Next-Generation Patient Recruitment for Clinical Trials
By Selena Chavis
For The Record
Vol. 29 No. 10 P. 14
EHRs open new doors to efficient, effective processes.
Advancements in HIT hold great promise for elevating research across the industry. It's one of the cornerstones of the EHR movement as interoperable frameworks continue to open doors to greater information exchange. Yet the health care industry's ability to advance the pace and depth of new discovery relies heavily on its ability to successfully recruit patients for clinical trials.
For more than a decade, stakeholders have worked to identify best practices for using EHRs to improve the outlook on burdensome patient recruitment processes, according to Doug Fridsma, MD, PhD, FACP, FACMI, president and CEO of the American Medical Informatics Association. "Using EHRs for patient recruitment isn't something new, although I will say that with the adoption of EHRs over the past six or seven years there has really been a renewed interest and opportunity to use them for those purposes," he says. "When you go back, there's a lot of work that has been done to identify suitable patients for clinical trials."
Several approaches have emerged in recent years for using EHRs to support patient recruitment, most falling into two categories: clinician point-of-care alerts and patient centric. Peter Embi, MD, MS, FACP, FACMI, president and CEO of the Regenstrief Institute, was involved in early and ongoing studies that have paved the way for best practices that speak to clinician point-of-care alerts.
The first study, published in an October 2005 issue of the Archives of Internal Medicine, demonstrated significant increases in patient enrollment by activating an EHR-based clinical trial alert (CTA) that prompted physicians to consider a patient's eligibility. "We saw a 10-fold increase in referrals and double enrollment by turning on the alert," Embi recalls. "With subsequent studies, there has almost always been an increase. It's just a matter of how much."
While the use of CTAs has made inroads in recent years, many industry experts believe that patient-centric approaches to HIT-based recruitment hold even greater promise. "I think the opportunity is really targeting your patient population," says Michael Cantor, MD, MA, FACP, director of clinical research informatics with New York University (NYU) School of Medicine and clinical director of NYU Langone Health DataCore. "Instead of putting up fliers in a waiting area or doing some kind of blast message, it helps you to find patients that actually meet your eligibility criteria."
Allen Hsiao, MD, FAAP, chief medical information officer at Yale School of Medicine and Yale New Haven Health, agrees, confirming a recent move by Yale to a more patient-centric approach. "This flips [recruitment] on its head. Now we're messaging patients through the patient portal that we know from the data may be a match for a certain study and we are asking them directly," he explains. "We're reaching out to patients who might not otherwise hear about the study and empowering our patients to decide for themselves rather than hoping that their doctors might remember to tell them about the study on a busy afternoon or full day of clinic."
Embi also touts the potential of patient-centric approaches while suggesting the need for more research. "I don't think that it's going to end up being the best approach for every single study nor is the alert to the clinicians," he says. "What we want at the end of the day is a toolbox that we can reach into and pull out the right tool for the right job. It wouldn't surprise me one bit if we found that [patient centric] was a superior approach in some settings and with some patients as compared with going through their doctors."
Evolving Methods, Opportunities
Workflow integration and timing are both critical to successfully using EHRs for patient recruitment, Fridsma says. "Once you identify someone, how can you leverage the EHR to manage that patient and integrate the care of that patient with the investigation that you have as part of research so that those things seamlessly fit together?" he asks, pointing out that opportunities are often lost due to treatment urgency or oversight.
For instance, if a patient presents with an advanced cancer diagnosis, the course of treatment moves quickly. "It needs to happen early in the process. The challenge is getting doctors to think about clinical trials as an option. It's a lot of work for doctors to pause their workflows to figure what patients might be eligible for," Fridsma says.
In terms of CTAs, Embi notes that a typical process workflow starts with algorithm design to leverage analytics to identify appropriate patients. "We take into account the nature of the studies, the kinds of data that are important to determine whether someone qualifies, the urgency of the study, the kinds of patients we look for, and where those patients would likely interact with the health care system," he says. "Then we tailor the approach to the study and the setting."
Once the system identifies patients who qualify for a study, CTAs are sent to appropriate clinicians prompting them to evaluate a patient's interest. If the patient agrees, the clinician clicks an appropriate tab in the system and the information is sent to the study coordinator in a secure manner. The patient is then contacted and the informed consent process begins.
While the Regenstrief Institute is not yet using a patient-centric workflow, Embi says plans are in place to expand processes to include the method. "What we find is that giving people the opportunity is the biggest obstacle. Most people who would participate in the study just don't know about it," he says.
Hsiao believes patient-centric processes will improve awareness of clinical trials. Stressing the importance of protecting patient privacy, he says patients need to decide for themselves.
"It was previously more centered around the physician, who may or may not bring it up to a patient or who may inject bias into the conversation. Or in some cases they may decide up front that the patient wouldn't be interested," Hsiao says. "If you have only 15 minutes in a patient visit, realistically, are you going to take time out for 10 minutes to explain a study to a patient or encourage them to enroll?"
