Pharmacist-led Medication Optimization for Heart Failure

Overseen By Ricky D Turgeon, BSc(Pharm), ACPR, PharmD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether pharmacist involvement in medication management can improve treatment for people with heart failure. Participants will either receive usual care or work with a pharmacist to optimize their heart medications through a Pharmacist-led Rapid Medication Optimization approach. The goal is to determine if this approach improves medication use, enhances quality of life, and reduces heart failure events. Individuals who recently began treatment at a post-discharge clinic and have been diagnosed with heart failure are well-suited for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative care strategies that could enhance heart failure management.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, since the study involves managing heart failure medications, you might continue with your current meds under the guidance of a pharmacist.

What prior data suggests that pharmacist-led medication optimization is safe for heart failure patients?

Research has shown that pharmacist-led programs for managing heart failure medications are safe and effective. These programs improve patients' use of heart failure medicines and reduce hospital visits. For example, one study found that patients met their medication goals more easily with a pharmacist's help. Another study demonstrated that pharmacists helped more patients reach their ideal medication levels within 90 days.

Although specific side effects were not detailed, the overall results suggest these programs are well-tolerated. They focus on helping patients manage their medicines safely and effectively, potentially lowering the chances of returning to the hospital due to heart failure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the pharmacist-led rapid medication optimization for heart failure because it offers a proactive approach to managing medications. Unlike standard care, which generally involves routine consultations with a physician, this method introduces pharmacist co-management to swiftly adjust medication dosages to their maximum-tolerated levels. This could mean a more personalized and timely adaptation of medications like ARNI, beta-blockers, MRA, and SGLT2 inhibitors, tailored to each individual's needs. By aligning closely with the latest heart failure guidelines, this method aims to enhance the effectiveness of heart failure management and potentially improve patient outcomes more quickly.

What evidence suggests that pharmacist-led medication optimization is effective for heart failure?

Research shows that clinics led by pharmacists can better manage heart failure medications and reduce hospital visits. In this trial, participants in the pharmacist co-management arm will receive pharmacist-led medication optimization, which studies have shown ensures patients receive the right heart failure medications and reach optimal doses more quickly. One study found that these clinics are linked to better use of recommended medications and fewer hospital stays. Another study noted that quickly adjusting medications and using remote monitoring can improve heart failure care. Overall, evidence suggests that involving pharmacists leads to better outcomes for heart failure patients. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 19 years old who have been diagnosed with heart failure with reduced ejection fraction (HFrEF) and are attending their first visit to a post-discharge medicine clinic. It's not suitable for those who don't meet these specific conditions.

Inclusion Criteria

I am 19 years old or older.

My heart doesn't pump blood well.

Attending their initial visit to the PDMC

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive usual care or pharmacist co-management to optimize heart failure medications

3 months

Initial consultation within 2 weeks of discharge, followed by two visits approximately 1 week apart

Follow-up

Participants are monitored for safety and effectiveness after treatment using telephone/electronically-administered questionnaires

3 months

Long-term follow-up

Participants are monitored using administrative health records to assess long-term outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Pharmacist-led Rapid Medication Optimization

Trial Overview The study is testing if adding a pharmacist to the healthcare team can improve the use of heart failure medications compared to usual care alone. Participants will be randomly placed in one of the two groups and monitored through questionnaires and health records for up to a year.

How Is the Trial Designed?

Group I: Usual care Experimental Treatment 1 Intervention

Usual care: Both the intervention group and comparator group will receive usual care by the Post-Discharge Medicine Clinic, which does not include clinical pharmacy services. The standard pathway in the St. Paul's Hospital Post-Discharge Medicine Clinic consists of an initial consultation with the clinic internist within 2 weeks of discharge, followed by two visits approximately 1 week apart with the Post-Discharge Medicine Clinic internist, followed by discharge from the clinic.

Group II: Pharmacist co-management Experimental Treatment 1 Intervention

In addition to usual care, participants with an initial Post-Discharge Medicine Clinic visit randomized to the intervention arm will receive pharmacist co-management of their medications, with the intent of to achieve rapid, maximum-tolerated pharmacotherapy for HF as outlined in the latest guidelines. This intervention will be delivered by a staff pharmacist at the St. Paul's Hospital, using the standard procedures outlined below: For HFrEF, where possible, a patient will be prescribed the combination of an ARNI, evidence-based beta-blocker, MRA, and SGLT2i at target HFrEF doses, along with personalized therapies as outlined in the 2021 CCS HF guidelines. For HFmrEF, we will target ACEI/ARB/ARNI, beta-blocker, MRA, and SGLT2i. For HFpEF, we will target SGLT2i + MRA +/- ACEI/ARB/ARNI. The intervention will incorporate key components identified in a systematic review of observational studies of pharmacist-led optimization of HF.

