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$14 Million Funding Award to Support First Statewide Comprehensive Post-Stroke Treatment Study Based on Wake Forest Baptist Model

The South is known as the Stroke Belt with good reason. Residents of North Carolina are 20 to 40 percent more likely to die of stroke than those living in other parts of the country.

While stroke awareness campaigns educate the public about symptoms and the importance of getting to a hospital quickly, patients and health care providers believe that what happens after stroke patients leave the hospital is just as important as how quickly they arrive.

Today, thanks to a $14 million, five-year award from Patient-Centered Outcomes Research Institute (PCORI) – an independent, non-profit, nongovernmental research funding organization created through the Affordable Care Act and authorized by Congress − stroke patients across North Carolina will help determine whether longer-term, post-stroke care improves their daily function. A secondary goal is to measure and reduce the degree of caregiver stress.

The award is one of five approved by PCORI this afternoon pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.

This award funds the first statewide study of its kind and scope and is being led by principal investigator Pamela W. Duncan, P.T, Ph. D., professor of neurology and senior policy advisor for innovations and transitional outcomes, Wake Forest Baptist Medical Center, co-investigators Cheryl D. Bushnell, M.D., director  of the Wake Forest Baptist Stroke Center and Wayne D. Rosamond, Ph.D., professor of epidemiology, Gillings School of Global Public Health, The University of North Carolina at Chapel Hill. Partnering in the statewide endeavor are 51 hospitals that are part of the North Carolina Stroke Care Collaborative registry, a partnership between the NC Division of Public Health and UNC-Gillings. Also collaborating is faculty from Eastern Carolina University School of Medicine Center for Health Disparities and the Duke University School of Nursing.

The five-year study called COMPASS (COMprehensive Post Acute Stroke Services) will compare patients who receive existing stroke treatment as they are discharged home, to patients who receive comprehensive stroke services once they return home.

“Stroke patients are at very high risk of complications once they leave the hospital. They often have physical deficits that make falls a common occurrence and there are cognitive problems that make easy tasks like filling a weekly pill dispenser impossible,” said Duncan.

COMPASS deploys nurse practitioners or physician assistants to coordinate discharge services and help in the transition from hospital to home. Within seven to14 days of discharge, these providers see the stroke patient at their home or in a clinic and, with the patient’s caregiver, develop an individualized care plan for each patient. A trained community coordinator works with local organizations to ensure that recovering patients and caregivers have the services and support they need. There is regular contact with the patient and caregiver after discharge for at least 90 days.

The comprehensive components of COMPASS were determined based on feedback from stroke survivors who shared their experiences and ideas for improved post discharge stroke care with the study investigators.

Jamie McGlaughon of Jacksonville, N.C., is one of those who provided advice. “When you are taken out of the hospital setting you just take a deep breath and think ‘maybe I can get through this’ and then you hit obstacles. The anxiety is so tremendous you almost regress, McGlaughton explained. “I am delighted to be involved. We are going to save lives—not like a surgeon would—but we are going to save people's ability to have a life.”

In this two-phase study, adult patients admitted to a NC Stroke Care Collaborative hospital, diagnosed with stroke and discharged directly from acute care at the hospital to the home will be eligible to enroll. In Phase I, COMPASS and usual care will be compared. Half of the participating hospitals will be randomly assigned to provide COMPASS to all stroke patients at discharge, while the remaining half will provide usual care. In Phase II, the usual care hospitals will provide COMPASS, while the Phase 1 hospitals will continue to provide comprehensive post-care services. At least 9,000 patients are expected to be reached through this study, which is slated to begin in 2016.

 “At this moment, there are no standards for the quality of stroke care after hospital discharge. We are confident that this large-scale study will allow us to set these standards by showing an improvement in function and quality of life, the outcomes most important to patients,” said Bushnell.

The statewide venture is made possible largely through the efforts of the Justus-Warren Heart Disease and Stroke Prevention Task Force. Since 1995, the Task Force has provided statewide leadership in the prevention and management of heart disease and stroke and has kept the issue of improving the cardiovascular health of North Carolinians in front of state lawmakers. In 2002, Rosamond, from UNC-Gillings, began to develop a network of hospitals that would become the North Carolina Stroke Care Collaborative registry, the hospitals in which the COMPASS intervention will be tested. For the past 12 years, these registry hospitals have been involved in quality improvement efforts in acute care of stroke patients.

“The COMPASS study builds on a successful history of partnership with hospitals in the NC Stroke Care Collaborative Project to create innovative approaches to improving acute stroke care,” said Rosamond. “This is an extraordinary opportunity to extend that and make real advances in the care of stroke patients when they return home.”

Karen McCall, chair of the Stroke Advisory Council of the Justus-Warren Task Force, praised the research collaboration. “We recognize the support we have received from the researchers at Wake Forest Baptist Medical Center, UNC-Gillings and the hospitals that are part of the NC Stroke Care Collaborative, said McCall. “Through the Stroke Advisory Council and the Task Force, we look forward to working with and continuing to support this very valuable resource to North Carolina.”

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 awards, visit the Research and Results page on www.pcori.org.

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