Clinical Research Directory

Do QT-Prolonging Drugs Cause Major Adverse Cardiac Events in Hospitalized Adults?

There are 28 non-cardiology medications from multiple families costing more than $13 billion annually in Canada, categorized as 'Known' QT-prolonging medications (QTPmeds) based on very low levels of evidence. The association between many commonly used medications listed as known QTPmeds and actual major adverse cardiac events (MACE) is weak. Meanwhile, QTPmeds-related warnings are ubiquitous in every healthcare setting, triggering 'hard stop' disruption millions of times per day to front line clinicians. Poor quality medication safety alerts are increasingly recognized as a source of inferior patient care and provider burnout which detracts from healthcare sustainability. In this study, anonymized hospital electronic medical record data from more than 990,000 adult patients across Ontario will be used to compare patients who experience MACE with those who do not, measuring their real-time exposure to QT-prolonging drugs. Additionally, machine-learning techniques will also be used to find which patient or treatment factors best predict risk. The objectives of this study are to 1) Investigate whether exposure to one or more 'Known' QTPmed is associated with an increased risk of MACE after adjusting for confounders; and 2) Identify predictors and their relative importance for QTPmeds-associated MACE. In summary, QT-prolonging medications have the potential to cause very serious adverse events, including death. However, it is not sufficiently clear which patients under which circumstances suffer events, or when is QT prolongation a useful surrogate marker for harm. Meanwhile, ubiquitous medication alerts related to QT-prolonging medications are at best imprecise and at worst, misleading, costly and potentially dangerous. Now that data resources are available with the data elements, structure and sample size required to rigorously assess this association, this study will address this question to improve patient safety, provider satisfaction and the cost-effectiveness of care.

Medicines in Breast Milk and Estimated Infant Exposure

The MedMilk (Medication concentrations in human Milk) study investigates how selected medicines taken by breastfeeding women are transferred into human milk and whether this may affect the breastfed child. The study includes breastfeeding women who are already using prescription or over-the-counter medicines as part of their usual care. Participants provide samples of breast milk and urine and complete a questionnaire about maternal and infant health. The collected data will be used to quantify medicine concentrations in milk and estimate the relative infant dose. The study aims to contribute new data to support safer prescribing and more informed counselling during breastfeeding

Assessing the Role of Pharmaceutical Technical Assistents in Hospital Wards: Measuring Efficiency and Medication Safety

The goal of this interventional study is to evaluate the impact of implementing pharmaceutical technical assistants (PTAs) to support the medication process on hospital wards on operational efficiency and medication safety among nurses and pharmaceutical technicial assistants. The main questions it aims to answer are: * What is the effect of PTAs on the time spent by (night) nurses on medication dispensation? * How does their involvement influence unplanned interactions between nursing staff and the pharmacy? * What is the impact of PTAs on the safety of medication processes, including missed or delayed doses, accuracy of dispensed medication, and reported medication errors? Researchers will compare periods with and without the involvement of PTAs in the medication management process on the hospital ward to assess differences in: * Time spent on medication dispensation. * Frequency of unplanned interactions between hospital wards and the pharmacy. * Rates of missed or delayed medication doses. * Accuracy of dispensed medication compared to prescriptions. * Reported medication errors. During the observed medication dispensation processes, involved nurses and PTAs will: * Be observed while preparing medications to measure time and interruptions. * Provide data on medication errors and delays through digital systems and reports. * Complete a demographic questionnaire about their professional background. This study involves both intervention and control periods, allowing researchers to measure the specific effects of PTAs' involvement in medication processes.

Evaluation of Medication Management Service

Medication management services (MMS) is a pharmacist-led service of optimizing the medication use and health outcomes, by promoting medication safety and enhancing the ability in self-management of health and diseases of patients and their caregivers. Yet, only limited evidence on the implementation of MMS service in Hong Kong is available. The goal of this clinical trial is to evaluate the cost effectiveness and effects of implementing MMS in community pharmacies owned by 8 non-government organizations (NGOs) in Hong Kong on humanistic and clinical outcomes in patients with hypertension and/or type II diabetes mellitus. The clinical trial aims to look into the following aspects: * To evaluate the perception and satisfaction of patients on MMS service * To investigate whether MMS could improve patients' adherence to their medication regimen, health-related quality of life, health outcomes and health service utilization, as well as their ability to understand and cope with their illness and drug-related problems * To identify and categorize the types of drug-related problems identified during MMS * To evaluate the cost-effectiveness of implementing MMS in community pharmacies MMS services will be rolled out in a total of 8 NGO community pharmacies progressively (2 pharmacies per phase) in 4 successive phases. Participants will complete the questionnaires at the following time points throughout the trial, namely 1) during recruitment, 2) baseline (1 month before MMS), 3) 3 months after MMS begins, 4) 12 months after MMS begins, and 5) 24 months after MMS begins. Researchers will compare the results of questionnaires conducted at different time points to identify the potential changes in the effects of MMS. Furthermore, researchers will link up the electronic health records of the participants and identify the potential changes in the health outcomes and health service utilizations after receiving MMS.