Less than 10 years ago, Yale School of Medicine’s clinical researchers were stuck in the mire of paper records. Researchers seeking health care information from patients’ doctors required interns or students to copy entire medical records by hand into research records. There was little integration between Yale’s in-patient system and its clinical research enterprise. The process was slow and burdensome, a drain on energy and creativity.
The tide turned in 2013. Under the direction of Yale Center for Clinical Investigation (YCCI), Yale became the first medical institution to integrate electronic health records (EHRs) with a clinical trials management system (CTMS). EHRs are digital versions of a patient’s paper chart, and Yale has used the health care software company Epic for its EHR since 2011. That same year, Yale introduced OnCore as its CTMS, a software system used to manage clinical trials in clinical research. OnCore maintains and supervises planning, performing and reporting functions, patient contact information, and tracks deadlines and milestones. The same year Yale rolled out Epic and OnCore institution-wide, in 2013, it integrated them so they could communicate with each other. This resulted in four improvements that enhanced research capabilities.
Increased efficiency in clinical research
As recently as 2013, 98% of patients’ outpatient medical data was on paper. Clinical researchers couldn’t easily access much more than a patient’s demographic information. Now, researchers can run a query to collect a wealth of information in just minutes. The integration of Epic and OnCore allows researchers to leverage EHR in a powerful, meaningful way. For example, a researcher can now easily identify all female patients over 40 treated at Yale facilities who are on a particular medication with a particular medical issue, and integrate these data into her research. In this way, Yale researchers are conducting a secondary data analysis on existing electronic health data. Researchers can also integrate patient-reported outcomes for quality-of-life studies and other important lines of research.
Patient Opt-out Policy
Prior to 2013, researchers had to recruit participants for clinical trials the old-fashioned way: with flyers, newspaper ads, and phone calls. With the Epic/OnCore integration, Yale transitioned to an Opt-out system for research participation. This means that EHR from the entire health system can now be used for research until a patient opts out. Patients can elect not to participate at any time. Now, researchers with IRB-approved protocols have access to medical records from patients treated at any of the Yale facilities for their studies. The Opt-out policy facilitates the potential availability of blood, tissue samples, and medical records from across the entire Yale health system.
Opt-out was initiated in early February 2014, and numerous community focus groups and meetings with IRBs and legal teams were held in subsequent months. Opt-out was heavily publicized in clinics by September 2015, but YCCI did not actually start using EHR until September 2016, after a one-year “washout period.” YCCI took these steps to maximize transparency with patients, and ensure people who were disinterested in participating had ample opportunity to opt-out before EHR were analyzed.
The Opt-out policy has been a boon to researchers. In the first 18 months since the Opt-out system was implemented, only 300 patients chose to opt-out via the online patient portal. Along with enrolling more minorities in studies, researchers are also enrolling patients across multiple hospitals. Previously, researchers could really only study patients who found their way to New Haven. Now, researchers can “see” patients in Greenwich, New London, and Bridgeport.
“The technology has removed geographical and other boundaries,” says Allen Hsiao, MD, associate professor of pediatrics and of emergency medicine and chief medical information officer of Yale School of Medicine and Yale New Haven Health. Patients see a benefit—more accurate and holistic care—and researchers see benefit, too, in terms of time and effort saved during testing.
As part of the Epic/OnCore integration, Yale launched MyChart in 2014. MyChart is a patient-facing portal that provides secure online access to medical records across its health systems. It also offers secure, HIPAA-compliant communications that allow patients to correspond directly with providers electronically, and preserves a record of correspondence that both patients and providers can easily reference. At first, patients could use MyChart to view their records and to schedule appointments online, but over the subsequent year Yale extended MyChart capabilities to include participation in research.
To help increase participation in clinical research, Yale designed a “Help Us Discover” tab in MyChart that links patients directly to clinical trials. Volunteers consent electronically and complete profiles for potential study recruitment. In the first 18 months, over 1,700 volunteers signed up and over 400 participated in studies, including 145 underrepresented minorities.
The “Help Us Discover” tab is a powerful way to recruit even more patients: researchers can reach participants who are more likely to respond after hours or on weekends, such as those working two jobs. In fact, nearly 40% of respondents, including 57% of minorities, respond to study requests during these “off-peak” times. Participants can volunteer for studies 24 hours a day. “It’s a very patient-centered way to recruit,” says Hsiao, “they can volunteer for research whenever it is convenient for them, not just during weekday business hours.”
Tracking Serious Adverse Events
Prior to Yale’s integration of Epic and OnCore, if a patient on a clinical trial or research study fell ill or died (a serious adverse event or SAE), there was no efficient method for alerting research investigators. This resulted in some serious faux pas. Researchers would call the patient’s family, for example, and ask why they didn’t show up to research follow-up meetings, only to learn of a serious illness or a tragedy secondhand. Families wondered why Yale didn’t have its act together.
Now, within seconds, when a research participant experiences illness or trauma, a message is sent from Epic to OnCore to alert investigators. Before the Epic/OnCore integration, the median time of alert was 13 days. As functionality has rolled out to hospitals across the Yale health system, that number has consistently improved. It is currently down to four days across the whole system.
Since SAE alerts were activated, investigators have been alerted to over 30,000 SAEs experienced by nearly 7,000 patients. This technology has provided more accurate and reliable data to researchers, and as a result, patient care and research are more coordinated than ever before.