Pragmatic Trial Of Alerts for Use of Mineralocorticoid Receptor Antagonists
- Conditions
- Heart Failure With Reduced Ejection Fraction
- Interventions
- Behavioral: Best Practice Alert
- Registration Number
- NCT04903717
- Lead Sponsor
- Yale University
- Brief Summary
The primary objective of this study is to determine if a best practice alert (BPA) system that prompts providers to consider the addition of a mineralocorticoid receptor antagonist (MRA) in eligible patients with heart failure with reduced ejection fraction (HFrEF) will result in increased prescription of this guideline-recommended therapy. The system will also inform providers about FDA-approved potassium binders for the treatment of hyperkalemia if elevated potassium is a barrier for MRA use and will provide educational information on the evidence for MRA therapy in these patients.
- Detailed Description
Despite the robust literature demonstrating improved outcomes with the use of mineralocorticoid antagonists (MRAs) in patients with heart failure with reduced ejection fraction (HFrEF), MRAs continue to be underused in clinical practice. This underuse often stems from the perceived risks of hyperkalemia, including a prior history of hyperkalemia and acute or chronic kidney disease, as well as the cautioned use for those with potassium greater than 5.0 mEq/L, as recommended in national societal guidelines. New potassium binders have recently been approved by the United States Food and Drug Administration (FDA) to treat hyperkalemia. It remains unknown if a best practice alert built into the clinical electronic health record can facilitate MRA prescription in eligible patients by providing guideline-based information about MRA recommendations and evidence, as well as informing practitioners about available treatments for hyperkalemia.
This is a pragmatic, cluster-randomized, open-label interventional trial to test the comparative effectiveness of an EHR BPA system that informs practitioners about MRAs for HFrEF and, if necessary, potassium-binders that are FDA-approved for hyperkalemia, versus usual care (no alert, current standard of care). One hundred and fifty outpatient Cardiology and Internal Medicine providers (to include physicians and advanced practice providers (nurse practitioners, physician assistants, and advanced practice registered nurses)) practicing at affiliated locations will be enrolled and undergo randomization to either the intervention (alert) group or a control (usual care) group. Those in the intervention group will receive an informational alert for their eligible adult outpatients (those with HFrEF not currently prescribed an MRA). Those in the control group will not receive any alerts and will continue to care for patients as usual. The primary outcome will be the proportion of patients with HFrEF who have an active prescription for an MRA at 6 months following randomization.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1210
- Adults equal to or greater than 18 years of age
- Outpatients of providers randomized into the study within Internal Medicine and Cardiology outpatient clinics
- Diagnosis of heart failure with reduced ejection fraction (LVEF less than or equal to 40% on the most recent TTE)
- Registration in the Yale Heart Failure Registry (NCT04237701)
- Not currently prescribed an MRA
- Absolute contraindication to MRAs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention - Best Practice Alert Best Practice Alert Providers randomized to the intervention arm will have a best practice alert appear for each of their eligible patients upon opening of the order entry screen in the patient's medical record which alerts to the presence of HFrEF and the fact that the patient is not currently prescribed an MRA. A link to an order set for MRAs (or to potassium binders should a patient be hyperkalemic) will provided, along with a link to current best practices surrounding the use of MRAs.
- Primary Outcome Measures
Name Time Method Proportion of patients with an active prescription for an MRA Measured at 6 months post-randomization Proportion of patients with an active prescription for an MRA, defined as a prescription present in the electronic health record for any drug in the MRA class that is active (not expired) and has remaining doses left at 6 months after the date of randomization.
- Secondary Outcome Measures
Name Time Method Rates Outpatient visits Measured at 1 monnh post randomization Rates of outpatient visits
Rate of Outpatient visits Measured at 12 months post randomization Rates of outpatient visits
All-cause mortality Measured at 12 months post randomization Rates of all-cause mortality
Percentage of patients with potassium binder prescription Measured at 6 months post randomization Percentage of participants with active prescription for potassium binders
Rates of Heart failure-related hospital admissions Measured at 12 months post randomization Rates of HF-related hospital admissions (uses computations phenotype)
Number of MRA prescriptions Within one year post randomization Number of any MRA prescription during study period.
Percentage of patients with Hyperkalemia (K>5.0) with MRA Within one year post randomization Percentage of patients experiencing hyperkalemia (K greater than or equal to 5.0 mEq/L) with an active MRA prescription
Percentage of patients with Hyperkalemia (K>5.5) with MRA Within one year post randomization Percentage of patients experiencing hyperkalemia (K greater than or equal to 5.5 mEq/L) with an active MRA prescription
Percentage of patients with potassium binder + MRA prescription Measured at 6 months post randomization Percentage of participants with active prescription for potassium binders and MRA
Rationale for provider not prescribing an MRA if indicated (intervention group only) Any rationale provided within one year post randomization Provider-documented (via the best practice alert) rationale for not prescribing indicated MRA (intervention group only)
Rationale for provider not prescribing a potassium binder if indicated (intervention group only) Any rationale provided within one year post randomization Provider-documented (via the best practice alert) rationale for not prescribing indicated potassium binder (intervention group only)
Percentage of patients with ED visits Measured at 12 months post randomization Percentage of patients with any ED visit
ED visit count Measured at 12 months post randomization Count of ED visits per patient
Rates of documented hyperkalemia during a hospital HF admission Within one year post randomization Documented hyperkalemia (K ≥ 5.5 mEq/L) at an HF-related hospital admission
Frequency of outpatient potassium monitoring Within one year post randomization Frequency of outpatient potassium monitoring
Frequency of outpatient potassium monitoring +/- potassium binder Within one year post randomization Frequency of outpatient potassium monitoring for those with an active prescription of potassium binder vs. not
Percentage of MRA prescriptions filled Within 30 days of written prescription Percentage of prescriptions filled of initial MRA prescriptions written during the study period.
Time to first MRA prescription From enrollment to time of MRA prescription Time (in days) to first MRA prescription
Percentage of patients with Hyperkalemia (K>5.0) Within one year post randomization Percentage of patients experiencing hyperkalemia (K greater than or equal to 5.0 mEq/L)
Type of potassium binder prescribed First potassium binder prescribed at any point between enrollment and study completion Type of first potassium binder prescribed
Rate of ED visit + IV diuretics Measured at 12 months post randomization Rates of total ED visits in which a dose of IV diuretics was given
Total healthcare associated costs Measured at 12 months post randomization Total healthcare-associated cost per patient
Rates of documented hyperkalemia at an ED visit Within one year post randomization Documented hyperkalemia (K ≥ 5.5 mEq/L) at an ED visit
Rates of documented hyperkalemia at an outpatient visit Within one year post randomization Documented hyperkalemia (K ≥ 5.5 mEq/L) at an outpatient visit
Percentage of patients with Hyperkalemia (K>5.5) Within one year post randomization Percentage of patients experiencing hyperkalemia (K greater than or equal to 5.5 mEq/L)
Frequency of outpatient potassium monitoring +/- MRA Within one year post randomization Frequency of outpatient potassium monitoring for those with an active prescription of MRA vs. not
Trial Locations
- Locations (1)
Cardiology/Internal Medicine Outpatient Clinics of Yale New Health System
🇺🇸New Haven, Connecticut, United States