Evaluating Strategies to Improve Guideline Directed Medical Therapy: The GDMT Research, Education & Assist Trial for Heart Failure Care (GREAT-HF Care)

Evaluating Strategies to Improve Guideline Directed Medical Therapy: The GDMT Research, Education & Assist Trial for Heart Failure Care (GREAT-HF Care)

Heart failure with reduced ejection fraction (HFrEF) is associated with high mortality and adverse events (hospitalization or urgent outpatient visits for HF), along with diminished quality of life. Despite convincing data that evidenced-based, guideline-directed medical therapies (GDMT) improve mortality and heart failure-related events, there remains insufficient utilization of these life-saving drugs (evidence-based beta-blockers (EBBB), angiotensin-neprilysin inhibitors (ARNI)/ angiotensin converting enzyme inhibitors (ACEi)/ angiotensin receptor blockers (ARB), mineralocorticoid receptor antagonists (MRA) and sodium-glucose cotransporter 2 inhibitors (SGLT2i) in patients with HFrEF. The primary objective of this study is to implement and evaluate a multifaceted, interdisciplinary intervention to improve GDMT use, reduce mortality, and reduce future heart failure events in patients with HFrEF.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Behavioral: Multiprong CDS with GDMT order set; Behavioral: Multiprong CDS with referral to pharmacist co-management; Behavioral: Focused education

Detailed Description

This is a cluster randomized study designed to evaluate the effectiveness of interventions aimed at improving GDMT in patients with HFrEF. Clinicians stratified based on practice specialty, location, and pharmacist referral habits will be permuted block randomized to achieve 45%/45%/10% proportional distribution across the following arms respectively: (1) usual care, (2) multi-pronged clinical decision support (CDS) inclusive of a patient portal message about GDMT, an interruptive advisory upon chart entry as a notification to clinicians on GDMT consideration and a Best Practice Advisory (BPA) that includes a GDMT order set, and (3) multi-pronged CDS as in #2 but replacement of GDMT order set with referral to integrated clinical pharmacist co-management. Secondarily, each of the 5 clinical practice sites of roughly equal HFrEF patient loads were assigned to receive either an early or delayed education rollout. Exploratory analyses will look to determine the independent and incremental benefits of education with other interventional approaches.

• Study Type: Interventional
• Enrollment (Actual): 4306
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Cardiology Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 18 years or older AND
• Completed visit at included Geisinger cardiology outpatient clinics (office visit or telemedicine) AND
• Clinicians are on a list of currently active Geisinger clinicians in outpatient cardiology clinics who can prescribe heart failure medications AND
• Active problem list diagnosis of HFrEF at time of Cardiology clinic encounter OR Left Ventricular Ejection Fraction (LVEF) < 40: most recent to the cardiology clinic encounter within 2 years of the visit.

Exclusion Criteria:

• Currently in hospice or palliative care (ICD 10 code: Z51.5)
• Patient is allergic to each category of GDMT
• Patient is prescribed medications from all four categories of GDMT, including ARNI specifically

