ADAPTABLE The Aspirin Study Steering Committee

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Presentation transcript:

ADAPTABLE The Aspirin Study Steering Committee 11 April 2017

Agenda for Today Enrollment Update Health Care Plan Update Query 1 Working Group Update Allocation of Non-Internet Participants All Other Business

28 sites active, 26 enrolling 4,376 Golden tickets entered 2,039 Randomized 29% of Projected enrollment ClinicalTrials.gov: NCT02697916

Site Enrollment Average (4/10) CDRN Site Site Activated Started Enrollment Total Enrolled Enrollment Rate/Month Mid-South Duke 11/9/2016 November 202 40.4 MidSouth Vanderbilt 4/18/2016 April 427 35.6 OneFlorida U of Florida 11/1/2016 138 27.6 PaTH UPMC 7/18/2016 August 229 28.6 NYC-CDRN Montefiore 107 21.4 GPC KUMC 101 20.2 CAPriCORN U of Chicago 2/16/2017 February 35 17.5 Weill Cornell 3/8/2017 March 17 17.0 REACHnet Ochsner 16.8 Penn State 9/23/2016 October 96 16.0 Utah 84 14.0 Iowa 109 13.6 Marshfield Clinic 26 13.0 MCW January 38 12.7 pScanner UCLA 11/7/2016 61 12.2 UTSW 11 11.0 Missouri 12/21/2016 10 10.0 Mt Sinai 8 8.0 Northwestern 8/30/2016 September 52 7.4 BSW 9/19/2016 32 5.3 Rush 5.0 NYU 24 4.8 Temple 14 2.3 Nebraska 2 2.0 UNC 1/13/2017 1 1.0 Tulane 3 0.5

Record Holders Highest weekly enrollment of 157 patients (April 3-9, 2017) Highest monthly enrollment of 450 patients (March 2017) Site Records: Weekly Enrollment KUMC – 48 patients (week of 4/3/17) University of Iowa – 37 patients (week of 2/13/17) UPMC – 30 patients (weeks of 3/13/17 & 3/27/17) Monthly Enrollment Vanderbilt – 97 patients (October 2016) UPMC – 83 patients (March 2017) Duke – 74 patients (March 2017)

Site Approach & Enrollment Update (4/10) 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 6,134 33% 819 13% 427 10 7% 52% 11 PaTH UPMC 13,879 5,220 38% 691 229 4% 13 REACHnet Ochsner 11,832 5,567 47% 520 9% 202 32 39% 9 Mid-South Duke 19,902 703 289 41% 26 29% 70% 17 OneFlorida U of Florida 29,738 4,414 15% 149 3% 138 23 93% 3 GPC Iowa 14,512 5,274 36% 224 109 6 2% 49% NYC-CDRN Montefiore 47,383 1,605 127 8% 107 40 84% KUMC 12,936 1,621 242 101 6% 42% 48 Penn St 2,708 2,647 98% 272 10% 96 35% Utah 5,219 3,417 65% 192 84 8 44% 5 pScanner UCLA 15,669 5,600 132 61 1 1% 46% CAPriCORN Northwestern 15,234 3,593 24% 108 52 48% 4 MCW 5,731 2,741 98 38 U of Chicago 5,446 543 36 35 24 97% BSW 2,081 1,700 82% 80 5% 40% Marshfield Clinic 8,277 1,927 23% 54 2 NYU 49,254 865 22% Weill Cornell 17,253 639 73 11% 7 Temple 4,101 1,162 28% 44 14 32% UTSW 2,459 254 19 58% Rush 8,826 840 43% Missouri 1,004 437 Mt Sinai 41,876 185 0% 29 16% Tulane 771 62 60% Nebraska 3,200 102 UNC 5,204 145 Johns Hopkins 23,935 20% TOTAL   362,935 57,402 4,376 2039 183 157

Retention Update (4/10) Retention 1781 Week 1 Visits Expected: 1438 Complete (81%), 343 Total Late (19%), 117 >90 days Late (7%) 418 3mo Visits Expected: 285 Complete (68%), 133 Total Late (32%), 43 >90 Days (10%) 312 6 Month Visits Expected: 229 Completed (73%), 83 Total Late (27%), 23 >90 Days Late (7%)

