Bridging Evidence & Practice

Sponsored by Elsevier's Clinical Key

Clinical Innovation + Technology hosted its annual CMIO Leadership Forum, Oct. 4-5, at the Trump Hotel Chicago,
with this year’s focus on “Transforming Healthcare Through Evidence-based Medicine.” The two-day educational conference was sponsored by Elsevier's Clinical Key.

 The CMIO Leadership Forum is designed to foster innovation in evidence-based medicine and promote sharing of evidence-based medicine best practices. Each year, it provides a symposium for physician and clinical leaders, C-suite executives, researchers and opinion leaders to share knowledge, information and best practices.  

This year’s Forum featured Farzad Mostashari, MD, ScM, the national coordinator for health IT, and David A. Kessler, MD, former FDA Commissioner, as the keynote speakers, in addition to many other informative presenters. This interactive leadership forum on the role of evidence-based medicine traversed topics such as: accountable care, medical home, meaningful use, engaging patients & physicians, government policy, EMRs, cost effectiveness, team-based collaborative care and global healthcare challenges.

Below is a sampling of presentations and discussions from the Forum. For full conference coverage, please visit Clinical-Innovation.com.

‘This time is different’

This is “a heady and hectic time” for healthcare, said Mostashari. “The pace of change only seems to be accelerating,” including changes in the structure of delivery and in how care is paid for.

With all the change in healthcare, including hospital consolidation, patient-centered medical homes, bundled payments and accountable care, “there is a lot of uncertainty about exactly what shape” the healthcare system will take in the future. “Increasingly, the position of the CMIO is at the center, at the fulcrum of translating the transformational work between the C-suite and the patient’s bedside.”

Despite the challenges, Mostashari remains optimistic about the future of healthcare, appreciating that transforming healthcare is a “tall order” and “sometimes it’s hard to feel that this time is going to be different.” However, healthcare has to find a way to deliver higher quality care at lower cost. “We have to.”

This time is different, he said, because “we have tools we never had before.” Plus, the three things that have to change for an ecosystem transformation are, in fact, all changing. Those three essentials are: how care is paid for, how care is delivered and how patients care for themselves. “All three are lining up,” he said. It’s not easy, partly because no one entity controls healthcare. But, “the changes are being brought together in a triple strand for a new DNA for our healthcare system.”

Population health management is “the clearest form” of change in the delivery of care. But, providers have to get the data first. That’s why, he said, quality measures were included in Stage 1 Meaningful Use, so providers could get the data, work on the workflows and get feedback from the data. Those measures “set the foundation for data collection and data use, and improvements and quality within the practice.”  

In the future, providers are going to have to coordinate care through exchange as well as better engage the patient. Although many people said requiring hospitals to get a certain percentage of their patients to use a patient portal isn’t fair, Mostashari said patients want messaging and a portal. Plus, “medicine is all about teaching and engaging.”

He said ONC set the threshold low for  required use of a patient portal but “that will be the foundation for patient engagement.” We can’t achieve lower costs for healthcare without the patient. “Patients are the biggest resource we have and they’re not being used.”
However, Mostahari concluded that “there’s a bright future ahead for healthcare.”

Evidence-based medicine faces ‘challenges’

Evidence-based medicine is currently plagued by several challenges that will impact its future, said Kessler.

The modern age of evidence-based medicine began when Congress added six words to the regulations surrounding new drug approval back in the 1960s, according to Kessler. Those words were that effectiveness had to be demonstrated by “adequate and well-controlled clinical trials.” The ‘s’ on the end of trials meant at least two clinical trials were required.

Today, limitations abound when it comes to clinical trials:

• Methodologies to detect safety issues “still elude us,” he said.  
• Purveyor bias. “Who is doing the trials and who is funding them?”  
• Contamination of literature. Kessler said a review of literature over the past 50 years is flawed because of the bias due to financial interest.  
• Sophistication of discipline. Determining whether the risks of a drug are acceptable is subjective, he said.

Outside of these limitations, Kessler said the No. 1 obstacle to evidence-based medicine is freedom, or the attitude that ‘I want access to what I want access to when I want it.’ “This is the message coming from Congress.” Researchers publishing negative reports find themselves on the hot seat when their efforts are viewed as a means to restrict access. For example, the researchers who studied whether diet drugs increase the rate of stroke were deposed by drug companies for days, Kessler said.

The last 50 years of research have brought us to our current point, he said. “How are the tools you have going to take us to the next stage? They’re only as good as the evidence that we have and we know.”

