No Benefit Shown In Quality Improvement Intervention For Patients with HFrEF

Adam D. DeVore, MD, MHS

Although there are multiple treatment options for heart failure with reduced ejection fraction (HFrEF), a lack of sufficient adoption of guideline-directed medical therapy has led to poor outcomes, including high rates of rehospitalization and death.

A recent study tested the effect of a hospital and post-discharge quality improvement intervention in comparison with usual care on heart failure outcomes.

The team, led by Adam D. DeVore, MD, MHS, Duke Clinical Research Institute, ultimately found no significant differences in time to first heart failure rehospitalization or death, or a change in composite heart failure quality-of-care score among patients with HFrEF.

Methods

A cluster randomized clinical took place at 161 hospitals in the United States in order to evaluate the effect of the quality improvement intervention

The hospitals enrolled adult patients with HFrEF, including symptomatic heart failure and left ventricular ejection fraction ≤40%, who were discharged to home.

Exclusion included previous heart transplant or current implantation of a left ventricular assist device, chronic use of dialysis, and terminal illness with life expectancy <1 year.

According to investigators, interventions included implementation of site-based quality improvement initiatives to target discharge, transition, and outpatient care delivery processes associated with medical therapy guidelines for this patient population,

Primary outcomes were a composite of first heart failure rehospitalization or all-cause death and change in an opportunity-based composite score for heart failure quality.

The team noted the composite quality score was evaluated at time of hospital discharge and during follow-up, made up of the percentage of total opportunities successfully accomplished.

Secondary outcomes included total number of heart failure rehospitalizations, all-cause death, and an opportunity-based quality score at the time of heart failure discharge.

Investigators conducted the primary analysis using Cox proportional hazards models with shared frailty in order to account for the clustering effect.

In addition, an analysis of subgroups, including age (≥65 years versus <65 years), sex, race, history of diabetes, chronic kidney disease, atrial fibrillation, new-onset heart failure, and left ventricular ejection fraction, was performed for both primary end points.

Results

Study data show a total of 161 hospitals were randomized to intervention (n = 82) or usual care (n = 79) from March 2017 - May 2020

A total of 5746 patients were enrolled with 2727 patients in the intervention group and 3019 patients in the usual care group.

After exclusions, the total number of patients was 5647 in analysis of the primary clinical outcome and 4646 patients were included in the analysis of the primary composite quality score outcome.

Investigators observed patient characteristics, with a mean age of 63 years and 33% women, with 87% chronic heart failure and 49% recent heart failure hospitalization.

In the primary clinical outcome, there were 2061 events observed, including 729 deaths

Datas show rehospitalization or all-cause mortality occurred in 38.6% in the intervention group compared to 39.2% of patients in the usual care group (adjusted hazard ratio, 0.92 (95% CI, 0.81 - 1.05).

In the baseline primary composite quality score, data show there were 4443 successful quality-of-care metrics (42.1%) in the intervention group and 5468 metrics (45.5%) in the usual care group.

A change from baseline to follow-up was 2.3% versus -1.0% with a difference of 3.3% (95% CI, -0.8% to 7.3%).

Investigators noted no significant difference between the 2 groups in achieving a higher opportunity-based heart failure quality score at the patient’s last follow-up (OR 1.06; 95% CI, 0.93 - 1.21).

Data show the frequency of total heart failure rehospitalizations was 1127 in the intervention group and 1326 in the usual care group, while all-cause death was similar in both groups.

Conclusion

The team concluded that in patients treated after hospitalization for HFrEF, quality improvement interventions did not reduce the composite of heart-failure rehospitalization of all-cause death.

“While the substantial rates of preexisting quality improvement participation might help explain the neutral results of the current study, guideline-directed medical therapy use rates remained insufficient, with less than 50% of the most effective treatments being applied to patients, even when excluding situations in which patients were not eligible,” investigators wrote.

The study, “Effect of a Hospital and Postdischarge Quality Improvement Intervention
on Clinical Outcomes and Quality of Care for Patients With Heart Failure With Reduced Ejection Fraction,” was published online in JAMA.