INTERVIEW

The Architecture of Creating New Knowledge

Genevieve Melton-Meaux, MD, PhD, Center for Learning Health System Sciences

What are learning health system sciences?

There’s really two parts to this question: What is a learning health system (LHS) and from what sciences does an LHS draw? A Learning Health System (LHS) is a virtuous cycle of data, knowledge and practice driven by culture, incentives and leadership. The Institute of Medicine (National Academy of Medicine) describes an LHS as:

A system in which science, informatics, incentives and culture are aligned for continuous improvement and innovation, with best practices seamlessly embedded in the care process, patients and families as active participants in all elements, and new knowledge captured as an integral by-product of the care experience.

The Journal of Learning Health Systems explains it as a constant spiral of learning where data flows into knowledge, knowledge flows into practice, and practice flows into data, repeating again and again, improving and benefiting patients and clinicians along the way.

To answer the second question, the strands of science or research this spiral of learning draws from are multidisciplinary. For example, the programs and units in the Center for Learning Health System Sciences (Center) support patient engagement, implementation science, evidencebased care, evaluation with rapid learnings, infrastructure to engage practices in research, and the use of digital solutions and artificial intelligence in clinical care. Our Center creates unique blends of all these sciences, bringing them together to drive our work. (https://med.umn.edu/clhss).

What are some of the benefits they present?

Bottom line: the patients we serve can positively and more quickly benefit from advances in research. Right now, the average translation gap for new science to reach patients is 17 years. The work we are doing as an LHS dramatically reduces that gap. We want to get to a point where routinely evidence informs health care delivery and health care delivery informs evidence.

What are the biggest challenges of incorporating these ideas into the health care delivery system?

This question really gets at why the Center was created—to provide the resources and support providers need to address a known issue in care delivery with evidence and to study design and the deep connection between health care delivery and researchers to integrate and disseminate evidence and best practices. That said, establishing an LHS is a significant change for all stakeholders, requiring consistent engagement at all levels, promotion by leadership, new logistics in care and research operations, data infrastructure, etc. For health care providers and staff, there is limited bandwidth to engage in new non-clinical activities, especially in the pandemic environment. Another major challenge is finding and training researchers with the skills needed to do this interdisciplinary work, which is why AHRQ (Agency for Healthcare Research and Quality) and PCORI (Patient-Centered Outcomes Research Institute) created funding opportunities to develop the skills of the next generation of LHS researchers. The Minnesota Learning Health System Mentored Career Development Program (MN-LHS) mentors junior faculty interested in gaining these skills.

What are some examples of how they can be incorporated now?

Most recently, MN-LHS Scholar Carolyn Bramante, MD, MPH, led the nation’s first study, a randomized controlled trial, on whether metformin, fluvoxamine and ivermectin, or their combinations could serve as possible treatments to prevent ER visits or hospitalization, as well as Long-COVID. The results of this clinical trial were published in the New England Journal of Medicine.

Our program for Digital Technology Innovation is currently evaluating tools for educating patients and clinicians about dermatology images, including a tool using artificial intelligence to narrow down the differential diagnosis when a patient presents with a skin condition. Together with M Health Fairview, researchers are also partnering with Q-rounds, a health care software, as a service (SaaS) company whose flagship product is an inpatient virtual rounding queue that hospitals use to provide rounding schedule transparency for the patients and care teams. By creating time transparency, everyone knows when to be present for rounds, resulting in a more efficient rounding process for providers by decreasing missed connections from family and care team members and an increase in patient satisfaction. This tool will be piloted at M Health Fairview Masonic Children’s Hospital NICU this fall.

Currently, the Rapid Prospective Evaluation program has six projects underway, ranging in variety from using decision aids to improve utilization of cardiac monitoring and reducing chemotherapy toxicity in older adults with cancer, to utilization of medication therapy management or reduction of opiate overuse/dependency and improved care through sepsis microlearning and expanding specialist telestroke care.

the average translation “...” gap for new science to reach patients is 17 years. “...”

