University of Arizona-Banner Health All of Us Research Program

亚利桑那大学横幅健康研究计划

• 批准号: 10338519
• 负责人: Monica Kraft
• 金额: $ 1150万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-04-01 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10338519
• 关键词: Advisory Committees; Alaska; Alaska Native; Algorithms; All of Us Research Program; Ambulatory Care; American Indians; Ancillary Study; Area; Arizona; Aspirin; Biomedical Research; Border Community; Buffers; Canis familiaris; Cardiovascular Diseases; Caring; Caucasians; Cerebrovascular system; Clinic; Clinical; Clinical Research; Clinical Trials; Communities; Complex; Consent; Consequentialism; Data; Data Set; Dreams; Electronic Health Record; Electronic Mail; Employee; Enrollment; Ensure; Enzymes; Event; Exhibits; Family member; Farming Community; Foundations; Gene Frequency; Geography; Goals; Health; Health Fairs; Health Personnel; Health care facility; Health system; Healthcare; Hearing; Heart; Hispanics; Holidays; Hospitals; Human Resources; Ice Cream; Individual; Infrastructure; Institutional Review Boards; Latino; Letters; Life; Medical; Medical center; Minority Participation; Native Hawaiian; Neighborhoods; Not Hispanic or Latino; Office Visits; Pacific Island Americans; Participant; Pathway interactions; Patients; Persons; Pharmacogenetics; Phase; Physicians; Plant Roots; Platelet aggregation; Plavix; Play; Poaceae; Policies; Population; Population Heterogeneity; Positioning Attribute; Procedures; Protocols documentation; Provider; Race; Recurrence; Research; Research Design; Risk; Role; Schedule; Secure; Short Interspersed Nucleotide Elements; Site; System; Telephone; Testing; Training; Tribes; United States Food and Drug Administration; United States National Institutes of Health; Universities; Visit; Walking; Work; aged; base; bilingualism; biobank; clopidogrel; cohort; data modeling; data warehouse; disorder prevention; drug development; ethnic health disparity; genetic variant; health plan; inhibitor/antagonist; interest; intrahepatic; member; multi-ethnic; multidimensional data; patient engagement; pharmacogenetic testing; precision medicine; premature; prevent; racial and ethnic; retention rate; social; treatment response; urgent care; volunteer; working group

The University of Arizona Banner Health (UA-Banner) All of Us Research Program (AoU RP) will utilize a participant-centered enrollment and retention strategy to accrue 20,000 full participants annually during Year 1 to 5 into the AoU RP cohort of one million or more full participants. Engagement and Enrollment: Our approach has undergone 12 months of planning and 6 months of extended beta phase testing during which we have enrolled >2,000 full participants aged ≥18 years into the AoU RP. We rely primarily on face-to-face engagement of potential participants who are receiving care in the UA-Banner Health System. We aim to operationalize 10 primary enrollment sites by the end of December 2017 which will then be increased to a total of 13 enrollment sites by December 2018. An enrollment site is a healthcare facility or medical complex within which the UA-Banner AoU RP has established one or more enrollment units. An enrollment unit is a fully-equipped station staffed by an appropriate number of fully-trained and certified personnel who can implement the AoU RP protocol in its entirety. Daily enrollment targets from each of the enrollment sites are depicted in Exhibit 1. We anticipate enrolling 102 full participants per day for 196 of the 250 working days in a year (366 days -104 weekend days – 12 public holidays) to meet our enrollment target of 20,000 participants per year. We expect that the remaining 54 working days serve as a buffer with a much lower average enrollment of 30 participants per day (1,620 per year). The assumptions underlying these annual cumulative enrollment calculations are discussed in the section on “Enrollment Targets.” At full capacity, we would have 65 clinical research coordinators (CRCs), 12 “promotores” and 20-24 physician champions across the 10 enrollment sites (deployment is 60% complete as of November 15, 2017). Our enrollment campaign entails seven initial engagement approaches by which Banner Heath patients and other individuals can enter the pathway to becoming full participants: (1) An AoU-RP introductory/invitation letter (approved by the IRB) and signed by a physician provider is sent to patients with an upcoming visit to see the physician provider at a healthcare facility 3-4 weeks prior to the scheduled visit followed by a telephone contact and face-to-face enrollment encounter on day of the scheduled office visit; (2) Impromptu in-person introduction to the AoU RP by our CRCs to patients, their family members and/or accompanying persons in the ambulatory care, urgent care and in-patient settings; (3) IRB-approved introductory/invitation email to Banner Health Plan members and an algorithm-driven targeted pop-up AoU RP promotional announcement on the My Banner portal accessible to all patients in the Banner Health system who have registered to use My Banner; (4) “Tabling” – an engagement approach that utilizes a UA-Banner AoU RP emblazoned information table staffed by 1-2 CRCs that is temporarily stationed in a high traffic area within the healthcare facility where patients and other persons can receive information, complete an “Expression of Interest Card,” register or even be accompanied directly to our enrollment unit on-site to begin the consenting processing followed by the baseline procedures; (5) Walk-ins – enrollment of eligible individuals including employees of UA-Banner who have heard about the AoU RP and are willing to undergo an unscheduled AoU-RP enrollment/baseline visit; (6) Engagement visits initiated by 12 promotores who are literally “pounding the pavement” in Hispanic/Latino neighborhoods to inform and identify potential participants and schedule enrollment visits to the facility based enrollment sites; and (7) Organized AoU RP promotional events (ice cream socials, Sonoran hot dog events, health fairs, enrollment site launch etc. ) which provide an opportunity to complete expression of interest cards, schedule visits, provide contact information or simply to obtain additional information about the AoU RP. Participant Engagement Boards (PEBs): C-suite to grass roots participant engagement is centered around two currently active PEBs: (1) the AI/AN PEB called the Community Advisory Committee has a composition that reflects as much possible the 22 AI/AN tribes in Arizona within the practical limit of size (9-member PEB) and (2) the second PEB is comprised of 20 members of whom nine are Hispanics or bilingual in English and Spanish to reflect the fact that >50% of our participants will be Hispanics/Latinos.

