Evaluating Strategies to Improve Guideline Directed Medical Therapy: The GDMT Research, Education & Assist Trial for Heart Failure Care
GREAT-HF Care
1 other identifier
interventional
4,306
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started Aug 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2023
CompletedStudy Start
First participant enrolled
August 1, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 17, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2025
CompletedSeptember 19, 2025
September 1, 2025
1.6 years
July 31, 2023
September 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
HF GDMT prescription increased (yes/no)
Within 60 and 90 days of index visit
Addition of SGLT2i or ARNI for HFrEF (yes/no)
Within 30, 60 and 90 days of index visit
Other Outcomes (1)
All-cause mortality, emergency visit for heart failure or hospitalization for heart failure
Within 365 days of index visit
Study Arms (6)
Control
NO INTERVENTIONClinicians in this arm will not receive CDS or focused education and will experience usual care.
Multiprong CDS with GDMT order set
EXPERIMENTALClinicians 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.
Multiprong CDS with referral to pharmacist co-management
EXPERIMENTALClinicians 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.
Focused education
EXPERIMENTALClinicians in this arm will receive focused education and no CDS.
Multiprong CDS with GDMT order set + focused education
EXPERIMENTALClinicians 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.
Multiprong CDS with referral to pharmacist co-management + focused education
EXPERIMENTALClinicians 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Geisinger Cliniclead
Study Sites (1)
Geisinger Cardiology Clinics
Danville, Pennsylvania, 17822, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 31, 2023
First Posted
August 14, 2023
Study Start
August 1, 2023
Primary Completion
February 17, 2025
Study Completion
May 17, 2025
Last Updated
September 19, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share