Pilot Studies Core

试点研究核心

• 批准号: 10443667
• 负责人: Abraham Aizer Brody
• 金额: $ 291.09万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10443667
• 关键词: Address; Aging; Alzheimer' s Disease; Alzheimer' s disease related dementia; Antipsychotic Agents; Assessment tool; Award; Biological; Caregiver Burden; Caregivers; Caring; Collaborations; Complex; Data; Dementia; Dementia caregivers; Development; Diagnosis; Discipline of Nursing; Doctor of Philosophy; Ensure; Environment; Ethics; Evidence based practice; Fostering; Funding; Future; Goals; Growth; Guidelines; Health; Healthcare; Healthcare Systems; Home; Hospital Nursing; Income; Individual; Infection; Infrastructure; Institutes; Intervention; Investments; Lead; Measurement; Medicine; Mentorship; Methodology; Monitor; National Institute on Aging; Nature; New York; Nurses; Nursing Homes; Outcome; Patients; Persons; Phase; Pilot Projects; Policies; Population; Pragmatic clinical trial; Process; Quality of life; Research; Research Personnel; Resources; Risk; Seeds; Structure; Testing; Time; Training; United States National Institutes of Health; Universities; Vulnerable Populations; Well in self; Woman; Work; adverse outcome; career; caregiving; collaboratory; community based service; community setting; data infrastructure; dementia care; design; efficacy trial; evidence base; experience; falls; improved; mid-career faculty; patient home care; pilot test; pragmatic trial; racial and ethnic; racial minority; restraint; sedative; sex; success; symposium; systems research; training opportunity; working group

PROJECT SUMMARY The lack of research testing interventions targeting patients with dementia (PWD) and their caregivers in real- world settings hinders the ability of health care systems (HCS) to adequately care for this rapidly expanding and highly vulnerable population. Pragmatic clinical trials that are embedded in HCS (ePCTs) can address this shortcoming. However, ePCTs are complex, require specific methodologies, skilled investigators, close partnerships with HCS, robust data infrastructures, and special regulatory and ethical considerations. Over the past several years, individual teams of investigators have begun to acquire experience conducting ePCTs among PWD and their caregivers. Their experience has reinforced how indispensable a pilot phase is to inform the successful conduct of the full ePCT. The Pilot Core of the National Institute on Aging (NIA) AD/ADRD HCS Research Collaboratory will therefore solicit, and fund over 30 pilot ePCTs and then guide all aspects of these studies throughout their lifecycles. The Core will 1) create a robust and transparent review process, 2) provide active technical assistance to increase the success of funded pilots, 3) promote the development of investigator expertise and leverage experiences across projects through structured trainings, and 4) facilitate the adaptation of pilot tested interventions into well-designed ePCTs. Ultimately, this will lead to full-scale ePCTs, and simultaneously build investigator capacity to conduct ePCTs. The Pilot Core will be led by Dr. Abraham Brody, PhD, RN, FAAN, Associate Professor of Nursing and Medicine at New York University, a nurse researcher with significant experience in dementia and ePCTs, who will work with a highly skilled, interdisciplinary, Executive Committee. The Pilot Core will leverage the overall infrastructure of the NIA AD/ADRD HCS Collaboratory to achieve: Aim 1: Solicit, rigorously review, select, and fund projects that will lead to future full-scale ePCTs focused on PWD and their caregivers; Aim 2: Provide the monitoring, mentorship, and resources to ensure rigorous, timely completion of pilot milestones, and effective sharing of pilot data and results; Aim 3: Promote the expertise of pilot project investigators in conducting ePCTs with PWD and their caregivers by: 1. Integrating them into the activities of the AD/ADRD Collaboratory and Working Group Cores, 2. Providing access to structured training opportunities led by the Training Core, and 3. Holding an annual Scientific Conference in Years 3-5 to present and share research and experiences; Aim 4: Assist pilot projects to transform completed pilot projects into successfully funded full-scale ePCTs in PWD and/or their caregivers. IMPACT: The NIA AD/ADRD Collaboratory Pilot Core will assist researchers to investigate practical interventions that can be implemented in HCS that serve over 5 million PWD and their caregivers. These pilots will seed multiple full-scale ePCTs aimed at improving the quality of life and health outcomes of this vulnerable population. It will also foster the expertise and career growth of pilot project leaders, enhancing the nation’s capacity to conduct ePCTs among PWD with HCS well into the future.

项目摘要 缺乏针对痴呆症（PWD）患者及其照顾者的干预措施的研究，这是真实的- 世界环境阻碍了卫生保健系统（HCS）充分照顾这一迅速扩大的能力 非常脆弱的人群。嵌入HCS（ePCT）的实用临床试验可以解决这一问题 缺点然而，ePCT是复杂的，需要特定的方法，熟练的研究者， 与HCS的合作伙伴关系、强大的数据基础设施以及特殊的监管和道德考虑。来 在过去的几年里，各个研究小组已经开始获得进行ePCT的经验 残疾人及其照顾者之间的关系他们的经验强调了试点阶段是多么的不可或缺， 成功实施ePCT。国家老龄问题研究所（NIA）AD/ADRD HCS试点核心 因此，研究合作实验室将征集和资助30多个试点ePCT，然后指导这些试验的各个方面。 在其整个生命周期中进行研究。核心将1）创建一个强大而透明的审查过程，2）提供 积极提供技术援助，以提高受资助试点项目的成功率，3）促进 通过结构化培训，利用调查员的专业知识和项目经验，以及4）促进 将试点测试的干预措施调整为设计良好的ePCT。最终，这将导致全面的 ePCT，同时建设调查员开展ePCT的能力。试点核心将由博士领导。 Abraham Brody博士，注册护士，FAAN，纽约大学护理和医学副教授， 在痴呆症和ePCT方面具有丰富经验的护士研究员，将与高技能， 跨学科，执行委员会。试点核心将利用国家信息评估的整体基础设施 AD/ADRD HCS协作室要实现的目标：目标1：征集、严格审查、选择和资助 导致未来全面的ePCT专注于PWD及其护理人员;目标2：提供监测， 指导和资源，以确保严格，及时完成试点里程碑，并有效地分享 试点数据和结果;目标3：促进试点项目调查人员在开展ePCT方面的专业知识， PWD及其护理人员：1。将其纳入AD/ADRD合作实验室和工作组的活动 集团核心，2.提供获得由培训核心领导的结构化培训机会的机会; 3.控股 在3-5年举行年度科学会议，介绍和分享研究和经验;目标4：协助 推行先导计划，把已完成的先导计划转化为获资助的全面电子化社区复康服务，以支援残疾人士及/或 他们的照顾者。影响：NIA AD/ADRD合作实验室试点核心将协助研究人员调查 可在为500多万残疾人及其照顾者提供服务的HCS实施的实际干预措施。 这些试点项目将为多个全面的ePCT提供种子，旨在改善患者的生活质量和健康结果。 这个弱势群体。它还将促进试点项目领导人的专业知识和职业发展， 国家在未来对患有HCS的残疾人进行ePCT的能力。