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

June 7, 2024 updated by: Ricky Turgeon, University of British Columbia

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

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ricky D Turgeon, BSc(Pharm), ACPR, PharmD
  • Phone Number: 236-777-6961
  • Email: ricky.turgeon@ubc.ca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 HFrEF.

Exclusion Criteria:

  • None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 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

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.
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.
Usual care

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite hierarchical outcome
Time Frame: 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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

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)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 7, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H24-00300

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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