Pharmacist-led Medication Optimization for Heart Failure

N/A

Recruiting

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥19 years

Diagnosis of HFrEF

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial will enroll 100 patients from a post-discharge medicine clinic to see if having a pharmacist manage heart failure medications can improve their use. Patients will be randomly assigned to receive usual care or care

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves medication management rather than new drugs, side effects may relate more to changes in current medication regimens rather than novel side effects from experimental treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 19 years old or older.

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My heart doesn't pump blood well.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Optimization Potential Score

Secondary study objectives

Composite hierarchical outcome

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Usual careExperimental Treatment1 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-managementExperimental Treatment1 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.

0 / 2Eligibility criteria met