Feedback is ‘missing link’ in evidence-based medicine cycle

While changes to the overall U.S. healthcare system and payment models are inevitable, a key component to these changes is communicating proper goals and expectations to providers and patients, said Carolyn M. Clancy, MD, director of the Agency for Healthcare Research and Quality (AHRQ).

Healthcare reform, including payment reform, has already begun. “We are slowly, clumsily, awkwardly, but step-by-step making our way through payment reforms,” she said. “We are getting to a place for quality and results, as opposed to how much stuff we do. But the transitional path won’t be that smooth.”

In this new environment, Clancy questioned: How is evidence integrated in? How has the nature of evidence changed? How do these changes affect providers, payers and patients? How do we make sure that these changes are beneficial?

Evidence is being produced at an extremely rapid rate, but its incorporation into clinical practice happens much more slowly, said Clancy, pointing to the widespread adoption of beta-blockers taking 25 years, after the initial landmark clinical trial. “Transparency efforts don’t offer enough usable data for decisions regarding a specific disease and selection of a treatment option, and remain a maddening challenge,” she added. “We face an underperforming healthcare system and untenable cost forecasts.”

Three contemporary areas of healthcare focus—patient-centered care, population health and advanced modern medicine (such as genomics and nanotechnology)—call for organizing care around the patient rather than around systems of care, which is the focus of AHRQ.

Patient-centeredness may be the most challenging, according to Clancy, because it is difficult to define and measure. “But, it also is likely the most important, because it includes elements of all other domains,” she added.

“We will develop a more intuitive grasp of the power of data over time,” she said. “Young physicians tend to be the first adopters of health IT, and new practice arrangements are increasingly offering more alternatives to physicians entering practice.” Clancy said that someday, health IT will make data collection, reporting and updating of quality measures, easy but “not today.”

Currently, quality assessment is based on the provider and setting, or processes, but in the future, it will be based on patient experience or outcomes. However, assessing and understanding those outcomes will be integral in the changes to the healthcare system, and communication is the “missing link” in this process, according to Clancy.

Decision aid can improve patient engagement

“We need shared decision-making but it’s got to be led by clinicians,” said Margaret Holmes-Rovner, PhD, professor at the Health Services Research Center for Ethics and Humanities in the Life Sciences at Michigan State University College of Human Medicine in East Lansing.
Studies have found that coaching patients to ask questions of their clinicians does not engage patients with the evidence and doesn’t improve the number of questions they ask. Access to medical records improves patients’ knowledge and is “almost universally popular with patients” and “tolerable to physicians, which is really critical,” she said.

Shared decision-making with decision aids, however, has been shown to improve knowledge and improve patients’ comfort with making decisions. “To affect outcomes, we have to have some form of concrete patient information,” even just a simple handout. “Getting patients comfortable through good clinical skills is not enough. They want real evidence.”

When patients use decision aids either before or during their clinician encounter, they have greater satisfaction with their encounter and it improves adherence with the negotiated plans that come about through a healthy debate about the evidence, Holmes-Rovner reported.
Rather than just handing decision aids to patients, “we found we needed to add other pieces to the chain of events to make it viable,” she said. “Presently, it is viable at least for the early adopters. It’s not being done 100 percent of the time by any means but we’re ready to move forward and work with CMIOs to get it routinely implemented.”

What’s missing is leadership, Holmes-Rover said. Make it easy by putting decision aids in the hands of providers and patients. Providers need brief training to understand that this kind of counseling is not going to significantly extend encounters. The information can be “gone through very quickly particularly if the patient had the opportunity to look at the information ahead of time.” Clinicians can then check to see how much the patient understands and move on to negotiate a care plan. This is a way to improve care coordination, she said.

Medical homes bring care to patients, not the reverse

Evidence-based medicine has evolved very quickly in the ambulatory setting, and the transition to the patient-centered medical home model will require technological and cultural changes to proactively bring care to the patient, as opposed to patients approaching providers for care, according to Donald R. Lurye, MD, CEO of Elmhurst Clinic in Elmhurst, Ill.

Traditionally, the ambulatory care environment has been a “cottage industry,” which has been unmeasured and unmonitored, grounded nearly exclusively on trusting relationships, says Lurye.

However, certain ambulatory environments, like Elmhurst Clinic, are being converted into patient-centered medical homes.
In the current healthcare environment of attempting to manage approximately 70,000 unique patients (as Elmhurst does) through evidence-based medicine, “you have to leverage technology.” He spoke to a few of the technologies that his practice employs to better care for this population.

