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Clinical Pathways Forum

Oncology Clinical Pathways: The Yale Experience

Authored by

Mishellene McKinney, MHA, RN, OCN

Affiliation

Clinical Pathways and Implementation Science, Roswell Park Comprehensive Cancer Center, Buffalo, NY

Disclosures

Ms McKinney is the director of Clinical Pathways and Implementation Science, Roswell Park Comprehensive Cancer Center.

Citation

J Clin Pathways. 2019;5(5):29-31. doi:10.25270/jcp.2019.06.00085

Founded in 2016, the Clinical Pathways Forum is a community of pathways professionals­—now totaling over 12 institutions from across the United States and Canada—who are utilizing clinical pathways in their practices and institutions to improve cancer care. Forum leader Mishellene McKinney, MHA, RN, OCN, organizes quarterly conference calls with Forum members to facilitate discussion of shared experiences and lessons learned regarding pathway use as clinical pathways become more prevalent and evolve to meet the needs of value-based health care systems and reimbursement models.


The mission of the Clinical Pathways Forum is to facilitate a knowledge exchange for overcoming the challenges of developing, implementing, and measuring clinical pathways to demonstrate the value of standardizing clinical care. The main activity of the Forum is to schedule time quarterly for conference calls to share experiences and lessons learned using clinical pathways. 

The Forum publishes highlights from each of the Forum conference calls that occur throughout the year in the Journal of Clinical Pathways (JCP). This third installment summarizes the speakers and discussion from the May 2019 call. 

Health care professionals from across the continuum of care are encouraged to join in these collaborative discussions. Forum contact information can be found in the online version of this article.

The May 2019 Clinical Pathways Forum Call 

During the May 21, 2019, Forum call, we had the opportunity to hear from Kerin Adelson, MD, chief quality officer and deputy chief medical officer for Yale Cancer Center and Smilow Cancer Hospital. Dr Adelson shared her experiences leading the implementation of Via Pathways at Yale. She explained how they made a business case for pathways and how they engaged physicians, and offered a fresh perspective on how to include the patients’ perspective in clinical pathways.   

The Yale Landscape

Yale’s main National Cancer Institute-designated academic hospital hub is located in New Haven with its other 5 hospital campuses spread across a large geographic area in Connecticut. Over the past decade, 12 care centers (community oncology practices) have been purchased with the vision that no patient would have to drive more than 30 miles to receive high-quality care, as all locations would provide care that is standardized across the network. With over 9500 analytic cases a year across this network, a substantial 25% of trial accrual comes from the community practices. All sites participate in quality improvement work.

Why Clinical Pathways in Oncology?

Dr Adelson described how there has been a movement toward more data-driven science, resulting in a shift in how we deliver care. This shift has come about as more and more oncologists begin to understand that all clinical decisions should be based foremost upon evidence and not individual physican preference. Early studies by Harlan et al1 and groundbreaking initiatives such as ASCO’s Quality Oncology Practice Initiative sought to narrow the gaps between evidence and practice in oncology.2 Dr Adelson explained that over 85% of failures that happen in care delivery are due to deficiencies in the systems and processes, not in failures of the individuals. She stated: 

“If we eliminate unnecessary variation, we will have fewer errors, which will improve outcomes. And we know from Toyota and Lean Six Sigma that it also saves money. When you do things the same over and over, it provides opportunities for streamlining our systems and improving outcomes. It was these two movements in health care, evidence-based medicine and quality improvement, that led to the development of clinical pathways in oncology.”

Dr Adelson reviewed the difference between guidelines and pathways, explaining that guidelines can be quite broad and may not be narrow enough to standardize care. From guidelines, experts can refine options into pathways, which are built on a hierarchy of efficacy, toxicity, and cost. In cases where treatment efficacy and toxicity are equal, cost is then considered. 

