Heart Failure, Heart Failure With Reduced Ejection Fraction
Conditions
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
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.
Interventions
BEHAVIORALMultiprong 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.
BEHAVIORALMultiprong 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.
BEHAVIORALFocused 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.
Sponsors
Geisinger Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Outcome results
None listed