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OpenTrials
Completed

NCT Number: NCT04903717

Pragmatic Trial Of Alerts for Use of Mineralocorticoid Receptor Antagonists

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.

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Key information

Conditions

Heart Failure With Reduced Ejection Fraction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiology/Internal Medicine Outpatient Clinics of Yale New Health System

New Haven, Connecticut, 06510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Proportion of patients with an active prescription for an MRA

    Time frame: 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 outcomes

  1. Number of MRA prescriptions

    Time frame: Within one year post randomization

    Number of any MRA prescription during study period.

  2. Percentage of MRA prescriptions filled

    Time frame: Within 30 days of written prescription

    Percentage of prescriptions filled of initial MRA prescriptions written during the study period.

  3. Time to first MRA prescription

    Time frame: From enrollment to time of MRA prescription

    Time (in days) to first MRA prescription

  4. Percentage of patients with Hyperkalemia (K>5.0)

    Time frame: Within one year post randomization

    Percentage of patients experiencing hyperkalemia (K greater than or equal to 5.0 mEq/L)

  5. Percentage of patients with Hyperkalemia (K>5.5)

    Time frame: Within one year post randomization

    Percentage of patients experiencing hyperkalemia (K greater than or equal to 5.5 mEq/L)

  6. Percentage of patients with Hyperkalemia (K>5.0) with MRA

    Time frame: 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

  7. Percentage of patients with Hyperkalemia (K>5.5) with MRA

    Time frame: 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

  8. Percentage of patients with potassium binder prescription

    Time frame: Measured at 1 month post randomization

    Percentage of participants with active prescription for potassium binders

  9. Percentage of patients with potassium binder prescription

    Time frame: Measured at 2 months post randomization

    Percentage of participants with active prescription for potassium binders

  10. Percentage of patients with potassium binder prescription

    Time frame: Measured at 3 months post randomization

    Percentage of participants with active prescription for potassium binders

  11. Percentage of patients with potassium binder prescription

    Time frame: Measured at 4 months post randomization

    Percentage of participants with active prescription for potassium binders

  12. Percentage of patients with potassium binder prescription

    Time frame: Measured at 5 months post randomization

    Percentage of participants with active prescription for potassium binders

  13. Percentage of patients with potassium binder prescription

    Time frame: Measured at 6 months post randomization

    Percentage of participants with active prescription for potassium binders

  14. Percentage of patients with potassium binder + MRA prescription

    Time frame: Measured at 1 month post randomization

    Percentage of participants with active prescription for potassium binders and MRA

  15. Percentage of patients with potassium binder + MRA prescription

    Time frame: Measured at 2 months post randomization

    Percentage of participants with active prescription for potassium binders and MRA

  16. Percentage of patients with potassium binder + MRA prescription

    Time frame: Measured at 3 months post randomization

    Percentage of participants with active prescription for potassium binders and MRA

  17. Percentage of patients with potassium binder + MRA prescription

    Time frame: Measured at 4 months post randomization

    Percentage of participants with active prescription for potassium binders and MRA

  18. Percentage of patients with potassium binder + MRA prescription

    Time frame: Measured at 5 months post randomization

    Percentage of participants with active prescription for potassium binders and MRA

  19. Percentage of patients with potassium binder + MRA prescription

    Time frame: Measured at 6 months post randomization

    Percentage of participants with active prescription for potassium binders and MRA

  20. Type of potassium binder prescribed

    Time frame: First potassium binder prescribed at any point between enrollment and study completion

    Type of first potassium binder prescribed

  21. Rationale for provider not prescribing an MRA if indicated (intervention group only)

    Time frame: Any rationale provided within one year post randomization

    Provider-documented (via the best practice alert) rationale for not prescribing indicated MRA (intervention group only)

  22. Rationale for provider not prescribing a potassium binder if indicated (intervention group only)

    Time frame: 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)

  23. Percentage of patients with ED visits

    Time frame: Measured at 1 month post randomization

    Percentage of patients with any ED visit

  24. Percentage of patients with ED visits

    Time frame: Measured at 3 months post randomization

    Percentage of patients with any ED visit

  25. Percentage of patients with ED visits

    Time frame: Measured at 6 months post randomization

    Percentage of patients with any ED visit

  26. Percentage of patients with ED visits

    Time frame: Measured at 12 months post randomization

    Percentage of patients with any ED visit

  27. ED visit count

    Time frame: Measured at 1 month post randomization

    Count of ED visits per patient

  28. ED visit count

    Time frame: Measured at 3 months post randomization

    Count of ED visits per patient

  29. ED visit count

    Time frame: Measured at 6 months post randomization

    Count of ED visits per patient

  30. ED visit count

    Time frame: Measured at 12 months post randomization

    Count of ED visits per patient

  31. Rates of Heart failure-related hospital admissions

    Time frame: Measured at 1 month post randomization

    Rates of HF-related hospital admissions (uses computations phenotype)

  32. Rates of Heart failure-related hospital admissions

    Time frame: Measured at 3 months post randomization

    Rates of HF-related hospital admissions (uses computations phenotype)

  33. Rates of Heart failure-related hospital admissions

    Time frame: Measured at 6 months post randomization

    Rates of HF-related hospital admissions (uses computations phenotype)

