Pragmatic Trial Of Alerts for Use of Mineralocorticoid Receptor Antagonists

NCT04903717 | Completed DMC

• 1 other identifier: 2000030513
• Study Type: interventional
• Target: 1,210
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• 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.

  Measured at 6 months post-randomization

Secondary Outcomes (56)

• Number of MRA prescriptions

  Within one year post randomization

• Percentage of MRA prescriptions filled

  Within 30 days of written prescription

• Time to first MRA prescription

  From enrollment to time of MRA prescription

• Percentage of patients with Hyperkalemia (K>5.0)

  Within one year post randomization

• Percentage of patients with Hyperkalemia (K>5.5)

  Within one year post randomization

Other Outcomes (8)

• Subgroup Analysis: Hyperkalemia at randomization

  At randomization

• Subgroup Analysis: Prior hyperkalemia (IDC-10 Code)

  From one year prior to randomization up to randomization

• Subgroup Analysis: Prior hyperkalemia (K history)

  From one year prior to randomization up to randomization

Study Arms (2)

Intervention - Best Practice Alert

EXPERIMENTAL

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.

Behavioral: Best Practice Alert

Usual Care

NO INTERVENTION

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

Interventions

Best Practice Alert 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.

Intervention - Best Practice Alert

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Absolute contraindication to MRAs

Sponsors & Collaborators

• Yale University: lead
• Vifor Pharma: collaborator
• Relypsa, Inc.: collaborator

Study Sites (1)

Cardiology/Internal Medicine Outpatient Clinics of Yale New Health System

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

• 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.

  PMID: 37943221 DERIVED

Study Officials

• Francis P Wilson, MD MSCE

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 26, 2021
• Study Start: November 3, 2021
• Primary Completion: August 6, 2023
• Study Completion: February 6, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon publication; indefinitely.

Locations

US (1)