Optimizing the Pharmacotherapy of Vascular Surgery Patients at Hospital Admission and Discharge (PHAROS): Protocol for a Quasi-Experimental Clinical Uncontrolled Trial.

Abstract

Background: Patient safety is essential in pharmacotherapy, especially in surgical contexts, due to the elevated risk of drug-related complications. Vascular surgery patients are particularly susceptible because of their complex medication needs and underlying health conditions. Improved safety monitoring and targeted pharmaceutical care in collaboration with physicians are crucial to minimize these risks and enhance patient outcomes.

Objective: This protocol evaluates whether structured pharmaceutical care interventions-including medication reconciliation, medication review, and patient education-can reduce the prevalence of drug-related problems at hospital admission and discharge in vascular surgery patients.

Methods: This prospective, uncontrolled study was conducted over 1 year in the Vascular Surgery Department at the National Institute of Cardiovascular Diseases in Bratislava, Slovakia. The study included adult patients with carotid artery disease or lower extremity artery disease who were on 3 or more medications, with an estimated sample size of approximately 100 patients. The primary intervention involved 3 key changes in practice: medication reconciliation at both admission and discharge, where hospital pharmacists review and verify medication lists; medication review to identify and address drug-related problems; and patient education at discharge. Pharmacist-proposed interventions were documented and communicated to the physician for treatment adjustments. The primary outcome is the change in drug-related problem prevalence from hospital admission to discharge. Secondary outcomes include the acceptance rate of pharmacist recommendations and patient understanding of pharmacotherapy. Data collection involved documenting the number, type, and frequency of drug-related problems; the anatomical therapeutic chemical classification of medications associated with drug-related problems; and patients' social, demographic, and clinical characteristics, with a focus on factors related to drug-related problems, comorbidities, and medication use. Data analysis will use the paired Wilcoxon signed-rank test to compare the prevalence of drug-related problems and medication counts between admission and discharge. Continuous variables will be presented as means (SDs), while categorical variables will be reported as counts and percentages. Patient understanding of pharmacotherapy will be evaluated using a 3-point scale, classifying understanding as good (2-3 points per medication), modest (1-2 points), or poor (0-1 point).

Results: Recruitment began in September 2021 and concluded in August 2022. Data collection occurred continuously during hospital stays, capturing demographics, comorbidities, pharmacotherapy, and drug-related problems at admission and discharge. Important milestones included the initial data review, which began in August 2023 to assess recruitment and data quality, including an early evaluation of drug-related problems. The primary analysis was completed in January 2024, focusing on the reduction in drug-related problems, intervention acceptance, and patient understanding. The final report was to be prepared by June 2024, disseminating the findings on pharmacist-led intervention impacts.

Conclusions: This study should demonstrate that pharmacist-led interventions in collaboration with physicians can reduce pharmacotherapy risks and optimize medicine management for patient safety.

Trial registration: ClinicalTrials.gov NCT04930302; https://clinicaltrials.gov/study/NCT04930302.

International registered report identifier (irrid): RR1-10.2196/60728.