The Impact of an Adaptive Patient-centered Web Application on Medication Optimization in HFrEF Patients
- Conditions
- Heart Failure
- Interventions
- Other: SmartHF application
- Registration Number
- NCT05858320
- Lead Sponsor
- University of Michigan
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 225
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SmartHF application SmartHF application The web application-based study intervention provides adaptive medication recommendations that can be shared with their HF provider. Control - Patients Standard Medication(s) SmartHF application No change to current medication(s)
- Primary Outcome Measures
Name Time Method Primary Endpoint: Change in GDMT medication score Baseline to Week 12 Change in GDMT medication score generated by the computable algorithm from baseline to Week 12
- Secondary Outcome Measures
Name Time Method Secondary Endpoint: Level of agreement between the medication optimization algorithm recommendations and actual GDMT prescribed Over 12 Weeks The level of agreement between the medication optimization algorithm recommendations (Yes/No) and actual GDMT prescribed (Yes/No)
Trial Locations
- Locations (5)
Washington University, Barns Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Trinity Healthcare St. Joseph Mercy Ann Arbor
🇺🇸Ypsilanti, Michigan, United States
Emory University, Grady Hospital
🇺🇸Atlanta, Georgia, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Hospital and Health System
🇺🇸Detroit, Michigan, United States