Accounting for the growth of observation stays in the assessment of Medicare\u27s Hospital Readmissions Reduction Program

IMPORTANCE: Decreases in 30-day readmissions following the implementation of the Medicare Hospital Readmissions Reduction Program (HRRP) have occurred against the backdrop of increasing hospital observation stay use, yet observation stays are not captured in readmission measures. OBJECTIVE: To examine whether the HRRP was associated with decreases in 30-day readmissions after accounting for observation stays. DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study included a 20% sample of inpatient admissions and observation stays among Medicare fee-for-service beneficiaries from January 1, 2009, to December 31, 2015. Data analysis was performed from November 2021 to June 2022. A differences-in-differences analysis assessed changes in 30-day readmissions after the announcement of the HRRP and implementation of penalties for target conditions (heart failure, acute myocardial infarction, and pneumonia) vs nontarget conditions under scenarios that excluded and included observation stays. MAIN OUTCOMES AND MEASURES: Thirty-day inpatient admissions and observation stays. RESULTS: The study included 8 944 295 hospitalizations (mean [SD] age, 78.7 [8.2] years; 58.6% were female; 1.3% Asian; 10.0% Black; 2.0% Hispanic; 0.5% North American Native; 85.0% White; and 1.2% other or unknown). Observation stays increased from 2.3% to 4.4% (91.3% relative increase) of index hospitalizations among target conditions and 14.1% to 21.3% (51.1% relative increase) of index hospitalizations for nontarget conditions. Readmission rates decreased significantly after the announcement of the HRRP and returned to baseline by the time penalties were implemented for both target and nontarget conditions regardless of whether observation stays were included. When only inpatient hospitalizations were counted, decreasing readmissions accrued into a -1.48 percentage point (95% CI, -1.65 to -1.31 percentage points) absolute reduction in readmission rates by the postpenalty period for target conditions and -1.13 percentage point (95% CI, -1.30 to -0.96 percentage points) absolute reduction in readmission rates by the postpenalty period for nontarget conditions. This reduction corresponded to a statistically significant differential change of -0.35 percentage points (95% CI, -0.59 to -0.11 percentage points). Accounting for observation stays more than halved the absolute decrease in readmission rates for target conditions (-0.66 percentage points; 95% CI, -0.83 to -0.49 percentage points). Nontarget conditions showed an overall greater decrease during the same period (-0.76 percentage points; 95% CI, -0.92 to -0.59 percentage points), corresponding to a differential change in readmission rates of 0.10 percentage points (95% CI, -0.14 to 0.33 percentage points) that was not statistically significant. CONCLUSIONS AND RELEVANCE: The findings of this study suggest that the reduction of readmissions associated with the implementation of the HRRP was smaller than originally reported. More than half of the decrease in readmissions for target conditions appears to be attributable to the reclassification of inpatient admission to observation stays

Comparison of Outcomes of antibiotic Drugs and Appendectomy (CODA) trial: a protocol for the pragmatic randomised study of appendicitis treatment.

INTRODUCTION: Several European studies suggest that some patients with appendicitis can be treated safely with antibiotics. A portion of patients eventually undergo appendectomy within a year, with 10%-15% failing to respond in the initial period and a similar additional proportion with suspected recurrent episodes requiring appendectomy. Nearly all patients with appendicitis in the USA are still treated with surgery. A rigorous comparative effectiveness trial in the USA that is sufficiently large and pragmatic to incorporate usual variations in care and measures the patient experience is needed to determine whether antibiotics are as good as appendectomy. OBJECTIVES: The Comparing Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial for acute appendicitis aims to determine whether the antibiotic treatment strategy is non-inferior to appendectomy. METHODS/ANALYSIS: CODA is a randomised, pragmatic non-inferiority trial that aims to recruit 1552 English-speaking and Spanish-speaking adults with imaging-confirmed appendicitis. Participants are randomised to appendectomy or 10 days of antibiotics (including an option for complete outpatient therapy). A total of 500 patients who decline randomisation but consent to follow-up will be included in a parallel observational cohort. The primary analytic outcome is quality of life (measured by the EuroQol five dimension index) at 4 weeks. Clinical adverse events, rate of eventual appendectomy, decisional regret, return to work/school, work productivity and healthcare utilisation will be compared. Planned exploratory analyses will identify subpopulations that may have a differential risk of eventual appendectomy in the antibiotic treatment arm. ETHICS AND DISSEMINATION: This trial was approved by the University of Washington\u27s Human Subjects Division. Results from this trial will be presented in international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02800785

Excess Mortality Among Patients Hospitalized During the COVID-19 Pandemic.

