GDMT Strategies for Heart Failure

(GREAT-HF Care Trial)

Overseen By Vanessa A Hayduk

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Geisinger Clinic

Disqualifiers: Hospice, Palliative care, GDMT allergy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 365

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve treatment for individuals with heart failure with reduced ejection fraction (HFrEF), a condition where the heart does not pump blood effectively. The study tests various strategies to ensure patients receive the most effective medications, known as guideline-directed medical therapies (GDMT). These strategies include educating doctors, using electronic reminders to address treatment gaps, and providing pharmacist support through co-management. Individuals diagnosed with HFrEF who have recently visited a Geisinger cardiology clinic may be suitable candidates for this trial. As an unphased trial, it offers participants the opportunity to contribute to innovative strategies that could enhance heart failure care.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the treatments tested in this trial are generally safe for people. Here's a simple breakdown of the safety evidence for each treatment:

1. **Clinical Decision Support (CDS):** Studies indicate that CDS systems, which assist doctors in making better treatment choices, do not directly harm patients. These tools are designed to improve care and have enhanced treatment outcomes in heart failure without causing harm.

2. **Focused Education:** Research demonstrates that education programs for heart failure patients help them understand their condition better and manage it more effectively. These programs are well-received, with no reports of negative effects from the education itself.

3. **Pharmacist Co-management:** Studies have shown that involving pharmacists in patient care is safe and can help patients adhere to their medication plans and reduce hospital visits for heart failure. This approach has not raised any direct safety concerns for patients.

Overall, these treatments aim to improve the care and management of heart failure. The evidence supports their safety, and they are designed to help patients and healthcare providers handle the condition better. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GDMT Strategies for Heart Failure trial because it could revolutionize how heart failure with reduced ejection fraction (HFrEF) is managed. Unlike current standard treatments, which often rely solely on medication management, this trial explores innovative approaches like Clinical Decision Support (CDS) systems, focused education for clinicians, and pharmacist co-management. These methods aim to close care gaps by actively involving pharmacists in patient care and using technology to guide treatment decisions. By integrating these strategies, the trial hopes to enhance the effectiveness of existing therapies and improve patient outcomes through a more personalized and proactive approach.

What evidence suggests that this trial's treatments could be effective for heart failure?

This trial will evaluate various strategies for managing heart failure with reduced ejection fraction (HFrEF). Research has shown that recommended treatments for HFrEF are highly effective. In this trial, some participants will be in arms where decision-support tools are used, which studies have found can enhance the use of these treatments, leading to better heart failure care. Other participants will be in arms where pharmacists manage care, a method shown to increase treatment use and reduce hospital visits for heart failure patients. Additionally, some arms will focus on patient education about their condition, which has been shown to help patients manage heart failure better and avoid hospital readmissions. Overall, these strategies have successfully improved treatment outcomes for HFrEF patients. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• CDS
• Focused Education
• Pharmacist co-management

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

Patients with heart failure receiving care from a multidisciplinary clinic with a pharmacist (MACS) had a higher likelihood of being prescribed ACE inhibitors or ARBs compared to those in a clinic without a pharmacist (GCHFS), indicating the pharmacist's role may enhance guideline-directed medical therapy (GDMT) for certain patients.

Despite the benefits, the MACS clinic showed lower prescription rates for β-blockers and mineralocorticoid receptor antagonists, suggesting that the involvement of pharmacists may lead to more cautious prescribing practices that consider patient demographics and comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the prescribing practice of guideline-directed medical therapy among ambulatory chronic heart failure patients. Parajuli, DR., Shakib, S., Eng-Frost, J., et al.[2023]

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]

Pharmacist medication reviews significantly reduced drug-related problems (DRPs) in patients with heart failure, decreasing the average DRPs per patient from 2.80 to 1.95 after intervention, based on a study of 128 patients (64 control and 64 intervention).

The intervention not only improved the overall management of medications but also showed high acceptance rates for critical areas such as medication adherence (78%) and renal dosing (67%), indicating the effectiveness of pharmacists in enhancing patient care in heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Pharmacist Medication Review Service in an Outpatient Heart Failure Clinic. Yates, L., Valente, M., Wadsworth, C.[2022]

A multifactorial educational intervention by pharmacists significantly improved treatment compliance and reduced hospital readmissions by 32.9% in heart failure patients over 12 months, compared to a control group.

