A Pilot Study to Increase Utilization of GDMT in Patients With HFrEF
Study Details
Study Description
Brief Summary
The purpose of this study is to test a clinical decision support (CDS) tool that provides clinicians (cardiologists and nurse practitioners) medication recommendations regarding guideline directed medical therapy (GDMT) in patients with heart failure and reduced ejection fraction (HFrEF).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The purpose of our study is to test whether home blood pressure monitoring (HBPM) with clinical-decision support (CDS) will optimize the use of GDMT in patients with HFrEF. HBPM allows cardiologists and NPs to monitor patients outside the clinical setting so that GDMT can be safely initiated and up-titrated. The CDS employs HBPM and electronic medical record (EMR) data to implement the ACC/AHA HF guidelines and provides cardiologists and NPs with GDMT recommendations.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Enrolled Subjects Test a clinical decision support (CDS) tool that provides clinicians (cardiologists and nurse practitioners) recommendations regarding guideline directed medical therapy (GDMT) in patients with heart failure and reduced ejection fraction (HFrEF). |
Other: Using a clinical decision software to provide specific recommendation of a medication at a certain dosage
During routine follow-up, clinicians, cardiologists, and NPs who have a scheduled visit with an enrolled patient will be offered a medication recommendation. The medication recommendation will be generated by the clinical decision support tool. The software will advise the cardiologist whether an HF medication should be initiated, discontinued, or the dosage titrated and if the patient requires labs. In addition, the software, or decision engine (DE), will be run once weekly and every time the patient has new basic metabolic panel results. If the patient is admitted to the hospital, skilled nursing facility, or inpatient rehabilitation unit, the use of DE will be placed on hold until the patient is discharged and at home.
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Outcome Measures
Primary Outcome Measures
- Proportion of patients at or above 50% target dose of GDMT in HFrEF patients [6 months]
Change in the proportion of patients at or above 50% target dose of GDMT in
Secondary Outcome Measures
- Percentage of accepted medication recommendations [6 months]
The percentage of DE output medication recommendations in which the clinician accepts alerts
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of HFrEF (left ejection fraction < 40%, assessed by transthoracic echo, cardiac MRI, cardiac SPECT) within the past year.
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New York Heart Association (NYHA) class II-III at most recent screening assessment.
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GDMT composite score of less than or equal to 50% at baseline
Exclusion Criteria:
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Previous contraindication to beta blockers, ACE inhibitors, and/or ARB.
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Baseline creatinine > 2 mg/dl or potassium level at baseline > 5 mEq/L or eGFR <30 mL/min/1.73 m2.
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Baseline systolic blood pressure < 100 mmHg.
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Concomitant use of ACE, ARB, and/or ARNI
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Polycystic kidney disease
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History of angioedema
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History of or currently on a transplant list
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Left ventricular assist device
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Uncontrolled asthma
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Severe COPD
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Cirrhosis
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Currently receiving hospice or comfort care
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Patient not proficient with written and spoken English
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Patient has diminished decision making capability
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History of non-compliance
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cedars Sinai Medical Center | Los Angeles | California | United States | 90048 |
Sponsors and Collaborators
- Cedars-Sinai Medical Center
Investigators
- Principal Investigator: Yaron Elad, MD, Cedars-Sinai Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HFDTx study 1618