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Researchers Are the Tail; the Health System Is the Dog

May 14, 2017
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Lessons learned from NIH Collaboratory’s pragmatic clinical trials
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One of the Top Tech Trend stories I wrote this year dealt with efforts to bridge the gap between research and clinical care to make the concept of a learning health system a reality. Last Friday researchers at the NIH Collaboratory Coordinating Center described some lessons learned from investigators involved in its pragmatic clinical trials.

Eric Larson, M.D., M.P.H., is executive director and senior investigator in the Kaiser Permanente Washington Health Research Institute and co-principal investigator of the NIH Collaboratory Coordinating Center, which is overseeing nine pragmatic clinical trials involving hospitals, community health centers, integrated delivery systems, nursing homes and acute and specialty care facilities.

Larson said pragmatic is the key word because these trials are practical. The researchers are embedded in healthcare systems and they seek to engage everyday patients.  “They have chosen questions relevant to decision making by patients and providers,” he said. This is the genesis of the learning health system, he argued. As researchers bring their hypotheses to the health system, providers can ask questions that influence the research and it creates a virtuous cycle that ends ultimately with dissemination of evidence-based improvements. Evidence informs practice and practice informs evidence.

An example of a pragmatic clinical trial is LIRE (Lumbar Imaging with Reporting of Epidemiology) run out of the University of Washington. The LIRE study is testing the effectiveness of a simple and inexpensive intervention: inserting epidemiologic benchmarks into lumbar spine imaging reports. The goal of the trial is to reduce subsequent tests and treatments, opioid prescriptions, spinal injections, or surgery.

Leah Tuzzio, M.P.H., a research associate at Kaiser Permanente Washington Health Research Institute, described some of the lessons learned after interviewing some of the principal investigators:

• Some lessons come with their own metaphors. In describing the work you have to do to build relationships with clinicians, some investigators said, “You need to date before you get engaged.” You must collaborate early and often with providers to set expectations about working together.

• The problem has to be one that the researcher and health system find important to resolve. Planning for sustainability from the beginning lays the foundation for spreading changes.

 • Researchers should build on relationships to understand the perspectives of various partners and make sure the intervention is in alignment with those priorities.

• Another investigator was quoted as saying there can be incredible delay and waste if people don’t trust each other. It’s inevitable that there will be challenges even if you assume the best intentions, he said.

• Unlike a randomized controlled trial, pragmatic trials use an iterative process and include a lot of refinements, so documenting the changes and lessons learned so they can be replicated is important.

• Some researchers have a “tail wagging the dog” problem, one investigator said.  “We need to remember that we are the tail and the health system is the dog.”

In that earlier Tech Trend article, Sarah Greene, executive director of the nonprofit Health Care Systems Research Network, reminded me that creating a seamless interplay between research and care delivery is difficult to pull off. There are operational, technical and financial issues to work through. “Culture is a huge consideration in a couple of different ways. It is not in the day-to-day job description of front-line practitioners to be thinking about research,” she said. “So the researchers have to understand the priorities, languages and norms that drive care delivery. It is incumbent on the researchers to do that work rather than expecting the operational people to just throw open the doors. That is a paradigm shift for a lot of people.”

Larson said you can’t expect pragmatic trials to be effective without the engagement of clinicians, but it is a challenge, because they are so busy. “They can be enthusiastic about an idea, but still not have a lot of extra time or energy to participate,” he said. If you engage them as much as possible in devising and planning of the question, you have a much better chance of getting a trial done.”

He closed his presentation with an aphorism: Innovation is not enough; we must focus on what happens afterward. “That is a mantra we should be driven by,” he said. “What is research going to do to make a difference?”