scholarly journals Assessing an Electronic Health Record research platform for identification of clinical trial participants

2021 ◽  
Vol 21 ◽  
pp. 100692
Author(s):  
Niina Laaksonen ◽  
Juha-Matti Varjonen ◽  
Minna Blomster ◽  
Antti Palomäki ◽  
Tuija Vasankari ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Electronic Health Record ◽  
Health Record ◽  
Research Platform ◽  
Electronic Health ◽  
Trial Participants

scholarly journals Clinical trial site identification practices and the use of electronic health records in feasibility evaluations: An interview study in the Nordic countries

2021 ◽  
pp. 174077452110385
Author(s):  
Niina Laaksonen ◽  
Mia Bengtström ◽  
Anna Axelin ◽  
Juuso Blomster ◽  
Mika Scheinin ◽  
...  
Keyword(s):  
Electronic Health Record ◽  
Data Sources ◽  
Pharmaceutical Companies ◽  
Health Record ◽  
Electronic Health Record Data ◽  
Trial Site ◽  
Record Data ◽  
Electronic Health ◽  
Site Identification ◽  
Trial Participants

Introduction: Feasibility evaluations are performed to create the best possible starting point for the set-up and execution of a clinical trial, and to identify any obstacles for successful trial conduct. New digital technologies can provide various types of data for use in feasibility evaluations. There is a need to identify and compare such data sources for trial site identification and for evaluating the sites’ patient recruitment potential. Especially, information is needed on the use of electronic health records. We investigated how different data sources are used by pharmaceutical companies operating in the Nordic countries for identifying trial sites and for evaluating their potential to recruit trial participants. Methods: This was a semi-structured qualitative interview study with 21 participants from pharmaceutical companies and contract research organizations operating in Finland, Sweden, Denmark and Norway. Qualitative content analysis was applied. Results: For identifying countries and trial sites on a global level, the trial sponsors mostly used databases on previous trial performance. The use of electronic health record data was very limited. Sites’ and investigators’ visibility in various databases was seen as fundamental for their countries becoming selected into new clinical trials. For estimating the sites’ recruitment projections, most sites were seen to base their patient count estimates solely on their previous experience. Some sites had reviewed their electronic health record data, which was considered to increase the accuracy of their recruitment estimates and these sites’ attractivity. Along with dialogs with investigators, the sponsors used various data sources to validate the investigators’ estimates. Legislative obstacles were seen to hinder the use of electronic health record queries for estimation of patient counts. Conclusion: Visibility in the databases used by trial sponsors is crucial for the countries and sites to be identified. Site selection appears to be based on trust and relationships built from experience, but electronic data provide the support upon which the trust is based. Estimation of the number of potential trial participants is a complex and time-consuming process for both investigators and sponsors. Sponsors seem to favour sites who could support their patient count estimates with electronic health record data as they were quicker in providing the estimates and more reliable than sites with no electronic health record evidence. The patient count evaluation process could be simplified, accelerated and made more reliable with more systematic use of electronic health record evidence in the feasibility evaluation phase. This would increase the accuracy of the patient count estimates and, on its part, contribute to improved recruitment success.

scholarly journals Text message alerts to emergency physicians identifying potential study candidates increase clinical trial enrollment

2019 ◽  
Vol 26 (11) ◽  
pp. 1360-1363 ◽  
Author(s):  
Laura E Simon ◽  
Adina S Rauchwerger ◽  
Uli K Chettipally ◽  
Leon Babakhanian ◽  
David R Vinson ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Electronic Health Record ◽  
Emergency Services ◽  
Text Message ◽  
Cluster Randomized Trial ◽  
Health Record ◽  
Research Subjects ◽  
Software Application ◽  
Clinical Trial Enrollment ◽  
Electronic Health

Abstract Prospective enrollment of research subjects in the fast-paced emergency department (ED) is challenging. We sought to develop a software application to increase real-time clinical trial enrollment during an ED visit. The Prospective Intelligence System for Clinical Emergency Services (PISCES) scans the electronic health record during ED encounters for preselected clinical characteristics of potentially eligible study participants and notifies the treating physician via mobile phone text alerts. PISCES alerts began 3 months into a cluster randomized trial of an electronic health record–based risk stratification tool for pediatric abdominal pain in 11 Northern California EDs. We compared aggregate enrollment before (2577 eligible patients, October 2016 to December 2016) and after (12 049 eligible patients, January 2017 to January 2018) PISCES implementation. Enrollment increased from 10.8% to 21.1% following PISCES implementations (P < .001). PISCES significantly increased study enrollment and can serve as a valuable tool to assist prospective research enrollment in the ED.

scholarly journals A European inventory of common electronic health record data elements for clinical trial feasibility

Trials ◽  
2014 ◽  
Vol 15 (1) ◽  
pp. 18 ◽  
Author(s):  
Justin Doods ◽  
Florence Botteri ◽  
Martin Dugas ◽  
Fleur Fritz ◽  
Keyword(s):  
Clinical Trial ◽  
Electronic Health Record ◽  
Health Record ◽  
Electronic Health Record Data ◽  
Record Data ◽  
Electronic Health ◽  
Data Elements

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

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Emily C. O’Brien ◽  
Sudha R. Raman ◽  
Alicia Ellis ◽  
Bradley G. Hammill ◽  
Lisa G. Berdan ◽  
...  
Keyword(s):  
Focus Groups ◽  
Electronic Health Record ◽  
Asia Pacific ◽  
Trial Participant ◽  
Health Record ◽  
Main Trial ◽  
Recruitment Methods ◽  
Ancillary Study ◽  
Electronic Health ◽  
Trial Participants

Abstract Background The 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. Methods We 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. Results Nearly 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. Conclusions 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. Trial registration ClinicalTrials.gov NCT02465515. Registered on 8 June 2015

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