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

Sponsor
University of Michigan (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05858320
Collaborator
Washington University, Barns Jewish Hospital, St. Louis, MO (Other), Henry Ford Hospital, Detroit, MI (Other), Emory University, Grady Hospital, Atlanta, GA (Other)
225
Enrollment
3
Locations
2
Arms
36
Anticipated Duration (Months)
75
Patients Per Site
2.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: SmartHF application
 Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
225 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Impact of an Adaptive Patient-centered Web Application on Medication Optimization in HFrEF Patients (SmartHF)
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2026
Anticipated Study Completion Date :
Jun 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: SmartHF application

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

Other: SmartHF application
Adaptive medication recommendations that can be shared with the participants HF provider.
Active Comparator: Control - Patients Standard Medication(s)

No change to current medication(s)

Other: SmartHF application
Adaptive medication recommendations that can be shared with the participants HF provider.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Emory University, Grady Hospital Atlanta Georgia United States 30303
2 Henry Ford Hospital and Health System Detroit Michigan United States 48202
3 Washington University, Barns Jewish Hospital Saint Louis Missouri United States 63110

Sponsors and Collaborators

  • University of Michigan
  • Washington University, Barns Jewish Hospital, St. Louis, MO
  • Henry Ford Hospital, Detroit, MI
  • Emory University, Grady Hospital, Atlanta, GA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Michael Dorsch, Associate Professor of Pharmacy, College of Pharmacy and Clinical Pharmacist, University of Michigan Inpatient Pharmacy Services, University of Michigan
ClinicalTrials.gov Identifier:
NCT05858320
Other Study ID Numbers:
  • HUM00227631
First Posted:
May 15, 2023
Last Update Posted:
May 15, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of May 15, 2023