Assessment of automated clinical trial recruitment and enrolment using patient-facing technology

Abstract

Objective: Interactive patient care systems (IPCS) at the bedside are becoming increasingly common, but evidence is limited as to their potential for innovative clinical trial implementation. The objective of this study was to test the hypothesis that the IPCS could feasibly be used to automate recruitment and enrolment for a clinical trial.

Methods: In medical-surgical units, we used the IPCS to randomise, recruit and consent eligible subjects. For participants not interacting with IPCS study materials within 48 hours, study staff-initiated recruitment in-person. Eligible study population included all caregivers and any patients >6 years old admitted to medical-surgical units and oncology units September 2015 to January 2016.

Outcomes: randomisation assessed using between-group comparisons of patient characteristics; recruitment success assessed by rates of consent; paperless implementation using successful acquisition of electronic signature and email address. We used χ² analysis to assess success of randomisation and recruitment.

Results: Randomisation was successful (n=1012 randomised, p>0.05 for all between-group comparisons). For the subset of eligible, randomised patients who were recruited, IPCS-only recruitment (consented: 2.4% of n=213) was less successful than in-person recruitment (61.4% of n=87 eligible recruited, p<0.001). For those consenting (n=61), 96.7% provided an electronic signature and 68.9% provided email addresses.

Conclusions: Our results suggest that as a tool at the bedside, the IPCS offers key efficiencies for study implementation, including randomisation and collecting e-consent and contact information, but does not offer recruitment efficiencies. Further research could assess the value that interactive technologies bring to recruitment when paired with in-person efforts, potentially focusing on more intensive user-interface testing for recruitment materials.

Trial registration number: NCT02491190.

Keywords: computer methodologies; health care; medical informatics; patient care.