Department of Medicine, University of Otago, Christchurch, New Zealand.
UniSA Clinical & Health Sciences, Quality Use of Medicines and Pharmacy Research Centre, University of South Australia, Adelaide, South Australia.
Trials. 2021 Nov 3;22(1):766. doi: 10.1186/s13063-021-05711-w.
Targeted deprescribing of anticholinergic and sedative medications in older people may improve their health outcomes. This trial will determine if pharmacist-led reviews lead to general practitioners deprescribing anticholinergic and sedative medications in older people living in the community.
The standard protocol items: Recommendations for Interventional Trials (SPIRIT) checklist was used to develop and report the protocol. The trial will involve older adults stratified by frailty (low, medium, and high). This will be a pragmatic two-arm randomized controlled trial to test general practitioner uptake of pharmacist recommendations to deprescribe anticholinergic and sedative medications that are causing adverse side effects in patients.
Community-dwelling frail adults, 65 years or older, living in the Canterbury region of New Zealand, seeking publicly funded home support services or admission to aged residential care and taking at least one anticholinergic or sedative medication regularly.
New Zealand registered pharmacists using peer-reviewed deprescribing guidelines will visit participants at home in the community, review their medications, and recommend anticholinergic and sedative medications that could be deprescribed to the participant's general practitioner. The total use of anticholinergic and sedative medications will be quantified using the Drug Burden Index (DBI).
The primary outcome will be the change in total DBI between baseline and 6-month follow-up. Secondary outcomes will include entry into aged residential care, prolonged hospitalization, and death.
Data will be collected at the time of interRAI assessments (T0), at the time of the baseline review (T1), at 6 months following the baseline review (T2), and at the end of the study period, or end of study participation for participants admitted into aged residential care, or who died (T3).
Ethical approval has been obtained from the Human, Disability and Ethics Committee: ethical number (17CEN265).
ClinicalTrials.gov ACTRN12618000729224 . Registered on May 2, 2018, with the Australian New Zealand Clinical Trials Registry.
在老年人中靶向减少抗胆碱能和镇静药物的使用可能会改善他们的健康结果。本试验将确定药剂师主导的药物审查是否会导致社区中老年人的普通医生减少使用抗胆碱能和镇静药物。
采用标准干预试验建议报告清单（SPIRIT）检查表来制定和报告方案。该试验将涉及按虚弱程度分层的老年人（低、中、高）。这将是一项实用的两臂随机对照试验，以测试普通医生接受药剂师建议的情况，即减少正在导致患者出现不良反应的抗胆碱能和镇静药物的使用。
居住在新西兰坎特伯雷地区的社区内虚弱的成年人，年龄在 65 岁或以上，正在接受公共资助的家庭支持服务或入住老年护理院，并且定期服用至少一种抗胆碱能或镇静药物。
新西兰注册药剂师将使用经过同行评议的减药指南，在家中对参与者进行家访，审查他们的药物，并向参与者的普通医生建议可能减少使用的抗胆碱能和镇静药物。使用药物负担指数（DBI）来量化抗胆碱能和镇静药物的总使用量。
主要结果将是基线和 6 个月随访之间总 DBI 的变化。次要结果包括进入老年护理院、延长住院时间和死亡。
数据将在 interRAI 评估时（T0）、基线审查时（T1）、基线审查后 6 个月（T2）以及研究结束时或进入老年护理院的参与者研究结束时或死亡时（T3）收集。
已从人类、残疾和伦理委员会获得伦理批准：伦理编号（17CEN265）。于 2018 年 5 月 2 日在澳大利亚和新西兰临床试验注册中心注册，注册号为 ACTRN12618000729224。
