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

Sponsor

Geisinger Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05990296

Collaborator

(none)

4,300

Enrollment

Location

Arms

17.1

Anticipated Duration (Months)

252.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Heart Failure With Reduced Ejection Fraction	Behavioral: Pharmacist co-management Behavioral: CDS Behavioral: Focused Education	N/A

Detailed Description

The intervention will involve and evaluate the following components: (1) focused clinician education, (2) multi-pronged clinical decision support (CDS), and (3) integrated clinical pharmacist care. The primary study design and evaluation will focus on clinician randomization to different CDS arms, including an arm that facilitates coordination with clinical pharmacists embedded within cardiology practices. Secondarily, two sets of clinics of roughly equal HFrEF patient loads will be assigned to either an early or delayed education rollout, such that clinical outcomes can be compared across patients whose clinicians have versus have not yet received the focused education. Exploratory analyses will look to determine the independent and incremental benefits of education and CDS (including pharmacist referrals). CDS will automatically be triggered within the electronic health record (EHR) and will include clinician-facing components, such as a best practice advisory (BPA) and custom order set, and patient-facing components, such as patient portal messaging directly to patients in advance of upcoming appointments.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

4300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a cluster randomized (at clinician level) design in terms of assignment to no-intervention control, CDS, and CDS + pharmacist-co-management arms, and non-randomized (at clinic level) in terms of assignment to education versus delayed education arms.This is a cluster randomized (at clinician level) design in terms of assignment to no-intervention control, CDS, and CDS + pharmacist-co-management arms, and non-randomized (at clinic level) in terms of assignment to education versus delayed education arms.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Clinicians in this arm will not receive CDS or focused education and will experience usual care.
Experimental: Clinical Decision Support (CDS) 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.	Behavioral: CDS 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. Patient responses to a pre-visit questionnaire encouraging them to ask about better treatment options will also be shown to clinicians within the BPA. Other Names: Opt-out default Active choice Default order of options Advisory Alert
Experimental: CDS + Pharmacist Co-Management Clinicians/patients in this arm will receive CDS for their eligible patients with HFrEF. 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: Pharmacist co-management Eligible patients within this arm will be referred to embedded pharmacist co-management. Pharmacists are expected to meet with patients and optimize GDMT through a collaborative practice agreement with clinicians. Other Names: Opt-out default Behavioral: CDS 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. Patient responses to a pre-visit questionnaire encouraging them to ask about better treatment options will also be shown to clinicians within the BPA. Other Names: Opt-out default Active choice Default order of options Advisory Alert
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: Focused Education + CDS Clinicians in this arm will receive focused education in addition to clinician/patient CDS for their eligible patients with HFrEF.	Behavioral: CDS 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. Patient responses to a pre-visit questionnaire encouraging them to ask about better treatment options will also be shown to clinicians within the BPA. Other Names: Opt-out default Active choice Default order of options Advisory Alert 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: Focused Education + CDS + Pharmacist Co-Management 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: Pharmacist co-management Eligible patients within this arm will be referred to embedded pharmacist co-management. Pharmacists are expected to meet with patients and optimize GDMT through a collaborative practice agreement with clinicians. Other Names: Opt-out default Behavioral: CDS 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. Patient responses to a pre-visit questionnaire encouraging them to ask about better treatment options will also be shown to clinicians within the BPA. Other Names: Opt-out default Active choice Default order of options Advisory Alert 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

Outcome Measures

Primary Outcome Measures

HF GDMT prescription increased (yes/no) [Within 30 days of index visit]
New GDMT HF medication class added, or upward dose titration of existing GDMT HF medication.

Secondary Outcome Measures

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

Other Outcome Measures

All-cause mortality, emergency visit for heart failure or hospitalization for heart failure [Within 365 days of index visit]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients aged 18 years or older AND
Completed visit at included Geisinger cardiology outpatient clinics (office visit, telemedicine, or telephone) 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.