First, the provider uses automated contact technology (Phytel), which has two components: Remind, which reads the EHR and calls or emails patients about appointment notifications resulting in a very low “no-show rate”; and Outreach, which targets two- and three-level preventions with evidence. To integrate Outreach into the practice, 46 Elmhurst Clinic physicians approved care protocols for primary prevention (adult and child wellness visits or annual OB/GYN appointments), secondary prevention (diabetes checkups every three to six months or at least annual lipid profiles) and tertiary prevention (follow up visits on melanoma or bladder cancer).

“Bit by bit, we introduced protocols into the system,” explained Lurye. “While we sleep, the product goes into the EHR to assess which patients are appropriate for an appointment.” Lurye estimated that the practice brings in a couple thousand visits per month that may not have come into the clinic otherwise.

“There is real clinical and economic value in seeking out patients in the community, and not waiting for them to seek you out,” Lurye noted.

In a medical home model, technology organizes evidence and non-physician staff implements a lot of the evidence, he said. “Physicians have way too much coming at them at any one time,” and thus he recommended using physicians to exercise clinical judgment and design interventions that work for each patient.

Can EHRs make docs aware of costs?

EHRs may help physicians understand the costs associated with certain unwarranted practices, said Andrew D. Auerbach, MD, MPH, a professor of medicine at the University of California, San Francisco.

In today’s healthcare environment, there is an increased focus—not just on clinical outcomes—but on increasing value or reducing costs associated with care. EHRs have the potential to make transparent some of the costs of performing certain procedures, said Auerbach.
Physicians first need to be made aware of the cost structure in their settings. The vast majority of costs—70 to 80 percent in healthcare are fixed costs—due to building upkeep, equipment and personnel, which occupy the bulk of costs, while variable salaries and discretionary items (e.g. drugs, materials) represent a small proportion. Fixed costs don’t vary over ranges of output, such as buildings and equipment that is paid for once or salaried personnel who already are factored into the budget. For instance, a PET scanner is “expensive, but it is paid for once. The cost of upkeep, space and the PET technologist don’t vary substantially as more people use it,” he said.

Where do EHRs fit in this spectrum of costs? Over the short term, Auerbach said reducing variably costed items will have limited impact; efforts to reduce utilization of costly items often are offset by compensatory efforts to maintain revenue to subsidize fixed costs; and the goal should focus on reducing fixed and variable costs in tandem.

Speaking to the efforts to target physicians for cost reduction, research has shown that, in general, they are educational in nature and result in a “slight decrease” in utilization patterns—and effects do not differ whether they are IT-based or not, according to Auerbach.
Despite some discouraging data, he concluded that physicians, as part of the healthcare system, “have to expand their recognition that costs are important, and EHRs can help reinforce positive behavior and discourage unwanted behavior.” He added that EHRs can do this because they provide decision support compared with paper models. “They have the flexibility to catch people who veer off [proper decision-making] paths.”

Future of evidence-based medicine is transforming

The concepts of evidence-based medicine are being transformed as the healthcare system is being transformed, said Peter C. Wyer, MD, co-chair of the section on evidence-based healthcare at the New York Academy of Medicine and Columbia University Medical Center in New York City.

The question now is how IT can mediate and enhance the whole framework of evidence-based practice as we move into a new information age, he said.

There is “fragmentation of what we would conveniently call evidence-based medicine.” The turf battles between the different streams of information haven’t helped us, he said. Evidence-based healthcare will embrace all dimensions—policy, guidelines and practice delivered to individual patients.

Evidence-based medicine has tightened the approach of looking at clinical trials, placing the emphasis on patient-important outcomes. There has been suppression of negative trials and use of composite endpoints to obscure outcomes. “Evidence-based medicine is not just clinical trials. It’s a discipline with the best tools we have to protect ourselves from being played like accordions by the pharmaceutical industry.”

There are new approaches to clinical trials these days, such as pragmatic v. explanatory trials, broader inclusion criteria, relaxed monitoring, active treatment to all patients; real-world conditions; and patient-centered outcomes.

To close the gap between research knowledge and clinical practice, “we see the difference between push and pull,” he said. Push is the prevailing notion of how research knowledge gets into practice whereas a process for pulling research knowledge into the care setting is needed. “A pull process would have solved a lot of dissemination and implementation issues. You need both push and pull.”

New pull modalities includes EHRs, administrative databases and practice-based research. “We’re at the dawn of the actual information age. We are at the beginning of an explosion of different kinds of information. I invite people to look at the EHR not just as a source of pushing and decision support aimed at implementing means of research but a powerful means of pulling.”