1 A Method for Orchestrating Patient Care and Clinical Research Visit Schedules Solomon Berhe 1, PhD, Linda Busacca 3, BA, Meir Florenz 3, MS, Carlos R. Lopez 2, MD Richard Steinman 3, AB, J Thomas Bigger 2, MD, Chunhua Weng 1, PhD 1 Department of Biomedical Informatics, 2 Department of Medicine, 3 The Irving Institute for Clinical and Translational Research Columbia University, New York, NY 10032

2 In 2009, Conway and Clancy suggested, “use of requisite research will be most efficient and relevant if generated as a by-product of care delivery.” (JAMA 09, Vol. 301, No.7). Motivation

3 Scheduling Clinical Research Appointments

4 Research Coordinator “What are the window dates/activities duration for the next research visit (month 30) for participant J. Smith?”

5 “I have to work Mon, Wed, Fri” “I can only meet in the afternoon” “No Response” “When between X and Y are you available?” Study Participant J. Smith “I prefer to come once for month 30 visit” Research Coordinator

6 Work Calendar Holidays Office Hours (Mon-Fri 8am – 5pm) Scheduled research appointment Conference (Away all day) Seminar (April/20 th 2-4pm) Meetings (Every Monday 1-2pm) … Private Calendar Lunch daily 1-2 Vacation (Jun/20 – Jun/27) Second job (Mon and Thu) … “When am I available?”

7 Coordinator searches manually for an optimal appointment slot Coordinator searches manually for an optimal appointment slot Participant constraints Researcher constraints Protocol constraints

8 Current Issues with Scheduling Research Appointment 1.Frequent activity 2.Iterative negotiation process with participants 3.Data in different locations and formats 4.Data accessible through different mediums 5.Highly error prone due to human errors 6.Potentially inconvenient to participants 7.Time consuming activity 8.Clinical care appointment not considered

9 Hypothesis Integrating clinical care workflows with clinical research workflows: 1.Increases efficiency of research appointment scheduling. 2.Increases participants’ convenience (e.g., coinciding research and care appointments).

10 Integrated Model for Patient CAre and Clinical Trials (IMPACT) Calendar Objective

11 Phase 1 1.Bi-weekly Interdisciplinary team meetings since Sept/ Prototype development 3.Scenario development 4.Scenario-based evaluation by research team Phase 2 (in progress) 1.Scenario-based evaluation by focus group 2.Ten scenarios, two 36 month studies, approx. five real coordinators, 50 test participants, 30 activities Methods

12 Results – Conceptual View Participant constraints Researcher constraints Protocol constraints EHR Clinical Appointment IMPACT Calendar Instant display of optimal time slots.

13 Results – Functional Modules 1.Import clinical appointment data 2.Synchronization with external systems 3.Project upcoming research appointment 4.Guide coordinator through study protocol 5.Multi-source temporal constraints-based schedule optimization (detailed next slide)

14 Results – Functional Modules – Coordinators’ temporal constraints: Non availability rules (explicit), scheduled research appointments events (implicit), appointment events scheduled in external systems (implicit) – Participants’ temporal constraints: Day preferences, time of the day preferences (AM/PM), and task completion preferences (fit all tasks in one day) (all explicit), and coinciding clinical care appointments (implicit) – Study Protocol temporal constraints: Protocol window rules (implicit)

15 Results – Interface Design Simple and intuitive results display Red: Coordinator not available or study protocol not satisfied Yellow: Coordinator available and study protocol satisfied Green: Coordinator available, study protocol satisfied, and patient preferred Month Display Day Display

16 IMPACT Calendar IMPACT Screener IMPACT Reminder IMPACT Middleware Infrastructure EHR/Upcoming Clinical visits CTMS/Study Protocol Coordinator Non-Availability Participant Preferences Query Optimal Time Slot Results – Backend Design

17 Results – Scenario Development 1.Coordinator specifies non-availability rules. 2.Synchronize IMPACT-Calendar with coordinator's Google calendar. 3.Import a list of potentially eligible participants for a research study. 4.Schedule a screening appointment that coincides with a clinical visit. 5.Schedule a Screening Visit 2 during Clinical Visit. 6.Conduct Screening Visit and Schedule Randomization Visit. 7.Conduct Randomization Visit and Schedule Month 1 Visit. 8.Schedule PRN Visit. 9.Cancel Month 1 Appointment and Schedule new Appointment. 10.Conduct Month 1 Visit and Schedule and Conduct Month 2-36 Visit.

18 Limitations Only fully useful in settings in which clinical and research setting are closely located (e.g., academic research hospital) Currently synchronization of single events supported but not of rules. No stress test performed yet (e.g., > appointments, 100 studies, 50 users, etc…) No results from a focus group

19 Conclusion The integration of clinical care appointment data with research data contains the potential to significantly increase the participant convenience, decrease task redundancy, and drug interaction. The IMPACT Calendar prototype, as part of the IMPACT infrastructure, contains the potential to significantly increase the efficiency of the way that research appointments are scheduled.

20 Acknowledgements Research Team: – Chunhua Weng, Linda Busacca, Meir Florenz, Carlos R. Lopez, Richard Steinman, J Thomas Bigger. Research Grants: – R01LM – R01LM – UL1 RR – R01 HS019853

21 Thank you!