Clinical trial NCT04903717: Pragmatic Trial Of Alerts for Use of Mineralocorticoid Receptor Antagonists
Official title: Pragmatic Trial Of Messaging to Providers About Treatment With Mineralocorticoid Receptor Antagonists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Vifor Pharma
name: Relypsa, Inc.
First posted: 2021-05-26
Enrollment: 1210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Absolute contraindication to MRAs

Primary outcomes:
measure: Proportion of patients with an active prescription for an MRA
timeFrame: Measured at 6 months post-randomization
Secondary outcomes:
measure: Number of MRA prescriptions
timeFrame: Within one year post randomization
measure: Percentage of MRA prescriptions filled
timeFrame: Within 30 days of written prescription
measure: Time to first MRA prescription
timeFrame: From enrollment to time of MRA prescription
measure: Percentage of patients with Hyperkalemia (K>5.0)
timeFrame: Within one year post randomization
measure: Percentage of patients with Hyperkalemia (K>5.5)
timeFrame: Within one year post randomization
measure: Percentage of patients with Hyperkalemia (K>5.0) with MRA
timeFrame: Within one year post randomization
measure: Percentage of patients with Hyperkalemia (K>5.5) with MRA
timeFrame: Within one year post randomization
measure: Percentage of patients with potassium binder prescription
timeFrame: Measured at 1 month post randomization
measure: Percentage of patients with potassium binder prescription
timeFrame: Measured at 2 months post randomization
measure: Percentage of patients with potassium binder prescription
timeFrame: Measured at 3 months post randomization
measure: Percentage of patients with potassium binder prescription
timeFrame: Measured at 4 months post randomization
measure: Percentage of patients with potassium binder prescription
timeFrame: Measured at 5 months post randomization
measure: Percentage of patients with potassium binder prescription
timeFrame: Measured at 6 months post randomization
measure: Percentage of patients with potassium binder + MRA prescription
timeFrame: Measured at 1 month post randomization
measure: Percentage of patients with potassium binder + MRA prescription
timeFrame: Measured at 2 months post randomization
measure: Percentage of patients with potassium binder + MRA prescription
timeFrame: Measured at 3 months post randomization
measure: Percentage of patients with potassium binder + MRA prescription
timeFrame: Measured at 4 months post randomization
measure: Percentage of patients with potassium binder + MRA prescription
timeFrame: Measured at 5 months post randomization
measure: Percentage of patients with potassium binder + MRA prescription
timeFrame: Measured at 6 months post randomization
measure: Type of potassium binder prescribed
timeFrame: First potassium binder prescribed at any point between enrollment and study completion
measure: Rationale for provider not prescribing an MRA if indicated (intervention group only)
timeFrame: Any rationale provided within one year post randomization
measure: Rationale for provider not prescribing a potassium binder if indicated (intervention group only)
timeFrame: Any rationale provided within one year post randomization
measure: Percentage of patients with ED visits
timeFrame: Measured at 1 month post randomization
measure: Percentage of patients with ED visits
timeFrame: Measured at 3 months post randomization
measure: Percentage of patients with ED visits
timeFrame: Measured at 6 months post randomization
measure: Percentage of patients with ED visits
timeFrame: Measured at 12 months post randomization
measure: ED visit count
timeFrame: Measured at 1 month post randomization
measure: ED visit count
timeFrame: Measured at 3 months post randomization
measure: ED visit count
timeFrame: Measured at 6 months post randomization
measure: ED visit count
timeFrame: Measured at 12 months post randomization
measure: Rates of Heart failure-related hospital admissions
timeFrame: Measured at 1 month post randomization
measure: Rates of Heart failure-related hospital admissions
timeFrame: Measured at 3 months post randomization
measure: Rates of Heart failure-related hospital admissions
timeFrame: Measured at 6 months post randomization
measure: Rates of Heart failure-related hospital admissions
timeFrame: Measured at 12 months post randomization
measure: Rates Outpatient visits
timeFrame: Measured at 1 monnh post randomization
measure: Rate of Outpatient visits
timeFrame: Measured at 3 months post randomization
measure: Rate of Outpatient visits
timeFrame: Measured at 6 months post randomization
measure: Rate of Outpatient visits
timeFrame: Measured at 12 months post randomization
measure: Rate of ED visit + IV diuretics
timeFrame: Measured at 1 month post randomization
measure: Rate of ED visit + IV diuretics
timeFrame: Measured at 3 months post randomization
measure: Rate of ED visit + IV diuretics
timeFrame: Measured at 6 months post randomization
measure: Rate of ED visit + IV diuretics
timeFrame: Measured at 12 months post randomization
measure: All-cause mortality
timeFrame: Measured at 1 month post randomization
measure: All-cause mortality
timeFrame: Measured at 3 months post randomization
measure: All-cause mortality
timeFrame: Measured at 6 months post randomization
measure: All-cause mortality
timeFrame: Measured at 12 months post randomization
measure: Total healthcare associated costs
timeFrame: Measured at 1 month post randomization
measure: Total healthcare associated costs
timeFrame: Measured at 3 months post randomization
measure: Total healthcare associated costs
timeFrame: Measured at 6 months post randomization
measure: Total healthcare associated costs
timeFrame: Measured at 12 months post randomization
measure: Rates of documented hyperkalemia at an ED visit
timeFrame: Within one year post randomization
measure: Rates of documented hyperkalemia at an outpatient visit
timeFrame: Within one year post randomization
measure: Rates of documented hyperkalemia during a hospital HF admission
timeFrame: Within one year post randomization
measure: Frequency of outpatient potassium monitoring
timeFrame: Within one year post randomization
measure: Frequency of outpatient potassium monitoring +/- MRA
timeFrame: Within one year post randomization
measure: Frequency of outpatient potassium monitoring +/- potassium binder
timeFrame: Within one year post randomization
Other outcomes:
measure: Subgroup Analysis: Hyperkalemia at randomization
timeFrame: At randomization
measure: Subgroup Analysis: Prior hyperkalemia (IDC-10 Code)
timeFrame: From one year prior to randomization up to randomization
measure: Subgroup Analysis: Prior hyperkalemia (K history)
timeFrame: From one year prior to randomization up to randomization
measure: Subgroup Analysis: Patient demographics
timeFrame: At randomization
measure: Subgroup Analysis: Chronic Kidney Disease
timeFrame: At randomization
measure: Subgroup Analysis: Insurance status
timeFrame: At randomization
measure: Subgroup Analysis: GDMT medications
timeFrame: At randomization
measure: Subgroup Analysis: Provider type
timeFrame: At randomization
Locations:
city: New Haven
country: United States
facility: Cardiology/Internal Medicine Outpatient Clinics of Yale New Health System
state: Connecticut
Study officials:
affiliation: Yale University
name: Francis P Wilson, MD MSCE
role: PRINCIPAL_INVESTIGATOR
References: