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.

亚利桑那大学横幅健康 (UA-Banner) 所有人研究计划 (AoU RP) 将利用 以参与者为中心的注册和保留策略，第一年每年吸引 20,000 名正式参与者 到 5 名进入由 100 万或更多完整参与者组成的 AoU RP 队列。参与和注册：我们的 该方法经过了 12 个月的规划和 6 个月的扩展测试阶段测试，在此期间我们 已将超过 2,000 名年龄≥18 岁的完整参与者纳入 AoU RP。我们主要依靠面对面 在 UA-Banner 卫生系统中接受护理的潜在参与者的参与。我们的目标是 到 2017 年 12 月底启用 10 个小学入学点，之后总数将增加 截至 2018 年 12 月，注册地点已达 13 个。注册地点是境内的医疗机构或医疗综合体 UA-Banner AoU RP 已建立一个或多个 招生单位。一个招生单位是一个设备齐全的车站 配备适当数量的经过充分培训和认证的人员 能够完整实施AoU RP协议的人员。 各招生地点每日招生目标为 如图表 1 所示。我们预计将招募 102 名完整参与者 一年 250 个工作日中的 196 个工作日（366 天 -104 天）每天 周末（12 个公共假期）以满足我们的入学目标 每年 20,000 名参与者。我们预计剩余的 54 工作日作为缓冲，平均水平要低得多 每天注册 30 名参与者（每年 1,620 名）。这 这些年度累计入学人数的假设 计算将在“招生目标”部分讨论。 如果满负荷运转，我们将拥有 65 名临床研究协调员 (CRC)、12 名“promotores”和 20-24 名医师冠军 10个注册站点（截至目前部署已完成60%） 2017 年 11 月 15 日）。我们的招生活动包括七项 Banner Heath 患者的初始参与方法 其他人也可以进入变得充实的道路 参与者： (1) AoU-RP 介绍/邀请函（经批准 由IRB）并由医生提供者签署发送给患者 即将前往医疗保健机构看望医生 在预定访问前 3-4 周安排设施，然后进行 当天电话联系和面谈报名 预定的办公室访问； (2)即席现场介绍 我们的 CRC 向患者、其家人和/或 在流动护理、紧急护理和住院环境中陪伴人员； (3) 经IRB批准 向 Banner Health Plan 会员发送介绍性/邀请电子邮件以及算法驱动的定向弹出 AoU RP My Banner 门户上的促销公告可供 Banner Health 系统中的所有患者访问 已注册使用“我的横幅”的人； (4) “Tableling”——一种利用 UA-Banner 的参与方法 AoU RP 印有信息表，配备 1-2 个临时驻扎在交通繁忙区域的 CRC 在医疗机构内，患者和其他人可以接收信息，完成 “意向书”，注册或直接陪同到我们的招生单位现场开始 基线程序之后的同意处理； (5) 现场报名——符合条件的个人报名 包括听说过 AoU RP 并愿意接受培训的 UA-Banner 员工 计划外的 AoU-RP 登记/基线访视； (6) 由 12 名发起人发起的参与访问 字面意思是在西班牙裔/拉丁裔社区“敲打人行道”，以通知和识别潜在参与者 并安排对设施注册地点的注册访问； （7）组织AoU RP宣传活动 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），提供 有机会完成兴趣卡表达、安排访问、提供联系信息或只是为了 获取有关 AoU RP 的更多信息。参与者参与委员会 (PEB)：最高管理层到基层 根参与者的参与主要围绕两个当前活跃的 PEB：(1) AI/AN PEB，称为 社区咨询委员会的组成尽可能反映了 22 个 AI/AN 部落的情况 亚利桑那州在实际规模限制内（9 名 PEB 成员）且 (2) 第二个 PEB 由 20 名成员组成 其中 9 名是西班牙裔或会说英语和西班牙语的双语者，以反映超过 50% 的参与者 将是西班牙裔/拉丁裔。