Physician participation is critical to the successes of most clinical trial recruitment efforts. Not only do clinicians play a vital role by identifying potentially eligible subjects, but patients are much more likely to participate in a study if their physician has suggested it to them [1]. Unfortunately, the identification and recruitment of eligible patients during the course of busy clinical practice can be difficult. In order to successfully recruit patients, physicians engaging in traditional recruitment have to remember which local clinical trials are active, recall the trial's details in order to determine patient eligibility, take time to explain the trial's details to potentially eligible patients, and often take more time to perform other recruitment activities. Doing all of this while also attempting to provide the individual patient with good care during a short clinic visit can be difficult, at best. Current privacy regulations add further challenges to overcome in solving this problem [2].
As a consequence, few clinicians, mostly those in university settings, do most of the recruiting for clinical trials [1, 3, 4]. Even in fields like oncology where clinical trial participation is considered optimal for many patients, only about 3% of eligible patients are enrolled into clinical trials and enrollment is often not representative of the general population [3, 5, 6]. In addition to frustrating progress, these factors can introduce bias to the trial and prevent some patients from receiving potentially beneficial 'state-of-the-art' therapy.
Numerous technological approaches have been developed in attempts to enhance clinical trial recruitment [7–14]. Some have shown promise by using computerized clinical databases to automate the identification of potentially eligible patients [15, 16]. Electronic Health Record (EHR)-based approaches have also been described, though mostly in specialized settings and few have demonstrated significant benefit in controlled studies [17–20]. Until recently, whether comprehensive EHRs could be leveraged for the benefit of clinical trial recruitment at the point-of-care as effectively as they have been for patient safety and healthcare quality remained to be determined [21].
The Clinical Trial Alert Approach
In 2004, we developed an EHR-based Clinical Trial Alert (CTA) approach. The approach was designed to overcome many of the known obstacles to trial recruitment by physicians while complying with current privacy regulations [22]. We conducted a before-after intervention study of the CTA approach applied to a large, multi-center, NIH-sponsored type 2 diabetes mellitus clinical trial, the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study for which the Cleveland Clinic was a study site. During our 4- month CTA intervention phase, the system alerted physicians to patients whose EHR data met selected trial eligibility criteria [23]. Upon triggering, the CTA served to remind the clinician about the trial and to facilitate referral of interested patients to a clinical trial's coordinator. Our subjects for this study were the 114 staff physicians (10 endocrinologists, 104 general internists) practicing at one of our health system's Internal Medicine and Endocrinology referral-center-based and community-based clinics. When presented with the CTA, physicians could choose to ignore the CTA or to use it.
In our intervention study, CTA use resulted in significant increase in the number of physicians participating in recruitment activities and in their rates of subject referrals and enrollments to the trial compared to baseline rates [23]. During the intervention study, all 114 physician subjects received at least one CTA to which they could respond. From among those, 48 (42%) participated by attending to and processing at least one CTA order form while the remainder ignored all CTAs presented to them. Of those who participated by attending to at least one alert during the intervention phase, 42 (88%) referred at least one patient to the trial coordinator, and 11 (23%) generated at least one enrollment. The number of physicians referring patients after CTA activation increased more than eight-fold, from 5 before to 42 after (P < 0.001). In addition, physician-generated referral rates increased more than ten-fold, from 5.7/month before CTA activation to 59.5/month afterward (P < 0.001), and enrolment rates more than doubled, from 2.9/month before to 6.0/month after (P = 0.007). While general internists had not contributed to recruitment before, they generated 170 (71%) of the referrals and 7 (29%) of the enrollments after CTA activation. CTA use was also associated with a substantial referral rate increase of 47% among endocrinologists. Despite these improvements in overall physician recruitment to this trial after CTA activation, 52% of physicians did not use the CTA even once and nearly 90% of all CTAs triggered were ignored by physicians.
Purpose for the Survey
While the preceding intervention study indicated that the CTA approach had a significant impact on recruitment and enrollment rates by physicians, it also revealed considerable inefficiencies. Moreover, the intervention study was not designed to answer certain important questions about physicians' attitudes and reasons for using or dismissing the EHR-based recruitment alerts. Despite prior research having been conducted in the areas of point-of-care recruitment and computerized clinical decision support, little is known about how physicians feel about point-of-care recruitment in EHR-equipped settings, and we know of no reports concerning their perceptions on using EHRs to facilitate point-of-care recruitment in the manner allowed by the CTA approach.
Therefore, we undertook a survey of those physicians who were exposed to CTAs during our recently completed intervention study. Our objective was to assess their perceptions of the CTA approach and of trial recruitment in general in order to better understand the findings of our intervention study and to inform further development, application, and evaluation of the EHR-based approaches to research subject recruitment.
