Pragmatic Trial Of Alerts for Use of Mineralocorticoid Receptor Antagonists

NCT ID: NCT04903717

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-03
• Study Completion Date: 2024-02-06

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention - 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.

Group Type: EXPERIMENTAL

Best Practice Alert

Intervention Type: BEHAVIORAL

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.

Usual Care

Providers will not receive a best practice alert for eligible patients and will continue to care for patients as usual.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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. 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vifor Pharma

INDUSTRY

Sponsor Role: collaborator

Relypsa, Inc.

INDUSTRY

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francis P Wilson, MD MSCE

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Cardiology/Internal Medicine Outpatient Clinics of Yale New Health System

New Haven, Connecticut, United States

Countries

United States

References

Clark KAA, Victoria-Castro AM, Ghazi L, Yamamoto Y, Coronel-Moreno C, Kadhim BA, Riello RJ 3rd, O'Connor K, Ahmad T, Wilson FP, Desai NR. Rationale, Design, and Patient Characteristics of a Cluster-Randomized Pragmatic Trial to Improve Mineralocorticoid Antagonist Use. JACC Heart Fail. 2024 Feb;12(2):322-332. doi: 10.1016/j.jchf.2023.08.025. Epub 2023 Nov 8.

Reference Type: DERIVED

PMID: 37943221 (View on PubMed)

Other Identifiers

2000030513

Identifier Type: -

Identifier Source: org_study_id