Care Paths and Oncology Outlook at Cleveland Clinic’s Taussig Cancer Institute

Clinical pathways have been a reliable tool for standardizing the cancer care process, particularly important in light of the transition from fee-for-service to value-based care across the health care continuum. Within the past 5 years, there has been substantial growth in the utilization of oncology clinical pathways by both providers and payers. The American Society of Clinical Oncology (ASCO) State of Cancer Care in America 2017 report documented a 42% increase from 2014 to 2016 in practices reporting compliance with a pathway program.^1,2 Furthermore, commercial payers have partnered with pathway vendors and oncology providers to implement oncology pathways as a method of reducing variation, controlling costs, and diminishing the complexities of prior authorization.

Even as clinical pathways have advanced in recent years, the optimal design and implementation of pathways is still evolving. According to the ASCO State of Cancer Care in America 2018, there are 12,423 US-based oncologists in the United States based in a variety of cancer centers, all of which are different in regard to location, infrastructure, size, setting, resources, programs, staff, and leadership.³ Thus, it is important to advance the growing knowledge and improve the use of clinical pathways through communication with leading cancer care institutions who have documented success developing and deploying their own pathways.

This article is the second installment in the Journal of Clinical Pathways “Cancer Center Spotlight” series, which provides readers with an inside look at clinical pathways programs at top cancer institutes within the United States. In this series, we profile cancer center clinical pathway teams and leaders to understand their pathways programs; their specific reasons for using clinical pathways; how their infrastructure and staff support pathways use; how the data captured by pathways is utilized for reporting and measuring; and how their pathways are evolving.

This installment focuses on the Taussig Cancer Institute at Cleveland Clinic, Cleveland, OH. Journal of Clinical Pathways staff traveled to their facility to speak with an array of important individuals familiar with and integral to pathway development, maintenance, and outcomes measurement. Their leaders and staff provided a comprehensive view of how Taussig Cancer Institute designs, implements, utilizes, and revises their clinical pathways as well as the role their pathways serve in meeting the larger mission of Cleveland Clinic.

Getting to Know the Taussig Cancer Institute
Cleveland Clinic is one of the largest academic medical centers in the state of Ohio and is nationally ranked in 15 adult specialties, nine pediatric specialties, and as the 4^th best hospital in the country by US News and World Report in 2019.⁴ In 2018, Cleveland Clinic saw a total of 7.9 million patient visits, 238,000 admissions, and 220,000 surgical cases. Cleveland Clinic employs over 60,000 caregivers, of which 3953 are physicians and scientists and 16,600 are nurses, as well as 1923 residents and fellows in training and 110 accredited training programs. Patients seek treatment at Cleveland Clinic from all 50 states and 135 countries around the world.⁴

Cleveland Clinic is predominantly housed in 59 buildings stretched across a 170-acre main campus in Cleveland, OH. Additionally, 11 regional hospitals and 19 full-service family health centers are active throughout northeast Ohio. Cleveland Clinic also has locations in Florida, Nevada, Toronto (Canada), and Abu Dhabi (United Arab Emirates).⁴ “We like to say that we are one Cleveland Clinic, no matter where people first see their care,” noted Brian Bolwell, MD, chairman of the Cleveland Clinic Taussig Cancer Institute, Cleveland Clinic Cancer Center.

Dr Bolwell described how the organizational structure of Cleveland Clinic allows for inter-institute collaboration and direct communication with leadership:

“Cleveland Clinic is organized a little differently than most academic medical centers. We are classified into vertically integrated institutes (eg, Heart and Vascular, Cancer, Neurological, etc) and within each institute resides a chairman, which allows for a fairly streamlined chain of command. I have a direct pathway to the CEO of Cleveland Clinic. This works to our advantage because we can be nimbler than many other academic health care organizations with respect to decision-making.”

