Inadequate recruitment of eligible subjects for clinical trials is a major impediment to the advancement of medicine. Use of an EHR-based, point-of-care Clinical Trial Alert (CTA) approach has been shown to significantly improve recruitment in a prior study and shows promise for wider use. However, fundamental gaps in our knowledge regarding determinants of EHR-based, point-of-care trial recruitment and the applicability of the CTA approach in different clinical settings must be addressed before potential benefits can be realized. Our long-term goal is to improve clinical research by leveraging health information technology. The objective of this particular application is to evaluate the CTA approach's effect on physicians' rates of subject recruitment across different clinical settings and determine the factors that effect this point-of-care recruitment in HER-equipped environments. Our central hypothesis is that by addressing the factors that influence trial recruitment participation, an EHR-based, point-of-care CTA approach will prove broadly efficacious. Guided by our strong preliminary data, we will test our hypotheses by pursuing two specific aims: (1) Determine the impacts on trial recruitment of an EHR-based CTA approach in different clinical settings within and across healthcare systems; (2) Identify the range of stakeholders' perceived barriers, facilitators, and information needs regarding HER-based, point-of-care recruitment in different clinical settings to inform improvements in the CTA approach. Under the first aim, we will perform a series of randomized cross-over designed interventions to evaluate CTA's impact on recruitment among primary care and subspecialist physicians across three healthcare systems. Under the second aim, we will conduct interviews and surveys of stakeholders including clinicians, patients and researchers involved in the CTA-driven process to ascertain their perceived barriers, facilitators, and information needs regarding point-of-care recruitment. Finally, we will analyze the findings from both aims to produce a summary report that will inform modifications to the CTA approach and next steps in this line of inquiry. This approach is innovative in that it will apply complementary methodological approaches to answer important questions regarding the utility of clinical trial recruitment using a promising EHR-based approach in a range of healthcare settings and the factors that influence its impact. The proposed research is significant because it is expected to advance our knowledge regarding EHR-facilitated trial recruitment at the point-of care.