Additionally, we are committed to data and technology democratization for greater good. One example is a collaborative project focused on best practices with traumatic brain injury management and appropriate anticoagulation. The best practice tools and decision support will use an interoperable approach with the FHIR (Fast Health Interoperability Resources) standard so that the tools can be deployed at multiple organizations and multiple vendor systems.

What are the goals of the new Center?

The Center for Learning Health System Sciences (CLHSS) is a collaboration between the University of Minnesota Medical School and the School of Public Health to create value in health delivery systems by establishing an iterative cycle of leveraging existing evidence and gathering new knowledge, applying our work into direct population health action and developing the learning health system field through education.

More specifically, the Center has three goals: • Build a research and education LHS program of distinction. • Decrease the time for science to successfully make it into patient care and into direct population health action. • Seamlessly integrate research, care delivery and continuous improvement to create new knowledge and directly improve care.

What is the Healthcare Innovation Program for Implementation & Evaluation (HI-PIE)?

HI-PIE studies how to translate and use evidence-based practices, interventions and policies effectively in real world settings within health care practices. The program is directed by Timothy Beebe, PhD, interim dean of the School of Public Health and consists of two units: Evidence Synthesis and Rapid Prospective Evaluation (RapidEval).

Evidence Synthesis is a collaboration of CLHSS and the Minnesota Evidence-Based Practice Center (EPC). The unit is co-led by Mary Butler, PhD, MBA, who also co-directs EPC and Josh Rhein, MD, assistant professor in the Division of Infectious Diseases and International Health. Together with their integration lead, Bronwyn Southwell, MD, assistant professor of Anesthesia, the team evaluates topic areas where evidence is emerging or evidence gaps exist to inform and adapt clinical practice (https://med. umn.edu/clhss/hi-pie/evidence-synthesis).

RapidEval features the unique opportunity for providers with an idea for improving care to be supported in generating high quality new evidence on health care practices. The unit focuses on and fosters rapid, iterative learning that builds upon the natural innovation taking place 8 within the health care system. The activities of the RapidEval Unit are aimed at and designed to increase adoption of best practices. RapidEval is led by Michael Usher, MD, a hospitalist and “triagist” managing patient flow and capacity at the M Health Fairview Systems Operations Center (https://med.umn.edu/clhss/hi-pie/rapideval)

How does clinical AI differ from digital technology innovation?

While they are complementary, each plays a different role. Digital Technology Innovation

The Architecture of Creating New Knowledge

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3Perfect Occupancy from cover

The pandemic has helped us see more clearly the true scope of this platform, especially when considering older adults, people with disabilities and individuals with complex heath conditions. On one end, it includes health care institutions, i.e., hospitals, clinics, primary and behavioral health care, and on the other, home and community based services, also referred to as long term services and supports. We have the opportunity to elevate patient-centric care by integrating and creating continuity within this otherwise bifurcated health care platform, especially for people with disabilities, with complex health conditions and older adults in order to attain better health outcomes.

The Health Care Platform

Whether through the Home and Community Based Services from the Minnesota Department of Human Services or by other service delivery providers, the role of long term services and supports has become an integral part of the health care platform in order to maintain daily living for many older adults, people with complex care conditions and many people with disabilities.

In essence, this integrated model, which is an emerging standard for physicians and clinicians as a patient-centric practice, recognizes the necessity of continuity of primary and behavioral health care coordination, when needed, with long term services and supports. Furthermore, they must all work in tandem for the patient’s health, well-being and daily living. It is optimal to assure that scope of practice integrates these key areas of concern that are essential for a patient’s health, well being and daily living. To do so advances a much-needed interoperability of our health care platform.

