ADAPTABLEThe Aspirin StudyCDRN Call

16 May 2016

Enrollment Updated

417 Participants given Golden tickets

38 Codes entered on Portal:

9 REACHnet

29 Mid-South

22 Participants Enrolled:

7 REACHnet

15 Mid-South

Coordinating Center Updates

Kick-Off Meeting June 21st in Chicago

Registration invites going out this week, please provide your attendee list

Requirements for attendance

Agenda Survey https://duke.qualtrics.com/SE/?SID=SV_6YlPYFIGAspKIFT

Portal Launch

May- through 6 month visit and limited reports

June- through end of study and remaining reports

Chicago Area Patient Centered Outcomes Research Network (CAPriCORN)

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ADAPTABLE CDRN CALL May 16, 2016

Clinician Engagement•Site PIs have done outreach to local cardiologists to gage interest and update them on the progress of ADAPTABLE

•2 webinar format meetings have been held to provide broad overviews of ADAPTABLE and share CAPriCORN specific recruitment strategies and local plans

•Site PIs have completed site plans for recruitment

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ADAPTOR Involvement/Patient Engagement

• PM and other CAPriCORN members met with the Chicago ADAPTOR at the

PCORnet Public Trustworthiness Meeting

• Conference call has been scheduled with the ADAPTOR for further engagement

• Patient-Clinician Advisory Committee and key patient/community representatives

have been engaged

• This engagement resulted in the proposal and development of an alternative community-based

recruitment strategy that will be submitted to the IRB for approval following the primary protocol approval.

• A draft work plan has been developed and shared with the community partners.

• The informatics team is working to create a patient-match system to determine CAPriCORN patient

record.

• ADAPTABLE team has spoken with both community partners and will continue to work collaboratively

to ensure the community-based recruitment approach aligns with community partners’ outreach efforts.

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Computable Phenotype Implementation and Evaluation

• We are currently working on performing validation runs of the phenotype at several participating sites

•Currently working on addressing other aspects related to the phenotype implementation

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PaTH Update

Local clinician engagement

Site level meetings with GIM & Cardiology practices pre & post study launch

Informatics

Planned practice & physician-level involvement for recruitment

PaTH Update

ADAPTOR Involvement & Participant Recruitment Strategy

ADAPTOR - multiple screenings – Mr. B?!?!?

Recruitment Strategy see draft response to IRB

PaTH Update

Computable Phenotype Implementation & Evaluation

Currently no changes other than aspirin (PaTH will not enroll aspirin-naïve patients)

Will add = for 65

CDM/SQL, Clarity/SQL

Minor site variations – ex future visit scheduled, specific clinics/departments/physicians

CDRN Update—GPCClinician Engagement

Identification of eligible clinics

Site PI presentations at department/division meetings

General Internal Medicine

Family Medicine

Cardiology

Nephrology

Endocrinology

Diabetes

Development of Powerpoint and infographic

E-mails to listservs when some physicians can’t be reached regularly/readily

KUMC and UNMC: Research newsletters, articles planned for release

CDRN Update—GPC Adaptor Involvement

GPC Engagement Team Interaction

Engagement Team members met one-on-one with Mr. Doug Young at his office

• Discussed health, interest in research, and perceptions about the study

• Have followed-up by email and phone

• Mr. Young has reviewed patient invitation letter

GPC would like Adaptor Rep to be first enrolled patient

GPC interest in drafting patient invitation letter directly from Adaptor rep

CDRN Update—GPC Recruitment Strategy

Primary modes of invitation: MyChart and E-mail

When unavailable hardcopy letters

Low response rate expected from hardcopy letters

• MyChart and E-mail response rate better based on initial PCORI cohort study within GPC

One site considering in-clinic recruitment, as well

Recruitment strategy can vary from site-to-site based on resources, preferences, IRB-allowance, etc.

