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.
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.
Study Type
INTERVENTIONAL
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. This alert informs the provider to the presence of HFrEF and absence of MRA prescription, notes the patient's current LVEF, and notes the most recent labs, including NT-ProBNP, potassium, and creatinine. Providers will also have access to a link to best available guideline recommended information regarding use of MRAs and a link to both an order set for prescribing an MRA and an alternate order set with option for potassium monitoring should hyperkalemia be a concern. If a patient is hyperkalemic (i.e. K ≥ 5 mEq/L), a link to an order set for prescribing a potassium binder will be provided instead. If a provider feels that the recommended therapy is not indicated for a particular patient, he/she can select an available reason from the list provided within the alert.
Cardiology/Internal Medicine Outpatient Clinics of Yale New Health System
New Haven, Connecticut, United States
Proportion of patients with an active prescription for an MRA
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.
Time frame: Measured at 6 months post-randomization
Number of MRA prescriptions
Number of any MRA prescription during study period.
Time frame: Within one year post randomization
Percentage of MRA prescriptions filled
Percentage of prescriptions filled of initial MRA prescriptions written during the study period.
Time frame: Within 30 days of written prescription
Time to first MRA prescription
Time (in days) to first MRA prescription
Time frame: From enrollment to time of MRA prescription
Percentage of patients with Hyperkalemia (K>5.0)
Percentage of patients experiencing hyperkalemia (K greater than or equal to 5.0 mEq/L)
Time frame: Within one year post randomization
Percentage of patients with Hyperkalemia (K>5.5)
Percentage of patients experiencing hyperkalemia (K greater than or equal to 5.5 mEq/L)
Time frame: Within one year post randomization
Percentage of patients with Hyperkalemia (K>5.0) with MRA
Percentage of patients experiencing hyperkalemia (K greater than or equal to 5.0 mEq/L) with an active MRA prescription
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Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,210
Time frame: Within one year post randomization
Percentage of patients with Hyperkalemia (K>5.5) with MRA
Percentage of patients experiencing hyperkalemia (K greater than or equal to 5.5 mEq/L) with an active MRA prescription
Time frame: Within one year post randomization
Percentage of patients with potassium binder prescription
Percentage of participants with active prescription for potassium binders
Time frame: Measured at 1 month post randomization
Percentage of patients with potassium binder prescription
Percentage of participants with active prescription for potassium binders
Time frame: Measured at 2 months post randomization
Percentage of patients with potassium binder prescription
Percentage of participants with active prescription for potassium binders
Time frame: Measured at 3 months post randomization
Percentage of patients with potassium binder prescription
Percentage of participants with active prescription for potassium binders
Time frame: Measured at 4 months post randomization
Percentage of patients with potassium binder prescription
Percentage of participants with active prescription for potassium binders
Time frame: Measured at 5 months post randomization
Percentage of patients with potassium binder prescription
Percentage of participants with active prescription for potassium binders
Time frame: Measured at 6 months post randomization
Percentage of patients with potassium binder + MRA prescription
Percentage of participants with active prescription for potassium binders and MRA
Time frame: Measured at 1 month post randomization
Percentage of patients with potassium binder + MRA prescription
Percentage of participants with active prescription for potassium binders and MRA
Time frame: Measured at 2 months post randomization
Percentage of patients with potassium binder + MRA prescription
Percentage of participants with active prescription for potassium binders and MRA
Time frame: Measured at 3 months post randomization
Percentage of patients with potassium binder + MRA prescription
Percentage of participants with active prescription for potassium binders and MRA
Time frame: Measured at 4 months post randomization
Percentage of patients with potassium binder + MRA prescription
Percentage of participants with active prescription for potassium binders and MRA
Time frame: Measured at 5 months post randomization
Percentage of patients with potassium binder + MRA prescription
Percentage of participants with active prescription for potassium binders and MRA
Time frame: Measured at 6 months post randomization
Type of potassium binder prescribed
Type of first potassium binder prescribed
Time frame: First potassium binder prescribed at any point between enrollment and study completion
Rationale for provider not prescribing an MRA if indicated (intervention group only)
