Post-Discharge Pharmacist-led Rapid Medication Optimization for Heart Failure (Post-Discharge PHARM-HF)
- Conditions
- Heart Failure with Reduced Ejection Fraction HFrEF
- Interventions
- Other: Pharmacist co-management of HFrEF medication optimizationOther: Usual care
- Registration Number
- NCT06450522
- Lead Sponsor
- University of British Columbia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 12
- Age ≥19 years;
- Attending their initial visit to the PDMC;
- Diagnosis of HF.
- None.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pharmacist co-management Pharmacist co-management of HFrEF 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. This intervention will be delivered by a staff pharmacist at the St. Paul's Hospital, using the standard procedures outlined below: Where possible, a patient will be prescribed the combination of an angiotensin receptor-neprilysin inhibitor (ARNI), evidence-based beta-blocker, mineralocorticoid receptor antagonist (MRA), and sodium-glucose cotransporter 2 inhibitor (SGLT2i) at target HFrEF doses, along with personalized therapies as outlined in the 2021 CCS HF guidelines, unless the patient is unable to tolerate these agents/doses. The intervention will incorporate key components identified in a systematic review of observational studies of pharmacist-led optimization of HF Usual care Usual care 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada