The 2025 International Stroke Conference (ISC) showcased new science and global best practices in stroke care. While several late-breaking trials showed no benefit, such findings still advance science and may already influence patient outcomes and practice. Here, we summarize key trials to help you review published data or track upcoming publications.
We are well into 2025 and deep into winter in the Northern Hemisphere. In the spirit of a year in review, we thought it might be helpful to overview the key Clinical Practice Guidelines and Scientific Statements from 2024. Did you miss any of these publications?
In 2020, we published a blog acknowledging the growing understanding of the impact of race and structural inequities on those who suffer stroke and the healthcare systems who care for them. Over the past 4 years, we’ve witnessed a significant growth in research, publications, and presentations focused on this topic. In 2023, The Joint Commission (TJC) added 6 elements of performance to its hospital accreditation standards to address healthcare disparities. https://www.jointcommission.org/-/media/tjc/documents/standards/r3-reports/r3_disparities_july2022-6-20-2022.pdf. The Centers for Medicare and Medicaid Services (CMS) is increasingly collecting more data to advance health equity and, in 2024, will require reporting of two mandatory measures in the Hospital Inpatient Quality Reporting Program to analyze resource use in 5 domains of SDOH. https://www.cms.gov/priorities/health-equity/minority-health/equity-programs/framework. However, it remains unclear how this growing body of research will impact stroke programs and stroke certification standards moving forward.
While efforts to address stroke prevention and acute stroke treatment over the past 20 years resulted in reduction in mortality, studies continue to show that white individuals have appreciated the largest reduction in mortality and minority populations experience the smallest reduction.1 While efforts are underway globally to address structural inequality, studies suggest that efforts over the past decade have failed to close the gap.2 Thought leaders in the area suggest significant efforts are needed to understand the causes of inequity within and outside of healthcare so they can be addressed.3 As certified stroke centers play a key role in the stroke system of care, stroke leaders should be aware of the efforts underway to address structural inequities and determine their role in advancing this work, with or without certification standards prompting them to do so. We’ve identified 3 key publications that address inequities at the micro, meso and macro level of stroke care delivery that may help programs focus their efforts on this space.
The American Heart/Stroke Association recently published a scientific statement on strategies to reduce racial and ethnic inequities in stroke preparedness, care, recovery and risk factor control.1 https://www.ahajournals.org/doi/10.1161/STR.0000000000000437. In addition to outlining the current state of the science, the statement provides a roadmap for health systems to address inequity through actions aimed to improve access to care, decrease barriers to medication adherence and improve care coordination and health education. The statement also describes concrete steps stroke centers and providers may take throughout the continuum of care to identify and decrease inequity.
Finally, Sur et al4 published a comprehensive review on stroke risk factor management through the lens of special groups and populations at risk for health disparities. In addition to discussing common risk factors and addressing how different populations are impacted, the authors also address healthcare access and adherence. They call on clinicians to improve their awareness of disparities related to risk factors, cultural awareness, and evidence-based practice while calling on healthcare systems to improve access to care, implement programs that provide equitable care and target initiatives to individual populations.
Stroke program leaders would benefit from staying up to date on the evolving publications on healthcare disparities in stroke and integrate strategies to address inequities into their program plans. Of note, after review of the impact of homelessness on inpatient resource use, CMS added three ICD-10 diagnosis codes describing homelessness (Z59.01-sheltered, Z59.02-unsheltered and Z59.00-unspecified) to the list of “CCs” (complications and co-morbidities) used in MS-DRG assignment. https://www.cms.gov/newsroom/fact-sheets/fy-2024-hospital-inpatient-prospective-payment-system-ipps-and-long-term-care-hospital-prospective-0 (scroll down to “Social Determinants of Health Diagnosis (SDOH) Codes”)
This, and other social drivers of health coding, along with the additional information required of hospitals accredited by TJC and the measures required by CMS, may result in additional data available to stroke program leaders to plan and evaluate the stroke program and tailor initiatives to populations most affected.
References:
It might seem like a huge leap for programs operating in non-academic environments to meet the requirement for patient-centered research when seeking a Comprehensive Stroke Center designation. But we’ve seen many programs successfully navigate this challenge. If you find yourself wondering how you’ll maintain clinical research in the non-academic setting, here are some insights that might be helpful:
How to Get Started
Finding opportunities to collaborate:
Certain infrastructure and expertise will be needed to successfully engage in clinical research. Some of these include:
Needed infrastructure to conduct clinical research is often perceived as a barrier to entry in the non-academic setting. However, there are often opportunities to leverage existing organizational resources.
I was clearly a novice when I designed my first research project. I was excited to find a program that wanted to collaborate. But I couldn’t come up with answers to their questions on how to compensate them for the effort required of their stroke coordinators. Fast-forward years later and I found numerous ways to obtain funding for efforts supported by existing staff.
