Pharmacist-Led Intervention to Enhance Direct Oral Anticoagulant Adherence and Treatment Outcomes in Atrial Fibrillation: A Pragmatic Clinical Trial

Shih-Yu Liu,1 Yen-Ming Huang,1– 3 Shin-Yi Lin,2,3 Chi-Chuan Wang1– 3 1Graduate Institute of Clinical Pharmacy, College of Medicine, National Taiwan University, Taipei City, Taiwan; 2School of Pharmacy, College of Medicine, National Taiwan University, Taipei City, Taiwan; 3Department of Pharmacy, National Taiwan University Hospital, Taipei City, TaiwanCorrespondence: Chi-Chuan Wang, School of Pharmacy, National Taiwan University, Room 203, No. 33, Linsen S. Road, Zhongzheng District, Taipei City, 100025, Taiwan, Tel +886-2-33668739, Fax +886-2-2391-9098, Email [email protected]: This study aims to evaluate the impact of a pharmacist-led education program on medication adherence and treatment outcomes among patient with atrial fibrillation (AF) using direct oral anticoagulants (DOACs) for stroke prevention. Additionally, we will compare self-reported adherence with claims data and examine whether DOAC blood concentration can serve as a biomarker for medication adherence and treatment outcomes.Patients and Methods: We will conduct a pragmatic randomized controlled trial at National Taiwan University Hospital (NTUH). Patients aged 18 years or older, diagnosed with AF, and newly initiated on DOACs for primary or secondary stroke prevention will be randomized to either the intervention or control group. The intervention group will receive pharmacist-led education at baseline; the control group will receive usual care. The primary endpoint is patients’ self-reported medication-use behavior, measured by the Traditional Chinese version of the Adherence to Refills and Medications Scale. We will also compare self-reported adherence with an objective adherence indicator, the DOAC trough concentration, determined by ultra-high-performance liquid chromatography coupled with tandem mass spectrometry. After randomization, participants will return to their routine clinical care, and all follow-up assessments will coincide with their regular clinic visits. Patients’ DOAC use behaviors and blood concentrations will be measured at 3- and 6-month follow-ups. Baseline characteristics and treatment outcomes will be obtained from NTUH electronic medical records and the National Health Insurance claims data.Conclusion: This trial will evaluate the effectiveness of pharmacist-led education in improving DOAC adherence and treatment outcomes over a 6-month follow-up period. The findings will inform the development and implementation of future pharmacist-led care models.Trial Registration: The study protocol has been registered at ClinicalTrials.gov (identifier NCT07159399).Keywords: pharmacist-led service, anticoagulation, pragmatic trial