HealthCore Overview Research subsidiary of Anthem Clients include life science companies, health plans, government agencies, and academic research centers Founding collaborator with the FDA Sentinel System Conduct over 60 queries a year within the Sentinel CDM Over 140 highly specialized, multi-disciplinary professionals primarily research scientists and data analysts dedicated to health services and outcomes research COMPANY CONFIDENTIAL | DO NOT COPY

HealthCore/Anthem Research Network (HCARN) A PCORnet Health Plan Research Network (HPRN) Funded to support PCORnet and the Demonstration Projects Additional methodology study to collaborate with PPRNs HealthCore has been a leader in utilization of the Common Data Model as a founding collaborative member of the FDA Sentinel System HealthCore executes over 60 routine safety queries a year

HIRD - Researchable Population Density by State 7/15/2019 HIRD - Researchable Population Density by State Medical and Pharmacy WA ME MT ND MI VT MN New Hampshire OR NY WI MA ID SD MI Rhode Island WY PA Connecticut IA NJ NE OH Delaware IN NV IL UT WV CO VA Washington, DC CA KS MO KY NC Virginia TN OK SC AZ AR NM Anthem states* >1,000,000 500,000 – 1,000,000 250,000 – 500,000 100,000 – 250,000 <100,000 AL GA MS TX LA FL *California, Colorado, Connecticut, Georgia, Indiana, Kentucky, Maine, Missouri, Nevada, New Hampshire, New York, Ohio, Virginia, Wisconsin COMPANY CONFIDENTIAL | DO NOT COPY Enter Filename Here

Pre & Post Query Run Checklist: Query 1- May 1, 2017 Pre & Post Query Run Checklist: Before responding to data characterization refresh 2 (due April 24) Update the PCORNET_TRIAL table to include as many patients as possible Make sure the REFRESH_PCORNET_TRIAL_DATE in the HARVEST table is correctly populated. Check that the length of PATID in all tables including PCORNET_TRIAL table matches by running the PCORNET_TRIAL Diagnostic Query. Check that the trial participants are present in the expected tables by running the PCORNET_TRIAL Diagnostic Query Check the completeness of the discharge disposition data for inpatient encounters Check the completeness of the principal diagnosis data for inpatient encounters. Ensure that ICD procedure codes after Oct 2015 are included and classified as ICD10* Ensure that ICD diagnoses codes after Oct 2015 are included and classified as ICD10* Before running ADAPTABLE Query 1 Update the PCORNET_TRIAL table to include all patients who enrolled on or before April 15, 2017 Make sure the REFRESH_PCORNET_TRIAL_DATE in the HARVEST table is correctly populated. NOTE: This date should be after April 15, 2017 – see ‘Reminders about populating the PCORENT_TRIAL table’ below. Ensure that PATID, TRIAL_ENROLL_DATE, TRIAL_END_DATE, and TRIAL_WITHDRAW_DATE variables are internally consistent across other CDM tables for the same patient Ensure that only data from participating ADAPTABLE DataMarts are queried After running ADAPTABLE Query 1 (due May 15) Review output to confirm that the layout and contents conform to the layouts in this work plan and the results you would expect. Section VII Table Shells should be used as a reference. *Partners who had potential problems with code type assignments received a communication from the PCORnet Coordinating Center. Tools to identify these errors are located here: https://pcornet.imeetcentral.com/p/ZgAAAAAAhMVg

Working Group Progress IRB Challenges - Address IRB challenges for pragmatic studies including approval of broad/novel patient approach methods, patient partner involvement, and use of social media channels to raise awareness Recruitment Optimization - Address challenges with implementing the Computable phenotype, best practice for organizing local tracking of eligible participants, and optimizing multi-touch approach Patient Engagement - Address patient engagement and outreach through channels such as social media and optimizing the role of the Adaptors as part of local CDRN team Patient Retention - Address perceived challenges with retention, delineate the role of local clinical team in supporting retention, and optimize communications and content to engage participants throughout the duration of the study

Allocation of Non-Internet Participants Cap of 1,000 non-internet participants total Allocation of 125 per each CDRN Reallocation Discussion

Other Items All Other Business? Next Call – May 9th at 9:00am (Eastern Time)