Pharmacist-led Intervention for Optimal Heart Failure Medications: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Feasibility of recruitment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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).
结局指标
主要结局
Feasibility of recruitment
时间窗: Baseline
Composite of: 1. Proportion eligible at pre-screening ≥50% of all HF clinic patients assessed based on inclusion criteria at pre-screening; 2. Proportion eligible at screening ≥25% of all patients based on inclusion and exclusion criteria on screening; 3. Mean recruitment ≥2 participants/week.
Feasibility of achieving rapid optimal medical therapy in intervention arm
时间窗: month 6
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
时间窗: month 12
Composite of: 1. Follow-up at 6 months complete in ≥90% at 6 months, ≥80% at 12 months, excluding deaths 2. ≥90% completion of PROM questionnaires at months 3 and 6, and ≥80% completion at month 12
次要结局
- Quality of life: 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12)(month 12)
- Treatment satisfaction(month 12)
- Medication adverse effects(month 12)
- Optimization of HFrEF medications(month 12)
- Medication adherence(month 12)
- Treatment burden(month 12)
研究者
Ricky Turgeon
Principal Investigator
University of British Columbia