An Integrated Model for Patient Care and Clinical Trials (IMPACT) to support clinical research visit scheduling workflow for future learning health systems

Abstract

We describe a clinical research visit scheduling system that can potentially coordinate clinical research visits with patient care visits and increase efficiency at clinical sites where clinical and research activities occur simultaneously. Participatory Design methods were applied to support requirements engineering and to create this software called Integrated Model for Patient Care and Clinical Trials (IMPACT). Using a multi-user constraint satisfaction and resource optimization algorithm, IMPACT automatically synthesizes temporal availability of various research resources and recommends the optimal dates and times for pending research visits. We conducted scenario-based evaluations with 10 clinical research coordinators (CRCs) from diverse clinical research settings to assess the usefulness, feasibility, and user acceptance of IMPACT. We obtained qualitative feedback using semi-structured interviews with the CRCs. Most CRCs acknowledged the usefulness of IMPACT features. Support for collaboration within research teams and interoperability with electronic health records and clinical trial management systems were highly requested features. Overall, IMPACT received satisfactory user acceptance and proves to be potentially useful for a variety of clinical research settings. Our future work includes comparing the effectiveness of IMPACT with that of existing scheduling solutions on the market and conducting field tests to formally assess user adoption.

Keywords: Clinical research informatics; Health resources; Learning health systems; Personnel staffing and scheduling; Software; Workflow.

Figure 1

The current workflow for scheduling a research visit. The scheduler or research coordinator needs to manually synthesize temporal constraints of multiple research resources and staff, as well as patients.

Figure 2

The semantic relationships of entities in the domain model.

Figure 3

The IMPACT architecture

Figure 4

Status Transition for a Research Visit that is Automated by IMPACT.

Figure 5

The IMPACT prototype screenshots for adding a research visit (e.g., a randomization visit). All protocol specified visits are ordered as flashcards so that a user can scroll left or right to see previous or future visits. The current visit is brighter than others. This screen displays the protocol window and its tasks and notes for the visit. The tasks and their affiliated resources can be edited. A user can click the button “Schedule” to trigger the multi-user constraint satisfaction algorithm to receive automatically recommended optimal dates and times.

Figure 6

The IMPACT prototype screenshots for recommending optimal visit dates and times. After a user clicks the button “Schedule” on the previous screen, this screen will be displayed showing all automatically recommended dates. The grey row indicates a highlighted datetime under consideration. A user can select a datetime from the recommended list, and available CRCs, equipment, and rooms in the lower panel, and click the “Book” button to pick this datetime.

Figure 7

The IMPACT prototype screenshots for displaying the monthly calendar view after adding a research visit. The system added a visit on 8/10, 14:30–17:30 on the weekly view of the calendar. Different events have different colors. The Yellow lane indicates the current date. On the left, there is an awareness window providing background notifications about the group activities to CRCs.