Heart Failure with Reduced Ejection Fraction HFrEF
Conditions
Brief summary
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.
Interventions
OTHERPharmacist co-management of HF medication optimization
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 HFrEF as outlined by the 2021 CCS HF guidelines, and for HFmrEF/HFpEF as outlined by the 2022 ACC/AHA HF 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+BB+MRA+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.
OTHERUsual care
Usual care
Sponsors
University of British Columbia
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥19 years; 2. Attending their initial visit to the PDMC; 3. Diagnosis of HF.
Exclusion criteria
* None.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Optimization Potential Score | 3 months | Score that quantifies guideline-directed medical therapy (GDMT) use in heart failure with reduced ejection fraction. The score ranges from 0 (worst) to 10 (best). For HFmrEF, this will be modified to assign equal weight to ACEI/ARB/ARNI (score range 0-8). For HFpEF, this will be further modified to assign equal weight to ACEI/ARB/ARNI, and to assign no points for beta-blocker use (score range 0-6). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite hierarchical outcome | 3 months | Hierarchical composite outcome of time to all-cause death, time to first all-cause hospitalization, the number of HF events (including HF hospitalizations or emergency department visits for HF), ≥5-point Kansas City Cardiomyopathy Questionnaire-12 summary score improvement, or ≥2-point OPS increase |
Countries
Canada
Outcome results
None listed