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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Failure, Heart Failure With Reduced Ejection Fraction

Intervention / Treatment
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* Behavioral: Multiprong CDS with referral to pharmacist co-management
* Behavioral: Multiprong CDS with GDMT order set
* Behavioral: Focused education


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: Currently in hospice or palliative care (ICD 10 code: Z51.5) Patient is allergic to or prescribed medications from all four categories of GDMT

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Clinicians in this arm will not receive CDS or focused education and will experience usual care. | |
| Experimental: Multiprong CDS with GDMT order set<br>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. | Behavioral: Multiprong CDS with GDMT order set<br>* 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.<br>* Other names: Alert;|
| Experimental: Multiprong CDS with referral to pharmacist co-management<br>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. | Behavioral: Multiprong CDS with referral to pharmacist co-management<br>* 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.<br>* Other names: Opt-out default;|
| Experimental: Focused education<br>Clinicians in this arm will receive focused education and no CDS. | Behavioral: Focused education<br>* 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.<br>* Other names: Interactive;|
| Experimental: Multiprong CDS with GDMT order set + focused education<br>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. | Behavioral: Multiprong CDS with GDMT order set<br>* 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.<br>* Other names: Alert;Behavioral: Focused education<br>* 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.<br>* Other names: Interactive;|
| Experimental: Multiprong CDS with referral to pharmacist co-management + focused education<br>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: Multiprong CDS with referral to pharmacist co-management<br>* 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.<br>* Other names: Opt-out default;Behavioral: Focused education<br>* 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.<br>* Other names: Interactive;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HF GDMT prescription increased (yes/no) | New GDMT HF medication class added, or upward dose titration of existing GDMT HF medication. | Within 30 days of index visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HF GDMT prescription increased (yes/no) | New GDMT HF medication class added, or upward dose titration of existing GDMT HF medication. | Within 60 and 90 days of index visit | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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