BACKGROUND: The extent to which the COVID-19 pandemic has affected outcomes for patients with unplanned hospitalizations is unclear. OBJECTIVE: To examine changes in in-hospital mortality for patients without COVID-19 during the first 10 months of the pandemic (March 4, 2020 to December 31, 2020). DESIGN, SETTING, AND PARTICIPANTS: Observational study of adults with unplanned hospitalizations at 51 hospitals across 6 Western states. EXPOSURES: Unplanned hospitalizations occurring during the spring COVID-19 surge (March 4 to May 13, 2020; Period 1), an intervening period (May 14 to October 19, 2020; Period 2), and the fall COVID-19 surge (October 20 to December 31, 2020; Period 3) were compared with a pre-COVID-19 baseline period from January 1, 2019, to March 3, 2020. MAIN OUTCOMES AND MEASURES: We examined daily hospital admissions and in-hospital mortality overall and in 30 conditions. RESULTS: Unplanned hospitalizations declined steeply during Periods 1 and 3 (by 47.5% and 25% compared with baseline, respectively). Although volumes declined, adjusted in-hospital mortality rose from 2.9% in the pre-pandemic period to 3.5% in Period 1 (20.7% relative increase), returning to baseline in Period 2, and rose again to 3.4% in Period 3. Elevated mortality was seen for nearly all conditions studied during the pandemic surge periods. CONCLUSION: Pandemic COVID-19 surges were associated with higher rates of in-hospital mortality among patients without COVID-19, suggesting disruptions in care patterns for patients with many common acute and chronic illnesses

In-Hospital Outcomes and Costs Among Patients Hospitalized During a Return Visit to the Emergency Department

ImportanceUnscheduled short-term return visits to the emergency department (ED) are increasingly monitored as a hospital performance measure and have been proposed as a measure of the quality of emergency care.ObjectiveTo examine in-hospital clinical outcomes and resource use among patients who are hospitalized during an unscheduled return visit to the ED.Design, setting, and participantsRetrospective analysis of adult ED visits to acute care hospitals in Florida and New York in 2013 using data from the Healthcare Cost and Utilization Project. Patients with index ED visits were identified and followed up for return visits to the ED within 7, 14, and 30 days.ExposuresHospital admission occurring during an initial visit to the ED vs during a return visit to the ED.Main outcomes and measuresIn-hospital mortality, intensive care unit (ICU) admission, length of stay, and inpatient costs.ResultsAmong the 9,036,483 index ED visits to 424 hospitals in the study sample, 1,758,359 patients were admitted to the hospital during the index ED visit. Of these patients, 149,214 (8.5%) had a return visit to the ED within 7 days of the index ED visit, 228,370 (13.0%) within 14 days, and 349,335 (19.9%) within 30 days, and 76,151 (51.0%), 122,040 (53.4%), and 190,768 (54.6%), respectively, were readmitted to the hospital. Among the 7,278,124 patients who were discharged during the index ED visit, 598,404 (8.2%) had a return visit to the ED within 7 days, 839,386 (11.5%) within 14 days, and 1,205,865 (16.6%) within 30 days. Of these patients, 86,012 (14.4%) were admitted to the hospital within 7 days, 121,587 (14.5%) within 14 days, and 173,279 (14.4%) within 30 days. The 86,012 patients discharged from the ED and admitted to the hospital during a return ED visit within 7 days had significantly lower rates of in-hospital mortality (1.85%) compared with the 1,609,145 patients who were admitted during the index ED visit without a return ED visit (2.48%) (odds ratio, 0.73 [95% CI, 0.69-0.78]), lower rates of ICU admission (23.3% vs 29.0%, respectively; odds ratio, 0.73 [95% CI, 0.71-0.76]), lower mean costs ($10,169 vs$10,799; difference, $629 [95$479-$781]), and longer lengths of stay (5.16 days vs 4.97 days; IRR, 1.04 [95% CI, 1.03-1.05]). Similar outcomes were observed for patients returning to the ED within 14 and 30 days of the index ED visit. In contrast, patients who returned to the ED after hospital discharge and were readmitted had higher rates of in-hospital mortality and ICU admission, longer lengths of stay, and higher costs during the repeat hospital admission compared with those admitted to the hospital during the index ED visit without a return ED visit.Conclusions and relevanceCompared with adult patients who were hospitalized during the index ED visit and did not have a return visit to the ED, patients who were initially discharged during an ED visit and admitted during a return visit to the ED had lower in-hospital mortality, ICU admission rates, and in-hospital costs and longer lengths of stay. These findings suggest that hospital admissions associated with return visits to the ED may not adequately capture deficits in the quality of care delivered during an ED visit

A Quality Framework to Address Racial and Ethnic Disparities in Emergency Department Care

