Clinical trial NCT05858320: The Impact of an Adaptive Patient-centered Web Application on Medication Optimization in HFrEF Patients
Official title: The Impact of an Adaptive Patient-centered Web Application on Medication Optimization in HFrEF Patients (SmartHF)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Heart Failure
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Washington University, Barns Jewish Hospital, St. Louis, MO
name: Henry Ford Hospital, Detroit, MI
name: Emory University, Grady Hospital, Atlanta, GA
First posted: 2023-05-15
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Endpoint: Change in GDMT medication score
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Secondary Endpoint: Level of agreement between the medication optimization algorithm recommendations and actual GDMT prescribed
timeFrame: Over 12 Weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University, Grady Hospital
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital and Health System
state: Michigan
city: Ypsilanti
country: United States
facility: Trinity Healthcare St. Joseph Mercy Ann Arbor
state: Michigan
city: Saint Louis
country: United States
facility: Washington University, Barns Jewish Hospital
state: Missouri
Study officials:
References:
citation: Dorsch MP, Sifuentes A, Cordwin DJ, Kuo R, Rowell BE, Arzac JJ, DeBacker K, Guidi JL, Hummel SL, Koelling TM. A Computable Algorithm for Medication Optimization in Heart Failure With Reduced Ejection Fraction. JACC Adv. 2023 Apr 12;2(3):100289. doi: 10.1016/j.jacadv.2023.100289. eCollection 2023 May.