ADAPTABLE Aspirin Trial Update

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Presentation transcript:

ADAPTABLE Aspirin Trial Update GPC Global Call April 20, 2017

GPC Cumulative Approach by Week

GPC Active Site Report April 20, 2017 Approached Visit Portal Enrolled Iowa 5274 228 111 KUMC 3916 269 114 MCW 2741 100 38 Marshfield 1927 104 51 UTSW 254 23 15 Missouri 617 28 10 Nebraska 102 7 3 Total 14831 759 342 % of Approached   5.12% 2.31% *GPC monthly average since first site’s activation ~4 patients/site/mo. ~25 patients/mo. across all sites

Enrollment Concerns CDRN Expectation: enroll 3,658 over next year At 2.5% avg. enrollment rate, GPC needs to approach 160,000 patients to meet goal 145,000 additional patients over next year Iowa has an estimate of 14,000 with new phenotype Seen in last 2 years in any clinic/department at UIHC If # applied to all participating sites: ~130,500 potentially eligible @ 2.5% only 3,263 enrolled if all approached

Let’s “turn the curve” Higher enrollment rates and approach numbers Engage with in-clinic and telephone follow-up Vanderbilt example: off-set costs of research assistants with per capita enrollment payments Best practice: study invite from PCP or cardiologist More difficult to operationalize invitations en masse “Go big or go home” approaches: mass e-mail/EHR message/letters If possible to combine mass mailings with invitation addressed by PCP or cardiologist, do it Electronic methods

Self-Reported Invitation Mode, Identified Participants Visiting Portal University of Iowa Everyone in our cohort received a letter ~5,300 people Less than half of them received email/EHR follow-up ~2,000 Yet electronic modes are reported slightly more often as an invitation mode by patients in the portal when they go to visit than letters They save money, and are driving people to the patient portal just as often as letters March 28, 2017

Self-Reported Invitation Mode, Randomized Participants University of Iowa Same idea but broken down to randomized participants Again, electronic methods are effective at getting individuals to enroll, but slightly less than letters In clinic biased a bit since our study nurse usually confirms that a patient wants to enroll with her in clinic before entering a study id into the portal March 28, 2017

Randomized Participants by # Contact Attempts University of Iowa Receiving boost in enrollment by contacting individuals multiple times Multi-touch ROI March 28, 2017

Other Updates Phase I Review complete (March 1, 2017) Thanks to all who helped Under Continuing Review, GPC lead IRB at Iowa Indiana final site to onboard following CR approval UTHSCSA active as of March 1, 2017 Finalizing CP v.2 with chart review Goal for first invite release: June 1, 2017

“First rodeo” http://www.todayifoundout.com/wp-content/uploads/2015/03/first-rodeo.jpg