1 A Method for Orchestrating Patient Care and Clinical Research Visit Schedules Solomon Berhe 1,...

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A Method for Orchestrating Patient Care and Clinical Research Visit Schedules

Solomon Berhe1, PhD, Linda Busacca3, BA, Meir Florenz3, MS, Carlos R. Lopez2, MD Richard Steinman3, AB, J Thomas Bigger2, MD,

Chunhua Weng1, PhD

1Department of Biomedical Informatics, 2Department of Medicine,3The Irving Institute for Clinical and Translational Research

Columbia University, New York, NY 10032

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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

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Scheduling ClinicalResearch Appointments

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Research Coordinator

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

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“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

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Work Calendar• Holidays• Office Hours (Mon-Fri 8am – 5pm)• Scheduled research appointment• Conference (Away all day)• Seminar (April/20th 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?”

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Coordinator searches

manuallyfor an optimal

appointment slot

Coordinator searches

manuallyfor an optimal

appointment slot

Participant constraints

Researcher constraints

Protocol constraints

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Current Issues with Scheduling Research Appointment

1. Frequent activity2. Iterative negotiation process with participants3. Data in different locations and formats4. Data accessible through different mediums5. Highly error prone due to human errors6. Potentially inconvenient to participants7. Time consuming activity8. Clinical care appointment not considered

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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).

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Integrated Model for Patient CAre and Clinical Trials (IMPACT)

Calendar

Objective

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• Phase 11. Bi-weekly Interdisciplinary team meetings since

Sept/20112. Prototype development3. Scenario development4. Scenario-based evaluation by research team

• Phase 2 (in progress)1. Scenario-based evaluation by focus group2. Ten scenarios, two 36 month studies, approx. five real

coordinators, 50 test participants, 30 activities

Methods

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Results – Conceptual View

Participant constraints

Researcher constraints

Protocol constraints

EHR

Clinical Appointment

IMPACT Calendar

Instant display of optimal time slots.

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Results – Functional Modules

1. Import clinical appointment data2. Synchronization with external systems3. Project upcoming research appointment4. Guide coordinator through study protocol5. Multi-source temporal constraints-based

schedule optimization (detailed next slide)

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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)

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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

preferredMonth Display Day Display

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IMPACT

CalendarIMPACTScreener

IMPACTReminder

IMPACT Middleware Infrastructure

EHR/UpcomingClinical visits CTMS/Study

ProtocolCoordinator

Non-AvailabilityParticipantPreferences

Query Optimal Time Slot

Results – Backend Design

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Results – Scenario Development1. 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.

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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., > 100000 appointments, 100 studies, 50 users, etc…)

• No results from a focus group

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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.

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Acknowledgements

• Research Team:– Chunhua Weng, Linda Busacca, Meir Florenz,

Carlos R. Lopez, Richard Steinman, J Thomas Bigger.

• Research Grants:– R01LM009886– R01LM010815 – UL1 RR024156 – R01 HS019853

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Thank you!