Harnessing data to improve patient care

  • Julie J. Novara

The National Patient-Centered Clinical Research Network (PCORnet) is accelerating research that puts the patient front and center.

For many years, patient data stored in the electronic health record (EHR) was used primarily as a memory aid to help doctors remember what they had done for patients in years past. But doctors knew it could do more, if only they had the infrastructure in place. When Congress authorized the creation of the Patient-Centered Research Institute (PCORI) in 2010, one benefit to researchers was the opportunity to use data to pose scientific questions that have the potential to transform patient care.

"We hadn't used data nearly enough to make patient care better," says Tim Carey, MD, Distinguished Professor at the University of North Carolina at Chapel Hill. "PCORI has accelerated that effort by forming data networks and standardizing those networks. It's allowing us to fairly rapidly—and much less expensively—investigate what works and for whom in healthcare because that's ultimately what PCORI's purpose is: to make care better for our patients." Carey, who up until recently was Co-Principal Investigator for the North Carolina Translational and Clinical Sciences (NC TraCS) Institute, is also the site Principal Investigator (PI) for UNC's PCORnet award and co-PI for the Stakeholders, Technology, and Research (STAR) Clinical Research Network to which UNC belongs. He adds that such patient-centered studies ultimately help clinicians provide the right treatment for the right patients at the right time.

Putting data to work

In modern medicine, patients often have multiple options available for treatment, says Mike Kappelman, MD, Professor at UNC-Chapel Hill School of Medicine and Co-Director of the Community and Stakeholder Engagement Program at NC TraCS. The more options exist the more data is needed to understand which treatment is best for which patients. Historically, investigators have created a custom infrastructure—partnerships, databases, and other resources—to support each new study they developed, a process that takes time and money. PCORI established a network called PCORnet to develop a long-lasting infrastructure available to many research studies that Kappelman says would help make patient-centered research more streamlined, efficient, impactful, and cost-effective. PCORnet has since grown into a partnership that includes nine clinical research networks and two health plan research networks.

One of the greatest benefits of the endeavor is the ability to share data on a national scale. Traditionally, each health system maintains its own data warehouse, and every time a patient has a healthcare encounter—such as a trip to a lab, an appointment with a doctor, or an inpatient stay at a hospital—the diagnoses, procedures, prescriptions, and other aspects of the encounter are entered into the patient's EHR. This data is then transferred into a health system's data warehouse where the records can be searched.

But EHR software varies across systems, says Kellie Walters, Assistant Director of Informatics Services at NC TraCS. Even when those systems use the same software, data fields can have different names, and organizational leaders set up different ways to organize the data.

"We often say comparing data from different health systems is like comparing apples to oranges," says Walters. "PCORnet is intended to not only enable data sharing but also to enable harmonized data sharing, that is to allow the data to look similar even when it comes from different systems. With PCORnet, we now have a common data model (CDM), which provides a well-documented guide of how to organize the data."

Each health system can use this model to make its data match certain specifications. For example, different health systems may label Asian ethnicity differently—Asian, Asian American, and the number 401—but the CDM would create one category—02—for Asian. The consistent representation reduces the burden on researchers because their comparisons become more like comparing apples to apples, and they can more easily find the data they need and provide more valid information to improve care.

A model of networking

The Integrated Services for Pain: Interventions to Reduce Pain Effectively (INSPIRE) Project is an example of this network in action. Guided by Paul Chelminski, MD, a Professor of Medicine at UNC-Chapel Hill, the collaborative effort between RTI International, Duke University, UNC-Chapel Hill, and Vanderbilt University studies whether clinicians can help patients become less reliant on opioids to manage chronic pain.

Opioids first became popular as a pain management prescription in the 1990s and have since become overused and misused. According to the Centers for Disease Control, "More than 67,000 people died from drug overdoses in 2018, making it a leading cause of injury-related death in the United States." Chelminski says no single pain medication was ever meant to be the centerpiece for pain management.

To discourage reliance on opioids, investigators of the INSPIRE Project are testing two main non-opioid based pain interventions. One is a shared decision-making model where a physician, pharmacist or other provider discusses treatment options—including the practice of self-care—with patients to help them understand and choose non-opioid based treatment. Chelminski says the shared decision model has been widely embraced as a beneficial patient-centered approach, and his team is hopeful it will benefit patients in this study.

In addition to considering shared decision making, investigators are testing a cognitive behavioral therapy called motivational interviewing (MI), an intervention that happens early in the treatment process and explores patients' willingness to change. While it doesn't provide the tools to change, Chelminski says it helps providers understand if their patients may be willing to embrace a plan for change.

INSPIRE's population-based study is using PCORnet's data infrastructure to supplement a more traditional research project. The clinical data helps them find eligible patients from a variety of geographic regions, age ranges, and ethnicities and provides a source for studying patient outcomes.

Chelminski and his team of researchers worked with NC TraCS, which manages UNC's participation in PCORnet and maintains UNC's PCORnet database, to leverage the PCORnet infrastructure in support of their study.

With PCORnet facilitating, investigators from collaborating institutions can share data despite each institution having its own protocols and administrative processes. Chelminski says for the INSPIRE Project, PCORnet has helped overcome regulatory and administrative obstacles to allow for the flow of data needed to implement the trial.

"It allowed the study to cross institutions and state lines, to play to the strengths of the organizations and institutions involved," Chelminski says.

A vote of confidence

In 2019, Congress voted to reauthorize PCORI, providing 10 more years of funding. Carey says this reauthorization gives PCORI an opportunity to build on the experiences of the institute over the last decade.

Carey notes the institute has reached out to members of the research and advocacy community regarding their priorities, and among the responses were issues such as maternal mortality and better treatments for developmental disabilities. In 2020, COVID-19 has also become a major focus.

"The first decade of PCORI was a lot of proof of principle—to show this type of research is important and can be done—along with developing methods, infrastructure, and initial rounds of projects," says Kappelman. "Reauthorization extends the period for doctors, researchers, and other stakeholders to plan, design, and conduct studies that answer critical questions and then disseminate those learnings back into their communities."

Plans for continued support of PCORnet following the PCORI reauthorization are in development. The reauthorization is a significant step toward giving clinicians and patients better information to make more informed healthcare decisions. Carey says that is good for patients and good for research, and he believes UNC is well-positioned to help PCORI achieve the mission of taking better care of patients for the long-term.

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