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Randomized Controlled Trial
. 2024 Jan 2;7(1):e2350511.
doi: 10.1001/jamanetworkopen.2023.50511.

Short-Stay Units vs Routine Admission From the Emergency Department in Patients With Acute Heart Failure: The SSU-AHF Randomized Clinical Trial

Peter S Pang  1 , David A Berger  2 , Simon A Mahler  3 , Xiaochun Li  4 , Susan J Pressler  5 , Kathleen A Lane  4 , Jason J Bischof  6 , Douglas Char  7 , Deborah Diercks  8 , Alan E Jones  9 , Erik P Hess  10 , Phillip Levy  11 , Joseph B Miller  12 , Arvind Venkat  13 , Nicholas E Harrison  1 , Sean P Collins  14
Affiliations
Randomized Controlled Trial

Short-Stay Units vs Routine Admission From the Emergency Department in Patients With Acute Heart Failure: The SSU-AHF Randomized Clinical Trial

Peter S Pang et al. JAMA Netw Open. .

Abstract

Importance: More 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.

Objective: To compare the effectiveness of SSU care vs hospitalization in lower-risk patients with AHF.

Design, setting, and participants: This 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.

Intervention: Randomized post-ED disposition to less than 24 hours of SSU care vs hospitalization.

Main outcomes and measures: The 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.

Results: Of 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 relevance: The 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 registration: ClinicalTrials.gov Identifier: NCT03302910.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Pang reported receiving grants from the American Heart Association and National Heart, Lung, and Blood Institute during the conduct of the study and personal fees from Roche, Kowa Pharma, Eagle Pharma, and The Heart Initiative; being 5% owner of The Heart Course; grants from Beckman Coulter, Siemens, and OrthoDiagnostics; and being an advisor for WebMD outside the submitted work. Dr Berger reported receiving grants from the American Heart Association Strategically Focused Research Network (Michigan Resuscitation Innovation and Science Enterprise) and Blue Cross Blue Shield of Michigan Foundation outside the submitted work. Dr Mahler reported receiving grants and consulting fees from Siemens, Abbott, QuidelOrtho, and Genetesis; grants from Roche, the Agency for Healthcare Research and Quality (AHRQ), the Health Resources and Services Administration, the Duke Endowment, Grifols, Pathfast, and Beckman Coulter; personal fees from Inflammatix and Radiometer; and ownership of Impathiq outside the submitted work. Dr Pressler reported receiving research support from the National Institutes of Health and AHRQ outside the submitted work. Dr Bischof reported receiving subcontract grants from AHRQ during the conduct of the study and grants from the Patient-Centered Outcomes Research Institute, Beckman Coulter, QuidelOrtho, Comprehensive Research Associates, and RCE Technologies outside the submitted work. Dr Diercks reported receiving grants from Roche Abbott, Ortho-Clinical Diagnostics, and Siemens outside the submitted work. Dr Levy reported receiving personal fees from the American College of Cardiology and current grant funding from the National Institutes of Health (01 HL153607; R01 HL163377; R01 HL146059; R01 HL127215; P50 MD017351; and T32 HL120822); being a past chair of the American College of Cardiology (ACC) Accreditation Oversight Committee and a current member of the ACC NCDR Oversight Committee; and having served as a consultant for Astra Zeneca, Bayer, Novartis, BTG Specialty Pharmaceuticals, UltraSight Medical, HeartBeam, Hemisens, Cardionomics, Life Recovery Systems. Quidel, Siemens, Roche Diagnostics, Ortho Diagnostics, Beckman Coulter, Pathfast, and the Baim Institute outside the submitted work. Dr Miller reported receiving research support from the National Institutes of Health, AHRQ, and PCORI and serving as a consultant for AstraZeneca, Siemens, Beckman Coulter, Panafina, and BioXcel. Dr Venkat reported receiving grants from the National Institutes of Health during the conduct of the study. Dr Harrison reported receiving grants from the National Center for Advancing Translational Science, Abbott, Doris Duke Foundation, Indiana Clinical and Translational Sciences Institute, and Blue Cross Blue Shield Foundation of Michigan and personal fees from Vave Health and EB Medicine outside the submitted work. Dr Collins reported receiving personal fees from Reprieve Cardiovascular, Abbott Diagnostics, Boehringer Ingelheim, Siemens, and Aiphia and grants from the National Heart, Lung, and Blood Institute and Patient-Centered Outcomes Institute during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Diagram
KCCQ-12 indicates 12-item Kansas City Cardiomyopathy Questionnaire; SSU, short-stay unit.
Figure 2.
Figure 2.. Change in 12-Item Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Scores at 30 Days
Boxes indicate the IQRs, with the top and bottom boundaries indicating the upper and lower quartile, respectively. The center line is the median, and the whiskers extend to the minimum and maximum values. SSU indicates short-stay unit.
Figure 3.
Figure 3.. Days Alive and Out of the Hospital Between Randomization and 30-Day Follow-Up
Boxes indicate the IQRs, with the top and bottom boundaries indicating the upper and lower quartile, respectively. The center line is the median, and the whiskers extend to the minimum and maximum values. The diamond represents the mean, and circles represent outliers. SSU indicates short-stay unit.
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