department visit or hospitalization within 14 days of positive test. Patients who received MAb infusion were compared to contemporaneous controls using inverse probability of treatment weighting, and to a pre-implementation cohort using propensity-weighted interrupted time series analysis. An exploratory analysis compared effectiveness of casirivimab/imdevimab and bamlanivimab. Results: 7404 patients who would have been MAb-eligible were identified in a pre-implementation cohort (July 1-November 27, 2020). In the post-implementation period (November 28, 2020-January 28, 2021), 594 received MAb treatment and 5536 MAb-eligible patients did not. Among Mab recipients, 479 (80.6%) received bamlanivimab and 115 (19.4%) casirivimab/imdevimab. The primary outcome occurred in 75 (12.6%) MAb recipients, 1018 (18.4%) contemporaneous controls, and 1525 (20.6%) patients in the pre-implementation cohort. MAb treatment was associated with fewer subsequent emergency department visits and hospitalizations (odds ratio estimating the average treatment effect 0.69, 95% CI 0.60-0.79). After implementation, propensity-weighted probability of emergency department visit or hospitalization decreased by 0.7% per day (95% CI 0.03-0.10%, p<0.001). Overall, 7 (1.2%) MAb patients experienced an adverse event; two (0.3%) were considered serious. In the exploratory analysis, the effect of casirivimab/imdevimab versus bamlanivimab was not significant (OR 0.52, 95% CI 0.17-1.63, p=0.26). Conclusions and Relevance: MAb treatment of high-risk ambulatory patients with early COVID-19 was well-tolerated and effective at preventing the need for subsequent medically-attended care.
ImportanceUrgent Care (UC) encounters result in more inappropriate antibiotic prescriptions than other outpatient setting. Few stewardship interventions have focused on UC.ObjectiveTo evaluate the effectiveness of an antibiotic stewardship initiative to reduce antibiotic prescribing for respiratory conditions in a UC network.Design, Setting, and ParticipantsThis quality improvement study conducted in a UC network with 38 UC clinics and 1 telemedicine clinic included 493 724 total UC encounters. The study compared the antibiotic prescribing rates of all UC clinicians who encountered respiratory conditions for a 12-month baseline period (July 1, 2018, through June 30, 2019) with an intervention period (July 1, 2019, through June 30, 2020). A sustainability period (July 1, 2020, through June 30, 2021) was added post hoc.InterventionsStewardship interventions included (1) education for clinicians and patients, (2) electronic health record (EHR) tools, (3) a transparent clinician benchmarking dashboard, and (4) media. Occurring independently but concurrent with the interventions, a stewardship measure was introduced by UC leadership into the quality measures, including a financial incentive.Main Outcomes and MeasuresThe primary outcome was the percentage of UC encounters with an antibiotic prescription for a respiratory condition. Secondary outcomes included antibiotic prescribing when antibiotics were not indicated (tier 3 encounters) and first-line antibiotics for acute otitis media, sinusitis, and pharyngitis. Interrupted time series with binomial generalized estimating equations were used to compare periods.ResultsThe baseline period included 207 047 UC encounters for respiratory conditions (56.8% female; mean [SD] age, 30.0 [21.4] years; 92.0% White race); the intervention period included 183 893 UC encounters (56.4% female; mean [SD] age, 30.7 [20.8] years; 91.2% White race). Antibiotic prescribing for respiratory conditions decreased from 47.8% (baseline) to 33.3% (intervention). During the initial intervention month, a 22% reduction in antibiotic prescribing occurred (odds ratio [OR], 0.78; 95% CI, 0.71-0.86). Antibiotic prescriptions decreased by 5% monthly during the intervention (OR, 0.95; 95% CI, 0.94-0.96). Antibiotic prescribing for tier 3 encounters decreased by 47% (OR, 0.53; 95% CI, 0.44-63), and first-line antibiotic prescriptions increased by 18% (OR, 1.18; 95% CI, 1.09-1.29) during the initial intervention month. Antibiotic prescriptions for tier 3 encounters decreased by an additional 4% each month (OR, 0.96; 95% CI, 0.94-0.98), whereas first-line antibiotic prescriptions did not change (OR, 1.00; 95% CI, 0.99-1.01). Antibiotic prescribing for respiratory conditions remained stable in the sustainability period.Conclusions and relevanceThe findings of this quality improvement study indicated that a UC antibiotic stewardship initiative was associated with decreased antibiotic prescribing for respiratory conditions. This study provides a model for UC antibiotic stewardship.
