PCORnet Phase 3 to Align With Learning Health System Goals

PCORnet, the national Patient-Centered Clinical Research Network created in December 2013, is gearing up to launch its third phase in 2022. During a recent presentation, Nik Koscielniak, Ph.D., M.P.H., a program officer in research infrastructure at the Patient Centered Outcomes Research Institute (PCORI), described how the PCORnet infrastructure is evolving to support a learning health system model as it moves into Phase Three.

Koscielniak noted that learning health systems have gone from being a highly theoretical concept to the adoption by AHRQ as a way to study change and improve care. While many questions remain in terms of how to build learning health systems, one question involves the infrastructure that's needed to support a scalable and patient-centered learning health system. PCORI has been a funder of infrastructure to support the large-scale comparative clinical effectiveness research that puts the patient at the center of research.

PCORnet's development began in 2013 when PCORI’s board of governors approved funding for an initial group of 29 partner networks, both health system–based Clinical Research Networks (CRNs) and patient-initiated Patient-Powered Research Networks (PPRNs). PCORnet's first phase of development lasted 18 months. A second phase involving 13 CRNs, 20 PPRNs, and two Health Plan Research Networks (HPRNs) operated from the fall of 2015 through late 2018. In its current iteration, PCORnet includes nine CRNs, two HPRNs, and a coordinating center.

Phase One focused on the planning and design period for infrastructure development, Koscielniak said. Phase Two focused on the infrastructure implementation, the capacity building and testing through demonstration projects. “As we wind down our Phase Two of PCORI-funded PCORnet infrastructure at the end of 2021, Phase Three is going to begin in 2022, and really transfers the focus from infrastructure building to infrastructure utilization,” he added.

To demonstrate this evolution and the effort to leverage real-world data to accelerate continuous learning during Phase Two, PCORI collaborated with the National Academy of Medicine to identify five research areas of high priority to health system leaders. PCORI provided funding for health system demonstration projects, one of which focused on predicting patients with preventable high utilization of health services.

PCORnet infrastructure also has supported the use of pragmatic and realistic trial designs to close the research-to-bedside time gap and continuous learning capability during COVID-19 and to rapidly support researchers to embed clinical trial operations into routine clinical care during the pandemic. “PCORnet was well-suited to provide a meaningful contribution to the evolving needs of the COVID-19 pandemic,” Koscielniak said. “PCORnet is being tapped by industry and government to address real-world issues of national importance related to COVID but also many other areas.”

One example is a $5 million study led by the University of California at San Francisco comparing the impacts of COVID-19-related policy decisions in seven different states on people’s health and financial well-being, focusing particularly on racial and ethnic minorities. The team will recruit participants through PCORnet.

Koscielniak said many of the current areas of alignment between learning health system concepts and PCORnet will be accelerated in Phase Three related to PCORI’s national research priority to make progress in learning health systems. PCORI also is conducting a series of convenings to develop strategic opportunities to enhance PCORnet common data model in areas of social determinants of health, patient-reported outcomes and patient-generated health data and opportunities for Medicare data access and linkages.

PCORI’s website notes that Phase 3 will focus on optimizing infrastructure to increase diversity of populations and care settings, efficiently implement research studies addressing PCORI’s Strategic Research Priorities, strengthen patient and stakeholder engagement, and deliver high-fidelity, high-integrity data.

At its September meeting, PCORI’s board of governors will consider CRN funding for Phase 3, which will begin in January 2022.