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

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.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Collins reported receiving grants from the National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ), American Heart Association (AHA), Ortho Clinical Diagnostics, Bristol Myers Squibb, Novartis, and AstraZeneca, and personal fees from Ortho Clinical Diagnostics, Boehringer Ingelheim, Roche, Bristol Myers Squibb, and Vixiar outside the submitted work. Dr Jenkins reported receiving grants from Patient-Centered Outcomes Research Institute (PCORI) during the conduct of the study. Dr Storrow reported other support from PCORI during the conduct of the study. Dr Levy reported receiving grants from PCORI during the conduct of the study, and other support from the American College of Cardiology, grants from Amgen, personal fees from Astra Zeneca, personal fees from Baim Institute, grants and personal fees from Bristol Myers Squibb, personal fees from Cardionomics, grants from Edwards Lifesciences, other support from Emergencies in Medicine, grants and personal fees from Novartis Pharmaceuticals, personal fees from Ortho Diagnostics, personal fees from Quidel Cardiovascular, grants and personal fees from Roche Diagnostics, and personal fees from Siemens outside the submitted work. Dr Pang reported receiving grants from PCORI during the conduct of the study; personal fees and nonfinancial support from Merck, Roche, and Baxter; grants from the AHA; other grants from the American College of Cardiology; grants, personal fees, and nonfinancial support from Novartis and Bristol Myers Squibb; grants from AHRQ, and grants from the NIH National Heart, Lung, and Blood Institute outside the submitted work. Dr Chang reported receiving grants from PCORI during the conduct of the study; grants from Ortho Clinical Diagnostics, grants from Beckman Coulter, personal fees from Roche, and grants from Siemens outside the submitted work. Dr Char reported receiving grants from PCORI during the conduct of the study. Dr Fermann reported receiving grants and personal fees from Janssen, personal fees from Milestone Pharmaceuticals, and grants and personal fees from Portola outside the submitted work. Dr Han reported receiving grants from the Geriatric Research, Education, and Clinical Center during the conduct of the study. Dr Hiestand reported receiving personal fees from PCORI during the conduct of the study and other fees from Siemens outside the submitted work. Dr Hogan reported receiving grants from Vanderbilt University during the conduct of the study. Dr Lee reported receiving grants from the Network for Investigation of Delirium: Unifying Scientist outside the submitted work. Dr Lindenfeld reported receiving grants from AstraZeneca and Sensible Medical and personal fees from Abbott, AstraZeneca, Boehringer Ingelheim, Edwards Lifesciences, CVRx, Volumetrix, VWave, and Boston Scientific outside the submitted work. Dr Rothman reported receiving grants from PCORI during the conduct of the study and personal fees from Abbott and EdLogics outside the submitted work. Dr Sterling reported receiving grants and other support from the National Institute of General Medical Sciences outside the submitted work. Dr Butler reported receiving other fees from Abbott, Amgen, Applied Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squib, CVRx, Janssen, LivaNova, Luitpold, Medtronic, Merck, Novartis, NovoNordisk, Relypsa, and Vifor outside the submitted work. No other disclosures were reported.

Figures

Figure 1.. Screening, Enrollment, and Follow-up in the Get With the Guidelines in Emergency Department Patients With Heart Failure Clinical Trial

Figure 2.. Cardiovascular Death and Heart Failure Adverse Events Over 90 Days Stratified by Study Arm

Figure 3.. Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) Summary Scores (SS) at Baseline and Study Days by Study Arm

A, KCCQ-12 SS at baseline and 30 days. B, KCCQ-12 SS at baseline and 90 days. Boxes range from the 25th to 75th percentile, and the lower and upper whiskers represent 1.5 times the interquartile range.