Back to resultsPHARM Optimal-HF Pilot
Primary Purpose
Heart Failure With Reduced Ejection Fraction
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pharmacist-led HFrEF medication optimization
Usual care
Sponsored by
About this trial
This is an interventional health services research trial for Heart Failure With Reduced Ejection Fraction focused on measuring medication, pharmacist, pharmaceutical care, pharmacotherapy
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated informed consent form; Stated willingness to comply with all study procedures and availability for the duration of the study; Age ≥18 years; Clinic diagnosis of HF with New York Heart Association (NYHA) functional class 1 to 3 at time of screening; Left ventricular ejection fraction (LVEF) ≤40% on cardiac imaging performed within 6 months prior to enrolment; Willingness to receive medications for the management of HFrEF; Access to necessary resources for participating (telephone ± computer with internet access). Exclusion Criteria: Already receiving target doses of sacubitril-valsartan, evidence-based beta-blocker and a mineralocorticoid receptor antagonist at time of screening; Lying/sitting systolic blood pressure <90 mm Hg at time of enrolment; Serum potassium ≥5.5 mmol/L at time of enrolment; ≥2 measurements indicating estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 within 3 months prior to enrolment; Being considered for heart transplant, durable mechanical circulatory support, or intravenous inotropes at time of screening; 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; Felt by the multidisciplinary HF clinic team to be unsuitable for the trial (e.g. substance abuse and other psychological disorders, significant language barrier).
Sites / Locations
- St. Paul's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Pharmacist-led HFrEF medication optimization
Usual care
Arm Description
Both the intervention group and comparator group will receive usual care by the multidisciplinary HF clinic, including standard-of-care clinical pharmacy services.
Outcomes
Primary Outcome Measures
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.
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
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
Secondary Outcome Measures
Optimization of HFrEF medications
Modified optimal medical therapy (OMT) score. Range 0 (worst) to 8 (best): suboptimal (0-4), acceptable (5-7), optimal (8).
Optimization of HFrEF medications
Modified optimal medical therapy (OMT) score
Optimization of HFrEF medications
Modified optimal medical therapy (OMT) score
Medication adherence
5-item Medication Adherence Report Scale (MARS-5)
Medication adherence
5-item Medication Adherence Report Scale (MARS-5)
Medication adherence
5-item Medication Adherence Report Scale (MARS-5)
Medication adverse effects
Open-ended question about HF medications
Medication adverse effects
Open-ended question about HF medications
Medication adverse effects
Open-ended question about HF medications
Quality of life: 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Quality of life: 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Quality of life: 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Treatment burden
Treatment Burden Questionnaire (TBQ)
Treatment burden
Treatment Burden Questionnaire (TBQ)
Treatment burden
Treatment Burden Questionnaire (TBQ)
Treatment satisfaction
Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)
Treatment satisfaction
Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)
Treatment satisfaction
Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)
Full Information
NCT ID
NCT05623358
First Posted
November 7, 2022
Last Updated
March 9, 2023
Sponsor
University of British Columbia
Collaborators
University of Alberta
1. Study Identification
Unique Protocol Identification Number
NCT05623358
Brief Title
PHARM Optimal-HF Pilot
Official Title
Pharmacist-led Intervention for Optimal Heart Failure Medications: A Pilot Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2023 (Anticipated)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
University of Alberta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Reduced Ejection Fraction
Keywords
medication, pharmacist, pharmaceutical care, pharmacotherapy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pharmacist-led HFrEF medication optimization
Arm Type
Experimental
Arm Title
Usual care
Arm Type
Other
Arm Description
Both the intervention group and comparator group will receive usual care by the multidisciplinary HF clinic, including standard-of-care clinical pharmacy services.
Intervention Type
Other
Intervention Name(s)
Pharmacist-led HFrEF medication optimization
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of recruitment
Description
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.
Time Frame
Baseline
Title
Feasibility of achieving rapid optimal medical therapy in intervention arm
Description
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
Time Frame
month 6
Title
Feasibility of patient-reported outcome measure (PROM) collection & participant retention
Description
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
Time Frame
month 12
Secondary Outcome Measure Information:
Title
Optimization of HFrEF medications
Description
Modified optimal medical therapy (OMT) score. Range 0 (worst) to 8 (best): suboptimal (0-4), acceptable (5-7), optimal (8).
Time Frame
month 3
Title
Optimization of HFrEF medications
Description
Modified optimal medical therapy (OMT) score
Time Frame
month 6
Title
Optimization of HFrEF medications
Description
Modified optimal medical therapy (OMT) score
Time Frame
month 12
Title
Medication adherence
Description
5-item Medication Adherence Report Scale (MARS-5)
Time Frame
month 3
Title
Medication adherence
Description
5-item Medication Adherence Report Scale (MARS-5)
Time Frame
month 6
Title
Medication adherence
Description
5-item Medication Adherence Report Scale (MARS-5)
Time Frame
month 12
Title
Medication adverse effects
Description
Open-ended question about HF medications
Time Frame
month 3
Title
Medication adverse effects
Description
Open-ended question about HF medications
Time Frame
month 6
Title
Medication adverse effects
Description
Open-ended question about HF medications
Time Frame
month 12
Title
Quality of life: 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Time Frame
month 3
Title
Quality of life: 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Time Frame
month 6
Title
Quality of life: 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Time Frame
month 12
Title
Treatment burden
Description
Treatment Burden Questionnaire (TBQ)
Time Frame
month 3
Title
Treatment burden
Description
Treatment Burden Questionnaire (TBQ)
Time Frame
month 6
Title
Treatment burden
Description
Treatment Burden Questionnaire (TBQ)
Time Frame
month 12
Title
Treatment satisfaction
Description
Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)
Time Frame
month 3
Title
Treatment satisfaction
Description
Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)
Time Frame
month 6
Title
Treatment satisfaction
Description
Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)
Time Frame
month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of signed and dated informed consent form;
Stated willingness to comply with all study procedures and availability for the duration of the study;
Age ≥18 years;
Clinic diagnosis of HF with New York Heart Association (NYHA) functional class 1 to 3 at time of screening;
Left ventricular ejection fraction (LVEF) ≤40% on cardiac imaging performed within 6 months prior to enrolment;
Willingness to receive medications for the management of HFrEF;
Access to necessary resources for participating (telephone ± computer with internet access).
Exclusion Criteria:
Already receiving target doses of sacubitril-valsartan, evidence-based beta-blocker and a mineralocorticoid receptor antagonist at time of screening;
Lying/sitting systolic blood pressure <90 mm Hg at time of enrolment;
Serum potassium ≥5.5 mmol/L at time of enrolment;
≥2 measurements indicating estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 within 3 months prior to enrolment;
Being considered for heart transplant, durable mechanical circulatory support, or intravenous inotropes at time of screening;
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;
Felt by the multidisciplinary HF clinic team to be unsuitable for the trial (e.g. substance abuse and other psychological disorders, significant language barrier).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ricky Turgeon, BSc(Pharm), ACPR, PharmD
Phone
2367776961
Email
ricky.turgeon@ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricky Turgeon, BSc(Pharm), ACPR, PharmD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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PHARM Optimal-HF Pilot
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