Heart Failure With Reduced Ejection Fraction
Conditions
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.
Interventions
BEHAVIORALBest 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.
Sponsors
Vifor Pharma
Relypsa, Inc.
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with an active prescription for an MRA | 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
| Measure | Time frame | Description |
|---|---|---|
| Type of potassium binder prescribed | First potassium binder prescribed at any point between enrollment and study completion | Type of first potassium binder prescribed |
| All-cause mortality | Measured at 1 month post randomization | Rates of all-cause mortality |
| Total healthcare associated costs | Measured at 1 month post randomization | Total healthcare-associated cost per patient |
| Rates of documented hyperkalemia at an ED visit | Within one year post randomization | Documented hyperkalemia (K ≥ 5.5 mEq/L) at an ED visit |
| Rates of documented hyperkalemia at an outpatient visit | Within one year post randomization | Documented hyperkalemia (K ≥ 5.5 mEq/L) at an outpatient visit |
| Rates of documented hyperkalemia during a hospital HF admission | Within one year post randomization | Documented hyperkalemia (K ≥ 5.5 mEq/L) at an HF-related hospital admission |
| Frequency of outpatient potassium monitoring | Within one year post randomization | Frequency of outpatient potassium monitoring |
| Frequency of outpatient potassium monitoring +/- MRA | Within one year post randomization | Frequency of outpatient potassium monitoring for those with an active prescription of MRA vs. not |
| Frequency of outpatient potassium monitoring +/- potassium binder | Within one year post randomization | Frequency of outpatient potassium monitoring for those with an active prescription of potassium binder vs. not |
| Number of MRA prescriptions | Within one year post randomization | Number of any MRA prescription during study period. |
| Percentage of MRA prescriptions filled | Within 30 days of written prescription | Percentage of prescriptions filled of initial MRA prescriptions written during the study period. |
| Time to first MRA prescription | From enrollment to time of MRA prescription | Time (in days) to first MRA prescription |
| Percentage of patients with Hyperkalemia (K>5.0) | Within one year post randomization | Percentage of patients experiencing hyperkalemia (K greater than or equal to 5.0 mEq/L) |
| Percentage of patients with Hyperkalemia (K>5.5) | Within one year post randomization | Percentage of patients experiencing hyperkalemia (K greater than or equal to 5.5 mEq/L) |
| Percentage of patients with Hyperkalemia (K>5.0) with MRA | 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 |
| Percentage of patients with Hyperkalemia (K>5.5) with MRA | 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 |
| Percentage of patients with potassium binder prescription | Measured at 1 month post randomization | Percentage of participants with active prescription for potassium binders |
| Percentage of patients with potassium binder + MRA prescription | Measured at 1 month post randomization | Percentage of participants with active prescription for potassium binders and MRA |
| Rationale for provider not prescribing an MRA if indicated (intervention group only) | Any rationale provided within one year post randomization | Provider-documented (via the best practice alert) rationale for not prescribing indicated MRA (intervention group only) |
| Rationale for provider not prescribing a potassium binder if indicated (intervention group only) | 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) |
| Percentage of patients with ED visits | Measured at 1 month post randomization | Percentage of patients with any ED visit |
| ED visit count | Measured at 1 month post randomization | Count of ED visits per patient |
| Rates of Heart failure-related hospital admissions | Measured at 1 month post randomization | Rates of HF-related hospital admissions (uses computations phenotype) |
| Rates Outpatient visits | Measured at 1 monnh post randomization | Rates of outpatient visits |
| Rate of Outpatient visits | Measured at 3 months post randomization | Rates of outpatient visits |
| Rate of ED visit + IV diuretics | Measured at 1 month post randomization | Rates of total ED visits in which a dose of IV diuretics was given |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subgroup Analysis: Prior hyperkalemia (K history) | 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 |
| Subgroup Analysis: Patient demographics | At randomization | The following demographics subgroups will be captured: Age \<65 years of age, sex, race |
| Subgroup Analysis: Chronic Kidney Disease | At randomization | Chronic kidney disease (CKD) stage ≥ stage III, glomerular filtration rate (GFR) \<60 |
| Subgroup Analysis: Insurance status | At randomization | Insurance status (commercial, public (Medicare, Medicaid), other, none) |
| Subgroup Analysis: GDMT medications | At randomization | Number of concomitant active prescriptions for GDMT medications (beta blocker, ACEi/ARB/ARNI, SGLT2-inhibitor) |
| Subgroup Analysis: Provider type | 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 |
| Subgroup Analysis: Prior hyperkalemia (IDC-10 Code) | From one year prior to randomization up to randomization | Prior documentation of hyperkalemia by ICD-10 Code during the past 1 year |
| Subgroup Analysis: Hyperkalemia at randomization | At randomization | Hyperkalemia at randomization at both thresholds of ≥ 5.0 mEq/L and K ≥ 5.5 mEq/L |
Countries
United States
Outcome results
None listed