Cleveland Clinic Awarded More Than $7M From Patient-Centered Outcomes Research Institute to Advance Treatment of MS, Hypertension

Cleveland Clinic has been awarded $7 million from the Patient-Centered Outcomes Research Institute (PCORI) to improve treatment strategies for multiple sclerosis (MS) and hypertension, also known as high blood pressure.

Daniel Ontaneda, M.D., Ph.D., a neurologist at the Mellen Center for Multiple Sclerosis Treatment and Research will lead a $6.7 million project, “Determining the Long-term Effectiveness of Early Intensive Versus Escalation Approaches for Prevention of Disability in Relapsing-remitting Multiple Sclerosis.”

The project will extend the multicenter DELIVER-MS study, a three-year randomized clinical trial comparing two treatment approaches in MS head-to-head: starting with an early highly effective treatment approach, using more potent therapies, or an escalation approach beginning with safer but potentially less effective treatments and escalating as needed.

With funding support from PCORI, the DELIVER-MS study was initiated in 2017 and followed 800 patients with relapsing-remitting MS who started either an early highly effective treatment approach or an escalation approach to assess the effect on brain volume loss on MRI. Now, as enrollees in DELIVER-MS complete their three-year follow-up, the new PCORI funding will extend the study and shift its approach to assess disability outcomes in this same patient population over the course of nine years. Emma Tallantyre BMBS, Ph.D., from the University of Cardiff in Wales, is the co-principal investigator along with Dr. Ontaneda for the long-term extension, which includes both U.S. and U.K. sites.

“Having more than two dozen approved MS treatment options is a huge advantage for doctors and patients, but there are currently no definitive data from randomized controlled trials to guide the choice between early intensive and escalation approaches,” says Dr. Ontaneda. “The funding provided by PCORI to support DELIVER-MS, and the forthcoming extension study, will address this knowledge gap and help inform clinical decision-making moving forward.”

This study is among several PCORI has funded focused on examining the longer-term outcomes of interventions in comparative clinical effectiveness research. The impact of health interventions can take years to appear, but shorter follow-up periods are still the norm for many studies. With long-term follow-up funding, this study has the potential to produce a more comprehensive understanding of treatment approaches for MS.

Anita Misra-Hebert, M.D., MPH, director of Cleveland Clinic’s Healthcare Delivery and Implementation Science Center, will lead a nearly $1 million project, “Implementation of Effective Hypertension Management Approaches: Cleveland Clinic,” which will introduce a comprehensive hypertension management program across the health system’s internal medicine and family medicine practice sites in Northeast Ohio.

“The prevalence of uncontrolled blood pressure remains significant throughout our Northeast Ohio primary care practices at roughly 27% of patients, with only 28% of those following up as requested after a high reading,” Dr. Misra-Hebert said. “This funding will allow us to introduce and evaluate a more proactive program to help address this critical gap by equipping a multidisciplinary care team with the tools and strategies needed to engage patients more effectively.”

Dr. Misra-Hebert’s project will implement findings from a PCORI-funded study showing the comparative clinical effectiveness of different methods to diagnose blood pressure.

Cleveland Clinic is a participant in PCORI’s Health Systems Implementation Initiative (HSII) and was selected for funding for this project through a funding award for PCORI HSII participants to promote evidence-based practice based on findings generated from PCORI-funded research.

Both funding awards have been approved pending completion of business and programmatic reviews by PCORI and issuance of formal award contracts.