Improving the outcomes of patients with stroke requires evaluation of new therapeutics, technology, or care models through clinical trials. A network of dedicated sites, such as StrokeNet, enables enrollment of large numbers of patients quickly and efficiently, testing effectiveness of these new treatment options faster. Wake Forest Baptist Health (WFBH) has partnered with 3 sites to develop the Western North Carolina (NC) StrokeNet. Our network includes 4 of the 6 comprehensive stroke centers in NC, the heart of the Stroke Belt: Wake Forest Baptist Health (RCC), Novant Forsyth Medical Center, Novant Presbyterian, and Mission Health. The referral and telestroke outreach of our network includes the Piedmont region and nearly all of NC west of the Piedmont, and part of southern Virginia--over 4 million individuals,16,800 square miles, and over 4,000 stroke patients admitted to these hospitals per year. We serve a diverse socioeconomic and rural catchment area, a population typically under-represented in clinical trials. WFBH has been highly successful with the design and conduct of clinical trials, including phase II, III, and pragmatic trials. WFBH's enrollment in all trials, and the combination of WFBH and Novant enrollment in NINDS sponsored trials has been outstanding. Mission and Novant Presbyterian have each participated in our pragmatic trial of post-acute services (COMPASS), each enrolling over 300 patients, and have success with enrolling in NIH and industry sponsored studies. We have experienced stroke leadership at the RCC, with Dr. Bushnell (neurology) as PI, Dr. Wolfe (vascular neurosurgery), co-PI, and Dr. Duncan (neurology), co-I, as well as a seasoned StrokeNet program manager, Ms. Sylvia Coleman, who will assist the partnering sites with trial selection, startup, and operations to meet the goals of efficiency and enrollment with StrokeNet clinical trials. The RCC team has experience in design and implementation of rehab/recovery and pragmatic trials, and development of community networks that will be beneficial to recruitment, retention, and dissemination of results?an asset to the overall StrokeNet.
Our aims are:
AIM 1 : Successfully implement StrokeNet trials in the Piedmont Triad and Western NC and design new stroke treatment trials.
AIM 2 : Implement a novel approach for recruitment, retention, and ascertainment of outcomes through 2a) existing telemedicine networks for recruitment and ascertainment of outcomes; and 2b) Creating the Western NC Advocacy Committee that will include patient advocates, patients, EMS providers, and clinicians to establish best strategies for community engagement;
AIM 3 : Develop community outreach programs to engage rural and urban communities in our referral region in StrokeNet trials.

Public Health Relevance

Clinical trials for stroke treatments should include patients who represent all communities, including those from urban and rural areas who often lack opportunities to participate. The Western NC StrokeNet is a partnership of 4 large hospitals, led by Wake Forest Baptist Health, who are committed to improving clinical trial success by connecting with communities from the Piedmont to all of western NC. We have the leadership, experience, and dedication to make an impact on the StrokeNet and clinical trials focused on acute stroke treatment, stroke prevention, and stroke rehabilitation and recovery.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Resource-Related Research Projects--Cooperative Agreements (U24)
Project #
5U24NS107235-03
Application #
9980509
Study Section
Special Emphasis Panel (ZNS1)
Program Officer
Vivalda, Joanna
Project Start
2018-08-01
Project End
2023-07-31
Budget Start
2020-08-01
Budget End
2021-07-31
Support Year
3
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Wake Forest University Health Sciences
Department
Neurology
Type
Schools of Medicine
DUNS #
937727907
City
Winston-Salem
State
NC
Country
United States
Zip Code
27157