A Pilot Study to Increase Utilization of GDMT in Patients With HFrEF

A Pilot Study to Increase Utilization of Guideline Directed Medical Therapy in Patients With HFrEF

The purpose of this study is to test a clinical decision support (CDS) tool that provides clinicians (cardiologists and nurse practitioners) medication recommendations regarding guideline directed medical therapy (GDMT) in patients with heart failure and reduced ejection fraction (HFrEF).

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: Using a clinical decision software to provide specific recommendation of a medication at a certain dosage

Detailed Description

The purpose of our study is to test whether home blood pressure monitoring (HBPM) with clinical-decision support (CDS) will optimize the use of GDMT in patients with HFrEF. HBPM allows cardiologists and NPs to monitor patients outside the clinical setting so that GDMT can be safely initiated and up-titrated. The CDS employs HBPM and electronic medical record (EMR) data to implement the ACC/AHA HF guidelines and provides cardiologists and NPs with GDMT recommendations.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Allison Peterson, PhD; Phone Number: 424-314-0048; Email: allison.peterson@csmns.org
• Study Contact Backup: Name: Maurice Herring; Phone Number: 310-248-8375; Email: maurice.herring@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars Sinai Medical Center
      • Contact: Maurice Herring; Phone Number: 310-248-8375; Email: maurice.herring@cshs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients >18 years with HFrEF who have suboptimal HF medical regimen

Description

Inclusion Criteria:

• Diagnosis of HFrEF (left ejection fraction < 40%, assessed by transthoracic echo, cardiac MRI, cardiac SPECT) within the past year.
• New York Heart Association (NYHA) class II-III at most recent screening assessment.
• GDMT composite score of less than or equal to 50% at baseline

Exclusion Criteria:

• Previous contraindication to beta blockers, ACE inhibitors, and/or ARB.
• Baseline creatinine > 2 mg/dl or potassium level at baseline > 5 mEq/L or eGFR <30 mL/min/1.73 m2.
• Baseline systolic blood pressure < 100 mmHg.
• Concomitant use of ACE, ARB, and/or ARNI
• Polycystic kidney disease
• History of angioedema
• History of or currently on a transplant list
• Left ventricular assist device
• Uncontrolled asthma
• Severe COPD
• Cirrhosis
• Currently receiving hospice or comfort care
• Patient not proficient with written and spoken English
• Patient has diminished decision making capability
• History of non-compliance

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Enrolled Subjects; Test a clinical decision support (CDS) tool that provides clinicians (cardiologists and nurse practitioners) recommendations regarding guideline directed medical therapy (GDMT) in patients with heart failure and reduced ejection fraction (HFrEF).

Other: Using a clinical decision software to provide specific recommendation of a medication at a certain dosage; During routine follow-up, clinicians, cardiologists, and NPs who have a scheduled visit with an enrolled patient will be offered a medication recommendation. The medication recommendation will be generated by the clinical decision support tool. The software will advise the cardiologist whether an HF medication should be initiated, discontinued, or the dosage titrated and if the patient requires labs. In addition, the software, or decision engine (DE), will be run once weekly and every time the patient has new basic metabolic panel results. If the patient is admitted to the hospital, skilled nursing facility, or inpatient rehabilitation unit, the use of DE will be placed on hold until the patient is discharged and at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients at or above 50% target dose of GDMT in HFrEF patients	Change in the proportion of patients at or above 50% target dose of GDMT in	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of accepted medication recommendations	The percentage of DE output medication recommendations in which the clinician accepts alerts	6 months

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Raj Khandwalla, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2022
• Primary Completion (Estimated): September 25, 2023
• Study Completion (Estimated): September 25, 2023

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: December 22, 2021
• First Posted (Actual): December 27, 2021

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: HFDTx study 1618

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data that underlie the results after deidentification.
• IPD Sharing Time Frame: Immediately following publication and ending 2 years.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No