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

University of Michigan225 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

225

Conditions

Heart Failure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18 years and older at screening 2. Diagnosis of heart failure with a left ventricular ejection fraction (LVEF) \</= 40% (HFrEF) 3. Have a general medicine provider or general cardiology provider for HFrEF 4. Have internet access and access to their health system's patient portal 5. Fluent in spoken and written English 6. At least two of the following: systolic blood pressure ≥ 110mmg, potassium ≤ 5.5, serum creatinine ≤ 2.5, heart rate ≥ 70 7. 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: 1. End-stage HF (hospice candidate) 2. Actively treated cancer, except non-melanoma skin cancer 3. Implanted ventricular assist device 4. Current treatment with chronic inotropic therapy 5. Patient's provider for HFrEF care is considered an advanced HF specialist 6. Currently pregnant or intends to become pregnant during the study period 7. Dialysis

Locations (5)

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

Trinity Healthcare St. Joseph Mercy Ann Arbor

Ypsilanti, Michigan, United States

Washington University, Barns Jewish Hospital

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Primary Endpoint: Change in GDMT medication score

Change in GDMT medication score generated by the computable algorithm from baseline to Week 12

Time frame: Baseline to Week 12

Secondary Outcomes

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)

Time frame: Over 12 Weeks