Sean P Collins1,2, Dandan Liu1, Cathy A Jenkins1, Alan B Storrow1, Phillip D Levy3, Peter S Pang4, Anna Marie Chang5, Douglas Char6, Deborah J Diercks7, Gregory J Fermann8, Jin H Han1,2, Brian Hiestand9, Christopher Hogan10, Christina J Kampe1, Yosef Khan11, Sangil Lee12, JoAnn Lindenfeld1, Jennifer Martindale13, Candace D McNaughton1, Karen F Miller1, Carolyn Miller-Reilly14, Kelly Moser1, W Frank Peacock15, Chad Robichaux16, Russell Rothman1, Jon Schrock17, Wesley H Self1, Adam J Singer18, Sarah A Sterling19, Michael J Ward1, Cheryl Walsh20, Javed Butler19. 1. Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee. 2. Geriatric Research, Education, and Clinical Center, Tennessee Valley Healthcare System, Nashville. 3. Department of Emergency Medicine, Detroit Medical Center, Detroit, Michigan. 4. Department of Emergency Medicine, Indiana University Medical Center, Indianapolis. 5. Department of Emergency Medicine, Thomas Jefferson University Medical Center, Philadelphia, Pennsylvania. 6. Department of Emergency Medicine, Washington University Medical Center in St Louis, St Louis, Missouri. 7. Department of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas. 8. Department of Emergency Medicine, University of Cincinnati Medical Center, Cincinnati, Ohio. 9. Department of Emergency Medicine, Wake Forest University Medical Center, Winston-Salem, North Carolina. 10. Department of Emergency Medicine, Virginia Commonwealth University Medical Center, Richmond, Virginia. 11. Department of Emergency Medicine, American Heart Association. 12. Department of Emergency Medicine, University of Iowa Medical Center, Iowa City. 13. Department of Emergency Medicine, Icahn School of Medicine at Mount Sinai, New York, New York. 14. School of Nursing, Emory University, Atlanta, Georgia. 15. Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas. 16. School of Medicine, Emory University, Atlanta, Georgia. 17. Department of Emergency Medicine, Metro Health Medical Center, Cleveland, Ohio. 18. Department of Emergency Medicine, Stony Brook University Medical Center, Stony Brook, New York. 19. Department of Medicine, University of Mississippi Medical Center, Jackson. 20. Patient Representative, Stockbridge, Georgia.
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.
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.
Authors: William B Stubblefield; Cathy A Jenkins; Dandan Liu; Alan B Storrow; John A Spertus; Peter S Pang; Phillip D Levy; Javed Butler; Anna Marie Chang; Douglas Char; Deborah B Diercks; Gregory J Fermann; Jin H Han; Brian C Hiestand; Christopher J Hogan; Yosef Khan; Sangil Lee; JoAnn M Lindenfeld; Candace D McNaughton; Karen Miller; W Frank Peacock; Jon W Schrock; Wesley H Self; Adam J Singer; Sarah A Sterling; Sean P Collins Journal: Circ Cardiovasc Qual Outcomes Date: 2021-09-24
Authors: Austin S Kilaru; Nicholas Illenberger; Zachary F Meisel; Peter W Groeneveld; Manqing Liu; Angira Mondal; Nandita Mitra; Raina M Merchant Journal: Circ Cardiovasc Qual Outcomes Date: 2022-09-08
Authors: Gregory J Fermann; Jon W Schrock; Phillip D Levy; Peter Pang; Javed Butler; Anna Marie Chang; Douglas Char; Deborah Diercks; Jin H Han; Brian Hiestand; Chris Hogan; Cathy A Jenkins; Christy Kampe; Yosef Khan; Vijaya A Kumar; Sangil Lee; JoAnn Lindenfeld; Dandan Liu; Karen F Miller; W Frank Peacock; Carolyn M Reilly; Chad Robichaux; Russell L Rothman; Wesley H Self; Adam J Singer; Sarah A Sterling; Alan B Storrow; William B Stubblefield; Cheryl Walsh; John Wilburn; Sean P Collins Journal: J Am Coll Emerg Physicians Open Date: 2022-04-09
Authors: Peter S Pang; Frances M Russell; Robert Ehrman; Rob Ferre; Luna Gargani; Phillip D Levy; Vicki Noble; Kathleen A Lane; Xiaochun Li; Sean P Collins Journal: JACC Heart Fail Date: 2021-07-07 Impact factor: 12.544