Improving medication adherence and satisfaction with pharmacist-provided services for heart failure patients using a risk management dashboard
| ISRCTN | ISRCTN13218468 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13218468 |
- Submission date
- 02/09/2024
- Registration date
- 03/09/2024
- Last edited
- 30/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Heart failure with reduced ejection fraction (HFrEF) is a severe health issue, leading to frequent hospital visits and high death rates. Although there are effective treatments available, many patients do not take their medications as prescribed, which worsens their condition. This study aims to see if using an interactive patient-centered dashboard during pharmacist consultations can help patients better understand their condition, stick to their medication schedule, and be more satisfied with the services provided by pharmacists.
Who can participate?
Adults aged 20 years or older diagnosed with HFrEF can participate and receive care at the National Taiwan University Hospital (NTUH), including its pharmacist-led heart failure clinic, cardiology department, or cardiology ward. Participants need to be able to give consent and complete some simple questionnaires.
What does the study involve?
Participants will be randomly assigned to receive either standard care from a pharmacist or standard care with the addition of an interactive dashboard. The dashboard will show personalized risk and survival information to help patients understand their health better. Participants will complete short questionnaires at the start and after 3 and 6 months to measure how well they follow their medication plan and how satisfied they are with the pharmacist's help.
What are the possible benefits and risks of participating?
Participants may become more actively involved in their treatment process. By better understanding their current health status and medications, they are more likely to improve their medication adherence. This increased engagement and understanding can lead to better health outcomes and greater satisfaction with the pharmacy care they receive. The study may also help develop better tools for managing heart failure.
The risks are very low, but some participants might feel anxious or uncomfortable seeing their health information on the dashboard.
Where is the study run from?
National Taiwan University Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
April 2024 to October 2025
Who is funding the study?
National Taiwan University (Taiwan)
Who is the main contact?
Dr Wan-Tseng Hsu, wantsenghsu@ntu.edu.tw and wantsenghsu@gmail.com
Contact information
Public, Scientific, Principal Investigator
R201, 2F, No. 33, Linsen S. Rd.
Zhongzheng Dist.
Taipei
100
Taiwan
 ORCID ID |
0000-0001-6358-999X |
|---|---|
| Phone | +886 (0)2 3366 8195 |
| wantsenghsu@ntu.edu.tw |
Study information
| Study design | Single-center pragmatic two-arm crossover randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A pragmatic improvement for medication adherence and patient satisfaction with pharmacist services with an interactive dashboard for heart failure with reduced ejection fraction |
| Study acronym | PRIME PharmD-HFrEF |
| Study objectives | Integrating a dashboard within pharmacist-led interventions can improve medication adherence among patients with heart failure with reduced ejection fraction (HFrEF). |
| Ethics approval(s) |
Approved 22/08/2024, National Taiwan University Hospital Research Ethics Committee B (No.7, Chung Shan S. Rd. Zhongshan S. Rd., Zhongzheng Dist., Taipei, 100, Taiwan; +886 (0)2 2312 3456 ext. 263417; ntuhrec@ntuh.gov.tw), ref: 202001049RINB |
| Health condition(s) or problem(s) studied | Heart failure |
| Intervention | Before conducting the education sessions, the pharmacists will review the patients’ medical records, including medications and laboratory data, using the portal system. This review is part of their standard routine before patient education into which dashboard interventions will be pragmatically integrated. After the screening, potential participants will first be invited by their attending pharmacist. The researchers will allocate participants to treatment groups using permuted block randomization to ensure a balanced distribution across the groups, with permuted blocks of size 4. Eligible and consenting participants randomly assigned to Group A will receive standard pharmacist-led education (e.g., regular follow-ups and medication education) along with the dashboard intervention, while those in Group B will receive only standard pharmacist-led education, with a crossover occurring after 3 months. The dashboard intervention is pragmatically incorporated into patient education. |
| Intervention type | Other |
| Primary outcome measure | Medication adherence will be assessed using the Morisky 8-item Medication Adherence Scale (MMAS-8) at baseline (T0), 3 months (T1), and 6 months (T2) after randomization. |
| Secondary outcome measures | 1. Patient satisfaction with pharmacist services will be evaluated using the adapted Chinese version of the Patient Satisfaction with Pharmacist Services Questionnaire 2.0 (C-PSPSQ 2.0) at baseline (T0), 3 months (T1), and 6 months (T2) after randomization. 2. Facilitators and barriers to the implementation: To explore potential facilitators and barriers to the implementation of the dashboard, a subgroup of pharmacists and patients will complete the Acceptability of Intervention Measure, Intervention Appropriateness Measure, and Feasibility of Intervention Measure (AIM-IAM-FIM) questionnaire at 6 months (T2) after randomization. |
| Overall study start date | 01/04/2024 |
| Completion date | 31/10/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 70 |
| Key inclusion criteria | Patients with heart failure and a documented left ventricular ejection fraction (LVEF) <40% |
| Key exclusion criteria | 1. Patients unable to provide full informed consent 2. Patients unable to comply with study procedures 3. Patients unable to complete the required questionnaires in person on three occasions or return for follow-up visits 4. Patients who cannot understand or respond to the required questionnaires |
| Date of first enrolment | 01/02/2025 |
| Date of final enrolment | 31/03/2025 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Zhongshan S. Rd.
Zhongzheng Dist.
Taipei
100
Taiwan
Sponsor information
Hospital/treatment centre
No.7, Chung Shan S. Rd.
Zhongshan S. Rd.
Zhongzheng Dist.
Taipei
100
Taiwan
| Phone | +886 (0)2 2312 3456 |
|---|---|
| 111361@ntuh.gov.tw | |
| Website | http://www.ntuh.gov.tw/en/default_P.aspx |
"ROR" |
https://ror.org/03nteze27 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- 關臺大, NTU
- Location
- Taiwan
Results and Publications
| Intention to publish date | 31/10/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Upon completion, the study protocol and trial results will be submitted for publication in international peer-reviewed journals. These publications will ensure that the findings are well-communicated. |
| IPD sharing plan | All de-identified data and dashboard code supporting this study may be provided upon reasonable written request from the corresponding author of the original article. The full protocol, final de-identified dataset, and statistical code will be made available exclusively for scientific purposes after the publication of the study outcomes. |
Editorial Notes
30/10/2024: Internal review.
03/09/2024: Study's existence confirmed by National Taiwan University Hospital Research Ethics Committee B.