Pharmacist-led Rapid Medication Optimization is already approved in Canada, United States, European Union for the following indications:

Approved in Canada as Pharmacist-led Medication Optimization for:

• Heart Failure with Reduced Ejection Fraction (HFrEF)

Approved in United States as Pharmacist-led Heart Failure Medication Titration Clinic for:

• Heart Failure with Reduced Ejection Fraction (HFrEF)

Approved in European Union as Pharmacist-led Medication Optimization for:

• Heart Failure with Reduced Ejection Fraction (HFrEF)

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Published Research Related to This Trial

A pharmacist-managed heart failure medication titration clinic significantly improved the percentage of patients reaching optimal doses of ACE inhibitors and ARBs, achieving 52.9% compared to 31% in the previous management by nurses or physicians.

The clinic also led to a higher attainment of optimal β-blocker doses, with 49% of patients reaching the target compared to only 24.7% before the clinic's implementation, demonstrating the effectiveness of pharmacists in managing heart failure medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a pharmacist-managed heart failure medication titration clinic. Martinez, AS., Saef, J., Paszczuk, A., et al.[2019]

Pharmacist care significantly improves medication adherence, patient knowledge, and quality of life in outpatients with heart failure, based on a systematic review of 24 randomized controlled trials involving 8029 patients.

While pharmacist interventions did not show statistically significant reductions in all-cause mortality or hospitalizations, they did enhance symptom control and overall quality of life, suggesting that pharmacists play a crucial role in managing complex medication regimens for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evidence for pharmacist care in outpatients with heart failure: a systematic review and meta-analysis. Schumacher, PM., Becker, N., Tsuyuki, RT., et al.[2021]

A pharmacy medication titration clinic effectively assisted patients with chronic heart failure in achieving their target medication doses, which is crucial for managing their condition.

This intervention highlights the importance of specialized clinics in optimizing medication management for chronic diseases, potentially improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pharmacist's Role in Medication Optimization for Patients With Chronic Heart Failure. Noschese, LA., Bergman, CL., Brar, CK., et al.[2020]

Nurse-led titration (NLT) of beta-adrenergic blocking agents, ACE inhibitors, and ARBs in patients with heart failure significantly reduced all-cause hospital admissions by 20% and heart failure-related admissions by 49%, based on a review of seven studies involving 1684 participants.

Patients receiving NLT were more likely to survive and reach target medication doses in half the time compared to usual care, highlighting NLT as an effective strategy to optimize heart failure treatment and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-led titration of angiotensin converting enzyme inhibitors, beta-adrenergic blocking agents, and angiotensin receptor blockers for people with heart failure with reduced ejection fraction. Driscoll, A., Currey, J., Tonkin, A., 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]

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]

This study is designed to evaluate the impact of pharmacist-led interventions on mortality and hospitalization rates in patients with systolic heart failure, involving 2,169 patients across 174 practices over a mean follow-up of 5 years.

The trial aims to provide strong evidence on whether optimizing pharmacological therapy through pharmacists can improve patient outcomes, with over 750 expected primary outcome events (deaths or hospitalizations) during the study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Heart failure and Optimal Outcomes from Pharmacy Study (HOOPS): rationale, design, and baseline characteristics. Lowrie, R., Mair, FS., Greenlaw, N., et al.[2012]

Citations

1. accpjournals.onlinelibrary.wiley.com accpjournals.onlinelibrary.wiley.com/doi/10.1002/jac5.1920

Evaluation of PHARM‐HF, a pharmacist‐led heart failure ... Pharmacist-led HF medication titration clinics have been associated with improved use of GDMT and reduced hospitalizations, though these ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12140189/

Pharmacist-led rapid uptitration clinic in heart failure ... Virtual wards offer a potential innovative solution in transforming heart failure management by combining rapid medication optimisation with remote monitoring.

3. journals.plos.org journals.plos.org/digitalhealth/article?id=10.1371/journal.pdig.0000868

Pharmacist-led rapid uptitration clinic in heart failure patients ... The study assessed clinical outcomes of 86 patients at baseline, following discharge from the virtual ward (typically after 4 weeks), and at 3–6 months post- ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10524094/

Pharmacist- and Nurse-Led Medical Optimization in Heart ... In this study, researchers reviewed published articles on initiatives led by nurses and pharmacists to start and adjust medical treatment for heart failure.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2949969025000314

Outcomes of a hybrid heart failure clinic model on ... This study aimed to evaluate the effectiveness of a hybrid clinic model led by pharmacists in optimizing GDMT.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9060399/

Impact of Pharmacist-Led Heart Failure Clinic on ... Our study found that pharmacist's intervention increased the proportion of patients who achieved GDMT at 90 days.

7. ahajournals.org ahajournals.org/doi/10.1161/circ.148.suppl_1.16261

Abstract 16261: Pharmacy-Led Optimization of Guideline- ... Research Question: Does a safety-net pharmacy-led program lead to significant change in medication rates, all-cause/HF admissions, and HF ...

8. ovid.com ovid.com/journals/jaccp/pdf/10.1002/jac5.1450~pharmacistled-optimization-of-heart-failure-medications-a

Pharmacist-led optimization of heart failure medications Contemporary registry data suggest that the majority of HFrEF patients are not on target therapy doses by 12 months, and less than 1% of patients are on con-.