Clinical trial NCT06900803: Evaluating Dashboard-Integrated Pharmacist-Led Education on Improving Sacubitril/Valsartan Adherence in Heart Failure (PharmD ASSIST HFrEF)
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction (HFrEF)
Sacubitril/Valsartan
Medication Adherence
Keywords: heart failure with reduced ejection fraction
medication adherence
dashboard
health information technology
patient education
pharmacist
pragmatic trial
randomized controlled trial
sacubitril/valsartan
implementation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Medication adherence to sacubitril/valsartan
timeFrame: 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).
Secondary outcomes:
measure: Patient satisfaction with pharmacist-provided services
timeFrame: 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).
measure: Optimized guideline-directed medical therapy (GDMT) score
timeFrame: 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).
measure: Medication adherence to guideline-directed medical therapy (GDMT)
timeFrame: 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).
measure: Time to high medication adherence
timeFrame: 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).
measure: Proportion of days covered (PDC)
timeFrame: 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).
measure: New York Heart Association (NYHA) functional classification
timeFrame: 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).
measure: Net Promoter Score (NPS)
timeFrame: From enrollment to the end of treatment at 12 months (two key time points: baseline (T0) and 3 months (T1) post-randomization).
Other outcomes:
Locations:
Study officials:
References: