Manfrin Andrea, Thomas Trudy, Krska Janet
Medway School of Pharmacy, University of Kent and Greenwich, Central Avenue Chatham Maritime, Chatham, ME4 4TB, Kent, UK.
BMC Health Serv Res. 2015 Apr 21;15:171. doi: 10.1186/s12913-015-0791-6.
The Italian Ministry of Health decided to introduce community professional services in 2010. This trial provides an opportunity to evaluate the outcomes of a new professional pharmacy service: Italian Medicines Use Review (I-MUR) aimed at reducing the severity of asthma and its associated costs.
METHODS/DESIGN: This is a cluster randomised controlled trial of the I-MUR service. Data will be collected over time before, during and after pharmacists' intervention. Fifteen Italian regions will be involved and it is aimed to recruit 360 community pharmacists and 1800 patients. Each pharmacist will receive training in medicines use review, recruit five patients, administer the Asthma Control Test and provide the I-MUR service. Pharmacists will be allocated to different groups, one group will be trained in and provide the I-MUR service immediately after completion of the baseline ACT score, the other group will receive training in the I-MUR and provide this service three months later. Group allocation will be random, after stratification by region of Italy. The I-MUR service will involve gathering data following each patient consultation including demographic details, patients regular medications, including those used for asthma, their attitude towards their medications and self-reported adherence to treatments. In addition, pharmacists will identify and record pharmaceutical care issues and any advice given to patients during the I-MUR, or recommendations given to doctors. Pharmacists will upload trial data onto a web platform for analysis. The primary outcome measure is the severity of asthma before, during and after the I-MUR assessed using the Asthma Control Test score. Secondary measures: number of all active ingredients used by patients during and after the I-MUR, number of pharmaceutical care issues identified during the I-MUR, patients' self-reported adherence to asthma medication during and after the I-MUR, healthcare costs based on the severity of asthma, before, during and after the I-MUR service provision.
This study has been developed because of the need for a new way of working for pharmacists and pharmacies; it is the first trial of any community pharmacy-based pharmaceutical care intervention in Italy. The results will inform future policy and practice in Italian community pharmacy.
ISRCTN72438848 .
意大利卫生部于2010年决定引入社区专业服务。本试验提供了一个评估新型专业药房服务——意大利药物使用评估（I-MUR）的机会，该服务旨在降低哮喘的严重程度及其相关成本。
方法/设计：这是一项关于I-MUR服务的整群随机对照试验。将在药剂师干预前、干预期间和干预后随时间收集数据。意大利的15个地区将参与其中，目标是招募360名社区药剂师和1800名患者。每位药剂师将接受药物使用评估培训，招募5名患者，进行哮喘控制测试并提供I-MUR服务。药剂师将被分配到不同组，一组在完成基线哮喘控制测试（ACT）评分后立即接受I-MUR服务培训并提供该服务，另一组将接受I-MUR培训并在三个月后提供该服务。在按意大利地区分层后，组分配将是随机的。I-MUR服务将包括在每次患者咨询后收集数据，包括人口统计学细节、患者常规用药（包括用于哮喘的药物）、他们对药物的态度以及自我报告的治疗依从性。此外，药剂师将识别并记录药学服务问题以及在I-MUR期间给予患者的任何建议或给医生的推荐。药剂师将把试验数据上传到网络平台进行分析。主要结局指标是使用哮喘控制测试评分评估的I-MUR前、期间和后的哮喘严重程度。次要指标：I-MUR期间及之后患者使用的所有活性成分数量、I-MUR期间识别出的药学服务问题数量、I-MUR期间及之后患者自我报告的哮喘药物治疗依从性、基于哮喘严重程度的I-MUR服务提供前、期间和后的医疗保健成本。
开展这项研究是因为需要药剂师和药房采用新的工作方式；这是意大利首次对任何基于社区药房的药学服务干预进行试验。结果将为意大利社区药房未来的政策和实践提供参考。
ISRCTN72438848 。
