12 Participants Needed

Pharmacist-led Medication Optimization for Heart Failure

RD
Overseen ByRicky D Turgeon, BSc(Pharm), ACPR, PharmD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of British Columbia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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 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.12345

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.12456

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.12467

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

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 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?
2Treatment groups
Experimental Treatment
Group I: Usual careExperimental Treatment1 Intervention
Group II: Pharmacist co-managementExperimental Treatment1 Intervention

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:
🇺🇸
Approved in United States as Pharmacist-led Heart Failure Medication Titration Clinic for:
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Approved in European Union as Pharmacist-led Medication Optimization for:

Find a Clinic Near You

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.
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.
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.
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]

Citations

Implementation of a pharmacist-managed heart failure medication titration clinic. [2019]
The Pharmacist's Role in Medication Optimization for Patients With Chronic Heart Failure. [2020]
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]
Pharmacist intervention in primary care to improve outcomes in patients with left ventricular systolic dysfunction. [2022]
The evidence for pharmacist care in outpatients with heart failure: a systematic review and meta-analysis. [2021]
The Heart failure and Optimal Outcomes from Pharmacy Study (HOOPS): rationale, design, and baseline characteristics. [2012]
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]
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