CDRN Update—GPC Computable Phenotype Implementation and Evaluation

SAS draft translated to i2b2 for feasibility counts to be sent to KUMC

Currently being reviewed

Iterative process of refining phenotype

i2b2 code has undergone multiple rounds of chart review for refinement

All site’s requested to complete chart review

Lessons Learned & Questions raised:

Will refine eligible patients (last visit date <6 months)

• Can expand if needed

Need for i2b2 code to incorporate clinic restriction

• Do not want to identify patients from untargeted clinics

NYC-CDRN Local Clinician Engagement

Our co-PIs at each site (Montefiore, Mount Sinai, Columbia, NYU, and Weill Cornell) pursued local buy-in by engaging clinical and administrative leadership and faculty at division and practice-basedmeetings, grand rounds, and through one-on-one meetings

Orientation to the trial included reviewing the study aims, criteria for eligibility and novel recruitment plans

Future plans: Physicians who have agreed to enroll their patients will be contacted on a regular basis with a list of eligible individuals

Physicians will have the ability to remove patients from the contact list

Physicians will receive regular updates on the status of enrollment, using division-wide or practice-based meetings, or one-on-one interactions.

NYC-CDRN Adaptor Involvement / Recruitment Strategy

Henry has been an active participant

Adaptor community, Steer. Cmte, NYC-CDRN trial discussions

Led PCAB meeting on ADAPTABLE, providing trial overview, sharing best practices, facilitating standard outreach language

Majority of recruitment via patient portal or e-mail

Patients will receive message indicating their eligibility and provided website link to Mytrus with their golden ticket #

Outreach via text message will be piloted by 1 site

Traditional strategies will also include:

• Clinical RA/NP f/u calls for recent/upcoming visits

• In clinic (exam or waiting room, cath lab) via tablet

• Mail-outs (letters with follow-up calls)

Outreach in English and/or Spanish depending on the site

NYC-CDRN Computable Phenotype

Implementation

From the Base Computable Phenotype, we opted to remove the following

• Eligibility criterion

– 1.B Prior coronary angiography showing ≥ 75% stenosis of at least one epicardial coronary vessel

– 7.B Female patients who are not nursing an infant

• Enrichment factor

– 3.D 3-vessel CAD

– 8.G LVEF < 50%

We’ve added Known Hx AF/Flu, INR >1.5, PLT<100,000 as exclusions

Evaluation

In the process of identifying units of measure, and, when there are multiple measurements, which measurements to include

Validation will begin shortly

pScanner Physician Engagement

Leadership engagement

Co-presentations by site PIs and cardiology champions

Cardiology Division faculty meeting

Primary Care Council: Practice leads from each Community Practice Network site

Awareness raising

Email blast to cardiologists and PCPs explaining study and announcing further presentations

Site-level physician meeting, FPG evening CME sessions, Medicine grand rounds

pScanner Recruitment Strategy

ADAPTOR Feedback

Held teleconferences with pSCANNER Adaptor and Cardiology leads: Dec, April

Additional patient (from our CHF survey) asked to get involved

Both now reviewing recruitment protocol and materials

Planned sequence

Mail initial contact letter (University letterhead/envelope)• Letter contains golden ticket number and portal address• For more info or opt-out, patients can email or call study

coordinator, encouraged to provide email address– 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

pScanner Computable Phenotype

AMI, PCI or CABG (ICD-9, ICD-10 or CPT)

Not using 75+% stenosis criterion (most get PCI or CABG)

Not requiring portal use or email address

Exclusions, enrichment factors as specified

UCLA: 11,881 met enrichment (orange), 2,841 did not (green)

Research Action for Health Network

Clinician EngagementSelection of participating physicians◦ Tablet placement for in-clinic recruitment◦ Provider filter in phenotype

Recruitment readiness◦ Conference calls◦ Department meetings◦ Clinic support specialists◦ PIs: peer-to-peer communication

◦ Site PI emailed announcement of App go live

Recruitment & Enrollment◦ Physician’s role in Recruitment App workflow◦ Review enrollment reports weekly

Research Action for Health Network

Ken’s Involvement

Recruitment video script & images

Recruitment App workflow

App email/text messages

Reminder email

Push card content and design

Recruitment letter For distribution by mail, email directly from health systems, through

Health in Our Hands patient network, or through health systems’ patient portals

Recruitment materials were also reviewed by Adaptors group –Thanks, Madelaine, Ken & all the Adaptors!

