Key result
A tailored self-care intervention did not improve the global rank of cardiovascular death, HF events, and KCCQ-12 score at 90 days compared to usual care (HR 0.89; 95% CI 0.73-1.10; P=.28).
Why the study?
Up to 20% of patients presenting to the emergency department (ED) with acute heart failure (AHF) are discharged without hospitalization, facing worse readmission and mortality rates than hospitalized patients.
Does a tailored self-care intervention improve a global rank of cardiovascular death, HF-related events, and KCCQ-12 scores at 90 days in patients with acute heart failure discharged from the ED?
RCT (n=479)
unblinded
1:1
Yes
Does a tailored self-care intervention improve a global rank of cardiovascular death, HF-related events, and KCCQ-12 scores at 90 days in patients with acute heart failure discharged from the ED?
Hazard Ratio: 0.89 (95% CI 0.73–1.1)
p-value: p=.28
A tailored self-care intervention for patients discharged from the ED with acute heart failure provided early benefits at 30 days but failed to significantly improve the primary composite outcome of death, HF events, and quality of life at 90 days.
Does not support tailored self-care after ED discharge for acute HF; challenges efficacy suggested by 30-day signals or prior smaller studies.
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.
No takes yet. Share an insight, caveat, or question.
Collins et al. (2020) conducted an RCT in Acute Heart Failure (n=479). Tailored self-care intervention vs. Usual care was evaluated on Global rank of cardiovascular death, HF-related events, and changes in the KCCQ-12 summary score at 90 days (HR 0.89, 95% CI 0.73-1.10, p=.28). A tailored self-care intervention did not improve the global rank of cardiovascular death, HF events, and KCCQ-12 score at 90 days compared to usual care (HR 0.89; 95% CI 0.73-1.10; P=.28).
Synapse has enriched 2 closely related papers on similar clinical questions. Consider them for comparative context: