Randomized Trial of a Multifactorial Fall Injury Prevention Strategy

描述（由申请人提供）：患者、护理人员、临床医生、保险公司和政策制定者都认为跌倒伤害是老年人的严重事件，也是一个主要的公共卫生问题。65岁以上的人每年有30%跌倒，75岁以上的比率甚至更高。严重摔伤是老年人致残和死亡的常见原因。这项随机试验是由来自14家美国Claude D. Pepper老年美国人独立中心（oaic）和10个医疗保健系统的研究人员、患者和利益相关者合作进行的，将确定以证据为基础的、多因素的、以患者为中心的干预措施的有效性，以降低非机构老年人严重跌倒损伤的风险。研究者、患者和利益相关者通过电话会议和焦点小组共同准备申请，并将继续在一个结构化的协作框架内共同努力实施试验，包括其中期和最终分析，以及其结果的传播。我们减少严重跌倒伤害的综合战略，由我们的患者顾问和利益相关者在电话会议和焦点小组期间的意见指导。包括几个以患者为中心的组件：(a)筛选识别跌倒高风险人群，(b)确定个人的特定风险因素，(c)实施基于证据的多因素、个性化干预，旨在减轻特定风险因素，以耶鲁大学开发的以患者为中心的方法为基础，并结合疾病预防控制中心和美国老年医学会指南的元素(d)减少跌倒时受伤的风险（例如，骨质疏松症治疗）；(e)基于ACOVE-2实践重新设计模型，改变组织和提供者的行为以启动护理流程。该试验将采用聚类随机化策略来分配参与者，将临床实践随机分配到我们的多因素干预或标准治疗中。我们建议在最多10个反映地理和社会人口多样性的试验地点招募6,000名符合条件的参与者。注册将在18个月的时间内进行，我们将跟踪参与者最多3年。主要结局是严重跌倒损伤，定义为导致医疗护理的损伤，包括非椎体骨折、关节脱位、头部损伤、撕裂伤和其他主要后遗症（如横纹肌溶解、内伤、体温过低）。由患者和利益相关者确定的次要结局包括所有伤害性跌倒、所有不受伤害的跌倒以及健康指标——跌倒效果、身体功能和残疾、焦虑和抑郁症状。在第一年，研究人员、患者和利益相关者将共同完善和试点一项策略，以确定有跌倒风险的人，并优化研究设计和干预措施。试验将包括适应性设计和预先指定的中期分析。此外，研究人员、患者和利益相关者将共同评估试验后跌倒损伤预防策略的可扩展性和可持续性。

DESCRIPTION (provided by applicant): Patients, caregivers, clinicians, insurers, and policymakers all agree that fall injuries represent grievous events for older persons and a major public health problem. Thirty percent of persons over the age of 65 fall each year, and for those over 75 the rates are even higher. Serious fall injuries are a common source of disability and death among the elderly. This randomized trial - a collaboration among investigators, patients, and stakeholders from the 14 U.S. Claude D. Pepper Older Americans Independence Centers (OAICs) and 10 healthcare systems where patients will be recruited - will determine the effectiveness of an evidence-based, multifactorial, patient-centered intervention to reduce the risk of serious fall injuries among non-institutionalized older persons. The investigators, patient and stakeholders worked together via conference calls and focus groups to prepare the application, and will continue to work together within a structured collaborative frame- work to implement the trial, including its interim and final analyses, and the dissemination of its results Our integrated strategy to reduce serious fall injuries, guided by input from our patient advisors and stakeholders during conference calls and focus groups, includes several patient-centered components: (a) screening to identify persons at high risk for falls, (b) defining a person's specific risk factors, (c) implementing an evidence-based multifactorial, individually-tailored intervention aimed at mitigating specific risk factors, based on the patient-centered approach developed at Yale and incorporating elements of the CDC and American Geriatrics Society Guidelines (d) reducing the risk of injury if the person falls (e.g., osteoporosis treatment); (e) changing organizational and provider behavior to initiate care processes, based on ACOVE-2 practice redesign model. The trial will utilize a cluster randomization strategy for participant allocation, randomizing clinical practices to our multifactorial intervention or standard care. We propose to enroll 6,000 eligible participants at up to 10 trial sites that reflect geographic and sociodemographic diversity. Enrollment will take place over an 18-month period, and we will follow the participants for a maximum of 3 years. The primary outcome is serious fall injuries, defined as those leading to medical attention, including non- vertebral fractures, joint dislocation, head injury, lacerations, and other major sequalae (e.g. rhabdomyolysis, internal injuries, hypothermia). Secondary outcomes, identified by patients and stakeholders, include all injurious falls, all falls regardless of injury, and indicators of well-being - fall efficacy, physcal function and disability, anxiety, and depressive symptoms. During Year 1, the investigators, patients and stakeholders will collaboratively refine and pilot a strategy for identifying persons t risk for falling and optimize the study design and intervention. The trial will incorporate an adaptive design and a pre-specified mid-term analysis. In addition, the investigators, patients and stakeholders will together evaluate the post-trial scalability and sustainability of the fall injury prevention strategy.