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: 10807201
• 负责人: FRANCISCO A MORENO
• 金额: $ 1221.69万
• 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 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10807201
• 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; Blood Platelets; Border Community; Buffers; Canis familiaris; Cardiovascular Diseases; Caring; Caucasians; Cerebrovascular system; Certification; Clinic; Clinical; Clinical Research; Clinical Trials; Communities; Complex; Consent; Data; Data Set; Dreams; Electronic Health Record; Electronic Mail; Eligibility Determination; Employee; Enrollment; Enzymes; Ethnic Origin; Event; Exhibits; Family member; Farming Community; Gene Frequency; Geography; Goals; Health; Health Fairs; Health Personnel; Health care facility; Health system; Healthcare; Hearing; Heart; Hispanic; Hispanic Populations; Holidays; Hospitals; Human Resources; Ice Cream; Individual; Inpatients; Institutional Review Boards; Ischemia; Latino; Latino Population; Letters; Life; Medical; Medical center; Minority Participation; Native Hawaiian or Other Pacific Islander; Neighborhoods; Not Hispanic or Latino; Office Visits; Participant; Pathway interactions; Patients; Persons; Pharmacogenetics; Phase; Physicians; Platelet Inhibitors; Platelet aggregation; Plavix; Play; Poaceae; Policies; Population; Population Heterogeneity; Positioning Attribute; Procedures; Productivity; Protocols documentation; Provider; Race; Recurrence; Research; Research Design; Risk; Role; Schedule; Secure; Site; System; Telephone; Testing; Training; Tribes; United States Food and Drug Administration; United States National Institutes of Health; Universities; Visit; Walking; Work; aged; bilingualism; biobank; clopidogrel; cohort; data modeling; data warehouse; disorder prevention; drug development; ethnic health disparity; genetic variant; health plan; interest; intrahepatic; member; multi-ethnic; multidimensional data; patient engagement; pharmacogenetic testing; precision medicine; premature; prevent; racial health disparity; retention rate; social; transmission process; 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）所有我们的研究计划（AoU RP）将利用一个 以参与者为中心的招生和保留策略，在第一年每年累积20，000名正式参与者 到5人进入100万或更多完全参与者的AoU RP队列。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beta阶段测试，在此期间，我们 AoU RP招募了> 2，000名年龄≥ 18岁的完整参与者。我们主要依靠面对面 参与潜在的参与者谁正在接受照顾的UA-Banner卫生系统。我们的目标是 到2017年12月底，将10个主要招生点投入运营，然后将总数增加到 截至2018年12月，13个入组研究中心。入组研究中心是指医疗机构或医疗综合体， 其中UA-横幅AoU RP已经建立了一个或多个 招生单位。一个招生单位就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 能够完整实施AoU RP协议的人员。 每个入组研究中心的每日入组目标为 如图1所示。我们预计将招募102名正式参与者 每年250个工作日中的196个工作日（366天-104天 星期日至12日公众假期），以达到招生目标 每年有20，000人参加。我们预计剩下的54个 工作日作为缓冲，平均值要低得多 每天招募30名参与者（每年1，620人）。的 这些年度累计入组的假设 计算方法在"注册目标"一节中讨论。 如果满负荷运转，我们将有65名临床研究协调员 （CRCs），12个"推广者"和20 - 24个医生冠军 10个注册站点（截至2013年12月31日， 2017年11月15日）。我们的招生活动需要七个 班纳健康公司的病人 而其他人则可以进入这条道路， 参加者：（1）一份AoU-RP介绍信/邀请信（已批准 由IRB签署）并由医生签署的文件发送给患者 在即将到来的访问中， 在计划访视前3 - 4周， 电话联系和面对面登记 （2）在第一次会议上， 由我们的CRC向患者、其家属和/或 在门诊护理、紧急护理和住院环境中的陪同人员;（3）IRB批准的 向Banner Health Plan会员发送介绍/邀请电子邮件，以及算法驱动的有针对性的弹出AoU RP 在My Banner门户网站上发布促销公告，Banner Health系统的所有患者均可访问 已注册使用My Banner的用户;（4）"列表"-一种利用UA Banner的参与方法 由1 - 2名临时驻扎在高流量区域的CRC组成的AoU RP标志信息表 在患者和其他人可以接收信息的医疗机构内， "意向表达卡"报名甚至陪同直接到我们招生单位现场开始 同意处理后的基线程序;（5）未经许可的登记-合格个人的登记 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入组/基线访视;（6）由12名 在西班牙裔/拉丁裔社区"冲击人行道"，以告知和识别潜在的参与者 并安排对基于设施的招募站点的招募访问;以及（7）组织AoU RP宣传 活动（冰淇淋社交活动、索诺兰热狗活动、健康博览会、招生现场发布会等）提供 有机会完成感兴趣的表达卡，安排访问，提供联系信息，或者只是 获取有关AoU RP的其他信息。参与者参与委员会（PEB）：从最高层到基层 根参与者参与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个印第安人/印第安人部落， 亚利桑那州的实际限制的大小（9名成员PEB）和（2）第二PEB是由20名成员 其中9人是西班牙裔或双语英语和西班牙语，以反映事实，> 50%的参与者 将是西班牙裔/拉丁裔。