Evaluating Strategies to Improve Guideline Directed Medical Therapy: The GDMT Research, Education & Assist Trial for Heart Failure Care
- Conditions
- Heart Failure With Reduced Ejection FractionHeart Failure
- Interventions
- Behavioral: Focused educationBehavioral: Multiprong CDS with GDMT order setBehavioral: Multiprong CDS with referral to pharmacist co-management
- Registration Number
- NCT05990296
- Lead Sponsor
- Geisinger Clinic
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 4300
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Focused education Focused education Clinicians in this arm will receive focused education and no CDS. Multiprong CDS with referral to pharmacist co-management + focused education 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. Multiprong CDS with GDMT order set + focused education Multiprong CDS with GDMT order set 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. Multiprong CDS with referral to pharmacist co-management + focused education Multiprong CDS with referral to 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. Multiprong CDS with GDMT order set 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. Multiprong CDS with referral to pharmacist co-management 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. Multiprong CDS with GDMT order set + focused education 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.
- Primary Outcome Measures
Name Time Method HF GDMT prescription increased (yes/no) Within 30 days of index visit New GDMT HF medication class added, switch to ARNI from ACE/ARB, or upward dose titration of existing GDMT HF medication.
- Secondary Outcome Measures
Name Time Method HF GDMT prescription increased (yes/no) Within 60 and 90 days of index visit New GDMT HF medication class added, switch to ARNI from ACEi/ARB, 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
Trial Locations
- Locations (1)
Geisinger Cardiology Clinics
🇺🇸Danville, Pennsylvania, United States