At NYU, Cantor runs the DataCore center, where queries are performed in the EHR for investigators. Depending on the clinical trial, patients meeting criteria are either contacted through their physicians or through the patient portal. Investigators approach the center with eligibility data, which can often be represented by lab values, certain diagnosis codes, and demographic data. Once criteria are plugged into the system, a report is run in a database behind the EHR to identify patients. In addition to this approach, clinical trial information is provided on NYU's website as well as in the portal, where patients view only trials matching their eligibility.
Similar processes exist at Yale, Hsiao notes, in that an investigator presents the opportunity for a study and recruitment needs to the institutional review board (IRB). A system query is built, patients are identified and contacted, and the system acts as an intermediary to notify the patient. Data on those expressing interest are provided to investigators.
"It's all system identified and generated," Hsiao says, emphasizing the importance of maintaining patient privacy. "If you are interested, click on the link, and patient information will be shared. If you are not interested, click on 'not interested,' and no investigator has been given your name or information."
In place for six studies, the process has received positive feedback from investigators and patients, Hsiao says. In a recent study covering patients taking a certain kind of depression medication, it took investigators four months to identify four patients before the patient-centric EHR process was in place. With the new system, the organization identified four patients within four hours.
Striking the Right Balance
Industry professionals agree that most health care organizations continue to grapple with how to optimize patient communications as they relate to research. Specifically, best practices are still emerging in terms of how often to contact a patient and whether to implement "opt-in" or "opt-out" communication strategies.
"There are some best practices at every stage of research," Fridsma notes. "Often, it depends on the IRB and others in terms of how conservative the approach. There's a lot of regulation in this area, and certainly there are some regulations coming down the pike that should provide some clarity."
For instance, the 21st Century Cures Act addresses electronic identification of patients for clinical research but not patient notification. The Common Rule and HIPAA work in complementary fashion to protect patient rights, although the Common Rule points to the establishment of an IRB to oversee patient communications in the case of research.
Institutions using a patient-centric approach to recruitment via EHR patient portals must determine whether they will institute an "opt-in" or "opt-out" strategy. The question becomes whether researchers will contact patients automatically unless asked not to or patients will request to receive notifications concerning research.
For Yale, the choice was made to become an opt-out institution, where the assumption is made that patients want to be contacted unless otherwise noted. "That went through several governance committees, very much involving our IRB, investigation committee, and patient advisory panels," Hsiao says. "The interesting thing we learned is that our patients want to participate in research by and large. They want cutting-edge medicine and treatment. They just want to make sure their privacy is protected … and that it is easy to opt out."
While NYU also made the opt-out choice, Cantor says the organization—like many across the industry—continues to navigate decisions around how often to contact patients about clinical research. For example, if a patient qualifies for 10 studies, should an organization send all options?
"Right now, it's more of a hypothetical issue. No system I know of has gotten to the point where all of their trials are communicating with patients in the EHR," Cantor says. "If [patients] are eligible for multiple trials, do you err on the side of patient autonomy or do you say, 'We don't want to overwhelm them'? At least here, what most people at NYU have been pushing for is to err on the side of patient autonomy, but we do get some pushback from clinicians."
According to Hsiao, Yale is currently following a litmus test of two contacts per calendar year, although he knows of other institutions that contact patients more regularly. "We don't have any idea if that is too much or too little. We need to have a second round of meetings with our patient advocacy groups," he says, adding that the answer may lie in adding patient preferences in the EHR.
"That's also an area that we need to study more. We recognize that's an issue in the clinical setting—we can't send a dozen alerts to a patient's doctor," Embi says, agreeing that the best answer may be to allow patients to "dial up" and "dial down" contacts on their own. "It remains an open question how much patients want to see. The truth is that most people are not going to end up getting a dozen alerts. Most people are going to end up qualifying for one or two studies."
Fridsma acknowledges that health care organizations face competing priorities when it comes to research and clinical care. "The way you organize research and the way you organize clinical care are often different. Trying to bridge that gap is problematic," he says.
For these reasons, Cantor says NYU has attempted to remove research efforts from clinical workflows. "One of the first studies where we used research recruitment alerts was in cardiology, and we found out that a lot of cardiologists don't even open the chart until they are done seeing the patient," he notes. "Clinicians are not focused on research. Especially in this environment, I think it's asking too much of clinicians unless it's their clinical trial."
Embi emphasizes that treatment must always come first, although in certain cases, trials are the preferred course of action for a patient. "A patient may be in the course of a disease where the best thing is to enroll in a trial. We take all that into account when we are putting alerts in place," he explains.
Perspectives are changing about how research aligns with clinical workflows, according to Fridsma. "There's been some work done to bridge the gap between how people think about information in clinical research activity and how they think about it in clinical care," he says. "As with any complex set of tasks, this is not just a technology problem, not just a business problem, not just a person problem or a sociotechnical problem. You have to align incentives, you have to get people to participate, you have to have all the other pieces in place."
The key is having discussions with all stakeholders, Hsiao says. "That's where we learn those valuable things. Patients want their privacy protected, but they also want their data used to improve health care," he says. "For instance, consider a patient with terminal cancer. What gives them hope is discovering a cure that can help someone else in the future. That's just so powerful when you hear things like that from patients."
— Selena Chavis is a Florida-based freelance journalist whose writing appears regularly in various trade and consumer publications, covering everything from corporate and managerial topics to health care and travel.