Indiana University Dementia Screening Trial: The IU CHOICE Study

描述（由申请人提供）：美国预防服务工作组（USPSTF）没有发现评估初级保健中痴呆筛查效果的临床试验。对未经证实的益处进行筛查的压力可能会转移卫生保健系统急需的资源，并对痴呆症和其他疾病患者的护理产生总体负面影响，最终减少当前识别痴呆症的机会。利用慢性护理模式和基于证据的综合生物心理社会痴呆症护理方案的框架，我们的研究人员开发并进行了一项协作性痴呆症护理管理计划的随机对照试验，发现该计划改善了与痴呆症护理相关的行为和心理症状，并且相对于常规护理减轻了痴呆症的负担。研究设计：在印第安纳州印第安纳波利斯的城市初级保健诊所就诊的4000名75岁及以上的美国人进行了一项两期随机对照痴呆筛查试验。干预：痴呆筛查程序，随后是痴呆协作护理程序。对照组：研究将有两个对照组：“不筛查”组和“仅筛查”组。潜在获益的主要结局：在随机化18个月时，通过神经精神量表（NPI）测量与痴呆相关的行为和心理症状。潜在危害的主要结局：随机分组18个月时，通过PHQ-9和GAD-7测量情绪和焦虑症状。影响：这项研究的结果将有助于指导美国预防服务工作组决定建议或反对在初级保健中对痴呆症进行常规筛查。此外，我们提出的研究产生的数据可用于模拟未来针对痴呆症的药物治疗的影响，但如果在老年人中进行常规筛查，则需要早期识别该综合征。

DESCRIPTION (provided by applicant): The United States Preventive Services Task Force (USPSTF) found no clinical trial that evaluated the efficacy of dementia screening in primary care. Pressures to institute screening of unproved benefit could divert much needed resources from health care systems and have an overall negative impact on care for patients with dementia and other illnesses, ultimately reducing current opportunities for dementia recognition. Using the framework of the chronic care model and evidence-based, comprehensive biopsychosocial dementia care protocols, our investigators developed and conducted a randomized controlled trial of a Collaborative Dementia Care Management program and found that such a program improves the behavioral and psychological symptoms related to dementia care and reduced the burden of dementia relative to usual care. Study Design: A two-phase randomized controlled dementia screening trial among 4,000 Americans aged 75 and older attending urban primary care clinics in Indianapolis, Indiana. Intervention: A dementia screening procedure followed by a Collaborative Dementia Care program. Controls: The study will have two control groups: "No Screening" and "Screening Only" groups. Primary Outcome of Potential Benefits: Behavioral and psychological symptoms related to dementia as measured by the Neuropsychiatric Inventory (NPI) at 18 months of randomization. Primary Outcome for Potential Harms: Mood and anxiety symptoms as measured by the PHQ-9 and GAD-7 at 18 months of randomization. Impact: The results of this study will help guide the United States Preventive Services Task Force in the decision to recommend for or against routine screening for dementia in primary care. In addition, the data generated by our proposed study could be used to model the impact of future pharmacological therapeutics targeting dementia but requiring early recognition of the syndrome as can occur if screening is done routinely among elders.