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| Name | Class |
|---|---|
| University of Alberta | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacist-led HFrEF medication optimization | Experimental |
| |
| Usual care | Other | Both the intervention group and comparator group will receive usual care by the multidisciplinary HF clinic, including standard-of-care clinical pharmacy services. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacist-led HFrEF medication optimization | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of recruitment | Composite of:
| 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:
| month 12 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ricky Turgeon, BSc(Pharm), ACPR, PharmD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Paul's Hospital | Vancouver | British Columbia | Canada |
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| Usual care | Other | 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. |
|
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 |