Provider-documented (via the best practice alert) rationale for not prescribing indicated MRA (intervention group only)
Time frame: Any rationale provided within one year post randomization
Rationale for provider not prescribing a potassium binder if indicated (intervention group only)
Provider-documented (via the best practice alert) rationale for not prescribing indicated potassium binder (intervention group only)
Time frame: Any rationale provided within one year post randomization
Percentage of patients with ED visits
Percentage of patients with any ED visit
Time frame: Measured at 1 month post randomization
Percentage of patients with ED visits
Percentage of patients with any ED visit
Time frame: Measured at 3 months post randomization
Percentage of patients with ED visits
Percentage of patients with any ED visit
Time frame: Measured at 6 months post randomization
Percentage of patients with ED visits
Percentage of patients with any ED visit
Time frame: Measured at 12 months post randomization
ED visit count
Count of ED visits per patient
Time frame: Measured at 1 month post randomization
ED visit count
Count of ED visits per patient
Time frame: Measured at 3 months post randomization
ED visit count
Count of ED visits per patient
Time frame: Measured at 6 months post randomization
ED visit count
Count of ED visits per patient
Time frame: Measured at 12 months post randomization
Rates of Heart failure-related hospital admissions
Rates of HF-related hospital admissions (uses computations phenotype)
Time frame: Measured at 1 month post randomization
Rates of Heart failure-related hospital admissions
Rates of HF-related hospital admissions (uses computations phenotype)
Time frame: Measured at 3 months post randomization
Rates of Heart failure-related hospital admissions
Rates of HF-related hospital admissions (uses computations phenotype)
Time frame: Measured at 6 months post randomization
Rates of Heart failure-related hospital admissions
Rates of HF-related hospital admissions (uses computations phenotype)
Time frame: Measured at 12 months post randomization
Rates Outpatient visits
Rates of outpatient visits
Time frame: Measured at 1 monnh post randomization
Rate of Outpatient visits
Rates of outpatient visits
Time frame: Measured at 3 months post randomization
Rate of Outpatient visits
Rates of outpatient visits
Time frame: Measured at 6 months post randomization
Rate of Outpatient visits
Rates of outpatient visits
Time frame: Measured at 12 months post randomization
Rate of ED visit + IV diuretics
Rates of total ED visits in which a dose of IV diuretics was given
Time frame: Measured at 1 month post randomization
Rate of ED visit + IV diuretics
Rates of total ED visits in which a dose of IV diuretics was given
Time frame: Measured at 3 months post randomization
Rate of ED visit + IV diuretics
Rates of total ED visits in which a dose of IV diuretics was given
Time frame: Measured at 6 months post randomization
Rate of ED visit + IV diuretics
Rates of total ED visits in which a dose of IV diuretics was given
Time frame: Measured at 12 months post randomization
All-cause mortality
Rates of all-cause mortality
Time frame: Measured at 1 month post randomization
All-cause mortality
Rates of all-cause mortality
Time frame: Measured at 3 months post randomization
All-cause mortality
Rates of all-cause mortality
Time frame: Measured at 6 months post randomization
All-cause mortality
Rates of all-cause mortality
Time frame: Measured at 12 months post randomization
Total healthcare associated costs
Total healthcare-associated cost per patient
Time frame: Measured at 1 month post randomization
Total healthcare associated costs
Total healthcare-associated cost per patient
Time frame: Measured at 3 months post randomization
Total healthcare associated costs
Total healthcare-associated cost per patient
Time frame: Measured at 6 months post randomization
Total healthcare associated costs
Total healthcare-associated cost per patient
Time frame: Measured at 12 months post randomization
Rates of documented hyperkalemia at an ED visit
Documented hyperkalemia (K ≥ 5.5 mEq/L) at an ED visit
Time frame: Within one year post randomization
Rates of documented hyperkalemia at an outpatient visit
Documented hyperkalemia (K ≥ 5.5 mEq/L) at an outpatient visit
Time frame: Within one year post randomization
Rates of documented hyperkalemia during a hospital HF admission
Documented hyperkalemia (K ≥ 5.5 mEq/L) at an HF-related hospital admission
Time frame: Within one year post randomization
Frequency of outpatient potassium monitoring
Frequency of outpatient potassium monitoring
Time frame: Within one year post randomization
Frequency of outpatient potassium monitoring +/- MRA
Frequency of outpatient potassium monitoring for those with an active prescription of MRA vs. not
Time frame: Within one year post randomization
Frequency of outpatient potassium monitoring +/- potassium binder
Frequency of outpatient potassium monitoring for those with an active prescription of potassium binder vs. not
Time frame: Within one year post randomization