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ADAPTABLE The Aspirin Study CDRN Update
10 Jul 2017
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Agenda for Today ADAPTABLE Coordinating Center Updates
Missing Early Visits Site Responsibilities Participant View in Portal Query 2 All Other Business
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Site Activation & Enrollment Update (7/10)
29 Sites Currently Active, 27 have enrolled 99,469 of 337,209 of total eligible approached 7,785 Golden Tickets Entered into the Patient Portal 3,700 Subjects Randomized Enrollment was at 37% of Projected end of June 2017 18.5% of total enrollment Retention 3,507 Week 1 Visits Expected: 2,832 Complete (81%), 675 Total Late (19%), 247 >90 days Late (7%) 1,016 3mo Visits Expected: 717 Complete (71%), 299 Total Late (29%), 120 >90 Days (12%) 827 6 Month Visits Expected: 600 Completed (73%), 227 Total Late (27%), 70 >90 Days Late (8%)
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Site Approach & Enrollment Update (7/10)
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 22,271 11,331 51% 1,461 13% 777 26 7% 53% 23 Mid-South Duke 20,127 1,633 8% 603 37% 459 88 28% 76% 16 PaTH UPMC 13,879 9,447 68% 1,144 12% 360 4% 31% 5 REACHnet Ochsner 13,560 6,941 681 10% 262 49 38% 4 OneFlorida U of Florida 29,738 4,673 16% 316 226 38 5% 72% 7 NYC-CDRN Montefiore 47,383 2,561 230 9% 182 72 79% Penn St 5,246 4,161 486 166 34% 3 Utah 6,054 5,954 98% 331 6% 149 15 3% 45% 2 GPC Marshfield Clinic 14,949 9,980 67% 290 147 1% Iowa 11,391 5,374 47% 296 144 17 49% KUMC 4,269 4,024 94% 288 128 44% MCW 12,220 6,108 50% 350 121 2% 35% CAPriCORN Northwestern 6,697 6,082 91% 199 94 U of Chicago 5,446 765 14% 85 11% 80 48 pScanner UCLA 15,669 5,229 33% 155 79 Weill Cornell 5,856 1,282 22% 186 15% 62 UNC 5,204 919 18% 134 61 14 46% 20 BSW 2,431 2,220 137 47 6 Temple 6,522 4,989 136 32 8 24% 1 Rush 8,826 2,419 27% 64 NYU 31,795 1,126 143 Mt Sinai 15,832 643 63 21 UTSW 2,459 522 21% 30 18 60% Missouri 1,204 617 11 Tulane 771 124 25% Nebraska 3,475 340 29% Johns Hopkins 23,935 0% 20% TOTAL 337,209 99,469 7,875 3700 400 103
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Monthly Enrollment (7/10)
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 50 77 90 171 163 151 # of Sites Approaching 2 4 6 10 14 16 Total Approached 126 381 380 1,196 1,920 2,342 7,499 4,160 7,299 2017 Site Jan 2017 Feb 2017 Mar 2017 Apr 2017 May 2017 Jun 2017 Total Enrolled 294 362 448 600 610 512 # of Sites Approaching 17 22 23 26 27 Total Approached 4,455 10,185 13,353 14,159 16,481 15,312
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Newsletter Update 1st Newsletter was distributed on June 8, 2017
Still Pending IRB Approval for some Sites Patient Responses
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ADAPTABLE The Aspirin Study
Missing Early Visits and Portal Demo
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Follow-up for Missing Early Visits
Top Priority List will be provided to each Site on a weekly basis Regular check-in calls with CC operations team to each individual enrolling site >15 days old Participants should be contacted for reminder to complete this visit Option to facilitate completion of visit over phone with participant >30 Days Continued efforts to contact participant Coordinator can enter Contact information and any additional visit information available Site payments will be based on completed early visits not randomization
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Required Fields for Missing Early Visits
Required fields on Contact & Insurance Form Address Phone Number Demographic Information If unknown, select ‘Prefer not to say’ for Race and Ethnicity If prompted to enter SSN, can check ‘Prefer not to provide…’ Portal Required field for Early Visit to fall off incomplete report $25 Visa Gift Card
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Participant Portal Demonstration
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ADAPTABLE The Aspirin Study
ADAPTABLE Query 2 Updates Laura Qualls and Mary Williams
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Agenda Updates to Query 2 CDM v3.1 compatibility Analytic changes
