Benefits of Medicines Use Review Service in Slovenia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 169
- 试验地点
- 14
- 主要终点
- medication adherence
研究概览
简要总结
Medicines Use Review service (PUZ) has been officially introduced in Slovenian pharmacy practice in 2015 and has been offered to pharmacy customers by pharmacist, certified to provide the service. Patients can to talk to a pharmacist and discuss their medicines, how they use it and any issues or question they might have. We designed a study to evaluate how Medicines Use Review (PUZ) work and how it is reaching the set objectives. The objectives of the PUZ service are to address actual patient medicines use and consequently improve medication adherence, identify and solve drug related problems and enhance medication knowledge. Pharmacists, who are certified to provide the service, recognized the patients, who might need the service and invited them to participate in the study. The study consisted of two visits in 12 weeks' time period. Patients, who decided to participate, were randomly allocated in two groups - intervention and control. Both groups were interviewed and fulfilled questionnaires at visit 1 (V1). Afterwards the test group patients received PUZ. After 12 weeks both groups attended the visit 2 (V2), where they were re-interviewed and fulfilled questionnaires again. After the study completion also the patients from control group received PUZ due to ethical reasons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Patients and pharmacist were blind to the intervention at the time of enrollment.
Afterwards, pharmacist were notified about the randomization to be able to prepare for the patients that will receive MUR at the visit 1. Patients were blinded until the visit 1 - until after the baseline data collection"
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least one prescription medicine for a chronic condition for at least six months
- •deemed to be suitable for MUR by a pharmacist, certified to provide the MUR service;
- •ability to communicate in Slovenian; The inclusion of patients was performed in accordance with the SOP MUR, to reflect how patients are generally offered MUR service in Slovenia.
排除标准
- •urgent need of MUR (the service delay due to randomization would risk their health);
- •referred for MUR by a healthcare professional (general practitioner, nurse, etc.);
- •the patient's carer, rather than the patient themselves, was able to attend the interviews and receive MUR;
- •previously received MUR or an advanced medication review;
- •difficulties understanding, communicating or other issues (vision, hearing) that might affect study outcomes.
研究组 & 干预措施
Intervention
Patients who received MUR at visit 1
干预措施: medicines use review (Behavioral)
Control
Patients received standard care and MUR after visit 2 (upon completion of the study)
结局指标
主要结局
medication adherence
时间窗: 12 weeks (V2-V1)
Self-reported medication adherence to multiple medications, evaluated by an 8-item Morisky Medication Adherence Scale (©MMAS-8) and scored with ©Morisky Widget MMAS-8 Software. MUR impact was defined as the relative difference in in MMAS-8 score after 12 weeks (V2-V1) between test and control group.
次要结局
- Medicine-associated burden(12 weeks (V1-V2))
- Patient information ('knowledge') regarding medicines(12 weeks)
- drug-related problems(12 weeks (V2-V1))
研究者
Mitja Kos
prof. dr. Mitja Kos, Head of the Department of Social Pharmacy
University of Ljubljana