In presenting the value of pathways to the doctors at Yale, Dr Adelson had to address the frequent criticism that pathways are “cookbook medicine” that take away individual physician decision making. To do that, she had to show how pathways have actually improved patient outcomes: “There have been US Oncology studies that show equal survival and lower cost with patients who are treated on clinical pathways.3 From Dana Farber, they looked at lung cancer pathways and showed that survival was the same but that they saved about $15k per patient annually.”4

Building the Business Case for Pathways

Dr Adelson was brought to Yale in 2014; they wanted someone who had experience implementing pathways. At the time, there were only a few physicians in the country who actually had pathway implementation experience. 

When I got to Yale, I thought we’d hit the ground running; I’d start building consensus, we’d go forward, and in a year or two, we’d have pathways. But it turned out that there had been no money budgeted for pathways. At the time, the business case was challenging. We had no value-based payment programs, favorable fee-for-service contracts, and a healthy drug margin, partially supported by the 340 B program. As at cancer centers across the country, oncology revenue supported less profitable but essential programs across the nonprofit health system.” 

In summary, not only was there no business case for spending money on pathways, but Yale faced potential loss in critical revenue if they implemented pathways.  

Enter the Oncology Care Model

In 2015, Yale applied to participate in the Oncology Care Model, which would provide a new revenue stream to support investing in clinical pathways. At the time, there were two main pathway products on the market. After reviewing the two products, Yale liked that Via took into account very specific patient scenarios. For example, if a patient had high cardiac risk, the physician could choose a non-anthracycline based regimen. Because Via gave the ability to be on pathway for different patient scenarios and the ability to integrate clinical trials, Yale elected to use it.

Engaging Physicians

Dr Adelson said she used a “moral imperative” to engage the doctors. By participating in Via, Yale would be standardizing and ensuring evidence-based treatment across their large network and could also promote accrual to clinical trials. The oncologists saw the value in being able to increase accrual across the network. As the chief quality officer, Dr Adelson was pleased, as she would now have the ability to track and report on treatment patterns through pathways, which was laborious, if not impossible, to do by using data from the electronic medical record (EMR). 

Guiding Principles of the Implementation 

The implementation was guided by several key principles (Figure 1). First, a representative from each disease team was asked to sign up for disease committees, so that they would understand and have investment in the pathway content. 

f1

In addition, Dr Adelson had already done a considerable amount of work to require structured staging in EPIC, Yale’s EMR, but then she discovered that staging data did not flow directly into Via. In this age of burnout where doctors are counting clicks, Dr Adelson said she could not ask them to duplicate staging documentation in Via and EPIC, so the staging requirement in EPIC was turned off. 

Another guiding principle was not to require the doctors to take action on each patient on the clinic list. Yale chose to only require pathway entries for new starts and changes in treatment because the doctors voiced there was no added value in requiring pathway documentation for patients continuing on the same treatment. The physicians were assured that trials would be the first choice whenever applicable and that the system would send an email to the research coordinator who runs that trial.

Yale implemented a hard stop at the pharmacist level to ensure that every patient whose disease had a pathway was navigated. Oncologic therapy would not be administered if the physician did not navigate. While it was not required to be “on pathway,” it was required to use the pathway. Yale achieved a utilization rate of over 94% navigating for all new chemotherapy starts. This requires a significant effort from a dedicated pharmacist who checks to see if each patient has been navigated in Via. If a patient has not been navigated, the pharmacist sends an email to the doctor telling him or her that they need to complete the navigation before treatment can be initiated. 

Finally, Dr Adelson had an extensive communication and training campaign that spanned a 6-month period. She performed multiple road shows for faculty, sent an array of emails, and made announcements in all internal publications. Physician engagement was increased by having physician champions from each disease team and community practice, and these representatives reviewed pathway content. Motivated doctors were also given access to a “sandbox,” an online system where they could use the pathways in a way that mimicked the production environment.    

Via came on site for training for 8 days at the beginning of the pathway launch in the fall of 2017. At the completion of training, all providers were expected to use the program. Training was mandated, and multiple live sessions were performed. For the few providers who did not attend the live training, recorded training videos were made available. Hands-on assistance from pharmacist superusers was provided during clinic hours to ensure that the users felt supported.  

