The Impact of an Adaptive Patient-centered Web Application on Medication Optimization in HFrEF Patients

Study Overview
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Brief Summary
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The SmartHF study is a 12-week prospective randomized controlled multicenter clinical trial. This study will investigate the efficacy of an adaptive web application to facilitate guideline-directed medical therapy (GDMT) optimization in HFrEF patients. Eligible participants will be randomized to the web application intervention or control in a 1:1 manner, stratified by site. The intervention is an adaptive medication optimization web application that extracts and analyzes the EHR data with a computable medication optimization algorithm. The algorithm provides a medication quality score and outputs medication optimization recommendations written in a patient -friendly manner.

Detailed Description
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The investigators have developed an adaptive medication optimization web application, named SmartHF, that provides patients with tailored information about potential HFrEF GDMT optimization. SmartHF guides patients to share the GDMT optimization recommendations with their provider during a clinic visit. Participants will be randomized to receive the web application intervention or control up to 30 days before a clinic visit in a 1:1 manner and followed for 12 weeks after the clinic visit. This trial will determine the efficacy of SmartHF in prescribing GDMT in HFrEF patients compared to controls.

Official Title
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The Impact of an Adaptive Patient-centered Web Application on Medication Optimization in HFrEF Patients (SmartHF)

Conditions
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Heart Failure

Intervention / Treatment
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* Other: SmartHF application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and older at screening Diagnosis of heart failure with a left ventricular ejection fraction (LVEF) </= 40% (HFrEF) Have a general medicine provider or general cardiology provider for HFrEF Have internet access and access to their health system's patient portal Fluent in spoken and written English At least two of the following: systolic blood pressure ≥ 110mmg, potassium ≤ 5.5, serum creatinine ≤ 2.5, heart rate ≥ 70 At least two eligible heart failure therapies (guideline-recommended BB, RASI, MRA, or SGLT2i) not yet initiated or below 50% of the target dose Exclusion Criteria: End-stage HF (hospice candidate) Actively treated cancer, except non-melanoma skin cancer Implanted ventricular assist device Current treatment with chronic inotropic therapy Patient's provider for HFrEF care is considered an advanced HF specialist Currently pregnant or intends to become pregnant during the study period Dialysis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SmartHF application<br>The web application-based study intervention provides adaptive medication recommendations that can be shared with their HF provider. | Other: SmartHF application<br>* Adaptive medication recommendations that can be shared with the participants HF provider.<br>|
| Active Comparator: Control - Patients Standard Medication(s)<br>No change to current medication(s) | Other: SmartHF application<br>* Adaptive medication recommendations that can be shared with the participants HF provider.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Endpoint: Change in GDMT medication score | Change in GDMT medication score generated by the computable algorithm from baseline to Week 12 | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Endpoint: Level of agreement between the medication optimization algorithm recommendations and actual GDMT prescribed | The level of agreement between the medication optimization algorithm recommendations (Yes/No) and actual GDMT prescribed (Yes/No) | Over 12 Weeks |