Editor's Note: This story was updated July 28, 2021, to include the publication of this study in the Journal of the American Medical Association.
The late-breaking clinical trial found no difference between the intervention group and the control group when examining an audit and feedback initiative that was hypothesized to improve heart failure care.
An effort to improve the quality of heart failure care focused on audit and feedback did not significantly improve either the outcomes of patients with heart failure or the quality of care they received, according to late-breaking clinical trial results presented today at the American College of Cardiology’s 70th annual Scientific Session & Expo.
The trial, called CONNECT-HF, was designed and led by the DCRI. Findings from the study, which were later published in Journal of the American Medical Association, were presented Monday by DCRI principal investigator and heart failure clinician Adam DeVore, MD, MHS.
CONNECT-HF was a cluster randomized trial that randomized 161 hospitals to either usual care or an intervention consisting of site-level audit and feedback regarding a site’s progress to pre-determined goals. The study included 5,647 patients who had been discharged after being hospitalized for acute heart failure with reduced ejection fraction.
Researchers were interested in determining whether monthly feedback reports and education sessions for clinicians would improve two outcomes: the rate that patients were either re-hospitalized for heart failure or died; and changes in an opportunity-based composite score for heart failure quality.
The study, which was conducted from 2017 to 2020, found no difference between the two groups in the rates of re-hospitalization and death (38.6 percent in the intervention group, compared to 39.2 percent in the usual care group).
Across both groups, only 44 percent of quality metric opportunities were being achieved prior to the study being conducted. However, neither group showed a significant change in the second outcome, heart failure quality-of-care scores.
“Data show us significant gaps in care for patients with heart failure. Although quality improvement programs are common in hospitals, there was no established data about which initiatives were the most effective in helping to close these gaps,” DeVore said. “CONNECT-HF has shown us that this type of audit and feedback initiative is likely not the most effective and that new approaches are needed for the care of heart failure patients.”
“Although our primary hypothesis was not confirmed in CONNECT-HF, the study has provided many learnings that are important to the future of clinical research at the DCRI and beyond,” DeVore continued. “The study incorporated pragmatic elements, such as broad inclusion and exclusion criteria, which helped us enroll more patients and design a trial that is highly representative of a real-world care setting. In addition, we’ve learned how to conduct an implementation study with the help of our sites and our patient partners.”
Moving forward, the investigators hope to study other interventions designed to improve the use of guideline-directed medical therapy for heart failure, including those that utilize novel technologies and wearables to allow for heart failure care outside traditional hospital and clinic settings.
In addition to DeVore, DCRI contributors to the CONNECT-HF paper in JAMA include Hussein Al-Khalidi, PhD; Michael Felker, MD, MHS; Lisa Kaltenbach, MS; Christopher Granger, MD; and Adrian Hernandez, MD, MHS.