Cleveland Clinic Cancer Center’s main hub is the 377,000 square foot Taussig Cancer Center building nestled among the main campus Cleveland Clinic, with satellite locations in northern Ohio, Florida, and Abu Dhabi (United Arab Emirates). More than 400 doctors, nurses, and other health care professionals provide comprehensive care in a variety of cancer services, including genetic counseling, patient navigator and support services, medical oncology/hematology, blood and marrow transplant, oncologic surgery, radiation therapy, and palliative and supportive care.

Due to the expansive nature of Cleveland Clinic, the cancer program has the bandwidth and resources to strive for excellence and recognition in a variety of specialties. One focus of the cancer center is on fostering excellence in treating rare cancers, Dr Bolwell explained. Additionally, the cancer center is growing a clonal hematopoiesis of indeterminate prognosis (CHIP) clinic in collaboration with the Heart and Vascular Institute. The new CHIP clinic—first of its kind in Ohio and one of only few in the United States—will screen and monitor patients with clonal hematopoiesis of indeterminate potential: somatic mutations in blood or bone marrow cells that increase the risk of blood cancers and heart disease.

Increasing access to care, which include telemedicine or outreach work in the community, is also a focus of the cancer center. In addition, they are looking for ways to better leverage social media to enhance networking efforts and support better patient care and experiences.

Nonetheless, the most important pillar of care at Cleveland Clinic Cancer Center—as described to us by multiple team members—is the clinical pathways, referred to by the staff as “care paths.” To gain a more complete understanding of the background, necessary processes, and utilization of the care paths, we spoke at length with two integral members of the pathways team: Marc Shapiro, MD, medical oncologist and staff physician specializing in lung and lower gastrointestinal cancers, and Hetty Carraway, MD, hematologist and vice chair of strategy and enterprise development at Taussig Cancer Institute, Cleveland Clinic Cancer Center.

Care Paths at the Taussig Cancer Institute
Taussig Cancer Institute’s care paths originated in 2011 as part of a Cleveland Clinic-wide initiative to provide consistent, high-value care. Inspiration for the care paths stemmed partly from Cleveland Clinic’s expansion outside of the main campus and across the greater Ohio region and into Florida. Taussig Cancer Institute was a leader in developing care paths, though other institutes were involved in designing their own care paths as well, including neurology, internal medicine, and cardiology. “It was certainly not a heavy-handed process. The idea, instead, was to gather all of the department chairs and put their collective ideas together through breakout sessions and detailed discussion regarding patient management. Then, we took the consensus plan back to our separate institutes and within the institutes’ specific programs, then formalized the first care paths for specific disease types,” explained Dr Shapiro.

Currently, Taussig Cancer Institute has 66 completed care paths in adult oncology. Decisions regarding which care paths to design and which qualifying characteristics of a disease warrant a care path are made by a physician committee of approximately 20 individuals in each program and led by one or two “champions.” For example, the lung cancer committee determined the need for two distinct care paths: non-small cell and small cell. Every other disease-classifying characteristic (ie, stage, ALK or EGFR mutation, etc) is included under treatment paths within either of these two care paths. On the other hand, the breast cancer committee designed care paths specific to different subsets of the disease, including non-invasive, metastatic, and locally recurrent, as well as separate care paths for neoadjuvant and adjuvant treatment.

The committees and their champions go through a rigorous process before publication of a care path on Cleveland’s Clinic’s intranet. The original consensus process involves an extensive literature review to ensure evidence-backed treatment is being supported in the care path. Committees are almost always comprised of regional representatives to ensure that recommended care is practical within their workflows.

After multiple iterations, a final draft is designed and forwarded to a secondary review team of approximately 10 individuals – diverse in specialty and uninvolved in the original committee. This team sends back comments and recommendations that are then considered before final dissemination across the cancer center network on the intranet.

Finally, all care paths are updated based on the frequency of newly published data, Food and Drug Administration (FDA) indications, and National Comprehensive Cancer Network (NCCN) guideline updates. At a minimum, care path committees meet annually for review. All practicing physicians in a given program are encouraged to participate in the committee review process, and there is a general sense of staff enthusiasm to be involved. “By and large, our physicians are engaged in this process and want to be identified as somebody that contributes to care decision-making, wherever they are located. It does not matter if they are in the regional location or at the main campus. They are all us. We are all Cleveland Clinic,” Dr Carraway noted.

