Proving IT's value: Indianapolis researcher's groundbreaking work spotlights abilities of computerized clinical support
Dr. Clement McDonald, a pioneering researcher with the Regenstrief Institute of Health Care in Indianapolis, published “Protocol-based Computer Reminders, the Quality of Care and the Non-Perfectability of Man,” in the Dec. 9, 1976 issue of the New England Journal of Medicine.
The previous spring in Indianapolis, four interns and five residents working in the general medicine clinic at Wishard Memorial Hospital volunteered to take part in McDonald's research, which would produce the aforementioned, seminal study in medical informatics.
McDonald's stated hypothesis: “To determine whether clinical errors can be reduced by prospective computer suggestions about the management of simple clinical events.”
But his much broader subtext was that, “There are limits to man's capabilities as an information processor that assure the occurrence of random errors in his activities,” McDonald wrote in his study findings. “Man is not perfectible,” he wrote.
One of the foremost pioneers in the field of applied medical informatics, McDonald was the long-time director of Regenstrief, which he joined in 1972.
The institute, founded in 1969 and affiliated with the Indiana University School of Medicine, is named for philanthropist and Hoosier industrialist Sam Regenstrief, who made a fortune manufacturing automatic dishwashers.
Today, it might be hard to imagine that the patient-safety benefits of computerized clinical decision support systems were ever anything less than articles of faith. But in fact, 35 years ago, when McDonald was writing up his research paper on the topic, you could count on your fingers the number of deployed clinical computer systems.
McDonald's own, the Regenstrief Medical Record system, was at the time, still “an evolving set of computer programs” that served as Wishard's outpatient medical record, as well as a record keeper for its pharmacy, lab and radiology department, according McDonald's article. The EHR referenced 390 care protocols, which were based on best practices gleaned from then-current medical literature. Each physician in the clinical trial saw patients with the EHR providing them alerts and not (as a control sample).
In 256 patient visits studied, 712 “events” were flagged with clinical recommendations provided by the Regenstrief decision support system. The protocols “were approximate, rather than precise,” so sometimes the doctors in training had “legitimate reasons” for ignoring some of the computer-assisted recommendations, according to McDonald, but “each of the nine physicians responded to a greater percentage of events when given computer recommendations than when not.”
“Thus, I conclude,” McDonald said, optimistically and prophetically, “that though the individual physician is not perfectible, the system of care is, and that the computer will play a major part in the perfection of future system.”
Dr. William Tierney is the current president and CEO of Regenstrief. Tierney recalls his days as a second-year resident at Wishard in 1977 when McDonald and his colleagues “worked the bugs out” of their Regenstrief EHR and rolled it out across the general medicine clinic.
Tierney says even then, McDonald and Regenstrief were doing “pivotal” work, which led to a realization where computerization would be most effective.
“When Clem McDonald first came here, what he wanted to do was to have the computer help the doctor make clinical diagnosis,” Tierney says. “That's where he thought medical information was going. It never went there. But now we know that capturing the data is the thing.”
Tierney joined the IU faculty in 1980 and worked with McDonald at Regenstrief as a general investigator, helping build and improve “one of the first comprehensive electronic health record systems in the country.” He joined his mentor in a 1984 write-up of an expanded trial of the Regenstrief decision support system that confirmed McDonald's earlier results.
That sort of research in applied informatics is what makes Regenstrief different from that of other information organizations, according to Tierney. Regenstrief's research tends to focus on the “why” not the “what,” historically providing “the evidence-basis for informatics,” Tierney says.
Tools remain an integral part of the Regenstrief mission, Tierney says. The institute developed, launched in 1994, and continues to maintain LOINC, the Logical Observation Identifiers Names and Codes, a code system for the electronic transmission of clinical data from laboratories now in widespread use in the U.S. and abroad. Regenstrief also helped kick-start in 2004 the Indiana Health Information Exchange, one of the earliest functioning regional health-information organizations. The IHIE grew out of Regenstrief's pioneering work in interoperability, which goes back to 1994 and an initial data-sharing arrangement between the emergency departments of Wishard and Community East hospitals.
Today, the Indianapolis-based IHIE claims it connects 19,000 physicians and 90 hospitals, community health clinics and long-term care facilities, making it one of the largest RHIOs in the U.S. Regenstrief still provides computer programming services for the now-independent IHIE and well as continuingly improving the EHR system at Wishard, Tierney says.
Today, the institute, still headquartered in Indianapolis, has 50 investigators and 150 full- and part-time staff, whose work has global reach.