Patient-Centered Outcomes Research Institute Funds Project as a Demonstration of PCORnet

A team from ImproveCareNow led by Heather Kaplan, MD, MSCE and Lisa Opipari-Arrigan, PhD will take part in a $2.5 million research project in partnership with the Health eHeart Alliance, to conduct a study using an innovative combination of “N-of-1” study designs and mobile health technology. ImproveCareNow will focus on using a series of N-of-1 studies to understand the effectiveness of the specific carbohydrate diet (SCD) in reducing symptoms in patients with Crohn’s disease and ulcerative colitis (also known as Inflammatory Bowel Disease or IBD) as compared to a liberalized SCD and unrestricted diet.


The study, funded by the Patient-Centered Outcomes Research Institute (PCORI), will also demonstrate the capacity and capabilities of PCORnet, the National Patient-Centered Clinical Research Network, an initiative to enable faster, more efficient, patient-centered clinical research. ImproveCareNow and Health eHeart each represent one of 20 PCORI-funded Patient-Powered Research Networks (PPRNs) participating in this network. By partnering on this project, ImproveCareNow and Health eHeart will leverage individual strengths and infrastructure, and share resources to accelerate and improve patient-centered research.

There are currently 25,000 patients with IBD and their families receiving care at ImproveCareNow centers and for many, discovering the role of diet in the reduction of symptoms of IBD and improvement in health and well-being is a high priority. To date there is limited evidence to support the effectiveness of the SCD compared to other diets in reducing IBD symptoms. Over the course of this project, a series of N-of-1 studies will be used to examine how the SCD affects individual patients. In addition, the research team aims to bring together the results of 100 individual N-of-1 studies to look at the effectiveness of the SCD in the pediatric IBD population.

“By using an N-of-1 approach, we will be able to generate evidence about the effectiveness of diet in managing IBD for the broader patient community and also, provide direct benefit to patients by giving them greater personal certainty about their treatment choices. This has tremendous potential to improve individual health in a way that is truly personalized and patient-centered.” Dr. Heather Kaplan, Principal Investigator

The use of mHealth (mobile health) technologies can make it easier for patients and clinicians to collaborate in conducting N-of-1 studies. Study participants will use Orchestra (mobile app and web portal), a novel mHealth platform developed at Cincinnati Children’s Hospital Medical Center and with support from ImproveCareNow, to collect and share information about their health and well-being, and to track the status of their diet. After completing an N-of-1 study, Orchestra will present personalized results to each patient-clinician team using easy-to-understand graphics.

“Through the use of a novel mHealth technology platform, patients and their clinicians will be able to collaborate in low friction, high efficiency ways to learn about the personal impact of varying diets on their health.  This technology has the potential for broad application across chronic conditions to help patients and their clinicians identify whether a specific treatment works for them.” Dr. Lisa Opipari, Co-Principal Investigator

The funding award from PCORI has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.

PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. For more information about PCORI’s funding, visit

PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of PCORI that aims to improve the nation’s capacity to conduct comparative clinical effectiveness research efficiently by creating a large, highly representative network for conducting clinical outcomes research that directly involves patients in the development and execution of the research. More information is available at





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