Key Points
- Many patients with heart failure with reduced ejection fraction (HFrEF) are not on optimal guideline directed medical therapy (GDMT), especially mineralocorticoid receptor antagonists (MRAs), despite their strong evidence base in improving clinical outcomes. GDMT under-prescribing is a cause of potentially preventable morbidity and mortality.
- It is unknown whether electronic clinical decision support (CDS) is able to improve MRA prescribing, and if so, what type of CDS is most effective.
- This was a pragmatic, cluster-randomized trial trial that included HFrEF patients, no active prescription of MRA, and an outpatient cardiologist in a large health system. Patients were cluster-randomized by cardiologist (60 per arm) into: automated EHR alerts automated EHR message and usual care.
- Patients randomized to the intra-visit BPA arm resulted in a significantly higher MRA prescription rate as compared to the monthly message or usual care.
- An automated, patient specific, visit based alert in the electronic medical record can increase appropriate GDMT prescription for HFrEF patients.
GDMT is known to reduce both mortality and heart failure hospitalization in patients with HFrEF. However, many patients who are otherwise eligible are not on one of the four pillars of modern optimal medical therapy. Overall, the under-prescription of MRAs is thought to have the largest population level effect on adverse HFrEF outcomes in America.
On March 5, 2023, Dr. Amrita Mukhopadhyay from the NYU Grossman School of Medicine presented the results of Building Electronic Tools to Enhance and Reinforce Cardiovascular Recommendations for Heart Failure (BETTER CARE-HF): A Pragmatic, Cluster-randomized Trial Comparing Two Ambulatory Clinical Decision Support Tools at a Late Breaking Clinical Trials session of ACC.23/WCC. Their manuscript was simultaneously published in the Journal of the American College of Cardiology.1
In this pragmatic randomized control trial, the authors compared two automated electronic health record (EHR) interventions meant to increase MRA prescription among eligible HFrEF patients against each other and usual care. The automated EHR alert, designed using an iterative process informed by behavioral psychology, prompted the patient’s clinician to prescribe an MRA during their individual visit. The automated EHR message was a monthly message to the patient’s provider listing patients eligible for MRA outside of their individual visit. The usual care arm had no additional alerts. The primary outcome was new MRA prescriptions.
Overall, 2211 patients with HFrEF, no active MRA prescription, and no contraindication to MRA who had a known cardiologist within a single large healthcare system were randomized to one of the three arms: the alert arm (n=775), the message arm (n=812) , or the control arm (n=644). The average age was 72.2 years and average ejection fraction 33%. About 70% of the patients were male and 70% were white, about 80% had background beta blocker therapy and 74% were on ACE inhibitor, angiotensin receptor blocker, or angiotensin receptor-neurolysin inhibitor.
A new MRA prescription was provided to 29.6% of patients in the BPA arm, 15.6% in the message arm, and 11.7% in the control arm. The alert arm had significantly higher MRA prescription compared to the message arm (RR 1.67, CI 1.21-2.29, p=0.002) and the control arm (RR 2.53, CI 1.77-3.62, p<0.0001), with an overall “number needed to alert” of 5.6. Older patients appeared to benefit more than younger patients. Hyperkalemia, defined as K> 5.1, was significantly higher in the alert versus control arm (RR 1.45, CI 1.04-1.96, p=0.017), however there was no difference between the arms in significant hyperkalemia, defined as K > 5.5.
This study has limited external validity as it is within a single center system using the EPIC EHR, and only cardiologists received the messages, therefore it may not apply to other systems, non-EPIC EHRs, or other provider types. This alert was focused on MRAs only, which are generic, relatively inexpensive, and readily available. Other GDMT might have additional barriers to prescription, such as cost, that could mitigate the positive effect of the alerts. Furthermore, all three arms had low rates of potassium monitoring after initiation, which means that some hyperkalemic events may have been missed.
Guidelines and evidence-based therapies are only as effective as their implementation; identifying disease modifying treatment is important, but ultimately in order to realize their benefit they must be delivered to the patients who need them most. This study demonstrates that appropriately designed and tested CDS has the potential to close the gap between ideal GDMT delivery and real-world practice, and highlights the importance of care delivery innovations and implementation science in improving prescription of life-saving HFrEF therapies. While it is reasonable to expect that increasing GDMT prescription via EHR interventions such as the ones described in this study will translate into improved population-level heart failure outcomes, further research is needed to prove it.
“This alert delivered at the time of visit more than doubled prescribing of MRA as compared to usual care,” said Dr. Mukhopadhyay. “EHR-embedded tools can be a rapid, low cost, and high-impact method to increase prescription of life-saving therapies across large populations. We do have plans to expand this even more throughout our system. It is important to continue evaluating these tools once they are implemented.”
References
- Mukhopadhyay A, Reynolds HR, Phillips LM, et al. Cluster-Randomized Trial Comparing Ambulatory Decision Support Tools to Improve Heart Failure Care. J Am Coll Cardiol 2023;(Pre-Print).
