Objective To examine the effect of optimising drug treatment on drug related hospital admissions in older adults with multimorbidity and polypharmacy admitted to hospital. Design Cluster randomised controlled trial. Setting 110 clusters of inpatient wards within university based hospitals in four European countries (Switzerland, Netherlands, Belgium, and Republic of Ireland) defined by attending hospital doctors. Participants 2008 older adults (≥70 years) with multimorbidity (≥3 chronic conditions) and polypharmacy (≥5 drugs used long term). Intervention Clinical staff clusters were randomised to usual care or a structured pharmacotherapy optimisation intervention performed at the individual level jointly by a doctor and a pharmacist, with the support of a clinical decision software system deploying the screening tool of older person’s prescriptions and screening tool to alert to the right treatment (STOPP/START) criteria to identify potentially inappropriate prescribing. Main outcome measure Primary outcome was first drug related hospital admission within 12 months. Results 2008 older adults (median nine drugs) were randomised and enrolled in 54 intervention clusters (963 participants) and 56 control clusters (1045 participants) receiving usual care. In the intervention arm, 86.1% of participants (n=789) had inappropriate prescribing, with a mean of 2.75 (SD 2.24) STOPP/START recommendations for each participant. 62.2% (n=491) had ≥1 recommendation successfully implemented at two months, predominantly discontinuation of potentially inappropriate drugs. In the intervention group, 211 participants (21.9%) experienced a first drug related hospital admission compared with 234 (22.4%) in the control group. In the intention-to-treat analysis censored for death as competing event (n=375, 18.7%), the hazard ratio for first drug related hospital admission was 0.95 (95% confidence interval 0.77 to 1.17). In the per protocol analysis, the hazard ratio for a drug related hospital admission was 0.91 (0.69 to 1.19). The hazard ratio for first fall was 0.96 (0.79 to 1.15; 237 v 263 first falls) and for death was 0.90 (0.71 to 1.13; 172 v 203 deaths). Conclusions Inappropriate prescribing was common in older adults with multimorbidity and polypharmacy admitted to hospital and was reduced through an intervention to optimise pharmacotherapy, but without effect on drug related hospital admissions. Additional efforts are needed to identify pharmacotherapy optimisation interventions that reduce inappropriate prescribing and improve patient outcomes. Trial registration ClinicalTrials.gov [NCT02986425][1]. Data for this study will be made available to others in the scientific community upon request after publication. Data will be made available for scientific purposes for researchers whose proposed use of the data has been approved by a publication committee. Data and documentation will be made available through a secure file exchange platform after approval of proposal and a data transfer agreement is signed (which defines obligations that the data requester must adhere to with regard to privacy and data handling). Partially deidentified participant data limited to the data used for this work will be made available, along with a data dictionary and annotated case report forms. For data access, please contact the corresponding author. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02986425&atom=%2Fbmj%2F374%2Fbmj.n1585.atom

中文翻译：

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优化治疗以防止患有多种病症的老年人入院 (OPERAM)：整群随机对照试验

目的 研究优化药物治疗对因多种疾病和多种药物入院的老年人药物相关入院率的影响。设计整群随机对照试验。在四个欧洲国家（瑞士、荷兰、比利时和爱尔兰共和国）的大学医院内设置 110 个住院病房群，这些病房由主治医生定义。参与者 2008 名患有多种疾病（≥3 种慢性疾病）和多种药物（长期使用≥5 种药物）的老年人（≥70 岁）。干预 临床工作人员集群被随机分配到常规护理或由医生和药剂师在个人层面联合进行的结构化药物治疗优化干预，在临床决策软件系统的支持下，该系统部署了老年人处方筛选工具和筛选工具以提醒正确的治疗 (STOPP/START) 标准以识别潜在的不适当处方。主要结果指标 主要结果是 12 个月内首次因药物入院。结果 2008 名老年人（中位数为 9 种药物）被随机分配到接受常规护理的 54 个干预组（963 名参与者）和 56 个对照组（1045 名参与者）中。在干预组中，86.1% 的参与者 (n=789) 开具了不适当的处方，每位参与者平均有 2.75 (SD 2.24) 次停止/开始建议。62.2% (n=491) 在两个月内成功实施了 ≥ 1 条建议，主要是停用可能不合适的药物。在干预组中，211 名参与者 (21.9%) 经历了与药物相关的首次住院，而对照组为 234 名 (22.4%)。在将死亡作为竞争事件截尾的意向治疗分析中（n=375，18.7%），首次药物相关住院的风险比为 0.95（95% 置信区间为 0.77 至 1.17）。在符合方案分析中，药物相关入院的风险比为 0.91（0.69 至 1.19）。首次跌倒的风险比为 0.96（0.79 至 1.15；首次跌倒 237 比 263），死亡风险比为 0.90（0.71 至 1.13；172 比 203 死亡）。结论 不当处方在患有多种疾病和多种药物入院的老年人中很常见，通过优化药物治疗的干预措施减少了不当处方，但对与药物相关的住院率没有影响。需要额外的努力来确定药物治疗优化干预措施，以减少不适当的处方并改善患者的结果。试验注册 ClinicalTrials.gov [NCT02986425][1]。本研究的数据将在发表后根据要求提供给科学界的其他人。数据将提供给研究人员用于科学目的，这些研究人员的数据使用建议已获得出版委员会的批准。在批准提案并签署数据传输协议（定义数据请求者在隐私和数据处理方面必须遵守的义务）后，将通过安全的文件交换平台提供数据和文档。将提供仅限于用于此工作的数据的部分去标识化的参与者数据，以及数据字典和带注释的病例报告表。资料访问请联系通讯作者。[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02986425&atom=%2Fbmj%2F374%2Fbmj.n1585.atom