ADAPTABLE The Aspirin Study Steering Committee 09 May 2017
Agenda for Today Enrollment Update Outreach Strategies Query 1 Lessons Learned All Other Business
29 sites active, 26 enrolling 5,571 Golden tickets entered 2,591 Randomized 31% of Projected enrollment ClinicalTrials.gov: NCT02697916
Monthly Enrollment (5/8) 2016 Site Apr 2016 May 2016 Jun 2016 Jul 2016 Aug 2016 Sep 2016 Oct 2016 Nov 2016 Dec 2016 Total Enrolled 8 32 22 51 76 91 171 163 150 # of Sites Approaching 2 4 6 10 14 16 Total Approached 126 381 380 1,196 1,920 2,342 7,499 4,155 7,473 2017 Site Jan 2017 Feb 2017 Mar 2017 Apr 2017 May 2017 Total Enrolled 296 360 450 599 122 # of Sites Approaching 17 22 23 26 Total Approached 5,645 12,432 14,532 18,231 4,364
Site Enrollment Average (5/8) CDRN Site Site Activated Started Enrollment Total Enrolled Enrollment Rate/Month Mid-South Duke 11/9/2016 November 287 47.8 Vanderbilt 4/18/2016 April 526 40.5 PaTH UPMC 7/18/2016 August 298 33.1 OneFlorida U of Florida 11/1/2016 166 27.7 GPC Marshfield Clinic February 71 23.7 NYC-CDRN Montefiore 136 22.7 KUMC 121 20.2 CAPriCORN U of Chicago 2/16/2017 58 19.3 Weill Cornell 3/8/2017 March 36 18.0 REACHnet Ochsner 222 17.1 Penn State 9/23/2016 October 110 15.7 Iowa 123 13.7 Utah 94 13.4 MCW January 53 13.3 pScanner UCLA 11/7/2016 68 11.3 UNC 1/13/2017 9 9.0 UTSW 17 8.5 Northwestern 8/30/2016 September 7.3 Rush 9/19/2016 20 6.7 Mt Sinai 12/21/2016 12 6.0 NYU 32 5.3 Missouri 10 5.0 BSW 35 Nebraska 3 3.0 Temple 22 3.1 Tulane 4 0.6
Record Holders Highest weekly enrollment of 191 patients (April 24-30, 2017) Highest monthly enrollment of 599 patients (April 2017) Site Records: Weekly Enrollment Vanderbilt – 50 patients (week of 4/24/17) KUMC – 49 patients (week of 4/3/17) University of Iowa – 37 patients (week of 2/13/17) Monthly Enrollment Vanderbilt – 97 patients (Oct 2016) & 96 (Apr 2017) UPMC – 83 patients (Mar 2017) Duke – 78 patients (Apr 2017) KUMC – 67 patients (Apr 2017)
Retention Update (5/8) Retention 2,313 Week 1 Visits Expected: 1844 Complete (80%), 469 Total Late (20%), 154 >90 days Late (7%) 566 3mo Visits Expected: 383 Complete (68%), 183 Total Late (32%), 68 >90 Days (12%) 496 6 Month Visits Expected: 355 Completed (72%), 141 Total Late (28%), 32 >90 Days Late (6%)
Approach Strategies Enrollment End Date: March 1, 2018 Conversion Rate Rapid Approach
ADAPTABLE Trial The Aspirin Study Paced Outreach David Crenshaw, Vanderbilt Follow us on Twitter @ADAPTABLEstudy ClinicalTrials.gov: NCT02697916
Vanderbilt: Paced Outreach Approach Expanded CP enables parallel clinic and email approaches Automated emails scheduled for release in a staggered manner to facilitate phone call follow up Both approaches help to “prime the pump” for the other. Over 50% of patients with a clinic visit have an email address on file Aligning email program to correspond date of email release with upcoming cardiology clinic appointment
