Clinical trial NCT05990296: Evaluating Strategies to Improve Guideline Directed Medical Therapy: The GDMT Research, Education & Assist Trial for Heart Failure Care
Official title: Evaluating Strategies to Improve Guideline Directed Medical Therapy: The GDMT Research, Education & Assist Trial for Heart Failure Care (GREAT-HF Care)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Heart Failure With Reduced Ejection Fraction
Keywords: Heart Failure with Reduced Ejection Fraction
Guideline Directed Medical Therapy
Angiotensin-neprilysin inhibitors (ARNI)
Sodium-glucose cotransporter 2 inhibitors (SGLT2i)
Clinical Decision Support
Best Practice Alert
Pharmacist
Education
Behavioral Economics
Best Practice Advisory
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 4300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a cluster randomized (at clinician level) design in terms of assignment to no-intervention control, multiprong CDS with GDMT order set, and multiprong CDS with referral to pharmacist co-management, and non-randomized (at clinic level) in terms of assignment to education versus delayed education arms.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: HF GDMT prescription increased (yes/no)
timeFrame: Within 30 days of index visit
Secondary outcomes:
measure: HF GDMT prescription increased (yes/no)
timeFrame: Within 60 and 90 days of index visit
measure: Addition of SGLT2i or ARNI for HFrEF (yes/no)
timeFrame: Within 30, 60 and 90 days of index visit
Other outcomes:
measure: All-cause mortality, emergency visit for heart failure or hospitalization for heart failure
timeFrame: Within 365 days of index visit
Locations:
city: Danville
country: United States
facility: Geisinger Cardiology Clinics
state: Pennsylvania
Study officials:
References: