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

Heart Failure Clinical Trial

— GREAT-HF Care  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05990296
• Other study ID #: 2023-1031
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: Geisinger Clinic
• Contact: Stephen J Voyce
• Phone: 5707034830
• Email: svoyce[@]geisinger.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4300
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Geisinger Cardiology Clinics	Danville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Geisinger Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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