Evaluation of Medication Management Service
Primary Care Community Pharmacy Project: Evaluation of Medication Management Service
1 other identifier
interventional
640
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2024
Typical duration for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2024
CompletedStudy Start
First participant enrolled
February 6, 2024
CompletedFirst Posted
Study publicly available on registry
February 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
February 23, 2024
January 1, 2024
2.5 years
January 9, 2024
February 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Medication adherence
Medication adherence will be assessed by the Medication Adherence Report Scale (MARS-5) which consists of a total of 5 items and is used to assess patient's adherence to their medications. Participants rate items on a 5-point scale. The score range for MARS-5 is 5-25, higher score indicates better adherence to take medications.
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 (10)
Additional health service utilization
Through study completion, an average of 1 year
Patient perception and satisfaction
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
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
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
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.
- +5 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALParticipants who join the trial will have have a control period (no intervention) of 3 to 12 months before receiving medication management service (MMS) at 8 NGO community pharmacies. Since there are 8 NGO community pharmacies, 2 NGO community pharmacies will start delivering MMS by phase at 3, 6, 9 and 12 month intervals. Therefore, all participants who join the trial will receive MMS by month 12 from recruitment date. During the MMS service, pharmacists will review the participants' medication history and conduct medication reconciliation, refer them to doctors for reviewing the prescribing decision if necessary, as well as provide education and lifestyle advice on medication management.
Control
NO INTERVENTIONParticipants who join the trial will have have a control period of 3 to 12 months before receiving medication management service (MMS) at 8 NGO community pharmacies. Participants will have no MMS intervention during the control period. Since there are 8 NGO community pharmacies, two NGO community pharmacies will start delivering MMS by phase at 3, 6, 9 and 12 month intervals. Therefore, all participants who join the trial will receive MMS by month 12 from recruitment date.
Interventions
Medication Management Service (MMS) is a service delivered by community pharmacists aiming at helping patients resolve their medication therapy problems (MTPs) by carrying out medication reconciliation, provision of education about their medication regimen, and also providing professional pharmacological advice to patients.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- aged below 18
- unable to give informed consent
- unable to communicate in Cantonese and/or English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Hong Konglead
- The Hong Kong Jockey Club Charities Trustcollaborator
- Hong Kong Sheng Kung Hui Welfare Council Limitedcollaborator
- Hong Kong Young Women's Christian Associationcollaborator
- Haven of Hope Hospitalcollaborator
- Pok Oi Hospitalcollaborator
- St. James' Settlementcollaborator
- Aberdeen Kai-fong Welfare Associationcollaborator
- Health In Actioncollaborator
- Lok Sin Tong Benevolent Society, Kowlooncollaborator
Study Sites (8)
Aberdeen Kai-Fong Welfare Association A-Lively Community Pharmacy
Hong Kong, Hong Kong
Health In Action Community Pharmacy
Hong Kong, Hong Kong
Hong Kong Sheng Kung Hui Welfare Council Community Pharmacy
Hong Kong, Hong Kong
PHARM+ Haven of Hope Community Pharmacy
Hong Kong, Hong Kong
PHARM+ Pok Oi Hospital Community Pharmacy
Hong Kong, Hong Kong
PHARM+ St. James' Settlement Community Pharmacy
Hong Kong, Hong Kong
PHARM+ The Lok Sin Tong Community Pharmacy
Hong Kong, Hong Kong
PHARM+ YWCA Community Pharmacy
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 9, 2024
First Posted
February 23, 2024
Study Start
February 6, 2024
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
May 1, 2027
Last Updated
February 23, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share