As stroke program leadership ponder taking a Primary Stroke Center (PSC) to Comprehensive Stroke Center (CSC) status, one of the more common challenges is how to scale a stroke research program to meet the research standard. This is particularly challenging at non-academic centers, although academic centers often still struggle with research program sustainability. Today, we offer suggestions for scaling and sustaining a stroke research program and successfully navigate CSC certification.
The first tip for success is to consider the necessary administrative management of research that is required to sustain a research program. Many clinical leaders assume that having a few passionate clinicians who are skilled in research is enough to sustain research protocols. However, administrative support in the form of research coordinators and administrative assistance is critical for navigating Institutional Review Board (IRB) approval and protocol management. Additionally, a strong relationship with a healthcare administrator is helpful to navigate budgeting, contracts, and billing. Research budgets are often structured differently than departmental budgets. Most funded research protocols require a thorough budget analysis and some negotiation to ensure the project is budget neutral or even beneficial for the program.
A second tip for success is to carefully monitor and manage enrollment in approved stroke research. Most funded trials will close an enrollment site if screening and enrollment is lower than expected. This is understandable as it is costly for the study to maintain a site that is under-performing. Often, identification of patients and successful enrollment in a study is team effort. Screening may be dependent on the awareness and investment of multiple caregivers and teams of individuals (e.g., emergency department, stroke team, interventional neurology for example). All should be aware of the research protocol, the importance of research to the stroke program, and who to contact if they identify a patient who might be eligible for enrollment. This is particularly important if the research protocol impacts patients during the first minutes and hours of a stroke, where care and treatment is time dependent. Communication of the research protocol and site performance is an ongoing process that must be incorporated into the ongoing work of the stroke program.
In conclusion, moving a program from PSC to CSC status will require close attention to building a sustainable and scalable research program. We encourage program leadership to think broadly to support their clinicians who are passionate about conducting stroke research. When executed well, both the program and patients benefit.
Finally, a successful and sustainable stroke research program understands the critical importance of research compliance. In our experience, most stroke programs lack expertise in research compliance and must partner with individuals or departments of research to ensure all documentation and research regulatory standards are strictly followed. While some programs will have departments of research with whom they can consult, others may have to seek this expertise outside of their organization. This is particularly true for non-academic organizations. Failure to meet regulatory requirements can result in the study at your site being stopped early. This can affect your program credibility for future research opportunities that may offer benefit to your patients.