Evaluation of Medication Management Service

This is a randomized controlled trial which will be conducted across 8 NGO community pharmacies in Hong Kong. The order of providing MMS service by 8 NGO community pharmacies to study participants will be determined by randomization. The time before each NGO community pharmacy provides MMS service to the study participants is considered as the control period (no MMS service will be provided). A total of 8 NGO community pharmacies will be divided into 4 groups and hence 2 pharmacies will have the same length of control period. The control periods will be categorized into 3-month, 6-month, 9-month and 12-month long. It is anticipated that a total of 640 participants will be recruited to the trial. Informed written consent will be obtained from the study participants before the study starts. Since this trial will involve accessing to personal and healthcare information of study participants for analysis, informed written consent will also be sought for the authorization to access clinical data on the Electronic Health Record Sharing System (eHealth) and the electronic health records from the Hospital Authority (HA) for service evaluation and research purposes. Eligible participants will receive MMS service provided by the pharmacists who work in the NGO community pharmacies after the control period. Different study instruments and methods will be used to evaluate humanistic, clinical and economic outcomes.

To evaluate the humanistic outcomes, participants will complete the validated questionnaires at 5 different 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. Descriptive statistics will be conducted to summarize the participants' characteristics and outcomes of interest. Linear and nonlinear mixed effect models will be conducted for continuous and binary outcomes, respectively.

To evaluate the clinical outcomes, electronic health records of the trial participants will be extracted from the electronic health database of the HA. The HA is the statutory organization that coordinates all public hospitals and primary care clinics, and is responsible for managing the majority of patients with chronic diseases in Hong Kong. Participants' demographics, medical records and clinical parameters will be collected from the HA clinical management system database. Clinical parameters such as blood pressure and blood glucose level will be used to evaluate the differences between before and after MMS. In addition, the attendance and admission records of A\&E and hospitalization will also be collected to evaluate the changes in the health service utilization before and after MMS.

For the evaluation of economic outcomes, a costing study will be conducted to collect the set-up costs and operation costs of MMS service via sending questionnaires to the 8 NGO community pharmacies. Participants will complete the validated questionnaire on health-related quality of life (EQ-5D) to estimate quality-adjusted life years (QALYs). The differences in health service utilization, medical costs and QALYs in participants before and after using MMS will be estimated. The Incremental cost-effectiveness ratio (ICER) based on incremental cost per additional QALY would be calculated. Probabilistic sensitivity analysis based on Monte Carlo simulation will be conducted to test the robustness of estimated costs and QALYs. Finally, a cost-effectiveness acceptability curve will be constructed to assess the simulated probability over a range of amounts that a decision-maker might be willing to pay the MMS for an additional QALY.

• Additional health service utilization [Срок оценки: Through study completion, an average of 1 year]
• Patient perception and satisfaction [Срок оценки: Patient perception and satisfaction will be assessed at 3 time points, namely 1) 3 months after MMS begins, 2) 12 months after MMS begins, and 3) 24 months after MMS begins.]
• Patient perceived sensitivity to medicines [Срок оценки: Patient perceived sensitivity to medicines will be assessed at 3 time points, namely 1) 3 months after MMS begins, 2) 12 months after MMS begins, and 3) 24 months after MMS begins.]
• Social impact [Срок оценки: Social impact will be assessed at 5 time points, 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.]
• Health-related quality of life [Срок оценки: Health-related quality of life will be assessed at 5 time points, 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.]
• Drug-related problems [Срок оценки: Throughout the study period, up to 24 months.]
• Change in costs [Срок оценки: Throughout the study period, up to 24 months.]
• Change in effectiveness [Срок оценки: Throughout the study period, up to 24 months.]
• Incremental cost effectiveness ratio (ICER) [Срок оценки: Throughout the study period, up to 24 months.]
• Beliefs in medicines [Срок оценки: Beliefs in medicines will be assessed at 5 time points, 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.]