Automated Email Schedule Monday Tuesday Wednesday Week 1 Initial email script 1 – Group 1 Week 2 Removal of declines, ineligible deceased for all groups Initial email script 1 – Group 2 Follow up email script - Group 1 Phone follow up Group 1 initial Week 3 Follow up email script - Group 2 Phone follow up Group 2 Initial Week 4 Final email script – Group 1 Phone follow up Group 1 final Week 5 Final email script – Group 2 Initial email - Group 3 Phone follow up Group 2 final
ADAPTABLE Trial The Aspirin Study Query 1 Follow us on Twitter @ADAPTABLEstudy ClinicalTrials.gov: NCT02697916
Query 1 Update Sent to Sites May 1, 2017 Responses due May 15, 2017 Endpoint Ascertainment Impact of Data Latency Alignment of PRO to CDM Events Queries to be sent Quarterly after each DRN-OC Refresh
ADAPTABLE Trial The Aspirin Study Lessons Learned to Date Follow us on Twitter @ADAPTABLEstudy ClinicalTrials.gov: NCT02697916
Other Items All Other Business? Next Call – June 13th at 9:00am (Eastern Time)
Site Approach & Enrollment Update (5/8) CDRN Site Total Number Eligible Total Number Approached % of Eligible Approached Golden Tickets Entered % Golden Tickets entered per Approached Total Enrolled # Non-internet Enrolled % Enrolled Per Approached % Enrolled Per Golden Ticket Entered Enrolled last week MidSouth Vanderbilt 18,440 6,919 38% 978 14% 526 13 8% 54% 16 PaTH UPMC 13,879 5,674 41% 914 16% 298 5% 33% 18 Mid-South Duke 19,902 845 4% 401 47% 287 48 34% 72% 25 REACHnet Ochsner 11,832 6,668 56% 600 9% 222 37 3% 37% 2 OneFlorida U of Florida 29,738 12,978 44% 195 2% 166 31 1% 85% 4 NYC-CDRN Montefiore 47,383 1,919 136 56 7% 82% 9 GPC Iowa 14,512 5,328 268 123 6 46% KUMC 12,936 3,916 30% 275 121 Penn St 2,708 2,647 98% 316 12% 110 35% Utah 5,219 3,463 66% 213 6% 94 3 Marshfield Clinic 8,277 4,822 58% 137 71 52% 12 pScanner UCLA 15,669 5,600 36% 141 68 48% CAPriCORN Northwestern 15,234 3,593 24% 124 58 1 U of Chicago 5,446 543 10% 60 11% 36 97% MCW 5,731 2,741 157 53 Weill Cornell 17,253 853 120 BSW 2,081 1,858 89% 89 35 5 39% NYU 49,254 1,126 140 32 23% Temple 4,101 6,315 154% 97 22 0% Rush 8,826 960 42 20 UTSW 2,459 495 20% 28 17 61% Mt Sinai 41,876 279 13% Missouri 1,004 617 10 UNC 5,204 347 32% Tulane 771 63 Nebraska 3,475 102 Johns Hopkins 23,935 TOTAL 387,145 80,676 21% 5,571 2591 257 122
ADAPTABLE Enrollment Projections by CDRN (5/8) 16-Apr 16-May 16-Jun 16-Jul 16-Aug 16-Sep 16-Oct 16-Nov 16-Dec 17-Jan 17-Feb 17-Mar 17-Apr 17-May PaTH Projected 25 75 100 125 150 175 Actual 19 14 34 33 102 48 123 94 32 % 0% 76% 19% 33% 34% 82% 38% 63% 18% GPC 8 1 16 31 10 117 54 141 32% 1% 21% 31% 8% 94% 36% 11% pSCANNER 50 2 26 12 4 3% 35% 12% 10% 7% NYCDRN 37 24 61 68 13 16% 37% 24% 41% 45% 9% ReachNET 18 20 23 28 36 4% 64% 72% 40% 23% 28% 15% 17% Mid-South 7 39 97 45 73 110 183 41 132% 56% 39% 97% 26% 49% 67% 73% 122% CAPriCORN 5 3 42 46 5% 1 Florida 27 112% 124% 48% 13% 2% Total 225 450 500 700 925 950 1150 1175 1325 22 51 76 91 171 163 296 360 599 122 44% 20% 51% Cumulative 275 1450 2150 2850 3775 4725 5875 7050 8375 40 62 113 189 280 451 614 764 1060 1420 1870 2469 2591 29% 27% 30%