Dr Shapiro further explained that the structured nature of care provides a sense of comfort and confidence in patients. “They like knowing that when they decide they want to get their treatments in any of our locations in the region or elsewhere, it would be the same treatment provided at the main campus,” he said. “I am able to tell them that their specific doctor was part of the consensus process that determined this treatment regimen.”

“The care paths are used not only at the main campus, but wherever patients enter. That can be in the regional sites, in Florida, or whatever location patients enter the touchpoint into Cleveland Clinic,” Dr Carraway echoed.

Additionally, clinical trials are considered an integral aspect of all care paths across the Cleveland Clinic network. The first line at the top of most care paths frequently says, “Clinical trials are always care-path appropriate.” Integration of a clinical trial will vary according to disease type and is specific per program depending on which clinical trials are open at a given moment. The staff make an effort to discuss all options with patient in regard to standard of care as well as clinical trial options.

Setting a Standard of Multidisciplinary Care
Care paths are designed to reflect the multidisciplinary nature of treatment at Cleveland Clinic. Regardless of disease type, care paths often span across institutes and their respective departments and integrate referrals from specialists across Cleveland Clinic. A care path design process can involve radiologists, pathologists, surgical specialists, pharmacists, and other subspecialties that are housed within other institutes, along with medical oncologists, hematologist oncologists, surgical oncologists, and radiation oncologists. Care paths are “a tool to enable all caregivers to work together and predict what treatment courses other institutes and departments will be providing patients,” Dr Shapiro added.

Dr Carraway commented that “developing a care path requires buy-in from the surgeon, the radiation oncologist, the medical oncologist, etc. Multidisciplinary care within a care path is intentional engagement from all entities of oncology care and sometimes entities outside of oncology.” The idea behind multidisciplinary care, she explained, is to span from preventative care to survivorship and end of life.

Faculty buy-in is an inherent aspect of the care paths, noted Alison Ibsen, the senior director of cancer programming. Ms Ibsen is an integral team member for ensuring the quality of multidisciplinary care across the Cleveland Clinic network. She is responsible for the design and management of all multidisciplinary disease programs. While there are 13 oncology programs housed within Taussig Cancer Institute—each with a medical oncology and surgical leader, along with a radiation oncology and hematology leader in some programs—there are many different programs within other institutes in the Cleveland Clinic network that are responsible for patient care. As senior director of cancer programming, Ms Ibsen is responsible for bringing together the various providers across programs and institutes to optimize care on a patient-by-patient basis. Providers involved in the care of a given patient comprise tumor boards and practice the care paths.

When care paths were initially rolled out to Taussig Cancer Institute, Ms Ibsen noted that “the people who are caring for the patients and diagnosing the patients are the ones who need to build the pathways.” In the event a faculty member is hesitant to agree on a decision made within the care path, the care path is revisited by its respective committee.

“The idea is that the care path is a living, breathing document. While static at a moment in time, it is updated and revisited frequently to make sure that all thoughts and perspectives from the departments and subspecialties involved are considered,” Ms Ibsen added.

Care Paths in the Blood and Marrow Transplant Program
While the cancer center care paths are relatively new, the blood and marrow transplant (BMT) program has been employing care paths since its inception, beginning with “treatment protocols” that have morphed into more advanced “care paths.” Experts in the BMT program are considered pioneers in the development and use of care paths, according to Navneet Majhail, MBBS, MD, MS, director of the BMT program. Dr Majhail went into detail about how his team utilizes and interacts with the care paths; this process example serves as an example of how other teams interact with the care pathways as well.

The BMT team—comprised of 12 doctors—meets every Monday from 5:00 pm to 6:00 pm for a “selection meeting” to discuss treatment plans for every new and existing patient to determine whether they will be treated in concordance with or against the care path for their specific disorders. The transplant team has established selected regimens for different types of transplant – for example, all patients receiving an HLA-identical sibling donor transplant for acute myeloid leukemia will receive the same conditioning regimen, supportive care, and graft-versus-host disease prophylaxis. Within care paths at Taussig Cancer Institute, there are opportunities for dosage adjustment and other adjustments based on specific patient adverse events. The selection meeting is also an opportunity for clinicians to offer new research as worthy of care path consideration.

