Clinical trial NCT06273761: Evaluation of Medication Management Service
Official title: Primary Care Community Pharmacy Project: Evaluation of Medication Management Service
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Medication Adherence
Medication Safety
Diabetes Mellitus, Type 2
Hypertension
Polypharmacy
High Risk Medications
Keywords: Medication Management Service
Community pharmacy service
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The Hong Kong Jockey Club Charities Trust
name: Hong Kong Sheng Kung Hui Welfare Council Limited
name: Hong Kong Young Women's Christian Association
name: Haven of Hope Hospital
name: Pok Oi Hospital
name: St. James' Settlement
name: Aberdeen Kai-fong Welfare Association
name: Health In Action
name: Lok Sin Tong Benevolent Society, Kowloon
First posted: 2024-02-23
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

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 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.

Eligibility criteria: Inclusion Criteria:

* aged 18 years or above
* diagnosed with Type 2 diabetes mellitus and/or hypertension
* having regular follow-up on Type 2 diabetes mellitus and/or hypertension at Hospital Authority
* no A\&E admission/hospitalization in the past 3 months
* no recent changes in medication regimen in the past 3 months
* polypharmacy (taking 5 or more chronic medications)
* using at least 1 high-risk medication (Anticoagulants, Oral hypoglycaemics, Insulins, psychotropic medications or immunosuppressants)
* able to communicate in Cantonese and/or English

Exclusion Criteria:

* aged below 18
* unable to give informed consent
* unable to communicate in Cantonese and/or English

Primary outcomes:
measure: Medication adherence
timeFrame: Medication adherence 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.
Secondary outcomes:
measure: Additional health service utilization
timeFrame: Through study completion, an average of 1 year
measure: Patient perception and satisfaction
timeFrame: 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.
measure: Patient perceived sensitivity to medicines
timeFrame: 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.
measure: Social impact
timeFrame: 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.
measure: Health-related quality of life
timeFrame: 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.
measure: Drug-related problems
timeFrame: Throughout the study period, up to 24 months.
measure: Change in costs
timeFrame: Throughout the study period, up to 24 months.
measure: Change in effectiveness
timeFrame: Throughout the study period, up to 24 months.
measure: Incremental cost effectiveness ratio (ICER)
timeFrame: Throughout the study period, up to 24 months.
measure: Beliefs in medicines
timeFrame: 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.
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Aberdeen Kai-Fong Welfare Association A-Lively Community Pharmacy
city: Hong Kong
country: Hong Kong
facility: Health In Action Community Pharmacy
city: Hong Kong
country: Hong Kong
facility: Hong Kong Sheng Kung Hui Welfare Council Community Pharmacy
city: Hong Kong
country: Hong Kong
facility: PHARM+ Haven of Hope Community Pharmacy
city: Hong Kong
country: Hong Kong
facility: PHARM+ Pok Oi Hospital Community Pharmacy
city: Hong Kong
country: Hong Kong
facility: PHARM+ St. James' Settlement Community Pharmacy
city: Hong Kong
country: Hong Kong
facility: PHARM+ The Lok Sin Tong Community Pharmacy
city: Hong Kong
country: Hong Kong
facility: PHARM+ YWCA Community Pharmacy
Study officials:
References: