Pharmacist-Led Education Through Interactive Visualization Dashboards for Adherence Support and Sustained Involvement in Sacubitril/Valsartan Therapy for Patients With Heart Failure With Reduced Ejection Fraction (PharmD ASSIST HFrEF): Study Protocol for Implementation in a Parallel-Group, Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Medication adherence to sacubitril/valsartan
研究概览
简要总结
The goal of this pragmatic clinical trial is to evaluate whether pharmacist-led education, integrated with interactive visualization dashboards, can enhance medication adherence in patients with heart failure who are prescribed sacubitril/valsartan. The main question it aims to answer is: Can pharmacist-led interactive visualization dashboards improve adherence to sacubitril/valsartan compared to usual care without the dashboard intervention?
Researchers will compare patients receiving pharmacist-led education with interactive dashboards to those receiving standard education, assessing differences in medication adherence and clinical outcomes, among others.
Participants will:
- Complete baseline and follow-up questionnaires on medication adherence and satisfaction with pharmacist-provided services, and others.
- Engage in education sessions led by pharmacists, with or without dashboard integration.
The study outcomes will include medication adherence, and secondary outcomes such as patient satisfaction with pharmacist-provided services, optimized guideline-directed medical therapy score, time to high medication adherence, the calculated proportion of days covered, New York Heart Association functional classification, and the net promoter score used for evaluating recommendation and satisfaction with the dashboard intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults aged 20 or older
- •a diagnosis of HFrEF, which is defined by a left ventricular ejection fraction of 40% or less
- •currently receiving sacubitril/valsartan at the time of recruitment
- •receiving care at the cardiology department or cardiology ward at National Taiwan University Hospital
- •referral from the clinicians at National Taiwan University Hospital
排除标准
- •unable or unwilling to provide informed consent, adhere to study protocols, or complete required questionnaires in person during three scheduled visits (i.e., 3, 6, 12 months after the baseline measurement)
- •having received care at the pharmacist-led HF clinic at National Taiwan University Hospital
研究组 & 干预措施
Low Adherence Cluster - Intervention Group
Dashboard interventions integrated into pharmacist-led education in the low adherence cluster
干预措施: interactive visualization dashboard (the Enhancing Sacubitril/valsartan Adherence from Initiation to Continuation [ESAIC] dashboard) (Device)
Low Adherence Cluster - Control Group
Pragmatic pharmacist-led education, without dashboard interventions, in the low adherence cluster
High Adherence Cluster - Intervention Group
Dashboard interventions integrated into pharmacist-led education in the high adherence cluster
干预措施: interactive visualization dashboard (the Enhancing Sacubitril/valsartan Adherence from Initiation to Continuation [ESAIC] dashboard) (Device)
High Adherence Cluster - Control Group
Pragmatic pharmacist-led education, without dashboard interventions, in the high adherence cluster
结局指标
主要结局
Medication adherence to sacubitril/valsartan
时间窗: From enrollment to the end of treatment at 12 months (four key time points: baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3) post-randomization).
Medication adherence will be assessed using the Morisky 8-item Medication Adherence Scale (MMAS-8) for sacubitril/valsartan, with scores ranging from 0 to 8, where higher scores indicate better medication adherence.
次要结局
- Patient satisfaction with pharmacist-provided services(From enrollment to the end of treatment at 12 months (four key time points: baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3) post-randomization).)
- Optimized guideline-directed medical therapy (GDMT) score(From enrollment to the end of treatment at 12 months (four key time points: baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3) post-randomization).)
- Medication adherence to guideline-directed medical therapy (GDMT)(From enrollment to the end of treatment at 12 months (four key time points: baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3) post-randomization).)
- Time to high medication adherence(From enrollment to the end of treatment at 12 months (four key time points: baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3) post-randomization).)
- Proportion of days covered (PDC)(From enrollment to the end of treatment at 12 months (four key time points: baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3) post-randomization).)
- New York Heart Association (NYHA) functional classification(From enrollment to the end of treatment at 12 months (four key time points: baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3) post-randomization).)
- Net Promoter Score (NPS)(From enrollment to the end of treatment at 12 months (two key time points: baseline (T0) and 3 months (T1) post-randomization).)