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Pilot Studies Core

试点研究核心

基本信息

批准号：
10673668
负责人：
Abraham Aizer Brody
金额：
$ 456.94万
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 2025-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10673668
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 Development Diagnosis Discipline of Nursing Doctor of Philosophy Ensure Environment Ethics Ethnic Origin Evidence based practice Fostering Funding Future Goals Growth Guidelines Health Healthcare Healthcare Systems Hospitals Income Individual Infection Infrastructure Intervention Investments Life Cycle Stages 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 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 home based service improved mid-career faculty patient home care pilot test pragmatic trial racial minority restraint sedative sex skills 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.

项目总结