Pilot Studies Core

试点研究核心

基本信息

批准号：
10229430
负责人：
Abraham Aizer Brody
金额：
$ 359.19万
依托单位：
BROWN UNIVERSITY
依托单位国家：
美国
项目类别：
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/10229430
关键词：
Address Aging Alzheimer&apos s Disease Alzheimer&apos 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 pragmatic trial racial and ethnic racial minority restraint sedative sex success symposium systems research training opportunity working group

项目摘要

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.

项目概要缺乏针对痴呆症患者（PWD）及其护理人员的实际研究测试干预措施世界环境阻碍了医疗保健系统 (HCS) 充分照顾这一迅速扩大的疾病的能力 HCS (ePCT) 中嵌入的实用临床试验可以解决这个问题。然而，ePCT 很复杂，需要特定的方法、熟练的研究者和密切的合作。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。过去几年，各个研究团队已开始获得进行 ePCT 的经验他们的经验强调了试点阶段的重要性。国家老龄化研究所 (NIA) AD/ADRD HCS 试点核心的成功实施。因此，研究合作实验室将征集并资助 30 多个试点 ePCT，然后对这些试点的各个方面进行指导核心将 1) 创建一个稳健且透明的审查流程，2) 提供积极的技术援助，以增加资助试点的成功率，3）促进发展研究者的专业知识并通过结构化培训利用跨项目的经验，以及 4) 促进将试点测试的干预措施改编为精心设计的 ePCT，最终将导致全面推广。 ePCT，并同时培养开展 ePCT 的研究者能力。试点核心将由 Dr. 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 方面拥有丰富经验的护士研究员，将与高技能、跨学科的执行委员会将利用 NIA 的整体基础设施。 AD/ADRD HCS 合作实验室旨在实现：目标 1：征求、严格审查、选择和资助项目，这些项目将导致未来全面的 ePCT 重点关注残疾人及其护理人员；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，并有效共享试点数据和结果；目标 3：提升试点项目研究者在开展 ePCT 方面的专业知识残疾人及其护理人员： 1. 将他们纳入 AD/ADRD 合作和工作的活动中集团核心，2. 提供由培训核心主导的结构化培训机会，以及 3. 持有在 3-5 年级举行年度科学会议，展示和分享研究和经验；目标 4：协助；试点项目，将已完成的试点项目转变为残疾人和/或残疾人领域成功资助的全面 ePCT 影响：NIA AD/ADRD 合作试点核心将协助研究人员进行调查。可以在 HCS 中实施的实际干预措施，为超过 500 万残疾人及其护理人员提供服务。这些试点项目将催生多个全面的 ePCT，旨在改善人们的生活质量和健康结果它还将培养试点项目领导者的专业知识和职业发展，从而增强这一弱势群体的能力。国家未来在残疾人中使用 HCS 进行 ePCT 的能力。