Administrative changes Query 2 Distribution Timeline Beta Testing Query 2 Release Query 2 Preparation Checklist PCORNET_TRIAL instructions (recap) PCORNET_TRIAL Diagnostic Query (recap) Open Floor Q&A
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CDM v3.1 Compatibility Changes
Added new CDM Enrollment Basis to Enrollment table: "D"="Outpatient prescription drug coverage" Incorporated the new PX_TYPE for CPT/HCPCS codes (“CH”) Added new CDM v3.1 Encounter Types to descriptive information in the EVT and EVT_DETAIL tables. NOTE: These encounter types are not considered inpatient admissions. "OS"="Observational Stay" "IC"="Institutional Professional Consult"
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Analytic changes Changes
Dates for procedure-based events will use the PX_DATE if known, and ADMIT_DATE if not (Query 1 used ADMIT_DATE for all events) Added dates to EVT_DETAIL Table (not returned) “Procedure Date” associated with procedure of interest “Admit Date” associated with event of interest “Discharge Date” associated with event of interest “Death Date” associated with event of interest
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Administrative Changes
Consistently use code "99" instead of "O"/"OT" for all “Other” category variable descriptions
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Query 2 Distribution Timeline
Beta Testing Schedule Release to Beta Testers on Friday, July 14th Beta Tester query results and feedback due Friday, July 21st Query 2 Release Release Date: August 7th Results Due: August 21st
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ADAPTABLE Query 2 Preparation Checklist
Update the PCORNET_TRIAL table to include all patients who enrolled on or before July 24, 2017 ( 2 weeks prior to query receipt) Update the REFRESH_PCORNET_TRIAL_DATE in the HARVEST table Ensure that PATID, TRIAL_ENROLL_DATE and TRIAL_WITHDRAW_DATE (if populated) are internally consistent with all other CDM dates for the same PATID Run the PCORNET_TRIAL Diagnostic Query to ensure that: The length of PATID in all tables including PCORNET_TRIAL table is consistent Trial participants are present in the expected tables
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Reminders about populating the PCORNET_TRIAL table
Field Source / Notes PATID Pseudoidentier created by the CDRN Must remain in sync with other CDM tables in the approved DataMart Will not be returned in query results TRIALID From Mytrus (= “ADPT”) PARTICIPANTID From Mytrus TRIAL_SITEID TRIAL_INVITE_CODE TRIAL_ENROLL_DATE - If applicable, must be shifted consistently w/other dates TRIAL_END_DATE Should be left blank at this time TRIAL_WITHDRAW_DATE The refresh schedule can be determined by each DataMart, but it must be current as of ~2 weeks prior to query response NOTE: This data is found within the Mytrus CDM Reports on the Mytrus Portal
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Reminder: PCORNET_TRIAL Diagnostic Query
The purpose of this program is to help network partners identify and resolve potential issues with the PCORNET_TRIAL table population. This is a self- service program to be used by network partners; output is not returned to the Coordinating Center. The program: Checks the length of the PATID in all tables used in ADAPTABLE Query 1 since differences in field length can cause errors Looks for ADAPTABLE trial participants in the Demographic, Enrollment, Encounter, Diagnosis, Procedures, and Vital tables. Patients who are not found in any of these tables are provided in the query output for further investigation if necessary. All trial participants must have a Demographic record, and the majority of trial participants are expected to have Enrollment, Encounter, and Diagnosis records. Trial participants may or may not have any Vital and Procedures records. The Death table is not checked since very few trial participants should be in this table. Note: The PDF output is an exception report. The number of PATIDs in the PCORNET_TRIAL table is shown in the log file.
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PCORNET_TRIAL Diagnostic Query Sample Query Results
T DataMartID T Response Date T Query T Site ID PARTID PATID NOT_IN_DSN T1AT1 21-Mar-17 ADPT_DIAGNOSTIC T1 AAA 9 diagnosis BBB 10 CCC 11 DDD 16 encounter EEE procedures vital FFF 8 Query results are saved as a PDF, csv file and SAS dataset.
