학술논문

Assessment of automated clinical trial recruitment and enrolment using patient-facing technology
Document Type
article
Source
BMJ Health & Care Informatics Online. 28(1)
Subject
Health Services and Systems
Health Sciences
Clinical Trials and Supportive Activities
Clinical Research
Patient Safety
Good Health and Well Being
Clinical Trials as Topic
Electronic Data Processing
Humans
Patient Selection
Program Evaluation
Random Allocation
Technology
patient care
health care
computer methodologies
medical informatics
Information Systems
Library and Information Studies
Public Health and Health Services
Medical Informatics
Health services and systems
Public health
Language
Abstract
ObjectiveInteractive 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.MethodsIn 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.Outcomesrandomisation 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.ResultsRandomisation 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