Selecting EHR-driven recruitment strategies: An evidence-based decision guide

Grout, Randall W.; Hood, Daniel; Nelson, Sarah J.; Harris, Paul A.; Embí, Peter J.

doi:10.1017/cts.2022.439

Cited by 4 publications

(7 citation statements)

References 31 publications

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“…Their comprehensive literature review found that use of the EHR to develop candidate lists for mail or telephone follow-up was the most commonly deployed strategy. 29 Few studies have collected systematic data on staff time needed for EHR-based strategies, and cost-effectiveness analyses are lacking. 28,32 Depending on the balance between sensitivity and specificity of the query and subsequent time needed to pre-screen charts prior to outreach, staff time can vary greatly.…”

Section: Discussionmentioning

confidence: 99%

“…They call for comparative effectiveness studies to refine the evidence on which EHR strategies may be more effective in a given context. 29 More generally, future studies are needed to better understand factors that make recruitment strategies, including EHR-specific strategies, more or less successful with diverse and underrepresented populations.…”

Section: Discussionmentioning

confidence: 99%

“…8,[26][27][28] Technical infrastructure and expertise, diversity in EHR vendors, and local data governance policies are all factors that significantly impact the success of EHR-driven recruitment efforts. 29 Translation of clinical eligibility criteria into variables that can be used to extract data from medical records takes time and works best when someone involved in the process is well-versed in both clinical medicine and information technology. GRADE used centralized strategies, including sharing lessons learned and search tips across sites and particularly across those with similar EHRs, to help mitigate differences in experience with EHR queries.…”

Section: Discussionmentioning

confidence: 99%

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Use of comprehensive recruitment strategies in the glycemia reduction approaches in diabetes: A comparative effectiveness study (GRADE) multi-center clinical trial

et al. 2023

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Background/Aims We present and describe recruitment strategies implemented from 2013 to 2017 across 45 clinical sites in the United States, participating in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study, an unmasked, randomized controlled trial evaluating four glucose-lowering medications added to metformin in individuals with type 2 diabetes mellitus (duration of diabetes <10 years). We examined the yield of participants recruited through Electronic Health Records systems compared to traditional recruitment methods to leverage access to type 2 diabetes patients in primary care. Methods Site selection criteria included availability of the study population, geographic representation, the ability to recruit and retain a diverse pool of participants including traditionally underrepresented groups, and prior site research experience in diabetes clinical trials. Recruitment initiatives were employed to support and monitor recruitment, such as creation of a Recruitment and Retention Committee, development of criteria for Electronic Health Record systems queries, conduct of remote site visits, development of a public screening website, and other central and local initiatives. Notably, the study supported a dedicated recruitment coordinator at each site to manage local recruitment and facilitate screening of potential participants identified by Electronic Health Record systems. Results The study achieved the enrollment goal of 5000 participants, meeting its target with Black/African American (20%), Hispanic/Latino (18%), and age ≧60 years (42%) subgroups but not with women (36%). Recruitment required 1 year more than the 3 years originally planned. Sites included academic hospitals, integrated health systems, and Veterans Affairs Medical Centers. Participants were enrolled through Electronic Health Record queries (68%), physician referral (13%), traditional mail outreach (7%), TV, radio, flyers, and Internet (7%), and other strategies (5%). Early implementation of targeted Electronic Health Record queries yielded a greater number of eligible participants compared to other recruitment methods. Efforts over time increasingly emphasized engagement with primary care networks. Conclusion Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness successfully recruited a diverse study population with relatively new onset of type 2 diabetes mellitus, relying to a large extent on the use of Electronic Health Record to screen potential participants. A comprehensive approach to recruitment with frequent monitoring was critical to meet the recruitment goal.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Use of comprehensive recruitment strategies in the glycemia reduction approaches in diabetes: A comparative effectiveness study (GRADE) multi-center clinical trial

et al. 2023

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“…TIC consultative and operational services include assistance with protocol development, study operations enhancement, trial budgeting guidance, regulatory agreements, data coordination and management, and data safety and monitoring. RIC consultative and operational services include community engagement studios, recruitment planning and feasibility assessment, recruitment materials, and selecting electronic health record (EHR)–based recruitment strategies . Joint TIC/RIC responsibilities include information gathering and synthesis related to identification and selection of trial sites.…”

Section: Tin Areas Of Impactmentioning

confidence: 99%

“…a TIN's response to sIRB mandate. b TIN's response to the NIH Data Sharing mandate.TIN Areasrecruitment planning and feasibility assessment, recruitment materials, and selecting electronic health record (EHR)-based recruitment strategies 23. Joint TIC/RIC responsibilities include information gathering and synthesis related to identification and selection of trial sites.…”

mentioning

confidence: 99%

Leveraging the Expertise of the CTSA Program to Increase the Impact and Efficiency of Clinical Trials

Harris,

Dunsmore,

Atkinson

et al. 2023

JAMA Netw Open

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ImportanceMulticenter clinical trials play a critical role in the translational processes that enable new treatments to reach all people and improve public health. However, conducting multicenter randomized clinical trials (mRCT) presents challenges. The Trial Innovation Network (TIN), established in 2016 to partner with the Clinical and Translational Science Award (CTSA) Consortium of academic medical institutions in the implementation of mRCTs, consists of 3 Trial Innovation Centers (TICs) and 1 Recruitment Innovation Center (RIC). This unique partnership has aimed to address critical roadblocks that impede the design and conduct of mRCTs, in expectation of accelerating the translation of novel interventions to clinical practice. The TIN’s challenges and achievements are described in this article, along with examples of innovative resources and processes that may serve as useful models for other clinical trial networks providing operational and recruitment support.ObservationsThe TIN has successfully integrated more than 60 CTSA institution program hubs into a functional network for mRCT implementation and optimization. A unique support system for investigators has been created that includes the development and deployment of novel tools, operational and recruitment services, consultation models, and rapid communication pathways designed to reduce delays in trial start-up, enhance recruitment, improve engagement of diverse research participants and communities, and streamline processes that improve the quality, efficiency, and conduct of mRCTs. These resources and processes span the clinical trial spectrum and enable the TICs and RIC to serve as coordinating centers, data centers, and recruitment specialists to assist trials across the National Institutes of Health and other agencies. The TIN’s impact has been demonstrated through its response to both historical operational challenges and emerging public health emergencies, including the national opioid public health crisis and the COVID-19 pandemic.Conclusions and RelevanceThe TIN has worked to reduce barriers to implementing mRCTs and to improve mRCT processes and operations by providing needed clinical trial infrastructure and resources to CTSA investigators. These resources have been instrumental in more quickly and efficiently translating research discoveries into beneficial patient treatments.

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