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

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will recruit 100 patients from a post-discharge medicine clinic to test if the addition of a pharmacist to manage heart failure medications can increase appropriate use of these medications. Participants will be randomly assigned to usual care alone or with the addition of a pharmacist to help manage medications. They will be followed for 3 months by telephone/electronically-administered questionnaires, and 12 months using administrative health records. Outcome data will include information from patients on quality of life, treatment burden, medication adherence, as well as information from their medical record on heart failure events.

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 data supports the idea that Pharmacist-led Medication Optimization for Heart Failure is an effective treatment?

The available research shows that Pharmacist-led Medication Optimization for Heart Failure is effective. One study describes a pharmacist-managed clinic that helped patients reach their target medication doses. Another study found that pharmacist-led interventions in primary care improved outcomes for patients with heart failure. Additionally, a systematic review and meta-analysis concluded that pharmacist care improves outcomes for heart failure patients, especially those managed outside of hospitals. These findings suggest that pharmacist-led approaches can be beneficial in managing heart failure compared to traditional methods. ^{1 2 3 4 5}

What safety data exists for pharmacist-led medication optimization for heart failure?

The available research indicates that pharmacist-led medication optimization for heart failure, including titration clinics, has been implemented successfully. These interventions have shown benefits such as increased use of evidence-based therapies, reduced heart failure hospitalizations, and decreased all-cause readmissions. However, large-scale, long-term clinical trials specifically testing the effect on mortality and morbidity are still needed. Overall, the involvement of pharmacists in heart failure care has been associated with positive outcomes, although reports have been mixed due to differences in study design. ^{1 2 3 6 7}

Is the treatment Pharmacist-led Rapid Medication Optimization a promising treatment for heart failure?

Yes, Pharmacist-led Rapid Medication Optimization is promising because it helps patients with heart failure reach their target medication doses, improves treatment outcomes, and reduces hospital visits. ^{1 2 3 4 7}

Eligibility Criteria

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

Attending their initial visit to the PDMC

I am 19 years old or older.

My heart doesn't pump blood well.

Exclusion Criteria

Not applicable.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Implementation of a pharmacist-managed heart failure medication titration clinic. [2019]

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

The Pharmacist's Role in Medication Optimization for Patients With Chronic Heart Failure. [2020]

3. England 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. [2023]

4. England pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

The evidence for pharmacist care in outpatients with heart failure: a systematic review and meta-analysis. [2021]

6. England pubmed.ncbi.nlm.nih.gov

The Heart failure and Optimal Outcomes from Pharmacy Study (HOOPS): rationale, design, and baseline characteristics. [2012]

7. 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]