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Coordinating Care

Ronna Linroth, PhD, worked with adults with disabilities for many years in a variety of settings. Dr. Linroth led the multidisciplinary team that developed a comprehensive rehabilitation clinic that offered coordinated services for adults with childhood onset conditions at Gillette Children’s Specialty Care in St. Paul, MN. Dr. Linroth’s Doctorate is in Applied Management and Decision Sciences with a focus on Leadership and Organizational Change. Dr. Linroth also holds a bachelor’s degree in Occupational Therapy and a master’s degree in Health and Human Services Administration. There is great need to coordinate care and assure the continuity of that care with a patient’s long term services and supports. Dr. Linroth, given her extensive career in health care and working with people with disabilities, offers profound insights on why this integrated model is greatly needed: “The fragmentation of care for adults with disabilities is a primary barrier to supporting patients with disabilities. Unless an individual can see a physician specializing in the coordinated care of individuals with chronic care needs and familiar with the underlying childhood conditions or adultacquired disabling conditions, the individual or family are the interpreters bearing information from the various subspecialists involved in their care.”

Dr. Linroth further elaborates:

“The urologist addresses the urology needs, the orthopedist the orthopedic needs, the neurologist the neurology needs, the cardiologist the cardiology needs, etc., and may not see the review of the long term services and support systems as their area to address. Patients are often seeing a variety of specialists and the general practitioner, usually an internist or family practice physician, may not have the whole picture and may be the last on the list of appointments to make.”

Yet in order for this integrated and practical model to be scalable and sustainable, health care leaders, institutions, the insurance sector and policy makers need to provide for physicians and clinicians to evolve their practices and health care system delivery models in order to provide for the continuity of care coordination with long term services and supports for their patients.

Dr. Linroth speaks to workable ways to make this transition doable:

“Physicians have constraints on their clinical time, and documentation in an electronic record has become standardized in the industry. Currently, documentation formats are designed primarily to capture reimbursement for the majority of patients, but all are customizable to a degree. Building long term services and support reporting into the electronic record for people with disabilities would not only act as a trigger for review of targeted populations, but also provide an efficient format for capturing information needed by medical/rehabilitation team members, patients and payers.”

An integrated model also takes into account that the health and wellbeing of a patient changes with the aging process. Furthermore, specific disabilities, as well as complex health conditions, can also be progressive. There is no doubt that the continuity of primary health care, along with behavioral health care coordination and long term services and supports, need to adapt proscriptively in support of the patient as a result of aging, progressive conditions or both.

Integrating Perfect Occupancy

Minnesota’s health care platform is already arrayed along a continuum of primary care to behavioral care to long term services and supports. So, this is

really about a concept applied from the productivity sciences by the work of my colleague Mr. Tor Dahl, chairman emeritus of the World Confederation of the Productivity Sciences and chairman of Tor Dahl & Associates, who introduced the term perfect occupancy, which is doing the right thing, in the right way, at the right time.

For this integrated health care model, we can apply the concept of perfect occupancy to our health care platform with the following definition:

Put the patient in the driver’s seat for their health, well-being, safety and daily living, in which there is continuity of their primary and behavioral care coordination with their long term services and supports in real-time, all the time.

Dr. Linroth elaborates on the need for primary health care, and when needed, behavioral health care, to take into account the effects of aging, progressive conditions and the integration with long term services and supports as a patient-centric modality.

Pain, changes in functional performance, need for assistive technology devices and services, status of personal care assistance, transportation and housing are areas to consider. Best practices in prevention or minimization of further disability due to overuse syndromes, age-related changes or progression of an underlying condition should guide the care visit and referral to the appropriate services in mental health, physical and occupational therapy, social work and other community supports. Primary care visits may fall to the wayside with the number of appointments the individual has with the rest of their medical team.

Physicians are not usually involved in the county’s assessment process. Perfect Occupancy to page 264

Physician Involvement

According the Minnesota Department of Human Services, the MnCHOICES Assessment uses a person-centered approach to gather information to assist an individual to make decisions about their long term services and supports. It assesses the person’s general health, their ability to take care of routine daily tasks and help the individual receives from family and friends. Once their assessment is complete, they will receive a community plan. The MnChoices Support Plan provides coordinated services and support plans for people who are eligible for publicly funded services. The coordinated services and support plan outlines the decisions the person makes for the services and supports they are eligible to receive.

