Evaluating Dashboard-Integrated Pharmacist-Led Education on Improving Sacubitril/Valsartan Adherence in Heart Failure (PharmD ASSIST HFrEF)
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
1 other identifier
interventional
200
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2025
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2025
CompletedFirst Posted
Study publicly available on registry
March 28, 2025
CompletedStudy Start
First participant enrolled
April 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2027
April 2, 2025
March 1, 2025
1.6 years
March 23, 2025
March 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Medication adherence to sacubitril/valsartan
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.
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 (7)
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).
- +2 more secondary outcomes
Study Arms (4)
Low Adherence Cluster - Intervention Group
EXPERIMENTALDashboard interventions integrated into pharmacist-led education in the low adherence cluster
Low Adherence Cluster - Control Group
NO INTERVENTIONPragmatic pharmacist-led education, without dashboard interventions, in the low adherence cluster
High Adherence Cluster - Intervention Group
EXPERIMENTALDashboard interventions integrated into pharmacist-led education in the high adherence cluster
High Adherence Cluster - Control Group
NO INTERVENTIONPragmatic pharmacist-led education, without dashboard interventions, in the high adherence cluster
Interventions
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 changes, an alternative dataset is deliberately entered, portraying either improvement or deterioration in the patient's status, thereby acting as a motivational tool. Throughout the education session, the dashboard continuously updates hazard ratios, enabling direct comparisons of patient outcomes under varying conditions or treatment scenarios. This dynamic process clearly demonstrates individualized risk-benefit trade-offs in diverse treatment contexts.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2025
First Posted
March 28, 2025
Study Start
April 7, 2025
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
October 31, 2027
Last Updated
April 2, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share
We believe that safeguarding patient confidentiality is of utmost importance, and the current study protocol does not include provisions for public data sharing.