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Original Investigation
November 18, 2020

Effect of a Self-care Intervention on 90-Day Outcomes in Patients With Acute Heart Failure Discharged From the Emergency Department: A Randomized Clinical Trial

Author Affiliations
  • 1Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee
  • 2Department of Emergency Medicine, Detroit Medical Center, Detroit, Michigan
  • 3Department of Emergency Medicine, Indiana University Medical Center, Indianapolis
  • 4Department of Emergency Medicine, Thomas Jefferson University Medical Center, Philadelphia, Pennsylvania
  • 5Department of Emergency Medicine, Washington University Medical Center in St Louis, St Louis, Missouri
  • 6Department of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas
  • 7Department of Emergency Medicine, University of Cincinnati Medical Center, Cincinnati, Ohio
  • 8Department of Emergency Medicine, Wake Forest University Medical Center, Winston-Salem, North Carolina
  • 9Department of Emergency Medicine, Virginia Commonwealth University Medical Center, Richmond, Virginia
  • 10Department of Emergency Medicine, American Heart Association
  • 11Department of Emergency Medicine, University of Iowa Medical Center, Iowa City
  • 12Department of Emergency Medicine, Icahn School of Medicine at Mount Sinai, New York, New York
  • 13School of Nursing, Emory University, Atlanta, Georgia
  • 14Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas
  • 15School of Medicine, Emory University, Atlanta, Georgia
  • 16Department of Emergency Medicine, Metro Health Medical Center, Cleveland, Ohio
  • 17Department of Emergency Medicine, Stony Brook University Medical Center, Stony Brook, New York
  • 18Department of Medicine, University of Mississippi Medical Center, Jackson
  • 19Patient Representative, Stockbridge, Georgia
JAMA Cardiol. Published online November 18, 2020. doi:10.1001/jamacardio.2020.5763
Key Points

Question  Does self-care coaching improve heart failure events and quality of life in patients with acute heart failure discharged after emergency department–based management?

Findings  In this randomized clinical trial including 479 patients with acute heart failure, there were no significant differences in the global rank primary outcome at 90 days between the intervention and usual care arms. However, there were significant differences in 30-day global rank and health status favoring the intervention arm.

Meaning  These data suggest that a self-care management plan does not impact 90-day events but may provide short-term improvements in heart failure outcomes and health status after emergency department–based management and discharge.

Abstract

Importance  Up to 20% of patients who present to the emergency department (ED) with acute heart failure (AHF) are discharged without hospitalization. Compared with rates in hospitalized patients, readmission and mortality are worse for ED patients.

Objective  To assess the impact of a self-care intervention on 90-day outcomes in patients with AHF who are discharged from the ED.

Design, Setting, and Participants  Get With the Guidelines in Emergency Department Patients With Heart Failure was an unblinded, parallel-group, multicenter randomized trial. Patients were randomized 1:1 to usual care vs a tailored self-care intervention. Patients with AHF discharged after ED-based management at 15 geographically diverse EDs were included. The trial was conducted from October 28, 2015, to September 5, 2019.

Interventions  Home visit within 7 days of discharge and twice-monthly telephone-based self-care coaching for 3 months.

Main Outcomes and Measures  The primary outcome was a global rank of cardiovascular death, HF-related events (unscheduled clinic visit due to HF, ED revisit, or hospitalization), and changes in the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) summary score (SS) at 90 days. Key secondary outcomes included the global rank outcome at 30 days and changes in the KCCQ-12 SS score at 30 and 90 days. Intention-to-treat analysis was performed for the primary, secondary, and safety outcomes. Per-protocol analysis was conducted including patients who completed a home visit and had scheduled outpatient follow-up in the intervention arm.

Results  Owing to slow enrollment, 479 of a planned 700 patients were randomized: 235 to the intervention arm and 244 to the usual care arm. The median age was 63.0 years (interquartile range, 54.7-70.2), 302 patients (63%) were African American, 305 patients (64%) were men, and 178 patients (37%) had a previous ejection fraction greater than 50%. There was no significant difference in the primary outcome between patients in the intervention vs usual care arm (hazard ratio [HR], 0.89; 95% CI, 0.73-1.10; P = .28). At day 30, patients in the intervention arm had significantly better global rank (HR, 0.80; 95% CI, 0.64-0.99; P = .04) and a 5.5-point higher KCCQ-12 SS (95% CI, 1.3-9.7; P = .01), while at day 90, the KCCQ-12 SS was 2.7 points higher (95% CI, −1.9 to 7.2; P = .25).

Conclusions and Relevance  The self-care intervention did not improve the primary global rank outcome at 90 days in this trial. However, benefit was observed in the global rank and KCCQ-12 SS at 30 days, suggesting that an early benefit of a tailored self-care program initiated at an ED visit for AHF was not sustained through 90 days.

Trial Registration  ClinicalTrials.gov Identifier: NCT02519283

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