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Randomized clinical trial of an emergency department observation syncope protocol versus routine inpatient admission.

ABSTRACT: Older adults are frequently hospitalized from the emergency department (ED) after an episode of unexplained syncope. Current admission patterns are costly, with little evidence of benefit. We hypothesize that an ED observation syncope protocol will reduce resource use without adversely affecting patient-oriented outcomes.This randomized trial at 5 EDs compared an ED observation syncope protocol to inpatient admission for intermediate-risk adults (?50 years) presenting with syncope or near syncope. Primary outcomes included inpatient admission rate and length of stay. Secondary outcomes included 30-day and 6-month serious outcomes after hospital discharge, index and 30-day hospital costs, 30-day quality-of-life scores, and 30-day patient satisfaction.Study staff randomized 124 patients. Observation resulted in a lower inpatient admission rate (15% versus 92%; 95% confidence interval [CI] difference -88% to -66%) and shorter hospital length of stay (29 versus 47 hours; 95% CI difference -28 to -8). Serious outcome rates after hospital discharge were similar for observation versus admission at 30 days (3% versus 0%; 95% CI difference -1% to 8%) and 6 months (8% versus 10%; 95% CI difference -13% to 9%). Index hospital costs in the observation group were $629 (95% CI difference -$1,376 to -$56) lower than in the admission group. There were no differences in 30-day quality-of-life scores or in patient satisfaction.An ED observation syncope protocol reduced the primary outcomes of admission rate and hospital length of stay. Analyses of secondary outcomes suggest reduction in index hospital costs, with no difference in safety events, quality of life, or patient satisfaction. Our findings suggest that an ED observation syncope protocol can be replicated and safely reduce resource use.

SUBMITTER: Sun BC

PROVIDER: S-EPMC4019722 | biostudies-literature | 2014 Aug

REPOSITORIES: biostudies-literature

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Randomized clinical trial of an emergency department observation syncope protocol versus routine inpatient admission.

Sun Benjamin C BC McCreath Heather H Liang Li-Jung LJ Bohan Stephen S Baugh Christopher C Ragsdale Luna L Henderson Sean O SO Clark Carol C Bastani Aveh A Keeler Emmett E An Ruopeng R Mangione Carol M CM

Annals of emergency medicine 20131113 2

<h4>Study objective</h4>Older adults are frequently hospitalized from the emergency department (ED) after an episode of unexplained syncope. Current admission patterns are costly, with little evidence of benefit. We hypothesize that an ED observation syncope protocol will reduce resource use without adversely affecting patient-oriented outcomes.<h4>Methods</h4>This randomized trial at 5 EDs compared an ED observation syncope protocol to inpatient admission for intermediate-risk adults (≥50 years ...[more]

PMID: 24239341

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Project description:ImportanceMore than 80% of patients who present to the emergency department (ED) with acute heart failure (AHF) are hospitalized. With more than 1 million annual hospitalizations for AHF in the US, safe and effective alternatives are needed. Care for AHF in short-stay units (SSUs) may be safe and more efficient than hospitalization, especially for lower-risk patients, but randomized clinical trial data are lacking.ObjectiveTo compare the effectiveness of SSU care vs hospitalization in lower-risk patients with AHF.Design, setting, and participantsThis multicenter randomized clinical trial randomly assigned low-risk patients with AHF 1:1 to SSU or hospital admission from the ED. Patients received follow-up at 30 and 90 days post discharge. The study began December 6, 2017, and was completed on July 22, 2021. The data were analyzed between March 27, 2020, and November 11, 2023.InterventionRandomized post-ED disposition to less than 24 hours of SSU care vs hospitalization.Main outcomes and measuresThe study was designed to detect at least 1-day superiority for a primary outcome of days alive and out of hospital (DAOOH) at 30-day follow-up for 534 participants, with an allowance of 10% participant attrition. Due to the COVID-19 pandemic, enrollment was truncated at 194 participants. Before unmasking, the primary outcome was changed from DAOOH to an outcome with adequate statistical power: quality of life as measured by the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12). The KCCQ-12 scores range from 0 to 100, with higher scores indicating better quality of life.ResultsOf the 193 patients enrolled (1 was found ineligible after randomization), the mean (SD) age was 64.8 (14.8) years, 79 (40.9%) were women, and 114 (59.1%) were men. Baseline characteristics were balanced between arms. The mean (SD) KCCQ-12 summary score between the SSU and hospitalization arms at 30 days was 51.3 (25.7) vs 45.8 (23.8) points, respectively (P = .19). Participants in the SSU arm had 1.6 more DAOOH at 30-day follow-up than those in the hospitalization arm (median [IQR], 26.9 [24.4-28.8] vs 25.4 [22.0-27.7] days; P = .02). Adverse events were uncommon and similar in both arms.Conclusions and relevanceThe findings show that the SSU strategy was no different than hospitalization with regard to KCCQ-12 score, superior for more DAOOH, and safe for lower-risk patients with AHF. These findings of lower health care utilization with the SSU strategy need to be definitively tested in an adequately powered study.Trial registrationClinicalTrials.gov Identifier: NCT03302910.

Project description:ObjectiveTo assess the association of Private, Medicare, and Medicaid/Uninsured insurance type with 30-day Emergency Department visits/Observation Stays (EDOS), readmissions, and costs in a safety-net hospital (SNH) serving diverse socioeconomic status patients.Summary background dataMedicare's Hospital Readmission Reduction Program (HRRP) disproportionately penalizes SNHs.MethodsThis retrospective cohort study used inpatient National Surgical Quality Improvement Program (2013-2019) data merged with cost data. Frailty, expanded Operative Stress Score, case status, and insurance type were used to predict odds of EDOS and readmissions, as well as index hospitalization costs.ResultsThe cohort had 1,477 Private; 1,164 Medicare; and 3,488 Medicaid/Uninsured cases with a patient mean age 52.1 years [SD=14.7] and 46.8% of the cases were performed on male patients. Medicaid/Uninsured (aOR=2.69, CI=2.38-3.05, P<.001) and Medicare (aOR=1.32, CI=1.11-1.56, P=.001) had increased odds of urgent/emergent surgeries and complications versus Private patients. Despite having similar frailty distributions, Medicaid/Uninsured compared to Private patients had higher odds of EDOS (aOR=1.71, CI=1.39-2.11, P<.001), and readmissions (aOR=1.35, CI=1.11-1.65, P=.004), after adjusting for frailty, OSS, and case status, while Medicare patients had similar odds of EDOS and readmissions versus Private. Hospitalization variable cost %change was increased for Medicare (12.5%) and Medicaid/Uninsured (5.9%), but Medicaid/Uninsured was similar to Private after adjusting for urgent/emergent cases.ConclusionsIncreased rates and odds of urgent/emergent cases in Medicaid/Uninsured patients drive increased odds of complications and index hospitalization costs versus Private. SNHs care for higher cost populations while receiving lower reimbursements and are further penalized by the unintended consequences of HRRP. Increasing access to care, especially for Medicaid/Uninsured patients, could reduce urgent/emergent surgeries resulting in fewer complications, EDOS/readmissions, and costs.

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Randomized clinical trial of an emergency department observation syncope protocol versus routine inpatient admission.

Publications

Randomized clinical trial of an emergency department observation syncope protocol versus routine inpatient admission.

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