Background Urgent care (UC) is a rapidly growing site of healthcare delivery. The CDC developed Core Elements for Outpatient Antibiotic Stewardship to guide development of outpatient stewardship but little experience exists in applying Core Elements to UC settings. Our objective was to evaluate the effectiveness of a UC stewardship program in a health system. Figure Methods We designed a UC stewardship program for Intermountain Healthcare’s 39 UC sites based on CDC Core Elements. The pre-intervention period was Aug 2017-June 2019. The intervention period was 12 months from Jul 2019 -June 2020. The program consisted of education for patients/providers about appropriate diagnosis and prescribing for respiratory conditions; media campaigns; EHR tools; and a prescribing dashboard for clinicians. The primary outcome was the percentage of respiratory visits where an antibiotic was prescribed. Secondary outcomes included the percentage of encounters receiving antibiotics for conditions where no antibiotics are indicated (e.g. bronchitis) and the percentage of encounters receiving first-line recommended therapy for conditions in which antibiotics may be warrented (otitis media, sinusitis, and pharyngitis). We used a binomial mixed effects hierarchical model to calculate the odds of antibiotic prescribing associated with the intervention period accounting for pre-intervention trends. Models account for clustering within providers and clinics. We present the results of an interim analysis after 7 months of the intervention. Results The overall number of UC encounters during the study period was 1,559,403 and 41.5% were for respiratory conditions. The percentage of patients with respiratory conditions that received an antibiotic prescription declined from 49.9% pre-intervention to 35.3% during the intervention (OR 0.73, 95% CI: 0.71, 0.76), reaching a low of 30% during February 2020 (Figure). Prescribing for conditions where antibiotics are not indicated decreased (OR 0.31, 95% CI 0.26–0.36) and first line recommended therapy increased (OR 1.28, 95% CI 1.20–1.26) during the intervention. Conclusion After 7 months of a planned 12 month intervention, the UC stewardship program was associated with improved antibiotic prescribing. Disclosures Rajendu Srivastava, MD, AHRQ, NIH, CDC (Grant/Research Support, I hold grants from AHRQ, NIH and CDC for a variety of clinical research and implementation studies)IPASS Patient Safety Institute (Other Financial or Material Support, I am a physician founder of this company to spread handoff best practices and reduce adverse events. My employer holds my equity in this company.)
Background: Pharyngitis is 1 of the most common conditions leading to inappropriate antibiotic prescriptions. When personal protective equipment (PPE) was at first constrained during the COVID-19 pandemic, Intermountain Healthcare recommended limiting rapid group A streptococcal pharyngitis (GAS) testing in urgent-care clinics to preserve PPE. Notably, the percentage of pharyngitis encounters prescribed an antibiotic and that underwent GAS testing is a key Healthcare Effectiveness Data and Information Set (HEDIS) measure. We have described our experience with urgent-care pharyngitis encounters and the impact of temporarily reducing GAS testing on antibiotic prescribing before and during the COVID19 pandemic. Method: We identified all urgent care encounters between July 2018 and August 2021 associated with a primary diagnosis of pharyngitis using ICD-10 CM codes and a validated methodology. Pharyngitis encounters were assessed for antibiotic prescriptions ordered through the electronic health record (EHR) and the use of point-of-care rapid GAS tests. Pharyngitis encounters were analyzed monthly. We assessed the percentage of encounters associated with an antibiotic prescription regardless of testing and the percentage of encounters associated with an antibiotic prescription when a GAS test was or was not performed. We examined 3 periods relating to COVID-19 and GAS testing recommendations: the prepandemic period (July 2018–March 2020), the pandemic onset period (April 2020–June 2020), and the pandemic period (July 2020–August 2021). Results: Prior to the pandemic, the monthly percentage of pharyngitis encounters for which rapid GAS testing was performed was nearly 90% (Fig. 1). The average monthly percentage of urgent-care pharyngitis encounters prescribed an antibiotic was 38.9%, and the average percentage of monthly pharyngitis encounters prescribed an antibiotic that also underwent GAS testing was 90.4%. This HEDIS measure declined from 90.4% during the prepandemic period to 29.8% in the pandemic onset period when GAS testing was limited. Following resumption of routine testing practices the monthly percentage of urgent-care pharyngitis encounters for which rapid GAS testing was performed returned to levels ≥80% by July 2020 (Fig. 1). The average percentage of monthly pharyngitis encounters prescribed an antibiotic that also underwent GAS testing rose to 87.3% during this period. Conclusions: Limited PPE in our urgent care centers during the initial months of the COVID-19 pandemic was associated with a mandated substantial decline in rapid GAS testing. As testing volume decreased, we noted a simultaneous relative increase of >30% in antibiotic prescribing for pharyngitis. These findings suggest that rapid streptococcal testing promotes appropriate antibiotic prescribing.Funding: NoneDisclosures: None
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