ToolBox Detect: Low Cost Detection of Cognitive Decline in Primary Care Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35,403
- 试验地点
- 1
- 主要终点
- Rate of detected impairment
研究概览
简要总结
Our study objective is to widely implement and evaluate a user-centered, scalable, electronic health record (EHR)-linked strategy for the routine detection of cognitive decline among diverse primary care settings. This strategy, called ToolboxDetect, will provide an efficient and sensitive cognitive screen that can be easily implemented in everyday clinical settings, and is responsive to patient, family, and caregiver concerns for potential symptoms of cognitive decline (CD) and cognitive impairment (CI).
详细描述
Our study objective is to widely implement and evaluate a user-centered, scalable, electronic health record (EHR)-linked strategy for the routine detection of cognitive decline among diverse primary care settings. We will conduct a large-scale, primary care practice-randomized trial to implement and comprehensively evaluate ToolboxDetect as a standard of care with AWVs, linked to an EHR (Epic). Diverse, academic and community settings are included to optimize future dissemination efforts.
ToolboxDetect is an iPad-based, self-administered assessment that leverages two well validated measures from the NIH Toolbox Cognition Battery: Dimensional Change Card Sorting (for executive function) and the Picture Sequence Memory (for episodic memory). It takes approximately 7-8 minutes to administer, and for practices randomized to the ToolboxDetect arm, this will be used as the practice standard to fulfill the requirement for cognitive testing as part of the Medicare Annual Wellness Visit (AWV).
The aims of our investigation are to:
- Evaluate the effectiveness of ToolboxDetect, compared to enhanced usual care, to promote timely detection of cognitive decline and its care management.
- Disseminate and implement ToolboxDetect among a large Federally Qualified Health Center Network and assess its feasibility and acceptability for use;
- Investigate the fidelity of ToolboxDetect, and identify any patient, caregiver, healthcare provider and/or system barriers to its optimal, sustained implementation;
- Determine costs associated with implementing ToolboxDetect from a primary care perspective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 65 and older will be considered.
- •Adults who may or may not have cognitive impairments.
- •Practices affiliated with Northwestern Medicine and Access Community Health Network.
排除标准
- •1. Severe, uncorrectable vision or hearing impairment
研究组 & 干预措施
ToolboxDetect Strategy
All practices randomized to the intervention arm will implement the ToolboxDetect battery as the standard of care routine cognitive assessment to fulfill the Medicare Annual Wellness Visit (AWV) requirement. The 7-8 minute ToolboxDetect battery contains self-administered versions of the NIH ToolBox Picture Sequence Memory Test (PSM) and the NIH ToolBox Dimensional Change Card Sorting (DCCS). PSM measures episodic memory and DCCS tests executive functioning.
The validated ToolboxDetect application will be imparted either as an application on an iPad or on a PC desktop/laptop computer commonly found in a clinical exam room for EHR access.
干预措施: ToolboxDetect (Other)
Enhanced Usual Care
At Northwestern Medicine, cognitive assessments included in Annual Wellness Visits or other routine or sick/problem-based visits vary by practice and also by clinician. However, the choice of test was limited to either a Mini-Cog©, Montreal Cognitive Assessment (MoCA), or Mini Mental Status Exam (MMSE).
While we will not make any explicit recommendations to these practices with regard to their use of a cognitive assessment, we will ensure that 1) any chosen test is linked to an Epic SmartData element, which will allow the clinician to record the results of the test as discrete data (which can then be queried), and that 2) providers receive a compiled list of local medical and non-medical referrals for any detected cases of CI. The Alzheimer's Association recommendations for early detection efforts among primary care practices will also be provided to each clinic's medical leadership.
结局指标
主要结局
Rate of detected impairment
时间窗: Up to 3 years
This will be operationalized as either results of an any administered cognitive test suggesting impairment ('detected'), or having any relevant ICD 10 classification code recorded in a patient's record after the trial launch date and throughout follow-up observation period ('diagnosis').
次要结局
- Rate of cognitive testing(Up to 3 years)
- Rate of cognition-related referrals(Up to 3 years)
- Rate of detected cases with mild impairment(Up to 3 years)
- Caregiver involvement(Up to 3 years)
研究者
Michael S. Wolf
Professor
Northwestern University