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Peter J. Embi, MD, MS; Anil Jain, MD; Jeffrey Clark, BS; Susan Bizjack, MSN; Richard Hornung, DrPH; C. Martin Harris, MD, MBA

Arch Intern Med. 2005;165:2272-2277.

Background  Failure to recruit a sufficient number of eligible subjects in a timely manner represents a major impediment to the success of clinical trials. Physician participation is vital to trial recruitment but is often limited.

Methods  After 12 months of traditional recruitment to a clinical trial, we activated our electronic health record (EHR)–based clinical trial alert (CTA) system in selected outpatient clinics of a large, US academic health care system. When a patient’s EHR data met selected trial criteria during the subsequent 4-month intervention period, the CTA prompted physician consideration of the patient’s eligibility and facilitated secure messaging to the trial’s coordinator. Subjects were the 114 physicians practicing at selected EHR-equipped clinics throughout our study. We compared differences in the number of physicians participating in recruitment and their recruitment rates before and after CTA activation.

Results  The CTA intervention was associated with significant increases in the number of physicians generating referrals (5 before and 42 after; P < .001) and enrollments (5 before and 11 after; P = .03), a 10-fold increase in those physicians’ referral rate (5.7/mo before and 59.5/mo after; rate ratio, 10.44; 95% confidence interval, 7.98-13.68; P<.001), and a doubling of their enrollment rate (2.9/mo before and 6.0/mo after; rate ratio, 2.06; 95% confidence interval, 1.22-3.46; P = .007).

Conclusions  Use of an EHR-based CTA led to significant increases in physicians’ participation in and recruitment rates to an ongoing clinical trial. Given the trend toward EHR implementation in health care centers engaged in clinical research, this approach may represent a much-needed solution to the common problem of inadequate trial recruitment.

Author Affiliations: Division of General Internal Medicine, University of Cincinnati College of Medicine (Dr Embi), and Institute for the Study of Health, University of Cincinnati Medical Center (Drs Embi and Hornung), Cincinnati, Ohio; and Department of Rheumatic and Immunologic Diseases (Dr Embi), Information Technology Division (Drs Jain and Harris and Mr Clark), Department of General Internal Medicine (Dr Jain and Harris), and Department of Endocrinology, Diabetes and Metabolism (Ms Bizjack), Cleveland Clinic Foundation, Cleveland, Ohio.

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