The use of electronic health records for recruitment in clinical trials: a mixed methods analysis of the Harmony Outcomes Electronic Health Record Ancillary Study

Emily C O’Brien,Lesley H Curtis,Alicia Ellis,Sudha R Raman,Tyrus Rorick,Salim Janmohamed,Zachary Lampron,Lisa G Berdan,Bradley G Hammill,Adrian F Hernandez

doi:10.1186/s13063-021-05397-0

Abstract

BackgroundThe electronic health record (EHR) contains a wealth of clinical data that may be used to streamline the identification of potential clinical trial participants. However, there is little empirical information on site-level facilitators of and barriers to optimal use of EHR systems with respect to trial recruitment.MethodsWe conducted qualitative focus groups and quantitative surveys as part of the EHR Ancillary Study, which is being conducted alongside the multicenter, global, Harmony Outcomes Trial comparing albiglutide to standard care for the prevention of cardiovascular events in type 2 diabetes. Subject matter experts used findings from focus groups to draft a 20-question survey examining the use of the EHR for participant identification, common site recruitment strategies, and variation in perceived barriers to optimal use of the EHR. The final survey was fielded with 446 site investigators actively enrolling participants in the main trial.ResultsNearly two-thirds of respondents were study coordinators (63.2%), 23.1% were principal investigators, and 13.7% held other research roles. Approximately half of the respondents reported using the EHR to find potential trial participants. Of these, 79.4% reported using EHR searches in conjunction with other recruitment methods, including reviewing of upcoming clinic schedules (75.3%) and contacting past trial participants (71.2%). Important barriers to optimal use of the EHR included the lack of availability of certain research-focused EHR modules and limitations on the ability to contact patients cared for by other providers. Of survey respondents who did not use the EHR to find potential participants, one-quarter reported that the EHR was not accessible in their country; this finding varied from 2.6% of respondents in North America to 50% of respondents in the Asia Pacific.ConclusionsWhile EHR screening was commonly used for recruitment in a cardiovascular outcomes trial, important technical, governance, and regulatory barriers persist. Multifaceted, scalable, and customizable strategies are needed to support the optimal use of the EHR for trial participant identification.Trial registrationClinicalTrials.gov NCT02465515. Registered on 8 June 2015

Highlights

The electronic health record (EHR) contains a wealth of clinical data that may be used to streamline the identification of potential clinical trial participants
While EHR screening was commonly used for recruitment in a cardiovascular outcomes trial, important technical, governance, and regulatory barriers persist
Multifaceted, scalable, and customizable strategies are needed to support the optimal use of the EHR for trial participant identification

Summary

Introduction

The electronic health record (EHR) contains a wealth of clinical data that may be used to streamline the identification of potential clinical trial participants. Since each EHR implementation is distinct [2], successful conversions of EHR-screened populations into clinical trial participants presents numerous challenges, including heterogeneous data structures, selection bias introduced by searches focused on care-seeking populations, and limited translatability of inclusion and exclusion criteria [3]. While these challenges are known, few studies have empirically assessed the actual and perceived utility of the EHR for facilitating clinical trial enrollment or barriers to optimal use of the EHR for trial participant identification. The primary goals of our analysis were 3-fold: (1) to describe existing site-level processes for using the EHR to identify and screen potential participants for an ongoing clinical trial, (2) to ascertain information on successful recruitment strategies and key barriers to using the EHR for trial recruitment from the perspective of site coordinators, and (3) to evaluate variation in perceived barriers to the use of the EHR by empirical recruitment patterns in the Harmony Outcomes Trial

Methods

Results

Discussion

Conclusion