The EHR Solution to Clinical Trial Recruitment in Physician Groups

Aug. 20, 2009

At Holston Medical Group (HMG) in Kingsport, Tenn., we have used an electronic health record (EHR) since 1996 to enhance the quality and efficiency of the care we provide. Over the years, as HMG has grown to include 102 providers in 26 locations across northeastern Tennessee and southwestern Virginia, the TouchWorks EHR from Allscripts has delivered benefits similar to those documented by other physician practices, including improved contracts with insurers, lower transcription costs, reduced physical space requirements, lower costs for chart pulling and filing, faster auditing, reductions in malpractice premiums, and higher patient and physician satisfaction.

Jerry Miller is President
and Founder of Holston Medical Group, Kingsport, Tenn. Contact him
at [email protected].

At Holston Medical Group (HMG) in Kingsport, Tenn., we have used an electronic health record (EHR) since 1996 to enhance the quality and efficiency of the care we provide. Over the years, as HMG has grown to include 102 providers in 26 locations across northeastern Tennessee and southwestern Virginia, the TouchWorks EHR from Allscripts has delivered benefits similar to those documented by other physician practices, including improved contracts with insurers, lower transcription costs, reduced physical space requirements, lower costs for chart pulling and filing, faster auditing, reductions in malpractice premiums, and higher patient and physician satisfaction.

What makes the HMG experience unique is the source of our funding for the EHR. The entire cost of the EHR’s implementation and operation is paid for by HMG’s extensive clinical research program, which in turn owes its success to the EHR. Over the last nine years, we have used our EHR to enroll thousands of patients in more than 250 clinical trials. Currently, HMG has 52 clinical trials underway with 600 patients actively enrolled. We employ 19 full-time and three part-time professionals devoted exclusively to managing its clinical trials, which generated $1.9 million in revenue in 2004 and nearly $2.5 million in 2005.

HMG’s success with clinical research would not have been possible without the EHR. Clinical trial sponsors return to us again and again because the EHR greatly enhances our ability to recruit patients for clinical trials and keep them in the study once they are enrolled. Besides creating a positive financial feedback loop, this capability has far-reaching implications for the clinical research industry and for healthcare in general.

Clinical trials are conducted to evaluate the effectiveness and safety of medications or medical devices by monitoring their effects on large groups of people. But in recent years, the trials’ sponsors in government and industry have had trouble finding enough patients to meet their enrollment criteria. Of the nearly 50,000 clinical trials currently underway in the United States, some 80 percent are delayed by one month or more because of unfulfilled enrollment, according to The Center for Information and Study on Clinical Research Participation. The delays contribute to a lengthier drug pipeline and higher drug costs.

In the 1960s, it took 8.1 years for a new medication to advance from discovery to approval by the Food and Drug Administration. By the 1990s, the average time in the drug pipeline had nearly doubled, to 15.3 years. Delays in getting medications to market cost pharmaceutical companies billions of dollars each year—an estimated $1 million a day in lost sales for a moderately successful medication, and upwards of $3 million a day for a blockbuster drug like Viagra.

Many factors explain why it is becoming harder to recruit patients for clinical trials. Federal regulations are becoming increasingly demanding, and ever more specific trial protocols make it harder to find the right patients. Moreover, with every passing year fewer American patients are medication-free—or “drug naive,” as researchers say—which is a basic requirement for enrollment in many clinical trials. In an effort to speed enrollment in clinical trials, pharmaceutical companies and government agencies are turning to private clinical research organizations (CROs) that get paid to recruit patients. CROs are now responsible for enrolling patients in an estimated 70 percent of U.S. clinical trials. The rise of the CRO has been accompanied by a corresponding fall in the role of academic medical centers, which saw their share of U.S. clinical trials shrink from 80 percent in 1991 to 30 percent in 2002.

Not surprisingly, annual spending on patient recruitment has nearly doubled since 2001 to more than $440 million per year. Because these expenses are passed on to healthcare consumers and payers, streamlining the patient-enrollment process could lead to more affordable medications. HMG’s experience, then, may serve as a model for physician groups across the nation that hope to reap the benefits—both organizational and societal—of conducting clinical research.

The EHR in Practice
Vendors of a variety of information technologies claim that their products can speed and improve patient recruitment. Any one of these IT solutions is superior to the costly and laborious manual searches of paper medical charts undertaken by many physician practices. But according to a widely quoted 2003 analysis of IT solutions by Forrester Research, (“When EMRs Meet Clinical Trials”) the EHR is the best available solution for clinical trial recruitment. The report found that the EHR fulfills seven key criteria for successful recruitment including richness of data, relevance, reach, freshness, consistency and interoperability.

At HMG, our nine years of experience strongly support Forrester’s findings. In particular, the EHR has three main capabilities that have contributed to streamlining and improving our research program:

  • Speed: Identification of patient candidates is automated via computer analysis of discreet data points;
  • Accuracy: Searches automatically assess a candidate’s eligibility for a clinical trial, resulting in lower “screen failure” rates;
  • Interoperability: Physicians at each of HMG’s 26 clinics are alerted to patients’ involvement in clinical trials, resulting in lower rates of protocol violations and faster reporting of adverse events. Interoperability also contributes to faster monitoring of trials.

