Post-Discharge Pharmacist-led Rapid Medication Optimization for Heart Failure (Post-Discharge PHARM-HF)

Post-Discharge Pharmacist-led Rapid Medication Optimization for Heart Failure (Post-Discharge PHARM-HF): a Randomized Controlled 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.

Study Overview

• Status: Terminated
• Conditions: Heart Failure with Reduced Ejection Fraction HFrEF
• Intervention / Treatment: Other: Usual care; Other: Pharmacist co-management of HF medication optimization

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥19 years;
2. Attending their initial visit to the PDMC;
3. Diagnosis of HF.

Exclusion Criteria:

• None.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Other: Usual care; Usual care
Experimental: Pharmacist co-management; 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.	Other: Pharmacist 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimization Potential Score	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).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite hierarchical outcome	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	3 months

Collaborators and Investigators

• Sponsor: University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2024
• Primary Completion (Actual): February 21, 2025
• Study Completion (Actual): February 21, 2025

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: H24-00300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No