I asked Dr. Lithgow about the involvement of physicians when they are asked by their patients to be aware of their patients’ MnCHOICES assessment and subsequent support plans. Dr. Lithgow’s thoughts illuminate the value for the patient when the physician becomes involved:

“To my knowledge, physicians are not usually involved in the county’s assessment process, and unless their patient provides assessment results or their personal support plan, the physician would not be aware of either. The MnCHOICES Planning Assessment is meant to be conducted faceto-face with a certified assessor within 20 days of a request and follows a computerized program for information gathering.”

Linroth further states:

“The format is person-centered, giving the individual with disabilities (and older adults) to have their priorities identified. To promote standardization of the process, assessors are required to complete the training requirements, take and pass the MnCAT Setp3-Part 3 Test, as well as maintain their certification by documenting completion of 45 CEUs. Physicians and other paid service providers may be involved by sharing information in writing or by phone before and/or after the assessment if the individual requesting the assessment gives their permission to be involved.” The importance of care coordination with long term services and supports are essential for the patient’s health, well-being and daily living. Elena Rosas, MD, is Medical Director and Adult Psychiatrist at Canvas Health in Oakdale, Minnesota. Dr. Rosas has worked at Canvas Health since 2010. She is board certified with the American Board of Psychiatry and Neurology. Dr. Rosas received her medical degree from the Medical School and Psychiatry Residency at the University of Minnesota. Behavioral health is advancing the integration of dual diagnostic care for clients with co-occurring disorders. At the same time, behavioral health is making gains in care coordination with primary health care in addressing the health and well-being of clients. Dr Rosas elaborates on the awareness and importance of continuity of care coordination with long term services and supports for patients:

“As a psychiatrist who has worked in community mental health for the past 16 years, the awareness of and coordination with a patient’s long

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3Treating Spinal Cord Injuries from cover

and aging of individuals with SCI have created the need for new researchbased information to improve clinical services, community support and a wide variety of outcomes for this population. The relatively low incidence of SCI increases the need for collaboration that involves investigators with the necessary expertise and combines the number of research participants who are available for testing interventions and for achieving other We view disability as an rigorous research aims and approaches. important aspect of diversity.

Hospitalization and rehospitalization

Even though lengths of stay in hospitals (11 days) and acute care units (31 days) have declined recently, these injuries place a significant burden on the health care system, the patients and their families. The financial burden depends on the SCI itself and the age at which it occurs. Estimated lifetime costs of treating the injury range from $1.2 million to $5.1 million in 2019 dollars (these estimates do not include any indirect costs such as losses in wages, fringe benefits and productivity). The average yearly expenses (health care costs and living expenses) and the estimated lifetime costs that are directly attributable to SCI vary greatly based on education, neurological impairment and pre-injury employment history.

Since 2015, about 30% of persons with SCI were rehospitalized one or more times during any given year following injury. Among those rehospitalized, the length of hospital stay averaged about 18 days. Diseases of the genitourinary system are the leading cause of rehospitalization, followed by diseases of the skin. Respiratory, digestive, circulatory and musculoskeletal diseases are also common causes of rehospitalization. Despite improving mortality rates, individuals with SCI continue to be at increased risk of experiencing acute and long-term health complications, including secondary health conditions. Pain is a leading secondary complication after SCI and may significantly affect functional ability and independence, psychological well-being, ability to return to work and quality of life.

