Evaluation of Medication Management Service

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

aged below 18

unable to give informed consent

unable to communicate in Cantonese and/or English

Trial design

Design model

Parallel

Treatments tested in this trial

  • Medication Management Service (MMS)

    Behavioral

    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.

Treatment groups

640 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

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.

Time frame
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

1

Additional health service utilization

Changes in health service utilization (e.g. A\&E admission, hospitalization) before and after receiving medication management service will be assessed using record linkage to the electronic health records from the Hospital Authority.

Time frame
Through study completion, an average of 1 year
2

Patient perception and satisfaction

Patient perception and satisfaction will be assessed by the Pharmacy Services Questionnaire (PSQ). The PSQ consists of 20 items and will be rated by participants on a 5-point scale. (5-Excellent, 4- Very good, 3-Good, 2-Fair and 1-Poor). The maximum score is 100 and the minimum score is 20. Higher scores indicate high levels of satisfaction.

Time frame
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.
3

Patient perceived sensitivity to medicines

Perceived Sensitivity to Medicines Scale (PSM-5) will be used to assess the patient's perception on their sensitivity to medicines. Patients will rate the items on a 5-point scale. (5-Strongly agree, 4- Agree, 3-Neutral, 2-Disagree and 1-Strongly disagree).The maximum score is 25 and the minimum score is 5. Higher scores indicate stronger perceived sensitivity to medicines.

Time frame
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.
4

Social impact

Social impact will be assessed by the Patient Enablement Index (PEI). The PEI is a 6-item questionnaire and is used to assess patient enablement. The maximum score of PEI is 12 and minimum score is 0. Higher scores indicate greater levels of enablement and a score of 0 indicates no enablement.

Time frame
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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Hong Kong

Lead sponsor

The Hong Kong Jockey Club Charities Trust

Collaborator

Hong Kong Sheng Kung Hui Welfare Council Limited

Collaborator

Hong Kong Young Women's Christian Association

Collaborator

Haven of Hope Hospital

Collaborator

Pok Oi Hospital

Collaborator

St. James' Settlement

Collaborator

Aberdeen Kai-fong Welfare Association

Collaborator

Health In Action

Collaborator

Lok Sin Tong Benevolent Society, Kowloon

Collaborator