Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06273761
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2024-01-09
Brief Title:
Evaluation of Medication Management Service
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Primary Care Community Pharmacy Project Evaluation of Medication Management Service
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 andor 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
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
Detailed Description:
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 AE 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
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 AE 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None