David R Nelson, MD, FAASLD University of Florida

1. Consent2Share • Successes and Challenges in Developing and Implementing Electronic Informed Consent Tools for Research David R Nelson, MD, FAASLD University of Florida

2. Disclosure • I and my spouse have no relevant relationships with commercial interests to disclose. AMIA 2017 | amia.org

3. Learning Objectives • After participating in this session the learner should be better able to: • Discuss technological, process, and ethical challenges and keys to success in designing electronic consent tools for point-of-care use. • Describe operational and technical challenges and keys to success in integrating research consent tools with EHRs and other enterprise information systems. • Critique qualitative and quantitative approaches to evaluating the effectiveness of electronic informed consent tools. AMIA 2017 | amia.org

4. UF Integrated Data Repository Healthcare Data Integrated Data Repository Privacy Wall Outpatient EMR Cohort Discovery Inpatient EMR Research Extract (PHI removed) Billing Extract-Transform-Load Claims i2b2 DataMart(Limited Data Set) Labs Pharmacy

5. How many people ages 45+ with a low back pain diagnosis were in the ED in 2016? • i2b2 • Informatics for Integrating Biology • and the Bedside • N = 3,468 patients • Female: 2,055 • Male: 1,413 • Black/African American 1,006 • White: 2,335 • Other: 127

6. “Consent2Share” • A process by which patients in the UFHealth System can agree to be contacted by a researcher in the future to ask the patient if they might be interested in a research study. • Built into the EMR (EPIC) • Becomes one of the navigating terms • Patient counts available via i2b2

7. What Type of Patients Can Agree? • Any Adult (older than18 years old) • Only those that can consent for themselves • A wife or husband cannot consent for their spouse • Any Child (younger than 18 years old) • Parent or legal guardian must agree for child • If child is >7, child should also agree by signing consent form. • When the child turns 18, they have to then consent for themselves

8. Consent2Share - Process • Consent form (eConsent) is included in the group of consent forms provided on the iPad at admission to the clinic • This research consent is always the last consent that will appear. • Any straight forward questions are addressed by trained admissions staff, other questions can be referred to either their doctor or the Consent2Share Hotline listed on the consent form • Patients are given time to review • Offer to print out a copy of the research consent if patient wants one.

9. eConsent2Share Form- Opt In

10. Pediatric Consent What they are agreeing to.

11. Help line Choose “Yes” or “No”

13. Patient’s Decisions • Potential Subject’s Outcomes • Clear Form -will be presented again at next clinic visit • They choose yes or no • “Yes”– indicated in EPIC, consent will not be presented again • “No”- indicated in EPIC, consent will not be presented again • “Ask Me Next Time” – indicated in EPIC, will present again at next clinic visit • Enrollment decision lasts unless patient changes their mind • If a minor, will present again after their 18th birthday • They can still consent to other research studies

14. View from the Researcher • Use i2b2 to query IDR to determine if there are sufficient potential study subjects • If they need to contact potential subjects, can factor in Consent2Share • Submit to the IRB, if approved, • Submit query to the Consent2Share data team • UF Data Management builds query list of patients and does QA • List of potential subjects with contact information is provided

15. IDR Linkage of Cohort Discovery To Consent

16. Integrated Data Repository and Consent2Share

17. Metrics to Date • 58 studies have used Consent2Share to identify patient cohorts • 28,205 potential study subject’s names provided to investigators • 14 patients have withdrawn from Consent2Share • 2 patients in “protected” classes (inmate, brain trauma) • 1 patient deceased • 11 contacted hotline-referred to research subject advocate 39,820 have Consented to Share

18. Recruitment Yield From IDR-Consent Linkage Research Example • Study: A study to identify the frequency of lysosomal acid lipase deficiency (rare genetic disease) in at-risk patient populations • Cohort Discovery: IDR cohort query identified 661 patients who met the required phenotype to be screened and had consented to be contacted (Consent2Share) • Recruitment Strategies: • High trust / high touch (Condition 1, C1): Pts with an existing relationship with study team (GI/Liver clinics) called by a study team coordinator • Low trust / low touch (Condition 2A, C2A): Non-specialty clinic patients sent a letter to contact study team if interested • Low trust / high touch (Condition 2B, C2B): Non-specialty clinic patients sent a letter, followed by coordinator call if no response after two weeks Flood-Grady E, et al. Contemporary Clinical Trials Communications 2017

19. Recruitment Yield From IDR-Consent Linkage Research Example Patients Reached, Recruited, and Enrolled with Condition C2B n (%) C2A n (%) C1 n (%) Reach Eligible Contacted 624 19 (3) 605 120 (20) 37 37 (100*) 10 (2) 53 (9) 17 (46*) Recruited 50 (94*) 8 (80) 12 (71) Enrolled Conclusion: Contact registries can facilitate rapid cohort identification and efficient screening of study participants * Difference is significant at p< 0.001 Flood-Grady E, et al. Contemporary Clinical Trials Communications 2017

20. Lesson’s Learned and Next Steps • Started out with a paper consent printed from the EMR • Asked for re-contact and left over tissue • After signed, would be scanned into the EMR • Self audit discovered 75 consents we couldn’t find • Stopped study, did a complete audit of 10,000 consent forms • Simplified the consent form and eliminated tissue collections • Moved to an EMR generated eConsent • Allowed expansion of program • Lower costs and more reliable • Next Steps • Integrate with EPIC patient portal • System-wide expansion across both GNV and Jacksonville campuses

21. Thank you! Email me at: nelsodr@ufl.edu