Applied Practice and Possible Leverage Points for Information Technology Support for Patient Screening in Clinical Trials: Qualitative Study (Preprint)

Abstract

Clinical trials are one of the most challenging and meaningful designs in medical research. One essential step before starting a clinical trial is screening, that is, to identify patients who fulfill the inclusion criteria and do not fulfill the exclusion criteria. The screening step for clinical trials might be supported by modern information technology (IT).

This explorative study aimed (1) to obtain insights into which tools for feasibility estimations and patient screening are actually used in clinical routine and (2) to determine which method and type of IT support could benefit clinical staff.

Semistandardized interviews were conducted in 5 wards (cardiology, gynecology, gastroenterology, nephrology, and palliative care) in a German university hospital. Of the 5 interviewees, 4 were directly involved in patient screening. Three of them were clinicians, 1 was a study nurse, and 1 was a research assistant.

The existing state of study feasibility estimation and the screening procedure were dominated by human communication and estimations from memory, although there were many possibilities for IT support. Success mostly depended on the experience and personal motivation of the clinical staff. Electronic support has been used but with little importance so far. Searches in ward-specific patient registers (databases) and searches in clinical information systems were reported. Furthermore, free-text searches in medical reports were mentioned. For potential future applications, a preference for either proactive or passive systems was not expressed. Most of the interviewees saw the potential for the improvement of the actual systems, but they were also largely satisfied with the outcomes of the current approach. Most of the interviewees were interested in learning more about the various ways in which IT could support and relieve them in their clinical routine.

Overall, IT support currently plays a minor role in the screening step for clinical trials. The lack of IT usage and the estimations made from memory reported by all the participants might constrain cognitive resources, which might distract from clinical routine. We conclude that electronic support for the screening step for clinical trials is still a challenge and that education of the staff about the possibilities for electronic support in clinical trials is necessary.