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Open Discussion Questions and answers
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Other Items All Other Business? SharePoint
Please be sure to update Approached Numbers for each site, especially newly approaching sites Next Call – All CDRN Monday Aug 7th at 2pm (Eastern Time)
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ADAPTABLE Trial Enrollment Details
Follow us on ClinicalTrials.gov: NCT
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ClinicalTrials.gov: NCT02697916
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ADAPTABLE Enrollment Projections by CDRN (7/10)
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 17-Jun 17-Jul PaTH Projected 25 75 100 125 150 175 Actual 19 14 33 34 101 49 122 95 144 60 12 % 0% 76% 19% 33% 34% 81% 39% 63% 82% 7% GPC 8 1 16 31 10 117 54 141 108 76 32% 1% 21% 31% 8% 94% 36% 62% 43% 6% pSCANNER 50 2 26 4 5 3% 35% 12% 10% NYCDRN 37 24 61 68 43 46 16% 37% 24% 41% 45% 29% 26% ReachNET 18 20 23 28 36 32 4% 64% 72% 40% 23% 28% 15% 17% 18% Mid-South 7 29 38 97 72 109 183 208 245 64 128% 58% 38% 97% 48% 67% 73% 122% 119% 140% CAPriCORN 3 42 1 Florida 200 27 112% 124% 13% Total 225 450 500 700 925 950 1150 1175 1325 1400 1425 22 77 90 171 163 151 294 362 448 600 610 512 110 44% 20% 22% 51% 46% Cumulative 275 1450 2150 2850 3775 4725 5875 7050 8375 9775 11200 40 62 112 189 279 613 764 1058 1420 1868 2468 3078 3590 3700 27% 30%
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Monthly Site Enrollment (7/10)
CDRN Site APR 2016 MAY 2016 JUN 2016 JUL 2016 AUG 2016 SEP 2016 OCT 2016 NOV 2016 DEC 2016 JAN 2017 FEB 2017 MAR 2017 APR 2017 MAY 2017 JUN 2017 C11 PaTH Johns Hopkins 1 Penn State University 8 15 5 33 24 40 21 Temple University 3 4 2 7 10 UPMC 19 14 9 44 22 82 68 60 University of Utah 20 17 12 34 C13 OneFlorida U of Florida Gainesville 28 31 36 16 27 23 C2 Mid-South Duke 30 69 74 78 97 UNC Chapel Hill Vanderbilt University 18 32 29 38 43 42 35 96 107 135 C3 pSCANNER UCLA 26 C4 GPC Marshfield Clinic 52 MCW 25 13 62 University of Iowa 63 KUMC University of Missouri University of Nebraska UTSW 11 C6 REACHnet Baylor Scott and White 6 Ochsner Tulane C8 NYC CDRN Montefiore Mount Sinai New York University Weill Cornell C9 CAPriCORN Northwestern Medical Rush U of Chicago TOTAL 50 77 90 171 163 151 294 362 448 600 610 512
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Site Enrollment Average (7/10)
CDRN Site Site Activated Started Enrollment Total Enrolled Enrollment Rate/Month Mid-South Duke 11/9/2016 November 459 57.4 Vanderbilt 4/18/2016 April 777 51.8 PaTH UPMC 7/18/2016 August 360 32.7 GPC Marshfield Clinic 11/1/2016 February 147 29.4 OneFlorida U of Florida 226 28.3 NYC-CDRN Montefiore 182 22.8 UNC 1/13/2017 61 20.3 MCW January 121 20.2 Penn State 9/23/2016 October 166 18.4 REACHnet Ochsner 262 17.5 Utah 149 16.6 CAPriCORN U of Chicago 2/16/2017 80 16.0 KUMC 128 Weill Cornell 3/8/2017 March 62 15.5 Iowa 144 13.1 pScanner UCLA 11/7/2016 79 9.9 Northwestern 8/30/2016 September 94 9.4 Rush 9/19/2016 32 6.4 Mt Sinai 12/21/2016 21 5.3 BSW 47 5.2 UTSW 18 4.5 NYU 4.0 Temple 3.6 Missouri 11 2.8 Nebraska 4 1.3 Johns Hopkins 8/31/2016 June 1 1.0 Tulane 5 0.6
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Golden Tickets Entered
