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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Adherence Cluster - Intervention Group | Experimental | Dashboard interventions integrated into pharmacist-led education in the low adherence cluster |
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| Low Adherence Cluster - Control Group | No Intervention | Pragmatic pharmacist-led education, without dashboard interventions, in the low adherence cluster | |
| High Adherence Cluster - Intervention Group | Experimental | Dashboard interventions integrated into pharmacist-led education in the high adherence cluster |
|
| High Adherence Cluster - Control Group | No Intervention | Pragmatic pharmacist-led education, without dashboard interventions, in the high adherence cluster |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| interactive visualization dashboard (the Enhancing Sacubitril/valsartan Adherence from Initiation to Continuation [ESAIC] dashboard) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction with pharmacist-provided services | Patient satisfaction will be assessed using the adapted Traditional Chinese version of the modified Patient Satisfaction with Pharmacist Services Questionnaire 2.0 (C-mPSPSQ 2.0). C-mPSPSQ 2.0 is a 6-item scale, with scores ranging from 4 to 24, where higher scores indicate better 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wan-Tseng Hsu, PhD | Contact | +886 2 - 3366 - 8195 | wantsenghsu@ntu.edu.tw | |
| Tung-Chun Russell Chien, PharmD | Contact | +886 2 - 3365 - 5365 | f12451007@ntu.edu.tw |
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We believe that safeguarding patient confidentiality is of utmost importance, and the current study protocol does not include provisions for public data sharing.
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| Optimized guideline-directed medical therapy (GDMT) score | The score, adapted from the ΔGDMT score from Man et al. (2024) and the Optimization Potential Score from Verma et al. (2023), is calculated by dividing the received dose by the target dose based on each class of GDMT according to the current HF guidelines, ranging from 0 to 1 per medication of GDMT. The maximum total score per patient is 5, with four pillars of GDMT and extra one point for a switch from ACEI/angiotensin receptor blockers to sacubitril/valsartan due to the complexity of reimbursement in Taiwan. If valid reasons for not prescribing GDMT are documented in the electronic health records, a score of 1 will still be assigned for each instance. | 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) | Medication adherence will be assessed using the Morisky 8-item Medication Adherence Scale (MMAS-8) for GDMT, 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). |
| Time to high medication adherence | The time to achieving high medication adherence (defined as a score of 8 on the Morisky 8-item Medication Adherence Scale [MMAS-8]) will be analyzed separately for patients who attain high adherence to sacubitril/valsartan and guideline-directed medical therapy (GDMT), 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). |
| Proportion of days covered (PDC) | The PDC will also be calculated to triangulate and validate the results of the Morisky 8-item Medication Adherence Scale (MMAS-8). The data of the PDC will be accessed through the National Health Insurance MediCloud System in Taiwan. The PDC for each guideline-directed medical therapy (GDMT) is calculated by the total days covered in the period divided by the total prescription days in the period, with the common threshold of 80% indicating acceptable 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). |
| New York Heart Association (NYHA) functional classification | The NYHA functional classification, which categorizes heart failure severity into four classes based on symptoms and limitations to physical activity, will be assessed by pharmacists. | 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) | The level of participant endorsement for the intervention (i.e., the ESAIC dashboard) will help identify areas for further enhancement and support its integration into routine clinical practice. The NPS ranges from 1 to 10, with increments of 1, and is classified into three distinct categories: promoters (scoring 9 or 10), passives (scoring 7 or 8), and detractors (scoring 6 or below). In this trial, both pharmacists and patients will provide NPS ratings. | From enrollment to the end of treatment at 12 months (two key time points: baseline (T0) and 3 months (T1) post-randomization). |
| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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