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Clinicians in this arm will not receive CDS or focused education and will experience usual care.
Experimental: Multiprong CDS with GDMT order set; Clinicians and patients with HFrEF in this arm will receive electronic notification of GDMT care gaps encouraging treatment options. The CDS will inform, encourage, and facilitate prescribing of GDMT via a focused order set.	Behavioral: Multiprong CDS with GDMT order set; Accepting the clinician-facing BPA default recommendation will open an order set for GDMT that lists common recommended options in such a way that facilitates optimal prescribing. Clinicians will also be exposed to an interruptive advisory upon chart entry as a notification to physicians on GDMT consideration. Patient responses to a pre-visit questionnaire encouraging them to ask about better treatment options will also be shown to clinicians within the interruptive BPA if completed in advance by the patient.; Other Names: Alert; Opt-out default; Active choice; Default order of options; Advisory
Experimental: Multiprong CDS with referral to pharmacist co-management; Clinicians and patients with HFrEF in this arm will receive electronic notification of GDMT care gaps encouraging treatment options. The clinician-facing BPA will include an option to refer patients to embedded pharmacist co-management. Pharmacists are expected to meet with patients and optimize GDMT through a collaborative practice agreement with clinicians.	Behavioral: Multiprong CDS with referral to pharmacist co-management; Accepting the clinician-facing BPA default recommendation will have eligible patients within this arm referred to embedded pharmacist co-management. Pharmacists are expected to meet with patients and optimize GDMT through a collaborative practice agreement with clinicians. Clinicians will also be exposed to an interruptive advisory upon chart entry as a notification to physicians on GDMT consideration. Patient responses to a pre-visit questionnaire encouraging them to ask about better treatment options will also be shown to clinicians within the interruptive BPA if completed in advance by the patient.; Other Names: Alert; Opt-out default; Active choice; Advisory
Experimental: Focused education; Clinicians in this arm will receive focused education and no CDS.	Behavioral: Focused education; A series of focused, interactive education sessions will train clinicians in why, when, and how to prescribe GDMT to patients, with incentives such as continuing medical education (CME) credits, and with virtual and recorded options available to those who are unable to attend in-person meetings.; Other Names: Education; Training; Interactive
Experimental: Multiprong CDS with GDMT order set + focused education; Clinicians in this arm will receive focused education in addition to clinician BPA heads-up and BPA with GDMT order set for their eligible patients with HFrEF.	Behavioral: Multiprong CDS with GDMT order set; Accepting the clinician-facing BPA default recommendation will open an order set for GDMT that lists common recommended options in such a way that facilitates optimal prescribing. Clinicians will also be exposed to an interruptive advisory upon chart entry as a notification to physicians on GDMT consideration. Patient responses to a pre-visit questionnaire encouraging them to ask about better treatment options will also be shown to clinicians within the interruptive BPA if completed in advance by the patient.; Other Names: Alert; Opt-out default; Active choice; Default order of options; Advisory; Behavioral: Focused education; A series of focused, interactive education sessions will train clinicians in why, when, and how to prescribe GDMT to patients, with incentives such as continuing medical education (CME) credits, and with virtual and recorded options available to those who are unable to attend in-person meetings.; Other Names: Education; Training; Interactive
Experimental: Multiprong CDS with referral to pharmacist co-management + focused education; Clinicians in this arm will receive focused education along with clinicians/patient CDS. The clinician-facing BPA will include an option to refer patients to embedded pharmacist co-management. Pharmacists are expected to meet with patients and optimize GDMT through a collaborative practice agreement with clinicians.	Behavioral: Multiprong CDS with referral to pharmacist co-management; Accepting the clinician-facing BPA default recommendation will have eligible patients within this arm referred to embedded pharmacist co-management. Pharmacists are expected to meet with patients and optimize GDMT through a collaborative practice agreement with clinicians. Clinicians will also be exposed to an interruptive advisory upon chart entry as a notification to physicians on GDMT consideration. Patient responses to a pre-visit questionnaire encouraging them to ask about better treatment options will also be shown to clinicians within the interruptive BPA if completed in advance by the patient.; Other Names: Alert; Opt-out default; Active choice; Advisory; Behavioral: Focused education; A series of focused, interactive education sessions will train clinicians in why, when, and how to prescribe GDMT to patients, with incentives such as continuing medical education (CME) credits, and with virtual and recorded options available to those who are unable to attend in-person meetings.; Other Names: Education; Training; Interactive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HF GDMT prescription increased (yes/no)	New GDMT HF medication class added, switch to ARNI from ACE/ARB, or upward dose titration of existing GDMT HF medication.	Within 30 days of index visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Addition of SGLT2i or ARNI for HFrEF (yes/no)	New prescriptions for SGLT2i and/or ARNI or switch from ACEi/ARB to ARNI	Within 30, 60 and 90 days of index visit
HF GDMT prescription increased (yes/no)	New GDMT HF medication class added, switch to ARNI from ACEi/ARB, or upward dose titration of existing GDMT HF medication.	Within 60 and 90 days of index visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality, emergency visit for heart failure or hospitalization for heart failure	Patient death (yes/no), patient with emergency visit with a primary diagnosis of heart failure (yes/no) or admitted for inpatient hospitalization with primary diagnosis of heart failure (yes/no)	Within 365 days of index visit

Collaborators and Investigators

• Sponsor: Geisinger Clinic

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): February 17, 2025
• Study Completion (Actual): May 17, 2025

Study Registration Dates

• First Submitted: July 31, 2023
• First Submitted That Met QC Criteria: August 11, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Clinical Decision Support; Education; Pharmacist; Heart Failure with Reduced Ejection Fraction; Behavioral Economics; Best Practice Alert; Guideline Directed Medical Therapy; Best Practice Advisory; Angiotensin-neprilysin inhibitors (ARNI); Sodium-glucose cotransporter 2 inhibitors (SGLT2i)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Physiological Phenomena; Alkaloids; Purinones; Purines; Socioeconomic Factors; Population Characteristics; Xanthines; Pharmacological and Toxicological Phenomena; Pharmacological Phenomena; Caffeine; Educational Status; Drug Interactions
• Other Study ID Numbers: 2023-1031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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