The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05990296
Recruitment Status : Recruiting
First Posted : August 14, 2023
Last Update Posted : March 6, 2024
Sponsor:
Information provided by (Responsible Party):
Stephen Voyce, Geisinger Clinic

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Heart Failure Heart Failure With Reduced Ejection Fraction Behavioral: Multiprong CDS with referral to pharmacist co-management Behavioral: Multiprong CDS with GDMT order set Behavioral: Focused education Not Applicable

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluating Strategies to Improve Guideline Directed Medical Therapy: The GDMT Research, Education & Assist Trial for Heart Failure Care (GREAT-HF Care)
Actual Study Start Date : August 1, 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
No Intervention: Control
Clinicians in this arm will not receive CDS or focused education and will experience usual care.
Experimental: 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.
 Behavioral: Multiprong 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.
Other Names:
  • Opt-out default
  • Active choice
  • Default order of options
  • Advisory
  • Alert
Experimental: 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.
 Behavioral: Multiprong 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.
Other Names:
  • Opt-out default
  • Active choice
  • Advisory
  • Alert
Experimental: Focused education
Clinicians in this arm will receive focused education and no CDS.
 Behavioral: Focused 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.
Other Names:
  • Education
  • Training
  • Interactive
Experimental: Multiprong CDS with GDMT order set + 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.
 Behavioral: Multiprong 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.
Other Names:
  • Opt-out default
  • Active choice
  • Default order of options
  • Advisory
  • Alert

Behavioral: Focused 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.
Other Names:
  • Education
  • Training
  • Interactive
Experimental: Multiprong CDS with referral to pharmacist co-management + 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.
 Behavioral: Multiprong 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.
Other Names:
  • Opt-out default
  • Active choice
  • Advisory
  • Alert

Behavioral: Focused 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.
Other Names:
  • Education
  • Training
  • Interactive


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. HF GDMT prescription increased (yes/no) [ 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.


Secondary Outcome Measures :
  1. HF GDMT prescription increased (yes/no) [ 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.

  2. Addition of SGLT2i or ARNI for HFrEF (yes/no) [ 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


Other Outcome Measures:
  1. All-cause mortality, emergency visit for heart failure or hospitalization for heart failure [ 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)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 or prescribed medications from all four categories of GDMT
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05990296


Contacts
Layout table for location contacts
Contact: Stephen J Voyce 5707034830 svoyce@geisinger.edu
Contact: Vanessa A Hayduk vhayduk@geisinger.edu

Locations
Layout table for location information
United States, Pennsylvania
Geisinger Cardiology Clinics Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Stephen J Voyce    570-703-4830    svoyce@geisinger.edu   
Contact: Vanessa Hayduk    570-714-6682    vhayduk@geisinger.edu   
Sub-Investigator: Eric Wright, PharmD, MPH         
Sub-Investigator: Amir Goren, PhD         
Sub-Investigator: Apoorva Pradhan, MD, MPH         
Sponsors and Collaborators
Geisinger Clinic
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Stephen Voyce, Associate Professor, Geisinger Clinic
ClinicalTrials.gov Identifier: NCT05990296    
Other Study ID Numbers: 2023-1031
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: March 6, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stephen Voyce, Geisinger Clinic:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases