当前位置: X-MOL 学术Pilot Feasibility Stud. › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
Improving medication prescribing-related outcomes for vulnerable elderly in transitions on high-risk medications (IMPROVE-IT HRM): a pilot randomized trial protocol
Pilot and Feasibility Studies Pub Date : 2024-04-10 , DOI: 10.1186/s40814-024-01484-6
Anne Holbrook , Dan Perri , Mitch Levine , Lawrence Mbuagbaw , Sarah Jarmain , Lehana Thabane , Jean-Eric Tarride , Lisa Dolovich , Sylvia Hyland , Victoria Telford , Jessyca Silva , Carmine Nieuwstraten

Seniors with recurrent hospitalizations who are taking multiple medications including high-risk medications are at particular risk for serious adverse medication events. We will assess whether an expert Clinical Pharmacology and Toxicology (CPT) medication management intervention during hospitalization with follow-up post-discharge and communication with circle of care is feasible and can decrease drug therapy problems amongst this group. The design is a pragmatic pilot randomized trial with 1:1 patient-level concealed randomization with blinded outcome assessment and data analysis. Participants will be adults 65 years and older admitted to internal medicine services for more than 2 days, who have had at least one other hospitalization in the prior year, taking five or more chronic medications including at least one high-risk medication. The CPT intervention identifies medication targets; completes consult, including priorities for improving prescribing negotiated with the patient; starts the care plan; ensures a detailed discharge medication reconciliation and circle-of-care communication; and sees the patient at least twice after hospital discharge via virtual visits to consolidate the care plan in the community. Control group receives usual care. Primary outcomes are feasibility — recruitment, retention, costs, and clinical — number of drug therapy problems improved, with secondary outcomes examining coordination of transitions in care, quality of life, and healthcare utilization and costs. Follow-up is to 3-month posthospital discharge. If results support feasibility of ramp-up and promising clinical outcomes, a follow-up definitive trial will be organized using a developing national platform and medication appropriateness network. Since the intervention allows a very scarce medical specialty expertise to be offered via virtual care, there is potential to improve the safety, outcomes, and cost of care widely. ClinicalTrials.gov identifier: NCT04077281.

中文翻译:

改善高风险药物过渡期弱势老年人的药物处方相关结果 (IMPROVE-IT HRM):一项试点随机试验方案

经常住院并服用多种药物(包括高风险药物)的老年人发生严重药物不良事件的风险特别高。我们将评估住院期间专家临床药理学和毒理学 (CPT) 药物管理干预、出院后随访以及与护理圈的沟通是否可行,以及是否可以减少该群体中的药物治疗问题。该设计是一项务实的试点随机试验,采用 1:1 患者水平隐藏随机化,并进行盲法结果评估和数据分析。参与者将是 65 岁及以上的成年人,入院内科服务超过 2 天,在上一年至少接受过一次其他住院治疗,服用五种或更多慢性药物,包括至少一种高风险药物。 CPT 干预确定药物治疗目标;完成咨询,包括与患者协商改善处方的优先事项;开始护理计划;确保详细的出院药物协调和护理圈沟通;出院后通过虚拟访问至少两次见病人,以巩固社区的护理计划。对照组接受常规护理。主要结果是可行性——招募、保留、成本和临床——药物治疗问题数量的改善,次要结果是检查护理过渡的协调、生活质量以及医疗保健利用和成本。随访至出院后 3 个月。如果结果支持加速的可行性和有希望的临床结果,将使用正在发展的国家平台和药物适当性网络组织后续最终试验。由于干预措施可以通过虚拟护理提供非常稀缺的医学专业知识,因此有可能广泛改善安全性、结果和护理成本。 ClinicalTrials.gov 标识符:NCT04077281。
更新日期:2024-04-10
down
wechat
bug