The emergency department serves as a vital source of health care for residents in the United States, including as a safety net. However, patients from minoritized racial and ethnic groups have historically experienced disproportionate barriers to accessing health care services and lower quality of services than White patients. Quality measures and their application to quality improvement initiatives represent a critical opportunity to incentivize health care systems to advance health equity and reduce health disparities. Currently, there are no nationally recognized quality measures that track the quality of emergency care delivery by race and ethnicity and no published frameworks to guide the development and prioritization of quality measures to reduce health disparities in emergency care. To address these gaps, the American College of Emergency Physicians (ACEP) convened a working group of experts in quality measurement, health disparities, and health equity to develop guidance on establishing quality measures to address racial and ethnic disparities in the provision of emergency care. Based on iterative discussion over 3 working group meetings, we present a summary of existing emergency medicine quality measures that should be adapted to track racial and ethnic disparities, as well as a framework for developing new measures that focus on disparities in access to emergency care, care delivery, and transitions of care

Comparison of Outcomes of antibiotic Drugs and Appendectomy (CODA) trial: a protocol for the pragmatic randomised study of appendicitis treatment

IntroductionSeveral European studies suggest that some patients with appendicitis can be treated safely with antibiotics. A portion of patients eventually undergo appendectomy within a year, with 10%-15% failing to respond in the initial period and a similar additional proportion with suspected recurrent episodes requiring appendectomy. Nearly all patients with appendicitis in the USA are still treated with surgery. A rigorous comparative effectiveness trial in the USA that is sufficiently large and pragmatic to incorporate usual variations in care and measures the patient experience is needed to determine whether antibiotics are as good as appendectomy.ObjectivesThe Comparing Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial for acute appendicitis aims to determine whether the antibiotic treatment strategy is non-inferior to appendectomy.Methods/analysisCODA is a randomised, pragmatic non-inferiority trial that aims to recruit 1552 English-speaking and Spanish-speaking adults with imaging-confirmed appendicitis. Participants are randomised to appendectomy or 10 days of antibiotics (including an option for complete outpatient therapy). A total of 500 patients who decline randomisation but consent to follow-up will be included in a parallel observational cohort. The primary analytic outcome is quality of life (measured by the EuroQol five dimension index) at 4 weeks. Clinical adverse events, rate of eventual appendectomy, decisional regret, return to work/school, work productivity and healthcare utilisation will be compared. Planned exploratory analyses will identify subpopulations that may have a differential risk of eventual appendectomy in the antibiotic treatment arm.Ethics and disseminationThis trial was approved by the University of Washington's Human Subjects Division. Results from this trial will be presented in international conferences and published in peer-reviewed journals.Trial registration numberNCT02800785

Self-selection vs Randomized Assignment of Treatment for Appendicitis.

Importance: For adults with appendicitis, several randomized clinical trials have demonstrated that antibiotics are an effective alternative to appendectomy. However, it remains unknown how the characteristics of patients in such trials compare with those of patients who select their treatment and whether outcomes differ. Objective: To compare participants in the Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) randomized clinical trial (RCT) with a parallel cohort study of participants who declined randomization and self-selected treatment. Design, Setting, and Participants: The CODA trial was conducted in 25 US medical centers. Participants were enrolled between May 3, 2016, and February 5, 2020; all participants were eligible for at least 1 year of follow-up, with all follow-up ending in 2021. The randomized cohort included 1094 adults with appendicitis; the self-selection cohort included patients who declined participation in the randomized group, of whom 253 selected appendectomy and 257 selected antibiotics. In this secondary analysis, characteristics and outcomes in both self-selection and randomized cohorts are described with an exploratory analysis of cohort status and receipt of appendectomy. Interventions: Appendectomy vs antibiotics. Main Outcomes and Measures: Characteristics among participants randomized to either appendectomy or antibiotics were compared with those of participants who selected their own treatment. Results: Clinical characteristics were similar across the self-selection cohort (510 patients; mean age, 35.8 years [95% CI, 34.5-37.1]; 218 female [43%; 95% CI, 39%-47%]) and the randomized group (1094 patients; mean age, 38.2 years [95% CI, 37.4-39.0]; 386 female [35%; 95% CI, 33%-38%]). Compared with the randomized group, those in the self-selection cohort were less often Spanish speaking (n = 99 [19%; 95% CI, 16%-23%] vs n = 336 [31%; 95% CI, 28%-34%]), reported more formal education (some college or more, n = 355 [72%; 95% CI, 68%-76%] vs n = 674 [63%; 95% CI, 60%-65%]), and more often had commercial insurance (n = 259 [53%; 95% CI, 48%-57%] vs n = 486 [45%; 95% CI, 42%-48%]). Most outcomes were similar between the self-selection and randomized cohorts. The number of patients undergoing appendectomy by 30 days was 38 (15.3%; 95% CI, 10.7%-19.7%) among those selecting antibiotics and 155 (19.2%; 95% CI, 15.9%-22.5%) in those who were randomized to antibiotics (difference, 3.9%; 95% CI, -1.7% to 9.5%). Differences in the rate of appendectomy were primarily observed in the non-appendicolith subgroup. Conclusions and Relevance: This secondary analysis of the CODA RCT found substantially similar outcomes across the randomized and self-selection cohorts, suggesting that the randomized trial results are generalizable to the community at large. Trial Registration: ClinicalTrials.gov Identifier: NCT02800785