Department of Pharmacology, All India Institute of Medical Sciences Bibinagar, Hyderabad, India.
Department of General Medicine, All India Institute of Medical Sciences Bibinagar, Hyderabad, India.
JMIR Res Protoc. 2024 Jun 11;13:e55638. doi: 10.2196/55638.
Falls in older patients can lead to serious health complications and increased health care costs. Fall risk-increasing drugs (FRIDs) are a group of drugs that may induce falls or increase the tendency to fall (ie, fall risk). Deprescribing is the process of withdrawal from an inappropriate medication, supervised by a health care professional, with the goal of managing polypharmacy and improving outcomes.
This study aims to assess the effectiveness of a deprescribing intervention based on the Assess, Review, Minimize, Optimize, and Reassess (ARMOR) tool in reducing the risk of falls in older patients and evaluate the cost-effectiveness of deprescribing FRIDs.
This is an open-label, parallel-group randomized controlled academic trial. Individuals aged 60-80 years who are currently taking 5 or more prescribed drugs, including at least 1 FRID, will be recruited. Demographic data, medical conditions, medication lists, orthostatic hypotension, and fall history details will be collected. Fall concern will be assessed using the Fall Efficacy Scale, and fall risk will be assessed by the Timed Up and Go test and Tinetti Performance-Oriented Mobility Assessment tool. In this study, all treating physicians will be randomized using a stratified randomization method based on seniority. Randomized physicians will do deprescribing with the ARMOR tool for patients on FRIDs. Participants will maintain diaries, and monthly phone follow-ups will be undertaken to monitor falls and adverse events. Physical assessments will be performed to evaluate fall risk every 3 months for a year. The rationality of prescription drugs will be evaluated using the World Health Organization's core indicators.
The study received a grant from the Indian Council of Medical Research-Safe and Rational Use of Medicine in October 2023. The study is scheduled to commence in April 2024 and conclude by 2026. Efficacy will be measured by fall frequency and changes in fall risk scores. Cost-effectiveness analysis will also include the incremental cost-effectiveness ratio calculation. Adverse events related to deprescription will be recorded.
This trial will provide essential insights into the efficacy of the ARMOR tool in reducing falls among the geriatric population who are taking FRIDs. Additionally, it will provide valuable information on the cost-effectiveness of deprescribing practices, offering significant implications for improving the well-being of older patients and optimizing health care resource allocation. The findings from this study will be pertinent for health care professionals, policy makers, and researchers focused on geriatric care and fall prevention strategies.
Clinical Trials Registry - India CTRI/2023/12/060516; https://ctri.nic.in/Clinicaltrials/pubview2.php.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/55638.
老年人跌倒可导致严重的健康并发症和增加医疗保健费用。跌倒风险增加药物（FRIDs）是一组可能导致跌倒或增加跌倒风险（即跌倒风险）的药物。药物减量是指在医疗保健专业人员的监督下停止使用不适当的药物，其目的是管理多种药物并用并改善结果。
本研究旨在评估基于评估、审查、最小化、优化和再评估（ARMOR）工具的药物减量干预措施在降低老年患者跌倒风险方面的有效性，并评估减少 FRIDs 药物使用的成本效益。
这是一项开放标签、平行组随机对照学术试验。将招募年龄在 60-80 岁之间、目前正在服用 5 种或以上处方药（包括至少 1 种 FRID）的个体。将收集人口统计学数据、医疗状况、药物清单、体位性低血压和跌倒史详细信息。使用跌倒功效量表评估跌倒担忧，使用计时起立行走测试和 Tinetti 表现导向移动性评估工具评估跌倒风险。在本研究中，所有治疗医生将使用基于资历的分层随机化方法进行随机化。使用 FRIDs 的患者将使用 ARMOR 工具进行药物减量。参与者将保留日记，并每月进行电话随访以监测跌倒和不良事件。每年进行 3 次的身体评估以评估 1 年内的跌倒风险。使用世界卫生组织的核心指标评估处方药的合理性。
该研究于 2023 年 10 月获得印度医学研究理事会安全合理用药资助。研究计划于 2024 年 4 月开始，2026 年结束。有效性将通过跌倒频率和跌倒风险评分的变化来衡量。成本效益分析还将包括增量成本效益比的计算。将记录与药物减量相关的不良事件。
该试验将为 ARMOR 工具在减少服用 FRIDs 的老年人群体中跌倒的有效性提供重要的见解。此外，它还将提供有关药物减量实践成本效益的有价值信息，为改善老年患者的健康和优化医疗保健资源分配提供重要意义。该研究的结果将与关注老年护理和跌倒预防策略的医疗保健专业人员、政策制定者和研究人员相关。
印度临床试验注册中心 CTRI/2023/12/060516；https://ctri.nic.in/Clinicaltrials/pubview2.php。
国际注册报告标识符（IRRID）：PRR1-10.2196/55638。