There are significant benefits to offering clinical trial opportunities to patients. Eligible patients receive access to the latest technology, medications, diagnostic techniques at no additional cost. Their access to new treatment occurs in a controlled and monitored environment. And they often receive extra care and follow-up as part of the clinical trial protocol.
Your program benefits from clinical research as well. Clinical trials help boost your team’s knowledge. It keeps your team current in emerging technology, pharmaceuticals, diagnostics and clinical practice. It positions your program as an advocate for patients and can highlight your program nationally through publications and conference posters and presentations.
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.
Comprehensive Stroke Centers (CSCs) certified by The Joint Commission, DNV and ACHC are expected to maintain a program of research generally defined as a study requiring International Review Board (IRB) approval and active enrollment of patients. Who better to accept this responsibility than CSCs with the largest and most acute patient populations?
As mechanical thrombectomy science evolved over the past decade, the neurointerventional (NIR) suite became a critical area for patient care and a focus of regulatory review for stroke certification.When assisting programs in seeking successful certification visits, we’ve noted a few common themes in need of attention in the NIR suite to ensure successful certification tracers.
Having an organized approach to these key areas will help to ensure a smooth certification review for your stroke program and will minimize the risk of findings on your next certification review. Most importantly, it will ensure you are providing the best care for your patients.
And as always, Stroke Challenges has several free resources including blogs on various stroke topics. We also offer both e-books and on-demand webinar training on topics including how to put your best foot forward during your stroke program opening presentation for certification, mastering your data tracer and several helpful on-demand data management presentations and workshops. Visit our website to see all that we offer!
STROKE CHALLENGES, CO-FOUNDERS
Debbie Hill, BS, FAHA
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Staying current with regulatory and stroke certification changes can be daunting for stroke coordinators and other stroke program leaders. Often changes are communicated to others in the organization such as those in the finance or regulatory departments. Without knowing the full impact of changes – or even discerning those related to the stroke program through a myriad of changes – updates to the stroke team may be delayed for weeks, months or even until an adverse impact to the program surface (financial losses, citations during intra-cycle or recertification reviews, etc.)
The purpose of this blog is to summarize the timing of routinely scheduled regulatory changes and provide useful resources that can be used to monitor for release of changes.
In the case of disease-specific certifications like stroke, agencies such as The Joint Commission, DNV-GL and HFAP, communicate directly with the hospital accreditation contact in the regulatory or compliance department. These individuals have access to the accreditation agency’s “extranet site” or “customer portal” where they receive periodic updates from the agency. Sometimes stroke coordinators have access to the extranet site or customer portal and can look for updates and other resources there. Talk to your hospital accreditation contact about access. Also, The Joint Commission, for instance, has a monthly publication called, Joint Commission Perspectives to formally notify hospitals of changes in conditions of participation, eligibility requirements and standards of compliance. DNV-GL sends stroke program Advisory Notices with updates. HFAP has a Blog on its website that may be helpful. Stroke program leaders will need to make sure that these periodic updates are forwarded to them. If e-Alerts/Advisories are offered that provide updates on certification, sign up for them. They are sent to your email daily/weekly/monthly and can help alert you to upcoming changes.
Scheduled updates are generally released once a year and most often give programs six months advance notice to implement the changes. For instance, The Joint Commission releases annual changes in June/July with effective dates at the beginning of the next year. There is also a public comment period that precedes the notice of updates. And we encourage all programs to review the proposed changes and comment. You can obviously only do that if you get the information timely.
The Joint Commission, DNV-GL and HFAP all released new certification manuals for 2019, adding their version of advanced Primary Stroke Centers performing thrombectomies. These are usually available free to already certified programs – through your hospital’s accreditation contact.
CMS has a regular schedule for annual updates outlining payments for hospital stays, emergency room visits and outpatient services for both hospitals and physicians.
Hospital scheduled updates are released for public comment in or around June/July with final regulations publicly announced in late August. Changes take effect at the beginning of Medicare’s fiscal year which is October 1.
Physician fees are updated a little later with changes effective at the beginning of the calendar year, January 1.
You may recall changes that came from CMS in the past such as stroke drip-and-ship payments, the 2-midnight rule, rehabilitation therapy payment caps, hospital 30-day readmission penalties and meaningful EHR use payments. The CMS changes are more complicated to follow. We suggest finding someone in the finance department that monitors these changes and asking them to help you stay abreast of what might impact your stroke program as they dissect the Medicare annual updates – for 2019, all 2,593 pages of it! Knowing the schedule of updates will help you know when to reach out to them.
Lastly subscribe to our blog, Twitter and Facebook! We will use our social media and blog to bring you useful information on managing your program and stroke care in general. Through our eBooks, consultative sessions and weekly postings, we hope to create a community of stroke leaders who help each other stay current!
