PHARM Optimal-HF Pilot

Pharmacist-led Intervention for Optimal Heart Failure Medications: A Pilot Randomized Controlled Trial

The goal if this pilot randomized controlled trial is to determine the feasibility of conducting and guide the design of a definitive trial of a pharmacist-led, remotely-administered intervention to optimize medications for heart failure (HF) with reduced ejection fraction (HFrEF) as part of a multidisciplinary HF clinic.

Both the intervention group and comparator group will receive usual care by the multidisciplinary HF clinic, including standard-of-care clinical pharmacy services.

In addition to usual care, participants randomized to the intervention arm will receive co-management of medications by a dedicated study pharmacist with advanced training and expanded scope of practice, with the aim of achieving optimal medical therapy for HFrEF based on the 2021 Canadian Cardiovascular Society HF guidelines. The intervention will consist of 30-minute remote (telephone) encounters with a clinical pharmacist every 1-2 weeks with the aim of initiating or titrating ≥1 medication per encounter using standard protocols, for an intervention duration of up to 4 months.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Other: Usual care; Other: Pharmacist-led HFrEF medication optimization

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Provision of signed and dated informed consent form;
2. Stated willingness to comply with all study procedures and availability for the duration of the study;
3. Age ≥18 years;
4. Clinic diagnosis of HF with New York Heart Association (NYHA) functional class 1 to 3 at time of screening;
5. Left ventricular ejection fraction (LVEF) ≤40% on cardiac imaging performed within 6 months prior to enrolment;
6. Willingness to receive medications for the management of HFrEF;
7. Access to necessary resources for participating (telephone ± computer with internet access).

Exclusion Criteria:

1. Already receiving target doses of sacubitril-valsartan, evidence-based beta-blocker and a mineralocorticoid receptor antagonist at time of screening;
2. Lying/sitting systolic blood pressure <90 mm Hg at time of enrolment;
3. Serum potassium ≥5.5 mmol/L at time of enrolment;
4. ≥2 measurements indicating estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 within 3 months prior to enrolment;
5. Being considered for heart transplant, durable mechanical circulatory support, or intravenous inotropes at time of screening;
6. Requiring diuretic dose greater than furosemide 80 mg equivalents or requiring the addition of a thiazide-like diuretic for more than 3 days at time of screening;
7. Felt by the multidisciplinary HF clinic team to be unsuitable for the trial (e.g. substance abuse and other psychological disorders, significant language barrier).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmacist-led HFrEF medication optimization	Other: Usual care; Both the intervention group and comparator group will receive usual care by the multidisciplinary HF clinic, including standard-of-care clinical pharmacy services. The standard pathway in the HF clinic consists of an initial consultation with the multidisciplinary team (cardiologist, physician trainees, registered nurse and clinical pharmacist), follow-up visits approximately every 3 months with the nurse and cardiologist until discharge, along with telehealth nurse calls for medication titrations.; Other: Pharmacist-led HFrEF medication optimization; In addition to usual care, participants randomized to the intervention arm will receive co-management of medications by a clinical pharmacist with advanced training and expanded scope of practice, with the aim of achieving optimal medical therapy (OMT) for HFrEF as outlined by the 2021 Canadian Cardiovascular Society (CCS) HF guidelines. This will consist of, where possible, 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 doses, along with personalized therapies as outlined in the 2021 CCS HF guidelines, unless the patient is unable to tolerate these agents/doses.
Other: Usual care; Both the intervention group and comparator group will receive usual care by the multidisciplinary HF clinic, including standard-of-care clinical pharmacy services.	Other: Usual care; Both the intervention group and comparator group will receive usual care by the multidisciplinary HF clinic, including standard-of-care clinical pharmacy services. The standard pathway in the HF clinic consists of an initial consultation with the multidisciplinary team (cardiologist, physician trainees, registered nurse and clinical pharmacist), follow-up visits approximately every 3 months with the nurse and cardiologist until discharge, along with telehealth nurse calls for medication titrations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of recruitment	Composite of: Proportion eligible at pre-screening ≥50% of all HF clinic patients assessed based on inclusion criteria at pre-screening;; Proportion eligible at screening ≥25% of all patients based on inclusion and exclusion criteria on screening;; Mean recruitment ≥2 participants/week.	Baseline
Feasibility of achieving rapid optimal medical therapy in intervention arm	Feasibility of optimizing HFrEF pharmacotherapy with study intervention, defined as ≥90% attainment of modified OMT score [acceptable] ≥5 at 3 months in intervention arm and ≥80% attainment of modified OMT score 8 [optimal] at 6 months in intervention arm	month 6
Feasibility of patient-reported outcome measure (PROM) collection & participant retention	Composite of: Follow-up at 6 months complete in ≥90% at 6 months, ≥80% at 12 months, excluding deaths; ≥90% completion of PROM questionnaires at months 3 and 6, and ≥80% completion at month 12	month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimization of HFrEF medications	Modified optimal medical therapy (OMT) score. Range 0 (worst) to 8 (best): suboptimal (0-4), acceptable (5-7), optimal (8).	month 3
Optimization of HFrEF medications	Modified optimal medical therapy (OMT) score	month 6
Optimization of HFrEF medications	Modified optimal medical therapy (OMT) score	month 12
Medication adherence	5-item Medication Adherence Report Scale (MARS-5)	month 3
Medication adherence	5-item Medication Adherence Report Scale (MARS-5)	month 6
Medication adherence	5-item Medication Adherence Report Scale (MARS-5)	month 12
Medication adverse effects	Open-ended question about HF medications	month 3
Medication adverse effects	Open-ended question about HF medications	month 6
Medication adverse effects	Open-ended question about HF medications	month 12
Quality of life: 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12)		month 3
Quality of life: 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12)		month 6
Quality of life: 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12)		month 12
Treatment burden	Treatment Burden Questionnaire (TBQ)	month 3
Treatment burden	Treatment Burden Questionnaire (TBQ)	month 6
Treatment burden	Treatment Burden Questionnaire (TBQ)	month 12
Treatment satisfaction	Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)	month 3
Treatment satisfaction	Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)	month 6
Treatment satisfaction	Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)	month 12

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: University of Alberta
• Investigators: Principal Investigator: Ricky Turgeon, BSc(Pharm), ACPR, PharmD, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 21, 2022

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: medication; pharmacotherapy; pharmaceutical care; pharmacist
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: H21-01774

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