Geisinger Cardiology Clinics
Danville, Pennsylvania, 17822, United States
NCT Number: NCT05990296
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Danville, Pennsylvania, 17822, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Opt-out default, Active choice, Advisory, Alert
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.
Other names: Opt-out default, Active choice, Default order of options, Advisory, Alert
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
Time frame: 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.
Time frame: 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.
Time frame: Within 30, 60 and 90 days of index visit
New prescriptions for SGLT2i and/or ARNI or switch from ACEi/ARB to ARNI
Time frame: 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)
Geisinger Clinic
Other
Evaluating Strategies to Improve Guideline Directed Medical Therapy: The GDMT Research, Education & Assist Trial for Heart Failure Care (GREAT-HF Care)
Acronym: GREAT-HF Care
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05752760
Cardiovascular Diseases, Heart Diseases
Milwaukee, Wisconsin, United States
View Trial DetailsNCT07519434
Cardiac Remodeling, Cardiovascular Diseases
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT07022379
Cardiovascular Diseases, Heart Diseases
Bordeaux, France
View Trial DetailsNCT06215911
Cardiovascular Diseases, Heart Diseases
Birmingham, Alabama, United States
View Trial Details