A clinical trial of an intervention designed to improve outcomes for patients hospitalized with heart failure shows that the strategy was not successful compared to results with usual care.
Researchers in the Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure (CONNECT-HF) set out to see if an intervention designed to improve care quality for hospitalized and postdischarge heart failure patients with reduced ejection fraction would result in improved outcomes.
Led by Adam DeVore, MD, from Duke Clinical Research Institute, Durham, North Carolina, the trial essentially showed that the intervention did not result in improved clinical outcomes or measures of quality of care, based on the coprimary outcomes of time to first heart failure rehospitalization or death, or change in a composite heart failure quality-of-care score, which was based on the percentage of guideline-recommendations that were followed.
The study was published online July 27 in JAMA.
“Adoption of guideline-directed medical therapy for patients with heart failure is variable,” DeVore and colleagues concluded.
“Interventions to improve guideline-directed medical therapy have failed to consistently achieve target metrics, and limited data exist to inform efforts to improve heart failure quality of care,” they write.
The results, though, suggest an increasingly important role for implementation science — basically, the study of how to implement and disseminate new clinical advances established in clinical trials, say the authors of an accompanying editorial.
“CONNECT-HF was a very important step for cardiometabolic medicine,” editorialist Ankeet S. Bhatt, MD, clinical research fellow at Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts, told theheart.org | Medscape Cardiology.
“As we say in the editorial, it really put implementation science on the map in cardiometabolic medicine, and I think it couldn’t have come at a more important time.”
CONNECT-HF was conducted at 161 US hospitals and included 5647 patients. All hospitals treated a minimum of 50 patients with heart failure annually and were able to perform the quality improvement intervention.
The intervention included an audit and feedback on the performance of each hospital.
In addition, nurse coordinators facilitated accurate medication reconciliation at patient discharge, provided education to the patient on self-management and medication adherence, and drafted discharge plans that included the rationale for the prescribed medications, as well as contingency plans.
The intervention did not improve outcomes. Specifically, heart failure rehospitalization or all-cause mortality occurred in 38.6% of the intervention group, compared with 39.2% of the usual care group (adjusted hazard ratio, 0.92; 95% CI, 0.81 – 1.05).
At baseline, the quality-of-care score was 42.1% in the intervention group compared with 45.5% in the usual care group, with changes from baseline to follow-up of 2.3% in the intervention group versus –1.0% in the usual care group (difference, 3.3%; 95% CI, –0.8% – 7.3%]), with no significant difference between the two groups in the odds of achieving a higher composite quality score (adjusted odds ratio, 1.06; 95% CI, 0.93 – 1.21).
Advances Not Fully Realized
Considerable advances have been made in the treatment of heart failure with reduced ejection fraction, but these advances have not been fully realized in clinical practice, editorialists Bhatt and colleagues write.
Deep, pervasive gaps remain in the optimal adoption of these therapies in patients with heart failure, but they also exist for other prevalent cardiometabolic conditions including diabetes, chronic kidney disease, atherosclerotic cardiovascular disease, and obesity, the editorialists write.
The basic premise of implementation science is to rigorously study how the advances made in therapies for illnesses such as heart failure, chronic kidney disease, diabetes, and atherosclerotic vascular disease, are actually being disseminated.
“We put so much effort, so much investment, and so much work in getting from discovery to the efficacy trials, and then once that trial is positive, what strategies do we need to employ to disseminate this treatment to patients in the community? We now have five successful therapies that are approved for patients with heart failure with reduced ejection fraction. But the reality is that these therapies rarely reach patients comprehensively, or if they do, they do so slowly,” Bhatt said.
The use of audit feedback, where sites were given feedback on how they were performing, is a “novel concept,” he added.
“This has been a mechanism in behavioral science which has been shown to change behavior. The idea behind it is that if you are aware of your performance, then you can change it. So, the audit is like a report card,” Bhatt said.
“There are a few strengths to the study. It was done in a rigorous fashion, it was a very large study, and they gave us a definitive answer on this strategy. The authors need to be congratulated on that,” he added.
“CONNECT-HF also gives us a launching point to now think about this entire field of implementation and dissemination science and see the best strategies to improve care for patients with heart failure. We can have great study results, but if they aren’t disseminated widely or efficiently, we can’t know how effective they are in the long run and in the real world.”
The study was funded by Novartis Pharmaceuticals Corporation. DeVore and Bhatt report no relevant financial relationships.
JAMA. Published online July 27, 2021. Article, Editorial
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