GDMT Strategies for Heart Failure

(GREAT-HF Care Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Geisinger Clinic

Disqualifiers: Hospice, Palliative care, GDMT allergy

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, it focuses on using specific heart failure medications, so you might need to adjust your treatment plan. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the treatment CDS, Focused Education, Pharmacist co-management for heart failure?

Research shows that having a pharmacist involved in heart failure care can lead to better outcomes, such as fewer hospital visits and better medication management. Pharmacists can help ensure patients follow their treatment plans and avoid medication errors, which improves overall health. ^{1 2 3 4 5}

Is GDMT for heart failure safe for humans?

The studies suggest that pharmacist involvement in GDMT for heart failure can improve medication use and patient care, but they also highlight the need for careful monitoring, especially in older adults, due to a higher risk of side effects. ^{3 6 7 8 9}

How is the GDMT treatment for heart failure different from other treatments?

The GDMT (guideline-directed medical therapy) for heart failure is unique because it involves a multidisciplinary approach, often including direct pharmacist input, to optimize medication use and improve patient outcomes. This approach focuses on early initiation and proper dose adjustment of multiple therapies to reduce mortality and hospital readmissions, which is not always emphasized in standard treatments. ^{3 8 10 11 12}

Research Team

Eligibility Criteria

This trial is for adults over 18 with heart failure who have a left ventricular ejection fraction of 40% or less. They must have visited certain cardiology clinics and not be in hospice care or allergic to all four categories of guideline-directed medical therapies.

Inclusion Criteria

My heart's pumping ability is significantly reduced.

I have completed a visit at a Geisinger cardiology clinic.

I am a Geisinger clinician who can prescribe heart failure medications.

Exclusion Criteria

I am currently receiving care focused on relieving symptoms and improving quality of life.

I am allergic to or cannot take heart failure medications from all four recommended categories.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of multifaceted, interdisciplinary interventions to improve GDMT use in patients with HFrEF

12 months

Regular visits as per clinical practice site schedule

Follow-up

Participants are monitored for safety and effectiveness after intervention

12 months

Follow-up assessments within 365 days of index visit

Treatment Details

Interventions

• CDS (Behavioral Intervention)
• Focused Education (Behavioral Intervention)
• Pharmacist co-management (Behavioral Intervention)

Trial Overview The study tests an approach combining computer decision support, pharmacist co-management, focused education, and a set order for medications to improve the use of life-saving drugs in patients with reduced heart function.

Participant Groups

Group I: Multiprong CDS with referral to pharmacist co-management + focused education Experimental Treatment 2 Interventions

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.

Group II: Multiprong CDS with referral to pharmacist co-management Experimental Treatment 1 Intervention

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.

Group III: Multiprong CDS with GDMT order set + focused education Experimental Treatment 2 Interventions

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.

Group IV: Multiprong CDS with GDMT order set Experimental Treatment 1 Intervention

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.

Group V: Focused education Experimental Treatment 1 Intervention

Clinicians in this arm will receive focused education and no CDS.

Group VI: Control Active Control 1 Intervention

Clinicians in this arm will not receive CDS or focused education and will experience usual care.

Who Is Running the Clinical Trial?

Geisinger Clinic

Lead Sponsor

Trials

159

Recruited

1,976,000+

Dr. Terry Gilliland

Geisinger Clinic

Chief Executive Officer since 2024

MD from University of California, San Francisco

Dr. Jason W. Mitchell

Geisinger Clinic

Chief Medical Officer

MD from University of New Mexico

Findings from Research

A survey of 15 cardiology residency programs in Canada revealed that while most programs have access to heart failure (HF) clinics and specialist services, only 20% require significant exposure to ambulatory HF rotations, indicating a gap in training.

Despite the suboptimal training in HF management, 87% of program directors recognized the importance of enhancing the curriculum to improve cardiology trainees' ability to implement guideline-directed medical therapy (GDMT) for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proposal for an Ambulatory Heart Failure Management Curriculum for Cardiology Residency Training Programs. Almufleh, A., Turgeon, RD., Ducharme, A., et al.[2022]

The One Minute Clinic for Heart Failure (TOM-C HF) is an efficient six-item screening tool that community pharmacists can use to identify heart failure patients at risk of worsening symptoms, taking only 1 to 5 minutes in most cases.

In a study involving 121 heart failure patients, 62% showed signs of worsening heart failure, with common symptoms including edema and increased shortness of breath, highlighting the potential of pharmacists to play a crucial role in early detection and management of heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart failure assessment at the community pharmacy level: a feasibility pilot study. Bleske, BE., Dillman, NO., Cornelius, D., et al.[2015]

References

1. Spain pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of a postdischarge pharmaceutical care program vs regular follow-up in patients with heart failure. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Pharmacist intervention in primary care to improve outcomes in patients with left ventricular systolic dysfunction. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Evaluation of the prescribing practice of guideline-directed medical therapy among ambulatory chronic heart failure patients. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical pharmacy services in heart failure: an opinion paper from the Heart Failure Society of America and American College of Clinical Pharmacy Cardiology Practice and Research Network. [2022]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Impact of Clinical Audit on Adherence to the Guidelines Directed Medical Therapy in Patients Admitted with Heart Failure. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Management of Heart Failure in the Older Adult: Treatment and Opportunities. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Pharmacist Medication Review Service in an Outpatient Heart Failure Clinic. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Heart Failure Drug Treatment-Inertia, Titration, and Discontinuation: A Multinational Observational Study (EVOLUTION HF). [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Pharmacist Impact Within an Interdisciplinary Inpatient Heart Failure Consult Service. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Proposal for an Ambulatory Heart Failure Management Curriculum for Cardiology Residency Training Programs. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Novel Strategies to Improve Prescription of Guideline-Directed Medical Therapy in Heart Failure. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Heart failure assessment at the community pharmacy level: a feasibility pilot study. [2015]