Participant Recruitment
Failure to recruit enough patients is one of the top reasons why clinical trials fail, which is why we’ve assembled specialists in the field of participant recruitment to partner on this problem. Our work makes it easier for investigators to leverage recruitment capabilities in the electronic health record, conduct multisite recruitment, and obtain IRB approval for recruitment methods and materials.
Campus Leads
Fred Stevenson, UCD
Joshua Grill, UCI
Adrijana McFerran, UCI
Douglas Bell, UCLA
Antonia Petruse, UCLA
Brandon Brown, UCR
Tia Levine, UCSD
Molly Belinski, UCSF (Work
Group Lead)
Ruth Gebrezghi, UCSF
Vanessa Jacoby, UCSF
Katherine Connors, Stanford
John Maul, Stanford
Contact
David Grady
Program Manager, UC BRAID
david.grady@ucbraid.org
415-514-8281
Goals
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Improve the cost, efficiency, and effectiveness of recruitment approaches
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Position member institutions to be attractive for research grant dollars, both locally and with multi-center studies and trials
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Develop capabilities to forge and respond to new public/private partnerships
Multisite Participant Recruitment using EHR-Derived Cohorts:
Guidelines and Best Practices for Researchers
Multisite participant recruitment using EHR-derived cohorts (hereafter referred to as “EHR recruitment”) requires special planning and consideration due to complexities around patient privacy, data limitations and security, and variance in local administrative practices. These guidelines and best practices are intended to aid researchers in creating a multisite EHR recruitment plan that is respectful to patients, minimizes the risk of loss of patient confidentiality, and helps researchers anticipate and prepare for patient feedback. This document was developed as a collaborative effort by the UC BRAID Participant Recruitment workgroup, comprised of representatives of University of California campuses at Davis, Irvine, Los Angeles, Riverside, San Diego, and San Francisco, with input from Stanford University.
Note: For the purposes of this document, “EHR recruitment” is defined as: Recruitment of patients who are identified via a systematic query of the electronic health record. The query generates a list of patients who may meet basic study eligibility criteria; providers may span multiple clinics and disease areas and initial contact is conducted outside of the clinic setting.
Characteristics of EHR recruitment:
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PI may be unknown to the patient.
- Lists of potentially eligible patients are derived via an EHR data extraction, typically by a certified EHR programmer.
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Initial contact is conducted outside of the clinic, typically by letter, email, or a patient portal.
Characteristics of non-EHR recruitment:
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Data is derived from any source other than the EHR (e.g., clinic administrative data, registries, publicly available mailing lists).
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Initial Patient eligibility is determined by a chart review.
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Initial recruitment approach is in a clinic setting.
IRB approval for any recruitment method is granted on a case-by-case basis; EHR recruitment may not always be appropriate or practical, depending on the context of the study design, patient population, availability of data, and research infrastructure at recruitment sites. Some patient populations may not be suitable for EHR recruitment, such as when eligibility is based on sensitive or rare diagnoses. In these cases, PIs may wish to establish additional collaborations with clinicians working in the disease area to determine appropriate and effective methods for recruiting these patients.
The full Guidelines and Best Practices can be downloaded here as a pdf. It has also been added for other institutions to the Trial Innovation Network Toolkit here.
UC IRB listings: UCD (Identify Potential Subjects) | UCI (Recruitment Methods) | UCLA (coming soon)
UCSD (Section 7) | UCSF (Multisite Recruitment)
CDI2/UC BRAID Health Data Warehouse: UC-Wide Recruitment Pilot Project
Using the power of the UC Health Data Warehouse to boost clinical study recruitment.
UC BRAID / CDI2 are executing clinical studies across the UC campuses as a strategy to support recruitment of diverse populations.
The Center for Data-driven Insights and Innovation (CDI2) and University of California Biomedical Research Acceleration, Integration, & Development (UC BRAID) offered an opportunity for study teams to pilot the use of the UC Health Data Warehouse to identify and recruit potentially eligible patients across the UC Health system as a way to efficiently meet enrollment goals and recruit a diverse study population. The UC Health Data Warehouse is a centralized repository of electronic health record data from across the six UC Academic Medical Centers. The UCHDW currently holds data on 8.7 million patients seen at a UC facility since 2012. These patients received care from nearly 100,000 health care providers in approximately 378 million encounters. In those encounters, UCH conducted over 1 billion procedures, ordered or prescribed more than 1.3 billion medications, made more than 5.2 billion vital signs and test result measurements, including 35,000 sequenced cancer genomes, and assigned more than 1.1 billion diagnosis codes. Over 800,000 of these patients receive primary care through UCH.
Studies selected for the pilot are working with the pilot coordinating team to identify cohorts of potentially eligible patients using coded variables such as ICD codes, lab values, and patient demographics; studies can contact the patient cohorts by US Mail or email. Contact by phone or text is not allowed as part of this service.
All data extraction and recruitment set-up services are provided free of charge during the pilot. Studies are responsible for all outreach to patients and other associated costs. To address disparities in technology adoption, studies planning to use email as an outreach method should also plan to send paper recruitment letters to patients without email addresses. Studies must use an approved email or recruitment letter template to ensure compliance with relevant policy and regulations. We expect all studies to prioritize equitable outreach and to plan and budget for this expense.
UC Health: A clinical trial pilot pioneers a new era of collaboration, innovation and equity
CTSA Participant Recruitment Programs