ADAPTABLE Follow-up Visits (7/10) CDRN Site Golden Tickets Entered Randomized Expected Completed <31 Days 31-60 Days 61-90 Days >90 Days C11 PaTH Johns Hopkins 3 1 Penn State University 486 166 159 124 4 10 20 Temple University 136 32 31 21 6 University of Pittsburgh 1143 360 351 264 16 41 University of Utah 331 149 142 131 5 C13 OneFlorida University of Florida Gainesville 315 226 211 148 11 7 40 C2 Mid-South Duke 603 458 434 340 25 24 14 UNC Chapel Hill 134 61 42 39 2 Vanderbilt University 1461 777 725 621 46 22 C3 pSCANNER University of California Los Angeles 155 79 78 64 9 C4 GPC Marshfield Clinic 290 147 122 90 Medical College of Wisconsin 349 121 98 8 University of Iowa 296 144 140 128 University of Kansas Medical Center 288 108 University of Missouri 30 University of Nebraska Med Ctr University of Texas Southwestern 18 C6 REACHnet Baylor Scott and White 137 47 Ochsner 680 261 257 227 15 Tulane C8 NYC CDRN Montefiore Medical Center 230 182 178 114 Mount Sinai Health System 63 New York University 143 23 Weill Cornell Medical College 186 53 35 C9 CAPriCORN Northwestern Medical 199 94 91 75 Rush 28 U of Chicago 85 80 68 TOTAL 7871 3697 3507 2832 167 247 675 late Week 1 visits
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ADAPTABLE Follow-up Visits (7/10)
3 Month Visit 6 Month Visit CDRN Site Expected Completed <31 Days 31-60 Days 61-90 Days >90 Days C11 PaTH Johns Hopkins Penn State University 43 36 1 4 47 32 11 2 Temple University 8 3 6 University of Pittsburgh 111 81 12 10 68 53 9 University of Utah 38 29 C13 OneFlorida University of Florida Gainesville 80 39 7 5 18 62 25 20 C2 Mid-South Duke 115 77 UNC Chapel Hill Vanderbilt University 216 166 308 242 22 C3 pSCANNER University of California Los Angeles 23 34 28 C4 GPC Marshfield Clinic Medical College of Wisconsin 17 University of Iowa 52 33 University of Kansas Medical Center 27 16 University of Missouri University of Nebraska Med Ctr University of Texas Southwestern C6 REACHnet Baylor Scott and White 15 Ochsner 93 57 132 98 Tulane C8 NYC CDRN Montefiore Medical Center 14 Mount Sinai Health System New York University Weill Cornell Medical College C9 CAPriCORN Northwestern Medical 26 Rush U of Chicago TOTAL 1016 717 92 49 120 827 600 78 35 44 70 299 3mo visits late, 227 6mo visits late
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Standing Reminders
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CDRN and 1:1 Call Schedule
May 1= All CDRN Call July 3= No Calls, July 4th week May 8= NYC-CDRN July 10= All CDRN Call May 15= CAPriCORN July 17= pSCANNER May 22= GPC CDRN July 24= NYC May 29= No Calls, Memorial Day July 31= CARriCORN June 5= All CDRN Call August 7= All CDRN Call June 8= PaTH August 14= NYC-CDRN June 12= OneFlorida August 21= CAPriCORN June 19= REACHnet August 28= GPC CDRN June 26= Mid-South
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CDRN Responsibilities
Create milestones for trial execution for every site Facilitate execution of contracts, IRB approvals Submit requested updates to CC on time Review and approve local site patient recruitment plans Follow up on any missed timelines and create work plans for catching up Escalate operational issues to CDRN PI regarding any site not meeting timelines and deliverable expectants
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CDRN Order of Priorities
Approach and Enrollment at active sites Activate remaining sites Datamart Refresh Response to ADAPTABLE queries
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CDRN Recurring Deliverables
Weekly: Missed Early Visit Check-in Follow-up Monthly: New Approaches/week by site All CDRN Call Bi-Monthly: 1:1 CDRN call with CC Ad-Hoc: Updated eligibility numbers from CP Updated team directory Reconcile Golden Ticket with CDM Site Metrics update
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