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

University of Michigan

Status and phase: Completed; Phase 3

Conditions: Heart Failure

Treatments: Other: SmartHF application

Study type: Interventional

Funder types: Other

Identifiers

NCT05858320

HUM00227631

Details and patient eligibility

About

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.

Full 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.

Enrollment: 225 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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225 participants in 2 patient groups

SmartHF application

Experimental group

Description:

The web application-based study intervention provides adaptive medication recommendations that can be shared with their HF provider.

Treatment:

Other: SmartHF application

Control - Patients Standard Medication(s)

Active Comparator group

Description:

No change to current medication(s)

Treatment:

Other: SmartHF application