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.