Research Action for Health Network

Dear <Patient Name>,

My name is Ken, and I am a patient with heart disease. I’m writing to remind you that you may be

eligible for the ADAPTABLE study. I’d like to tell you about my story and why your participation in

ADAPTABLE is important:

Since experiencing a heart attack several years ago, I’ve become more interested in learning

about, and participating in, clinical research. When my doctor told me about ADAPTABLE, I was

thrilled that results from this study could help patients like you and me. I’m currently serving as

an ADAPTABLE patient partner, working closely with my doctor and other researchers to conduct

this study. By participating in this study, you will join thousands of other patients from across the

country in helping researchers figure out which aspirin dose is most effective at reducing risk for

a stroke, heart attack, or death.

I encourage you to visit www.adaptablepatient.com to learn more. You can enroll using your

personal access code: <XEDGJLKSF238>

Questions? For more information:• Talk to your doctor

• Call the ADAPTABLE study team at Ochsner: 1-844-816-0297

• Visit www.adaptablepatient.com

Sincerely,

Ken

ADAPTABLE Patient Partner

Reminder EmailFrom our Adaptor

Research Action for Health Network

Phenotype Verification SAS code received from Duke CC

Added local exclusions A-fib diagnosis, abnormal coagulation profile (790.92 & 791), and long term anti-

coagulant use (V58.61 & Z79.01)

SAS code reviewed, refined (rendered executable), and run on Ochsner CDM

Randomly selected 30 cases to verify against EHRs

Revised phenotype based on chart review findings

Repeated previous 2 steps 3 times

Example revisions: Missing RXNORM_CUI for generic anti-coagulant

Missing decimals in some diagnosis codes

Clarifications: Timeframe for qualifying events (e.g. 412 = prior MI, i.e. > 5 years ago)

Age > or = 65 (updated SAS code to include = 65 with reference date of 3/31/16 for calculating age)

Mid-South

• Recruitment Summary

*non-representative sample of older patients

• Phone calls most successful method with only 6 of 50 people not contacted directly after 2 attempts

• 9 of 21 people entering codes have not enrolled - identifying impediments

Initial Contact Method and Follow Up Contact Method

Percentage Enrolled Percentage Entered Site Without Enrolling

Phone call (phone follow up completed on first 50)N=100 (16 entered site with code)

9% N=9 7% N=7

Email (1 email follow up for all recipients)N=51 (5 entered site with code)

6% N=3 4% N=2

Standard Mail (phone follow up for all recipients)* n=50

0% 0%

Clinician Engagement

• Practice level buy-in sought through presentations at general cardiology faculty meetings and by direct communication with ten high volume physician practices.

• Direct email to medical practitioners and residents underway

We are not seeking patient referrals at this point, but may consider other strategies based on the response rates of various recruitment approaches

FAQ sheet provided to clinicians

Recruitment is being done by research staff, primarily by email, mail, phone, or in-person in some practices

Engagement Next Steps

• Looking forward, we are planning to expand into other local practices in the Vanderbilt Health Affiliated Network.

• Looking to expand the Mid-South CDRN regionally for a broader reach

ADAPTOR Engagement

• ADAPTOR engagement has been focused primarily on recruitment material review

• Clinic recruitment will begin soon: – Help guide our recruitment protocol

– Train the research staff in terms of how to approach patients

– Share insight into living with CHD to better prepare research staff.

Phenotype Development

• Phenotype is complete and has been shared with the group, including an extensive categorization of ICD-10 data codes

• Further refinement by Brad Hammill at Duke regarding the crosswalk from the ICD-9 to ICD-10 and additional iterations identifying other mapping pathways.

• Definition of CHD phenotype improved and specific cases validated by chart review for inpatient MI

Enrichment Factors

• Age - clarified as greater than or equal to 65 • Serum creatinine >1.5 – identified through phenotype• Diabetes – identified through phenotype• 3 vessel coronary artery disease

– 3 vessel coronary artery disease imported from local PCI registry, but only a small percentage of patients have applicable data in registry

• Cerebrovascular disease flagged for special handling – How and when to contact patients placed on 325mg aspirin as a

response to stroke

• Ejection fraction < 50% - Identified and validated• Current smoker – difficult to capture outside of self-reporting

All Other Business

Next CDRN call moved to Monday June 6th due to Memorial Day

Next SC call June 14th at 9AM

Kick-Off Meeting June 21st in Chicago!