Speed
The EHR’s inherent ability to bring together data from multiple practice sites under one electronic umbrella enables quick development of a critical mass of patients’ records. The sheer scale of HMG’s EHR database (nearly 200,000 patient records) is invaluable in prospectively assessing the actual number of patients that may meet protocols. In one recent case, a large pharmaceutical company phoned us to ask if we could identify 25 patients with rheumatoid arthritis for an upcoming clinical trial of a new arthritis medication. Within half an hour, a search of the EHR’s database identified 430 patients eligible for participation in the study. This capability spares a trial’s sponsors many months of costly advertising and call screening, and minimizes the risk that a candidate pool will fall short of minimum enrollment requirements.

Adding to the EHR’s ability to quickly assess the number of eligible patients in the database is that searches include our physicians’ current schedules. Because all scheduling information is entered into the EHR, our research staff can easily search through upcoming patient visits for a particular complaint that might qualify the patient for a trial, even if their medical records are not yet in the system.

Accuracy
A major source of delay and added costs in clinical trials is the time and effort wasted on candidates who fail to pass screening following their initial identification. Trial sponsors have recently placed strict limits on the number of these so-called “screen failures” that they will pay for, meaning trial sites must either sharply reduce their failure rate or absorb the excess costs. The screening process requires two stages. In the first stage, a staff coordinator at the trial site creates a search within the EHR and then manually analyzes the results, searching through the medical records of each patient identified by the EHR to ensure they meet the strict eligibility and exclusion requirements set out in the trial protocols.

To view chart click here.

After culling those candidates who clearly do not meet protocols, the coordinator moves on to the second stage of screening—interviews or “screen visits” with the selected candidates to verify inclusion/exclusion criteria. If the record proves to be inaccurate, inconsistent with central lab values or out-of-date, then the patient is considered a “screen failure” and is rejected from the trial. The screening process is so time-consuming and costly that clinics with consistently high screen-failure rates are quickly crossed off the list for future trials. Conversely, clinics with a low incidence of screen failures tend to attract more trials.

Although screen-failure statistics are difficult to compile, HMG’s repeat sponsors have told us that our screen-failure rate is among the lowest in the nation. We attribute our low failure rate to the EHR’s ability to utilize the complete medical record in assessing a patient’s eligibility—including highly specific laboratory values, prescription data, problem lists and demographics. Moreover, because our providers update each patient’s record during actual encounters, rather than relying on latent entries via dictation and transcription, the record is far more likely to be free of errors and up to date.

Interoperability
While repeated screen failures can be costly and time-consuming, a far more expensive and problematic source of delay in clinical trials comes of protocol violations. These violations occur when a patient is determined to be ineligible for the trial after being enrolled. Protocol violations most commonly result from errors in the screening process, including incomplete and inaccurate medical records. Another common violation results from a patient receiving a prescription for an excluded medication from a physician who is not involved in the trial. Most protocols forbid enrolled patients from receiving other medications that may cause unwanted drug interactions and skew the study’s results.

Patients who violate protocols must be reported to the sponsor and the site’s Institutional Review Board (IRB), whose purpose is to monitor the study and protect the rights and welfare of its human participants. Because it is expensive for sponsors to pay clinics to enroll patients whose data they cannot use, a clinic with high rates of protocol violations is unlikely to be asked to participate in future trials. Protocol violation rates, like screen failure rates, are difficult to track.

HMG has among the nation’s lowest incidence of protocol violations. We attribute this success rate to the interoperability of the Web-based EHR, which enables all 102 of our physicians to gain instant access to the full clinical record from anywhere and at anytime. A cursory glance at a patient’s record will quickly reveal their participation in a clinical trial. In that case, the EHR directs physicians to phone the appropriate HMG coordinator to ensure that treatments they prescribe do not violate the trial’s protocols.

Another benefit of the EHR’s interoperability is the ease with which physicians can report adverse events. Under Food and Drug Administration rules, clinical researchers have a legal responsibility for timely reporting of serious adverse events affecting trial enrollees, such as hospitalization, life-threatening illnesses or death to the IRB. The EHR makes reporting a simple matter, and also allows HMG to track the date of the event and of its resolution.

Finally, the EHR’s interoperability, portability and connectivity contribute to speeding sponsor monitoring of clinical trials and converts monitors into evangelists for HMG. Federal rules require all clinical trial sponsors to conduct frequent onsite monitoring. Monitors analyze the medical records of enrolled patients to assure that patients are safe, that screen failures are accounted for, and that the trial’s protocols are not violated. In an organization with paper medical charts, this process can take up to two weeks, depending on the number of patients enrolled.

Since the complete record is instantly available to the monitor, HMG employees need not be assigned to track down paper charts. To reassure the monitor that the electronic record has not been tampered with, they may be given a temporary password, which gives them read-only access to the entire EHR. Overall, HMG’s monitoring process requires significantly less time for monitoring than a paper-based physician practice.

Conclusion
Holston Medical Group’s nine years of experience using an EHR in clinical research indicates that the Web-based technology can significantly streamline patient recruitment, speed monitoring, and help to prevent protocol failure—all while increasing our revenue stream. As a direct result of the EHR’s productivity, HMG’s income from clinical research has risen from $86,700 in its first year (1996) to $1.9 million in 2004, with estimated 2005 revenues of $2.5 million. That 68 percent average annual revenue increase has enabled us to pay substantial bonuses to participating physicians—a total of $330,000 in 2004, with roughly $420,000 for 2005—and to cover the entire annual cost of operating the research department and the EHR itself. Last year, after all these costs were paid, research revenues contributed another $285,000 to our general budget.

Taken together, these results suggest that an electronic health record can greatly enhance the efficiency and effectiveness of a clinical research program in the ambulatory setting, while simultaneously boosting the research organization’s bottom line.

For more information on TouchWorks EHR from Allscripts,
www.rsleads.com/612ht-200

August 2009

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