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

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SmartHF application
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory University, Grady Hospital
  • University of MichiganRecruiting
  • Henry Ford Hospital and Health System
  • Washington University, Barns Jewish Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SmartHF application

Control - Patients Standard Medication(s)

Arm Description

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

No change to current medication(s)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

First Posted
May 1, 2023
Last Updated
July 24, 2023
Sponsor
University of Michigan
Collaborators
Washington University, Barns Jewish Hospital, St. Louis, MO, Henry Ford Hospital, Detroit, MI, Emory University, Grady Hospital, Atlanta, GA
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1. Study Identification

Unique Protocol Identification Number
NCT05858320
Brief Title
The Impact of an Adaptive Patient-centered Web Application on Medication Optimization in HFrEF Patients
Acronym
SmartHF
Official Title
The Impact of an Adaptive Patient-centered Web Application on Medication Optimization in HFrEF Patients (SmartHF)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2023 (Actual)
Primary Completion Date
June 1, 2026 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Washington University, Barns Jewish Hospital, St. Louis, MO, Henry Ford Hospital, Detroit, MI, Emory University, Grady Hospital, Atlanta, GA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SmartHF application
Arm Type
Experimental
Arm Description
The web application-based study intervention provides adaptive medication recommendations that can be shared with their HF provider.
Arm Title
Control - Patients Standard Medication(s)
Arm Type
Active Comparator
Arm Description
No change to current medication(s)
Intervention Type
Other
Intervention Name(s)
SmartHF application
Intervention Description
Adaptive medication recommendations that can be shared with the participants HF provider.
Primary Outcome Measure Information:
Title
Primary Endpoint: Change in GDMT medication score
Description
Change in GDMT medication score generated by the computable algorithm from baseline to Week 12
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Secondary Endpoint: Level of agreement between the medication optimization algorithm recommendations and actual GDMT prescribed
Description
The level of agreement between the medication optimization algorithm recommendations (Yes/No) and actual GDMT prescribed (Yes/No)
Time Frame
Over 12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mike Dorsch, PharmD, MS
Phone
734-647-1452
Email
mdorsch@med.umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jolene Daniel
Phone
734-232-2610
Email
jolened@med.umich.edu
Facility Information:
Facility Name
Emory University, Grady Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Modele Ogunniyi, MD, MPH
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mike Dorsch, PharmD, MS
Phone
734-647-1452
Email
mdorsch@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Jolene Daniel
Phone
734-232-2610
Email
jolened@med.umich.edu
Facility Name
Henry Ford Hospital and Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khaled Abdul-Nour, MD
Facility Name
Washington University, Barns Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory Ewald, MD

12. IPD Sharing Statement

Citations:
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: Advances. Published online April 12, 2023:100289.
Results Reference
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The Impact of an Adaptive Patient-centered Web Application on Medication Optimization in HFrEF Patients

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