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

Browse trials for

• Heart Failure 5,701

Keywords

• heart failure with reduced ejection fraction
• medication adherence
• dashboard
• health information technology
• patient education
• pharmacist
• pragmatic trial
• randomized controlled trial
• sacubitril/valsartan
• implementation

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 200 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Study arms

• Experimental
  Low Adherence Cluster - Intervention Group

  Dashboard interventions integrated into pharmacist-led education in the low adherence cluster

  Device: interactive visualization dashboard (the Enhancing Sacubitril/valsartan Adherence from Initiation to Continuation [ESAIC] dashboard)

• No intervention
  Low Adherence Cluster - Control Group

  Pragmatic pharmacist-led education, without dashboard interventions, in the low adherence cluster

• Experimental
  High Adherence Cluster - Intervention Group

  Dashboard interventions integrated into pharmacist-led education in the high adherence cluster

  Device: interactive visualization dashboard (the Enhancing Sacubitril/valsartan Adherence from Initiation to Continuation [ESAIC] dashboard)

• No intervention
  High Adherence Cluster - Control Group

  Pragmatic pharmacist-led education, without dashboard interventions, in the high adherence cluster

Interventions

• Deviceinteractive 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 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.

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.

   Time frame: 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

1. 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.

   Time frame: 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. 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.

   Time frame: 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).

3. 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.

   Time frame: 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).

4. 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.

   Time frame: 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).

5. 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.

   Time frame: 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).

6. 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.

   Time frame: 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).

7. 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.

   Time frame: From enrollment to the end of treatment at 12 months (two key time points: baseline (T0) and 3 months (T1) post-randomization).

Individual participant data

Plan to share: No — We believe that safeguarding patient confidentiality is of utmost importance, and the current study protocol does not include provisions for public data sharing.