Increasing Stroke Program Focus on Social Drivers of Health (SDoH)

/in , , , , /by

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:

  1. Towfighi A, Boden-Albala B, Cruz-Flores S, et al. Strategies to Reduce Racial and Ethnic Inequities in Stroke Preparedness, Care, Recovery, and Risk Factor Control: A Scientific Statement From the American Heart Association. Stroke. 2023;54(7):e371-e388. doi:10.1161/STR.0000000000000437
  2. Hyldgård VB, Søgaard R, Valentin JB, Lange T, Damgaard D, Johnsen SP. Is the socioeconomic inequality in stroke prognosis changing over time and does quality of care play a role?. Eur Stroke J. 2023;8(1):351-360. doi:10.1177/23969873221146591
  3. Kapral MK. Kenton Award Lecture-Stroke Disparities Research: Learning From the Past, Planning for the Future. Stroke. 2023;54(2):379-385. doi:10.1161/STROKEAHA.122.039562
  4. Sur NB, Kozberg M, Desvigne-Nickens P, Silversides C, Bushnell C. Improving Stroke Risk Factor Management Focusing on Health Disparities and Knowledge Gaps. Stroke. 2024;55(1):248-258. doi:10.1161/STROKEAHA.122.040449

Stroke Program Research in the Non-Academic Setting

/in , , , /by

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:

  • Participating in new device trials can allow your program to offer novel treatment options. These generally offer funding and require minimal program resources.
  • Joining multicenter trials is a good entry point for programs aiming to conduct clinical research. They often provide funding for additional resources or a fee for each patient enrolled.
  • Membership in a research consortium such as NIH StrokeNET (https://www.nihstrokenet.org/) can serve as a pipeline for small and large stroke clinical trials. 
  • Working internally on a smaller scale by asking researchable questions to promote evidence-based practice can be less resource intensive than managing large clinical trials. These are typically dubbed “investigator-initiated” trials and investigators must seek funding.
What You Will Need

Certain infrastructure and expertise will be needed to successfully engage in clinical research. Some of these include:

  • Clinical leaders and clinical research coordinators with a working knowledge of patient enrollment requirements, informed consent, protocol compliance and reporting requirements.
  • A program leader with experience with clinical research contract provisions and implementation logistics. In the absence of this, a strong relationship with a healthcare administrator is helpful to navigate contracts, budgeting, and billing.
  • A program leader with an understanding of organizational will and/or guidelines associated with conducting clinical research including regulatory compliance and institutional review board (IRB) requirements.
Who Can Help

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. 

  • Seek out a good mentor internally (or externally) – someone with clinical research experience, preferably in the non-academic setting, who can provide insights, advice and connections.
  • Clinical research is foundational to cancer programs. If your organization is conducting cancer research, seek to collaborate and leverage their existing resources (clinical research coordinators, contractual expertise, budgeting, and financial reporting expertise, etc.)
  • Seek out departments that might be conducting patient-centered research internally, i.e., nursing, rehab services, pharmacy, etc. and tap into their experience organizing, resourcing and funding their projects.
  • If your organization has a research department, consult with them to understand their requirements or guidelines for conducting clinical research. Be sure to cover expectations for compliance with applicable regulations, ethical standards, institutional policies, and protection of research participants.
Securing Funding

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. 

  • New device, software or medication trials generally come with funding from the “industry sponsor.” Here, the “devil is in the details!” Be sure to dig deep, understand and negotiate with the trial sponsor to make sure all aspects of the “effort” are covered.
  • Multi-center trials and consortium projects also generally come with funding for participating sites. This funding may be a set fee “per patient enrolled” in the trial. If so, it is important to determine if the program costs are covered and there is sometimes room for negotiation. 
  •  Sources of funding for “investigator-initiated” trials vary. Consult your organization’s Development Office for funding opportunities. They may also know of local philanthropic organizations that fund small projects. Small grants are often available from industry (pharma, software, technology and device companies). Ask your local rep how to access these. Also, check with advocacy organizations or regional networks for available funding.

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.

 

 

Stroke Program Research – From PSC to CSC – Strategies for Success

/in , , , /by

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.  

Stroke Program Research: A Challenge for Even the Biggest and Best

/in , , /by

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?

Read more

Outpatient Stroke Care: The Next Frontier?

/in , /by

National trends continue to predict that healthcare will move from an inpatient model to an outpatient model over the coming years. This shift is already underway and driven by multiple factors. As this shift occurs, those in acute stroke management may be left wondering about the impact on stroke care.

Read more