ADAPTABLE Update
14 December 2015
Agenda for Today
CDRN Presentations
Mytrus Update
Other Items
CDRN Presentations
pSCANNER
PaTH
NYC-CDRN
pSCANNER CDRN
Recruitment Plans
December 14, 2015
Patient Engagement
Initial pSCANNER ADAPTOR Feedback
 Calls with Cardiology leads, Dec 8, 10
 Edits to recruitment protocol and materials
ADAPTORs expect to provide further feedback on
recruitment materials as a group
Maybe, cognitive interviews
 Meet first 2-4 eligible patients before/after visit
 Think aloud protocol
 Audio-record, transcribe, code issues, edit
Phased Physician Engagement
Cardiologist Co-investigators: Gregg Fonarow, UCLA;
Shaista Malik, UC Irvine; Ajit Raisinghani, UCSD
Phased: 1. Cardiology, 2. Primary care
Buy-in from key leadership at each site
 Cardiology: Chair of Medicine, Cardiology Div. Chief
 Primary care: Faculty Practice Group CMO, etc.
Awareness raising
 Email blast to cardiologists and PCPs explaining study
and announcing presentations
 Presentations at: Cardiology faculty meeting, FPG
evening CME sessions, Medicine grand rounds
Patient Identification
EHR Phenotype Development & Enrichment Factors
AMI, PCI or CABG (ICD-9, ICD-10 or CPT)
 Not planning to use the CathPCI registry to identify CAD
-- too few patients have 75+% stenosis w/o treatment
Enrichment factors, exclusions as specified
Not requiring portal use or email address
 UC Irvine doesn’t have Epic, portal data uncertain
 Patients already get too many messages from portal
(every scheduling, encounter, lab event yields 1+)
Recruitment sequence
Individual physician outreach via inbasket messages
 List their eligible patients based on EHR-phenotype
 Reply: blanket opt-in, opt-out, exclude (or delay) individuals
 Can suggest additional patients missed by phenotype
 Response deadline (3-4 wks) with weekly reminders
 Default opt-in
Mail recruitment letter to patients
 University letterhead/envelope
 Letter contains golden ticket number
 Patients can email study coordinator or return a printed form to
opt-in, opt-out or request more information
 Reply email to contain clickable golden ticket link
Non-responder follow-up
 Second mail item
 Email those that have it (40% at UCLA)
 Telephone remaining non-responders
Phased Approach
Start with cardiology practices
 Monitor response rates, adjust engagement strategy
Proceed to internal and family medicine
 Sites with highest eligible patient concentration first
 Inbasket message
• Flag patients already recruited through cardiology
• Delete patients already opted out
Practice-level outreach where response to physician
survey is low (or expected to be low)
Stakeholder Engagement Update
PaTH CDRN
Our goal is to conduct research that matters most
to our patients.
 University of Pittsburgh/UPMC
 Penn State College of Medicine/Hershey Medical Center
 Temple University School of Medicine/Temple Health
 Johns Hopkins University/Johns Hopkins Health
System/Johns Hopkins Health Care
 Geisinger Health System (*not participating in ADAPTABLE)
 University of Utah Health Care
Engagement Plans & Activities
Identify Patient Stakeholder “Adaptor”
Form Working Group
Develop & Circulate Engagement Materials
 Adaptor Welcome Letter & Partner Guide
 Fact Sheet & Study Infographic
 Clinician Presentation
All sites discuss study with clinician leadership
Engagement Plans & Activities
Engage regulatory staff & WG for ICF review
Submit protocol & ICF for PNPRC Review (PaTH
Network Protocol Review Committee)
All sites schedule time to present study at
upcoming faculty & departmental meetings
(Cardiology & General Internal Medicine)
Web Posting
Recruitment Plans
Potentially eligible subjects will be identified using
the computable phenotype applied to each
network site’s EHR
Clinician review/Best Practice Alerts
Study staff will contact potentially eligible
subjects with the recruitment letter via EHR
patient portal, email, or US Postal Service (as
determined by site preference and allowed by site
regulatory practice)
Interested patients will go to the ADAPTABLE
patient portal for electronic consent and additional
eligibility confirmation
New York City Clinical Data
Research Network (NYC-CDRN)
ADAPTABLE Engagement
Activities
December 14, 2015
Clinician Engagement
NYC-CDRN Participating Sites
Montefiore Medical Center
Mount Sinai Hospital
Columbia University Medical Center
New York University Langone Medical Center
Weill Cornell Medicine
NYC-CDRN Site co-PIs – Role
Each site has identified co-PIs, a cardiologist and a primary
care provider
Site co-PIs serve as:
 local advocates and sources of trial information
 spearhead clinician engagement, patient recruitment
Cardiology
Primary Care
Montefiore
Jorge Kizer*
Diane McKee
Mount Sinai
Sameer Bansilal
Alex Federman*
Columbia
Elsa Giardina
Andrew Moran**
NYU
John Dodson**
Joseph Ladapo
Cornell
Rajesh Swaminathan
Keith LaScalea
*CDRN ADAPTABLE co-PIs; **CDRN Steering Committee members
Site co-PIs – Activities to Date
Bi-weekly strategic planning calls that focus on:
 Physician outreach,
 Patient outreach/enrollment/follow-up,
 Computable phenotype definition and exclusion criteria,
 Research coordinator/tech roles,
 Use of innovative technologies, etc.
Ad-hoc joint calls with tech leads to address
 Data-specific needs (i.e., elements not in the CDM)
Meetings and presentations to garner buy-in and support
 Presentations to cardiology practices, general medicine practices,
and other high volume providers of eligible patients
 Face-to-face meetings, faculty meetings, grand rounds
Other Communication
Site-specific ADAPTABLE meetings
 Co-PIs are meeting with their local teams (including
tech staff) to discuss:
• Site-specific plans for recruitment,
• Capabilities and constraints
• Innovative ways to minimize role of research
coordinator role to reduce costs
Patient Engagement
Patient Engagement
ADAPTOR
 Highly engaged Patient Advisory Board (PAB) member
 ADAPTABLE Steering Committee member
NYC-CDRN ADAPTABLE study team working on
 Patient outreach, enrollment and follow-up flow
 Patient outreach materials (English and Spanish)
 Clinic flyer materials (English and Spanish)
Next steps
 Engage PAB members to review & refine study
materials and protocol
IRB Engagement
IRB Engagement
Central IRB at the Biomedical Research Alliance of New
York (BRANY) & other CDRN site IRB representatives
engaged in DCRI ICF review
Next steps
 Engage Privacy Committee on the NYC-CDRN sitespecific activities to facilitate IRB approval
Thank you for your time!
Questions?
Mytrus (Portal) Update
Portal being updated
ADAPTORs are involved
WebEx rollout expected January 2016
Other Items
Contracts
IRB structure
 Please send to Sharon via email
Any other items?
Next call: Monday 28 December 2015 2pm EST