“For example, some of our doctors may return from the American Society of Hematology (ASH) annual meeting with new research that has the potential to alter our care paths. We will search the available published literature and determine how the data presented at ASH aligns with published data to determine if a care path alteration is warranted,” Dr Majhail detailed.

The BMT program employs nine nurse coordinators who also function as patient navigators. These nurse coordinators are responsible for coordinating patient care as soon as patients enter the program. This use of nurse coordinators spans across other departments.

“I know that in some hospitals offering BMT, there may be 10 different doctors in a given program that will perform 10 different transplant for the same diagnosis. Here are Taussig Cancer Institute, we have submitted ourselves to tireless effort to streamline the care for these patients and remove variability every step of the way,” he explained.

Assessing Care Path Data for “Adherence”
The complexity and multidisciplinary nature of Taussig Cancer Institute’s care paths ultimately led to a need for structured data analysis to measure adherence. As the first care paths began to be utilized across Cleveland Clinic in 2013, Kate Tullio was hired as the manager for cancer health analytics. One of her responsibilities is to determine how to best collect data around care paths and evaluating adherence to care paths across Taussig Cancer Institute. Care path data was originally collected manually from the electronic health record (EHR), with the goals of identifying areas of automation and optimization where possible, which continues today.

Each cancer program has shared with Ms Tullio the metrics that are most important to them to determine care path adherence. More often than not, adherence to the care path reaches far past simple drug adherence; genetic testing, imaging, hydration, and follow-up protocols among other components have been identified as integral adherence touch points for different programs and their respective care paths.

Currently, Ms Tullio and her fellow cancer health analysts pull the available data sets out of Epic—Taussig Cancer Institute’s chosen provider for electronic medical recording—to determine adherence for components such as imaging and drug use. However, she said that “at a tertiary care facility like the Cleveland Clinic, we often have patients who received parts of their care outside the network and parts of their care inside the network.” For cases like these, it can be difficult to automate data collection as issues such as scanned documentation in the EHR from outside facilities are prevalent.

More often than not, Ms Tullio and colleagues find that after pulling reports from Epic and manually sifting through notes on complex patients, there are often legitimate and permissible situations for patients to deviate from a care path, including double primary diagnoses or contraindications. For example, a patient may initially look to be “off care path” for use of a chemotherapy regimen that is not initially recommended. Their analysis might find that the patient had a clinical contraindication to the initially recommended regime (eg, kidney failure), and as a result, the regimen prescribed was appropriate.

Taussig Cancer Institute is in the process of automating care paths in Epic. They are utilizing mapped algorithms to assist in creating decision-making aids within the medical record. But, while Epic provides a space for discreet data elements that need populating, there is no built-in solution for language processing to go through a free-text note and parse out what is needed. Thus, the data analytics team at Taussig Cancer Institute has now taken the initiative to design an automated means of determining adherence from Epic datasets at any given touchpoint.

“We have started to automate care path adherence and compliance. The initial stages are underway of pulling data in an automated fashion, and so much more work will go into this,” said Jacob Lindberg, manager of informatics, reporting, and communications. The result of such a massive data-pulling initiative will be a new data model which, once queried and manipulated, will help display care path adherence.

“This idea of having a systematic way of obtaining and relaying data related to adherence, quality, outcomes, and cost back to our provider teams would be tremendous. It is clearly what we all want, but it is just a bit out of reach at the moment,” commented Ms Ibsen.

Mr Lindberg is a member of a 14-person informatics team under the “continuous improvement” department at Taussig Cancer Institute. Within the department are three operations analysts who are responsible for extracting and scrubbing data from Epic and claims data from payers; four system analysts who engage in traditional programming such as application and website development; two research database analysts who support data gathering for clinical trials; two data architects who will be helping design, extract, and build cancer data assets; two program managers who support the application development in the department, among other tasks; and a communications manager who is involved in project management and other communication projects for the team.