Patients receiving the intervention had fewer hospital days (5.9 days vs. 9.6 days) and reported higher satisfaction with care, while also resulting in cost savings of €578 per patient, demonstrating both efficacy and economic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of a postdischarge pharmaceutical care program vs regular follow-up in patients with heart failure. López Cabezas, C., Falces Salvador, C., Cubí Quadrada, D., et al.[2022]

In a study of 266,589 heart failure patients across Japan, Sweden, and the United States, the initiation of novel guideline-directed medical therapies (GDMTs) like dapagliflozin and sacubitril/valsartan was significantly delayed compared to traditional therapies, with initiation times ranging from 19 to 44 days.

Despite the potential benefits of these therapies, only a small percentage of patients achieved the target doses recommended by guidelines, with dapagliflozin showing the highest persistence at 75.7%, while other medications like MRAs had a much lower persistence rate of 5.1%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart Failure Drug Treatment-Inertia, Titration, and Discontinuation: A Multinational Observational Study (EVOLUTION HF). Savarese, G., Kishi, T., Vardeny, O., et al.[2023]

In a study involving 2,164 patients with left ventricular systolic dysfunction, a pharmacist-led intervention improved the prescribing of heart failure medications, with significant increases in treatment initiation and dose adjustments compared to usual care.

Despite these improvements in medication management, the intervention did not lead to better clinical outcomes, such as reduced death or hospital admissions for heart failure, indicating that the baseline treatment levels were already high among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacist intervention in primary care to improve outcomes in patients with left ventricular systolic dysfunction. Lowrie, R., Mair, FS., Greenlaw, N., et al.[2022]

A 12-month study auditing discharge prescriptions for 716 patients with acute heart failure showed that clinical audits significantly improved adherence to guideline-directed medical therapy (GDMT), reducing unreasonable omissions of key medications to zero by the end of the study.

The initial high rates of inappropriate prescribing practices, such as the omission of ACE inhibitors and beta-blockers, were completely eliminated through monthly feedback to physicians, demonstrating the effectiveness of clinical audits in enhancing medication management for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Clinical Audit on Adherence to the Guidelines Directed Medical Therapy in Patients Admitted with Heart Failure. Shukkoor, AA., George, NE., Radhakrishnan, S., et al.[2021]

Heart failure (HF) is a significant health issue for the elderly, leading to high rates of morbidity and hospitalizations, necessitating careful management and monitoring of medications due to increased risk of adverse effects.

Pharmacists play a crucial role in improving care outcomes for elderly patients with HF by actively participating in the transitions of care process, helping to address medication-related issues and ensuring effective communication among healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Heart Failure in the Older Adult: Treatment and Opportunities. Won, KJ., Bethishou, L., Tsu, LV.[2019]

Clinical pharmacists play a crucial role in heart failure care by improving medication management, which leads to better patient satisfaction, adherence, and a reduction in medication errors, especially during transitions between care settings.

Interventions by clinical pharmacists have been associated with positive outcomes such as increased use of evidence-based therapies and reductions in hospitalizations and readmissions, highlighting the importance of their specialized training in cardiovascular and transplant pharmacotherapy.

NCBI (Pubmed)

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. Milfred-LaForest, SK., Chow, SL., DiDomenico, RJ., et al.[2022]

There is a significant gap in the use and dose titration of guideline-directed medical therapy (GDMT) for heart failure patients, despite strong evidence showing that proper implementation can reduce morbidity and mortality.

Emerging strategies to improve GDMT adherence include multidisciplinary team approaches, remote patient monitoring, and electronic health record alerts, which are essential as new treatments like SGLT2 inhibitors expand indications across different heart failure types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Strategies to Improve Prescription of Guideline-Directed Medical Therapy in Heart Failure. Brooksbank, JA., Faulkenberg, KD., Tang, WHW., et al.[2023]

The implementation of an interdisciplinary heart failure consult service, which included pharmacists, led to significant increases in the use of guideline-directed medical therapy (GDMT) among veterans, particularly for those with heart failure with reduced ejection fraction.

Despite the increased medication optimization, the 30-day readmission rates for heart failure did not significantly change between the pre-consult and consult groups, indicating that while pharmacist involvement improved medication adherence, it did not immediately impact short-term hospital readmissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Pharmacist Impact Within an Interdisciplinary Inpatient Heart Failure Consult Service. Blizzard, S., Verbosky, N., Stein, B., et al.[2020]

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