Ongoing communication after going live with Via included reporting pathway usage patterns to physicians, leadership, and disease committees. Doctors get a report every month on their Via on-/off-pathway rate. While being “on pathway” is not a requirement, the reason for going off pathway must be documented. The on-pathway rate has increased from the 70th percentile in the early stages of implementation to being consistently in the 80th percentile today. Dr Adelson attributes this partly to improvements in the pathways themselves but also because the doctors are participating in the pathway development committees, which has created more buy-in. 

Lessons Learned

Dr Adelson said the build to integrate Via with EPIC was a significant effort and took more time than anticipated. To add a further layer of complexity, the clinical trial placement in Via is manual, time-consuming, and requires ongoing maintenance. 

After the pathways went live, Dr Adelson wanted to re-engage the doctors in evaluating the pathways. Doctors would receive a quality bonus for reviewing six off-pathway navigations of their colleagues and answering key questions for each off-pathway decision: (1) was the reason adequately documented? (2) do you agree with the decision? (3) was the off-pathway choice guideline adherent? (4) for late-line therapy beyond pathway options, were goals of care addressed? and (5) if the pathway was inadequate, do we need to provide feedback on content to Via? 

A Patient-Centered Vision for the Future of Pathways

Closing her presentation, Dr Adelson posed this question to the forum: “If you think about the hierarchy of efficacy, toxicity, and cost, I want to ask you the question of what is missing from the hierarchy of priorities? What is entirely unrepresented in the pathway is the patient’s perspective.” Patients care most about things like: Will I feel sick? Will I be able to work? Will I be able to pay my rent? Will this treatment cure my cancer? We don’t do a good job of explaining the actual burden of treatment to patients.

Patients define quality and value differently than providers do. Patients want care aligned with personal values, they want to be treated with respect, communicated with in a way they understand, and they want choices. ASCO developed 15 criteria for high-quality oncology pathways, recommending that pathways should be patient-focused and should account for patient differences and preferences.5 Dr Adelson said there is no product on the market that is adequately meeting these needs. 

Dr Adelson thinks she may have the answer to addressing the gap in patient-focused pathways. She has obtained funding from Genentech to develop MyPATHway, a prototype that is a clinical pathway on the physician-facing side but is a shared decision-making tool on the patient side. Her vision is for the patient to be able to log in, to review different evidence-based treatments, and then to be able to see the treatment burden, expected toxicity, costs, and potential financial toxicity, so that, ultimately, patients can use pathway inputs to make decisions that are most aligned with their values.  

References

1. Harlan LC, Greene AL, Clegg LX, Mooney M, Stevens JL, Brown ML. Insurance status and the use of guideline therapy in the treatment of selected cancers. J Clin Oncol. 2005;23(36):9079-9088. doi:10.1200/JCO.2004.00.1297

2. Neuss MN, Desch CE, McNiff KK, et al. A process for measuring the quality of cancer care: the Quality Oncology Practice Initiative. J Clin Oncol. 2005;23(25): 6233-6239. doi:10.1200/JCO.2005.05.948

3. Neubauer MA, Hoverman JR, Kolodziej M, et al. Cost effectiveness of evidence-based treatment guidelines for the treatment of non-small-cell lung cancer in the community setting. J Oncol Pract. 2010;6(1):12-18. doi:10.1200/JOP.091058

4. Jackman DM, Zhang Z, Dalby C, et al. Cost and survival analysis before and after implementation of Dana-Farber clinical pathways for patients with stage IV non-small-cell lung cancer. J Oncol Pract. 2017;13(4):e346-e352. doi:10.1200/JOP.2017.021741

5. Zon RT, Edge SB, Page RD, et al. American Society of Clinical Oncology criteria for high-quality clinical pathways in oncology. J Oncol Pract. 2017;13(3):207-210. doi:10.1200/JOP.2016.019836

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