Evaluating Dashboard-Integrated Pharmacist-Led Education on Improving Sacubitril/Valsartan Adherence in Heart Failure (PharmD ASSIST HFrEF)

Официальное название

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

Обзор

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.

Вмешательства

• Устройство interactive visualization dashboard (the Enhancing Sacubitril/valsartan Adherence from Initiation to Continuation [ESAIC] dashboard)
  The dashboard serves as an interactive communication tool during education sessions, promoting real-time dialogue between patients and pharmacists. By collaboratively entering patient-specific data, patients gain insight into personalized visual representations of actionable risk factors. Initially, data specific to the patient are inputted to generate a baseline assessment, presenting hazard ratios that indicate the current condition and pinpoint areas needing improvement. To simulate potential

Первичные конечные точки

• Medication adherence to sacubitril/valsartan [Срок оценки: 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).]

Вторичные конечные точки (7)

• Patient satisfaction with pharmacist-provided services [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: From enrollment to the end of treatment at 12 months (two key time points: baseline (T0) and 3 months (T1) post-randomization).]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06900803 · 202501197RINC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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