Implementation Science: A Yardstick for Reform
—By Sarah Mann
Experts recommend that heart patients should leave the hospital with statins, or that seniors and people with respiratory problems should have an annual flu shot.
And yet, these interventions may not be common practice in every office or exam room.
The medical community is looking forward to the day when every patient receives proven interventions and treatments based on sound knowledge. In the meantime, a new and growing field of research is attempting to address the whats, hows, and whys underlying inefficiencies and gaps in clinical delivery. Known as implementation science or health services research, this field seeks to determine how to more thoroughly incorporate proven treatments and interventions into standard practice.
“Implementation science represents a philosophical commitment to bringing the same scientific rigor to health care delivery systems as we bring to biomedical discoveries,” said Mildred Solomon, Ed.D., AAMC senior research director for implementation science. “Implementation science is a natural consequence of the success of our biomedical enterprise. There has been an explosion of new knowledge about interventions that work. We have built so much structure to support biomedical research and discoveries, and now it is time to harvest those discoveries.”
With more than 30 years of experience researching and evaluating quality improvement programs for health care organizations and government agencies, Solomon sees medical schools and teaching hospitals as a natural home for implementation science.
“Academic medical centers are ideally suited to realize the promise of implementation science,” she said. ”What’s transformative is that they have the opportunity to recruit transdisciplinary teams of clinicians, research methodologists, systems engineers, behavioral economists, and others from across the university, professional schools and hospitals to redesign care and then study what does and doesn’t work. In addition, academic medical centers train future care providers and researchers so the next generation will be learning how to carry the knowledge gained through implementation research forward to benefit more patients and communities.”
Implementation science began to take off in the United States about a decade ago, but was established earlier in other nations, such as Canada and the United Kingdom. In 2001, the Institute of Medicine released a report that found the American health care system had poorer outcomes compared with several other countries, despite a sophisticated and costly health care system. The report set the stage for a dialogue on how to funnel as much science as possible into everyday medical practice, Solomon said.
“The research mission of academic medicine includes a social contract to make sure patients and underserved populations benefit from new discoveries,” said Ann Bonham, Ph.D., AAMC chief scientific officer. “Implementation science is helping us fulfill that contract.”
Health leaders are beginning to notice the benefits of implementation science. NIH Director Francis S. Collins, M.D., Ph.D., earlier this year coauthored a paper in the Journal of the American Medical Association calling for a scientific approach to the redesign of the health care system, with a focus on comparative effectiveness research (CER), which compares treatments to determine the most effective intervention, and the use of implementation science to promote the adoption of CER findings.
Additionally, health reform legislation, with its emphasis on improved outcomes and lower costs, called for an independent Patient-Centered Outcomes Research Institute to support CER and implementation research.
In Canada, the field is referred to as knowledge translation. At the Canadian Institute of Health Research, the country’s equivalent of the NIH, knowledge translation is written into the agency’s mandate, and researchers are required to develop a knowledge translation plan as part of every clinically oriented investigation.
“If we are doing research and a good part of the time it is not being incorporated into practice, that is a problem, from the perspective of the researchers, the patients, and the health care system,” said Andreas Laupacis, M.D., M.Sc., executive director of the Li Ka Shing Knowledge Institute at St. Michael’s Hospital in Toronto and a professor at the University of Toronto Faculty of Medicine. The first step in implementation science is determining why there is a gap between effective treatments and standard practice, Laupacis said. There could be monetary or logistical barriers preventing more widespread adoption, or busy clinicians simply may be unaware of new research.
A major challenge for the field is injecting broad knowledge into more narrow health infrastructures like the average doctor’s office, Laupacis said. For instance, low breast cancer screening rates could be the result of access in one area and poor education in another, so researchers might need to develop different interventions that address local causes.
“If you discover the cystic fibrosis gene, it is the same gene whether it is discovered in Toronto, Boston, Philadelphia, or Singapore, so the research is instantly generalizable,” Laupacis said.
The Veterans Health Administration was one of the early adopters of implementation science in the United States In 1998, officials in the Veterans Affairs Health Services Research and Development Service noticed that the effective treatments they were discovering were simply not reaching the patient. In response, they developed the Quality Enhancement Research Initiative (QUERI) to study ways to incorporate health interventions into routine care. QUERI now has nine centers across the country, each focusing on a different disease or injury common to veterans, such as heart disease or spinal cord injury.
“We are figuring out how to effectively manage people with chronic diseases, and that is an ongoing process that involves lots of decisions and information,” said QUERI Director David Atkins, M.D., M.P.H. “It involves whether patients take medications, what advice doctors give, and how nurses help coordinate care, so implementing things that are more complicated is a challenge that implementation research addresses.”
The Diabetes Mellitus (DM) QUERI center focuses on reducing preventable complications, such as vision loss and kidney disease, through better management of cardiovascular risk factors and improved self-management. One DM-QUERI project uses a peer-support group to help patients monitor their conditions. Participants are matched by age with a partner, learn how to set diet and exercise goals, and are then encouraged to have weekly discussions with their partner. At the end of a six-month trial, the participants showed improved insulin levels versus a control group.
The NIH began to take on implementation science more systematically in 2002. The National Institute of Mental Health (NIMH) was one of the agency’s leaders in the effort. David Chambers, D.Phil., associate director of dissemination and implementation research at NIMH, said NIMH began by developing a common framework to guide implementation research across all institutes. “Institutes often have their own missions, so we had to find local experts within the different institutes who were interested in contributing to this overall vision,” he said. “When I came to NIH in 2001, it became clear that no matter what clinical area the institute was focusing on, the problems of trying to get interventions taken up were quite similar.”
Implementation science remains a small part of NIH’s overall portfolio, but it is growing, Chambers said. In NIMH alone, funding for implementation and dissemination research was about $40.5 million in fiscal 2009. Currently, an estimated 11 institutes at the agency are funding some form of implementation research.
For example, NIH’s John E. Fogarty International Center for Advanced Study in the Health Sciences is investing in implementation science to help researchers determine the most effective way to implement known efficacious interventions in global health settings.
“People want to know if these programs work, and we can look to implementation research to tell us what strategies are working and why,” said Sejal Mistry, M.H.A., M.A., a policy analyst at Fogarty. “All research is such a large investment, and people want to see that their dollars are leading to results.”