SCI Research

To improve the lives of those with SCI and to reduce the overall burden on the health care system from these injuries, the University of Minnesota’s Department of Rehabilitation Medicine led the process of receiving funding from the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR), in partnership with regional health care experts, researchers and consultants who have SCI (lived experience). As a result, we were one of 14 recipients in the U.S. that received $2.2 million over five years to improve patient care, research SCI and broadly share our findings. The research will be done under the auspices of a Minnesota Spinal Cord Injury Center of Excellence; patient care will be managed under the Minnesota Regional Spinal Cord Injury Model System (MN Regional SCIMS). In addition to the NIDILRR grant, our work is partially funded by the University of Minnesota (U of M) Medical School, the U of M Department of Rehabilitation Medicine and Regions Hospital. We also have the support of local and national community and consumer advocacy organizations.

MN Regional SCIMS service activities

The MN Regional SCIMS is a multidisciplinary continuum of care for people with SCI, including the following services: emergency medical, acute care, acute rehabilitation and post-acute care. We will serve individuals with traumatic SCI in Minnesota, North Dakota, South Dakota, Iowa, Wisconsin and Northern Michigan.

Our catchment area serves a wide geographic region of medically underserved areas. Therefore, a model system gives us the opportunity to meet the needs of this population and add diversity to the national SCI database. The system of care —and our research— will be built on a foundation of diversity, equity and inclusion. We welcome and value the voices and perspectives from all individuals with intersecting identities and lived experiences, and we believe those diverse perspectives significantly contribute to excellence in medicine and rehabilitation. We view disability as an important aspect of diversity and are committed to providing equitable access to resources for all employees, students and research participants. To better serve diverse populations, we have assembled a leadership team that is representative of women (65%), people of color (29%) and individuals from other traditionally underrepresented groups, such as those with physical disabilities (18%).

Our core model system activities, including clinical care and research, are focused on improving health and function after SCI and reducing or mitigating secondary health complications. Acute care rehabilitation services and ongoing health maintenance are essential for preventing and managing

these complications. Care will be provided by the world-renowned resources of Courage Kenny Rehabilitation Institute (CKRI), Mayo Clinic, Regions Hospital and the University of Minnesota/M Health Fairview. Collectively, we provide the following services: • Trauma care.

• Inpatient rehabilitation. • Outpatient care. • Health and wellness programs. • Adaptive fitness and activity-based therapy. • Vocational rehabilitation.

• State-of-the-art technology, such as neuromodulation, noninvasive magnetic stimulation, robotic devices and electrical stimulation, to support independent living.

Administration and collaboration

Our Executive Committee, led by myself and Dr. Kimberley Monden (UMN), oversees all project activities, including dissemination and implementation. The committee is comprised of the project directors, directors of clinical care, directors of research and representatives from the Community Engagement Committee, which includes individuals with lived experience, and leaders of SCI community organizations. Each member of this committee serves as a direct link to their site leadership and staff. We will include a rotating presence of individuals with lived experience from our Community Engagement Committee to ensure diverse perspectives from the SCI community. This committee meets quarterly to monitor progress toward project goals. Other committees include the Clinical Care Committee, the Data Management and Analysis Committee and the Research Committee.

Research projects

Our research efforts are aligned with NIDILRR’s long-range plan focus area of health and function, which is aimed at developing an evidence base for interventions that maximize the independence of people with disabilities. Consistent with that agenda, the MN Regional SCIMS’s research activities focus on maintaining health, minimizing hospitalizations and maximizing community living outcomes. Our team collaborates with local, national and international members of the SCI research community in many ways, including serving on society committees, advisory boards, journal editorial boards and various SCI-specific research groups.

One of our initial research projects will focus on identifying an effective pharmacological treatment for severe neuropathic pain in SCI–a primary issue affecting quality of life. Identification of an oral medication that is effective, safe and well tolerated would represent a major improvement in the clinical approach to this kind of neuropathic pain. Part of our research will be to identify and validate predictive biomarkers of neuropathic pain after SCI and response to pharmacological therapy. This work is innovative as it seeks to develop a new, mechanism-based pharmacological intervention for neuropathic pain in SCI.

Treating Spinal Cord Injuries to page 224

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