Pragmatic Trial Of Messaging to Providers About Treatment With Mineralocorticoid Receptor Antagonists
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,210
- 试验地点
- 2
- 主要终点
- Proportion of patients with an active prescription for an MRA
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Absolute contraindication to MRAs
结局指标
主要结局
Proportion of patients with an active prescription for an MRA
时间窗: 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.
次要结局
- Rates Outpatient visits(Measured at 1 monnh post randomization)
- Rate of Outpatient visits(Measured at 12 months post randomization)
- All-cause mortality(Measured at 12 months post randomization)
- Percentage of patients with potassium binder prescription(Measured at 6 months post randomization)
- Rates of Heart failure-related hospital admissions(Measured at 12 months post randomization)
- Number of MRA prescriptions(Within one year post randomization)
- Percentage of patients with Hyperkalemia (K>5.0) with MRA(Within one year post randomization)
- Percentage of patients with Hyperkalemia (K>5.5) with MRA(Within one year post randomization)
- Percentage of patients with potassium binder + MRA prescription(Measured at 6 months post randomization)
- Rationale for provider not prescribing an MRA if indicated (intervention group only)(Any rationale provided within one year post randomization)
- Rationale for provider not prescribing a potassium binder if indicated (intervention group only)(Any rationale provided within one year post randomization)
- Percentage of patients with ED visits(Measured at 12 months post randomization)
- ED visit count(Measured at 12 months post randomization)
- Rates of documented hyperkalemia during a hospital HF admission(Within one year post randomization)
- Frequency of outpatient potassium monitoring(Within one year post randomization)
- Frequency of outpatient potassium monitoring +/- potassium binder(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)
- Type of potassium binder prescribed(First potassium binder prescribed at any point between enrollment and study completion)
- Rate of ED visit + IV diuretics(Measured at 12 months post randomization)
- Total healthcare associated costs(Measured at 12 months post randomization)
- Rates of documented hyperkalemia at an ED visit(Within one year post randomization)
- Rates of documented hyperkalemia at an outpatient visit(Within one year post randomization)
- Percentage of patients with Hyperkalemia (K>5.5)(Within one year post randomization)
- Frequency of outpatient potassium monitoring +/- MRA(Within one year post randomization)