“We have the capabilities to create this systematic approach to measuring care path adherence. We have the desire to do it. We are just trying to find the time and resources to make it happen,” Mr Lindberg explained.

Payer Interfacing
Just as care path adherence analytics are a work-in-progress at Taussig Cancer Institute, innovative payer relationships are in the exploratory stages as well. Taussig Cancer Institute has begun engaging the payers they contract with in the design and use of their care pathways.

“We are getting fairly creative, but there are a lot of things that are in the talking stages at the moment. Hopefully, some of the neat ideas that are being floated around will come to fruition,” Dr Bolwell suggested.

One such example is housed within the breast cancer program. Taussig Cancer Institute clinicians administer radiation therapy to its patients with breast cancer over a 1-week span, while the standard of care elsewhere is often 5 weeks. Dr Bolwell explained that Taussig Cancer Institute has the data to suggest that this 1-week administration schedule leads to decreased costs and improved patient satisfaction, all while maintaining a comparable efficacy to the standard of care. Dr Bolwell and colleagues hope to leverage this data when interfacing with payers to effect change in care in years to come.

Taussig Cancer Institute is also engaged in reducing payer authorization wait times. Payers have up to 14 days to render a decision regarding planned payment for FDA-approved treatments, even for treatment that is widely accepted as standard of care, explained Jason Valent, MD, program director, plasma cell disorders, department of hematology and oncology. For patients with multiple myeloma—especially those with kidney failure—it is imperative that treatment begins as soon as possible. One of Cleveland Clinic’s largest ongoing initiatives is to reduce the time to treatment initiation by obtaining payer authorization in a more timely fashion, Dr Valent explained. As a result, Cleveland Clinic has designated an entire department within Taussig Cancer Institute to reducing authorization wait times. The prior authorization department, which includes pharmacy and financial navigators, is immediately notified when treatment is planned. Once notified, they immediately open the claim in “real time” with the payer. This eliminates any lag time from the Taussig Cancer Institute side of the authorization.

Because many therapies are administered orally, authorization falls under the patients’ prescription coverage portion of their insurance. Taussig Cancer Institute employs three care coordinator nurses who are dedicated to ensuring that prescription orders travel through proper authorization with payers, and then copay assistance programs are brought into the fold when the copays are particularly excessive. Specialty pharmacists within Cleveland Clinic work closely with the full-time pharmacist and care coordinators to ensure that payer authorizations and copay assistance occur within days.

“With all of these resources, I think we are truly giving our patients the best possible chance to receive timely care,” Dr Valent postulated.

The Future of Care at Cleveland Clinic
In terms of future directions for Cleveland Clinic as a whole, the focus will be on continued maintenance and refinement of care paths, further geographic expansion with the United States as well as internationally, and a persistent push to be the world’s leader in patient experience, clinical outcomes, research, and education. Through continued use of care paths, integration of the care paths into the electronic medical record, and refinement of a data synthesis system to track care path adherence, Cleveland Clinic seeks to remain a model for innovative, standardized cancer care among academic medical centers in the country.

References

1. American Society of Clinical Oncology. The state of cancer care in America, 2016: A report by the American Society of Clinical Oncology. J Oncol Pract. 2016;12(4):339-383. doi:10.1200/JOP.2015.010462

2. American Society of Clinical Oncology. The state of cancer care in America, 2017: A report by the American Society of Clinical Oncology. J Oncol Pract. 2017;13(4):e353-e394. doi:10.1200/JOP.2016.020743

3. American Society of Clinical Oncology. The state of oncology practice in America, 2018: Results of the ASCO practice census survey. J Oncol Pract. 2018;14(7):e412-e420. doi:10.1200/JOP.18.00149

4. Cleveland Clinic. Tell our story. clevelandclinic.org website. Accessed May 18, 2020. https://onbrand.clevelandclinic.org/learn-our-story