亚利桑那大学班纳健康(UA-Banner)所有人研究计划(AOU RP)将利用 以学员为中心的注册和保留战略，在第一年每年吸引20,000名正式学员 到5到100万或更多的正式参与者的AOU RP队列中。参与和注册：我们的 方法已经经历了12个月的规划和6个月的扩展测试阶段，在此期间我们 已经招募了2,000名年龄18岁的≥正式参与者参加AOU RP。我们主要依靠面对面的交流 在UA-Banner卫生系统接受护理的潜在参与者的参与度。我们的目标是 在2017年12月底之前启用10个小学招生站点，然后将增加到总数 到2018年12月，13个注册站点。登记地点是医疗机构或医疗综合体 UA-Banner AoU RP已经建立了一个或多个 招生单位。招生单位是装备齐全的站点 配备适当数量的经过全面培训和认证的 能够全面实施AOU RP协议的人员。 每个招生地点的每日招生目标是 如图1所示。我们预计招收102名正式参与者 一年250个工作日中的196天(366天--104天) 周末-12个公众假期)以满足我们的招生目标 每年20,000名参与者。我们预计剩下的54人 工作日作为一个缓冲，其平均值要低得多。 每天招收30人(每年1,620人)。这个 这些年度累计注册人数背后的假设 计算将在“招生目标”一节中讨论。 在满负荷的情况下，我们将拥有65名临床研究协调员 (CRC)，12名“推广者”和20-24名医生冠军 10个注册站点(截至部署完成60% 2017年11月15日)。我们的招生活动需要七个人 Banner Heath患者的初始参与方法 而其他人可以进入变得饱满的道路 参与者：(1)AOU-RP介绍信/邀请函(批准 由IRB)，并由医生提供者签名发送给患者 即将去看一家医疗保健机构的医生 设施在预定访问前3-4周，然后 年的电话联系和面对面的招生会面 预定的办公室访问；(2)即兴介绍 我们的癌症控制中心对患者、他们的家属和/或 门诊护理、紧急护理和住院环境中的陪护人员；(3)IRB批准的 向Banner Health Plan成员发送介绍性/邀请电子邮件和算法驱动的目标弹出窗口AOU RP 在我的Banner门户网站上发布促销公告，Banner Health System中的所有患者都可以访问 已注册使用My Banner的用户；(4)“列表”--一种利用UA-Banner的参与方式 AOU RP徽章信息表，配备1-2个CRC，临时驻扎在交通繁忙的地区 在患者和其他人可以接收信息的医疗设施内，完成 《意向书》报名或直接陪同到我们招生单位现场开始 同意程序，然后是基线程序；(5)符合条件的个人的即场登记 包括UA-Banner的员工，他们听说了AOU RP，并愿意接受 计划外的AOU-RP登记/基线访问；(6)由12名推广者发起的接洽访问 字面意思是在西班牙裔/拉丁裔社区“敲打人行道”，以告知和识别潜在的参与者 并安排对基于设施的注册站点的注册访问；以及(7)组织AOU RP促销活动 活动(冰淇淋社交活动、索诺兰热狗活动、健康博览会、招生网站启动等)它们提供了一种 有机会完成意向卡、安排访问、提供联系信息或只需 获取有关AOU RP的其他信息。参与者参与度委员会(PEB)：GRASS的首席执行官 Root参与者参与度以两个当前活动的PEB为中心：(1)称为 社区咨询委员会的组成尽可能反映了22个人工智能/人工智能部落 亚利桑那州在实际规模限制内(9名成员)和(2)第二个成员委员会由20名成员组成 其中9人是西班牙裔或会说英语和西班牙语的双语，以反映我们50%的参与者 将会是西班牙裔/拉丁裔。