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)发现没有评估初级保健中痴呆症筛查效果的临床试验。对未经证实的福利进行筛查的压力可能会从医疗保健系统中分流急需的资源，并对痴呆症和其他疾病患者的护理产生总体负面影响，最终减少目前痴呆症识别的机会。使用慢性护理模式的框架和基于证据的全面生物心理社会痴呆症护理方案，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，发现这样的计划改善了与痴呆症护理相关的行为和心理症状，并与常规护理相比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岁及以上的美国人中，进行了一项两阶段随机对照痴呆症筛查试验。干预：痴呆症筛查程序，然后是协作性痴呆症护理计划。对照：这项研究将有两个对照组：“不筛查”和“只筛查”组。潜在益处的主要结果：在随机试验的18个月时，通过神经精神病学问卷(NPI)测量与痴呆症相关的行为和心理症状。潜在危害的主要结果：在随机试验的18个月时，用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是否建议在初级保健中进行痴呆症常规筛查。此外，我们拟议的研究产生的数据可以用来模拟未来针对痴呆症的药物治疗的影响，但需要及早识别综合征，如果在老年人中进行常规筛查，就可能发生这种情况。

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.