JITA A Platform for Enabling Real Time PointofCare

JITA: A Platform for Enabling Real Time Point-of-Care Patient Recruitment Session Title: Recruitment Technologies & Cohort Discovery Session Number: VS 12 Jomol P. Mathew, Ph. D. University of Massachusetts Medical School #IS 20

Disclosure I and my spouse have no relevant relationships with commercial interests to disclose. 2020 Informatics Summit | amia. org 2

Learning Objectives After participating in this session the learner should be better able to understand: • Barriers to participation in clinical trials • Approaches to make clinical trials accessible to patients • Approaches to improve real time recruitment 2020 Informatics Summit | amia. org 3

The UMass Center for Clinical & Translational Sciences ~300 Active Clinical Trials 2019 Informatics Summit | amia. org

Clinical Trial Recruitment: Challenges & Opportunities • EHR applications, clinical data repositories and cohort identification tools have historically helped trial sites with recruitment. • Timely recruitment is still a significant challenge. • Many studies need to approach patients for consent while the patient is in the hospital Emergency Rooms (ED) or admitted into the hospital • Traditional cohort identification does not work in this setting as the data are not real time • EHR based alerts were effective in prior studies – concerns about provider fatigue

A Holistic Approach to Making Clinical Trials Accessible to our Patients and Providers • Understand barriers to participation in clinical trials • Provider surveys • Patient surveys • Analyze patterns from currently enrolled patients • Develop Targeted Technological Interventions • My. Chart • EPIC BPA for providers • IRIS Patient Research Portal • Learn from our data & continuously refine • Understand what type of technology/approach will work for our patient population and providers

An Integrative Framework: IRIS • Components • Conquering Disease Portal: Provide simplified information to patients & providers • Voice Aided clinical trial search and explanation • Just in Time Recruitment using HL 7 and messaging • Potential benefits • Engage study teams and patients directly • Real time alerts while the patient is in the clinic/ED/hospital allowing study teams to approach the patient while the information is relevant to the patient • Analytics will help refine continuously 2020 Informatics Summit | amia. org 7

IRIS - Conquering Disease Portal Patient centric platform for finding clinical trials Simplified Information for Patients & Providers Admin Console for Clinical trial content curation and publishing Research patients can express interest in trials Study teams get direct notification via email from interested patients Volunteer Registry for healthy volunteers Optional: • Integration with On. Core (CTMS) on trial information • Linkable from EHR

Conquering Disease Portal: Administration

Conquering Disease Portal: Trial Publication & Update workflow Publication Update

Conquering Disease Portal: Metrics and Logs

Voice Assisted Technology for Recruitment Pilot with Alexa: Patients can use the ‘Alexa skill’ to search and get trial explanation

IRIS: JUST-IN-TIME ALERTS (JITA) Cloud (AWS) based platform that analyzes HL 7, alerts study teams & helps manage recruitment

JITA: Rules Processing 1. Eligibility Rules Authoring 2. Rules Matching Functions 3. Study Matching Functions 4. Triggering of Alerts 5. Email/Text Generation

JITA: Text/Email Alerts

JITA: Study Dashboard

JITA: Patient Recruitment Activity Tracker

JITA: Pilot Study • Ongoing trial with significant challenges in recruiting participants. • Clinical trial on wearable biosensors to evaluate opioid tolerance on acute pancreatitis patients who present in the ED with elevated lipase values. • Recruitment efforts using our central research data warehouse and i 2 b 2 identified potential candidates - after they were discharged from the hospital, thus missing the opportunity. • The study team had to constantly watch the physical ED dashboard and comb through the EHR of ED patients 18

JITA: Pilot Testing Methods & Results • JITA leveraged ADT and LAB messages to identify potential candidate patients. • When patients are admitted to the hospital from the ED for clinical care, authorized study team members received the JITA alert. • The study team member can login and obtain pertinent information on the ‘potential participant’. • demographics, medical record number, matching date/time, patient room and bed number. • The study team member can approach the patient and obtain consent. • Over the course of the three-month pilot phase, the study received over 90 patient alerts. 19

IRIS-JITA: Next Steps • Facilitate recruitment for other studies • Gastroenterology Study: Study team received 11 patient alerts in less than 45 days, approached 10, and recruited 2 participants. • Administer patient and provider surveys - understand adoption barriers and continuously refine using input. • Fully integrate & release the framework for use by other institutions. • Seeking collaborations • If interested, please contact us. 20

Thank you! Email us at: Jomol. Mathew@wisc. edu & Katherine. Luzuriaga@umassmed. edu