  34. Rates of Heart failure-related hospital admissions

    Time frame: Measured at 12 months post randomization

    Rates of HF-related hospital admissions (uses computations phenotype)

  35. Rates Outpatient visits

    Time frame: Measured at 1 monnh post randomization

    Rates of outpatient visits

  36. Rate of Outpatient visits

    Time frame: Measured at 3 months post randomization

    Rates of outpatient visits

  37. Rate of Outpatient visits

    Time frame: Measured at 6 months post randomization

    Rates of outpatient visits

  38. Rate of Outpatient visits

    Time frame: Measured at 12 months post randomization

    Rates of outpatient visits

  39. Rate of ED visit + IV diuretics

    Time frame: Measured at 1 month post randomization

    Rates of total ED visits in which a dose of IV diuretics was given

  40. Rate of ED visit + IV diuretics

    Time frame: Measured at 3 months post randomization

    Rates of total ED visits in which a dose of IV diuretics was given

  41. Rate of ED visit + IV diuretics

    Time frame: Measured at 6 months post randomization

    Rates of total ED visits in which a dose of IV diuretics was given

  42. Rate of ED visit + IV diuretics

    Time frame: Measured at 12 months post randomization

    Rates of total ED visits in which a dose of IV diuretics was given

  43. All-cause mortality

    Time frame: Measured at 1 month post randomization

    Rates of all-cause mortality

  44. All-cause mortality

    Time frame: Measured at 3 months post randomization

    Rates of all-cause mortality

  45. All-cause mortality

    Time frame: Measured at 6 months post randomization

    Rates of all-cause mortality

  46. All-cause mortality

    Time frame: Measured at 12 months post randomization

    Rates of all-cause mortality

  47. Total healthcare associated costs

    Time frame: Measured at 1 month post randomization

    Total healthcare-associated cost per patient

  48. Total healthcare associated costs

    Time frame: Measured at 3 months post randomization

    Total healthcare-associated cost per patient

  49. Total healthcare associated costs

    Time frame: Measured at 6 months post randomization

    Total healthcare-associated cost per patient

  50. Total healthcare associated costs

    Time frame: Measured at 12 months post randomization

    Total healthcare-associated cost per patient

  51. Rates of documented hyperkalemia at an ED visit

    Time frame: Within one year post randomization

    Documented hyperkalemia (K ≥ 5.5 mEq/L) at an ED visit

  52. Rates of documented hyperkalemia at an outpatient visit

    Time frame: Within one year post randomization

    Documented hyperkalemia (K ≥ 5.5 mEq/L) at an outpatient visit

  53. Rates of documented hyperkalemia during a hospital HF admission

    Time frame: Within one year post randomization

    Documented hyperkalemia (K ≥ 5.5 mEq/L) at an HF-related hospital admission

  54. Frequency of outpatient potassium monitoring

    Time frame: Within one year post randomization

    Frequency of outpatient potassium monitoring

  55. Frequency of outpatient potassium monitoring +/- MRA

    Time frame: Within one year post randomization

    Frequency of outpatient potassium monitoring for those with an active prescription of MRA vs. not

  56. Frequency of outpatient potassium monitoring +/- potassium binder

    Time frame: Within one year post randomization

    Frequency of outpatient potassium monitoring for those with an active prescription of potassium binder vs. not

Other outcomes

  1. Subgroup Analysis: Hyperkalemia at randomization

    Time frame: At randomization

    Hyperkalemia at randomization at both thresholds of ≥ 5.0 mEq/L and K ≥ 5.5 mEq/L

  2. Subgroup Analysis: Prior hyperkalemia (IDC-10 Code)

    Time frame: From one year prior to randomization up to randomization

    Prior documentation of hyperkalemia by ICD-10 Code during the past 1 year

  3. Subgroup Analysis: Prior hyperkalemia (K history)

    Time frame: From one year prior to randomization up to randomization

    Prior documentation of hyperkalemia by history of K 5.0 mEq/L during the past 1 year

  4. Subgroup Analysis: Patient demographics

    Time frame: At randomization

    The following demographics subgroups will be captured: Age <65 years of age, sex, race

  5. Subgroup Analysis: Chronic Kidney Disease

    Time frame: At randomization

    Chronic kidney disease (CKD) stage ≥ stage III, glomerular filtration rate (GFR) <60

  6. Subgroup Analysis: Insurance status

    Time frame: At randomization

    Insurance status (commercial, public (Medicare, Medicaid), other, none)

  7. Subgroup Analysis: GDMT medications

    Time frame: At randomization

    Number of concomitant active prescriptions for GDMT medications (beta blocker, ACEi/ARB/ARNI, SGLT2-inhibitor)

  8. Subgroup Analysis: Provider type

    Time frame: At randomization

    The following provider characteristics will be captured: title (advanced practitioner, resident physician, fellow physician, attending physician), history of or current Cardiology fellowship training, years of training post-graduate medical school

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Relypsa, Inc.
  • Vifor Pharma

Registry information

Official study title

Pragmatic Trial Of Messaging to Providers About Treatment With Mineralocorticoid Receptor Antagonists

Acronym: PROMPT-MRA

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
May 26, 2021
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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