Devising Pathways Strategies That Maintain the Principles of Personalized Medicine
As clinical pathways are utilized by more institutions to provide standardized, evidence-based care for patients with cancer, these tools have demonstrated a clear ability to reduce costs,1 improve hospital efficiency,2 reduce treatment-related toxicity,3 and improve or maintain clinical outcomes.4,5 These results make clinical pathways an attractive option for many institutions that have struggled to provide quality care while managing costs in the face of rising drug prices.
However, some oncologists worry that pathways may be too confining and do not allow for personalized care to be provided to each patient, especially when incentives are used to encourage physicians to remain on-pathway.6 Others worry that pathways developed by payer organizations might be designed to give greater weight to cost than efficacy.7 This has resulted in tension between health care stakeholders and, in some cases, has made physicians hesitant to adopt pathways.8
For these reasons, many are saying that physicians should take the lead in developing clinical pathways that are based on best practices as supported by the strongest and most recent evidence.7,8 The Dana-Farber Cancer Institute, one of the premiere care facilities in the country, recently began using clinical pathways to improve the quality and efficiency of care provided to patients with cancer. Developers of the pathways were careful to devise strategies that maintained the principles of personalized medicine and did not restrict or confine physician autonomy.
To discuss how they did this and how pathways can be effective in a clinical environment, Journal of Clinical Pathways spoke with David Jackman, MD, Medical Director of Clinical Pathways, and Carole K Dalby, RN, MBA, OCN, Director of Quality Improvement and Dana-Farber Pathways Operations. Ms Dalby leads strategic planning for enhancing the delivery of care at Dana-Farber, and Dr Jackman is an experienced oncologist with a focus in thoracic medicine.
What factors led to the decision to make clinical pathways a part of Dana-Farber’s practices?
CKD: Over the last decade, there has been a vast and welcome explosion in our understanding of cancer biology and strategies to impede cancer growth. Where treatment decisions were once based on a handful of patient and tumor characteristics (eg, histology, stage, line of therapy, performance status), modern cancer care demands consideration of a host of factors, including elements such as complex genomic data and immunohistochemical markers. Pathways can be a way for us to bring personalization and standardization together—to bring each patient all of the tests and drugs and strategies that his or her particular cancer demands, while also making sure that those resources are not incorrectly or needlessly applied when not indicated. A robust pathways platform can be an invaluable decision aid, helping to coalesce and interpret complex results and associate them with the treatments and clinical trials that are most appropriate for a given patient.
DJ: I would echo Carole’s comments. We are not alone in our hope that pathways might improve and streamline cancer care. As various forces and stakeholders look to the creation and implementation of clinical pathways in cancer care, we see an opportunity to leverage our scientific and clinical expertise to create pathways that represent the best and most appropriate care we can and should offer. Furthermore, pathways afford us a way to disseminate expertise throughout our network so that patients who come into contact with any part of the Dana-Farber system can feel assured that they have access to the same expertise, the same information about clinical trial availability, and the same fundamental approach to care.
What are each of your roles in pathway development, implementation, and evaluation?
CKD: My role is the development of our business model, oversight of the project and project managers, contract negotiation, IT integration, marketing and communications, data access, reporting and analytics, implementation, and integration throughout the institute. David and I share many of these responsibilities. Between the two of us, we ensure comprehensive creation of the pathways and facilitate the review and oversight of the program.
DJ: In addition to sharing many of the responsibilities within our pathways program with Carole, one of my primary responsibilities is to work with physicians from each of our disease centers to develop fully customized treatment pathways. It is important to provide clarity and coherence to the process, so that each pathway is a recognizable part of our larger pathways platform. In addition, as with any structural change that will fundamentally affect the way we deliver care, another important role is to gain buy-in. We are asking a lot of our providers—to create these pathways, to use them, to revise them, to learn from them.
Ms Dalby, are there specific goals that you feel pathways play a key role in helping to achieve?
CKD: We have several specific goals we seek to achieve through pathways. Our pathways are a tool by which we can innovate, collaborate, disseminate scientific knowledge, and standardize care delivery where appropriate. Dana-Farber pathways have been created as a means to meet the needs of modern cancer therapy and to prepare our institution for future advances. It is only through safe, effective, and efficient care that we will be able to support the cancer community and enhance innovation in care delivery.
Dr Jackman, from a clinical perspective, what makes pathways a beneficial tool for physicians treating cancer patients?
DJ: Dana-Farber clinical pathways benefit our physicians in several important ways. First, and perhaps most fundamentally, the meetings taking place across our institute to build and adapt our pathways have provoked important discussions around optimal care and outcomes, the latest information in the medical literature, the roles of cost and value, and when and where our approach (and, thus, our pathways) needs to be more granular. Secondly, the clinical pathways platform can be a useful tool itself, giving our providers timely access to regimen-associated citations and information, customized patient education materials, thorough and standardized consents and treatment plans, and information about the availability and eligibility criteria of pertinent clinical trials.
Is there ever a concern that these pathways could be too restrictive, and, if so, what measures have been taken to address this concern?
DJ: This is a key question, and one that we have tried to address on several levels. From a programmatic standpoint, we have stressed that our providers should always—always—provide the patient with whatever treatment approach is the best and most appropriate for the patient in front of them, regardless of whether it is on- or off-pathway. To support that message, we have offered no incentives or disincentives to providers regarding their “on-pathway rate.”
Secondly, we have tried to involve our providers at a grass-roots level in the building of the pathways so that they have a genuine stake in what the pathways look like and so that they can create them in a way that captures an appropriate level of granularity. For example, for patients with metastatic colon cancer who cannot receive oxaliplatin due to concerns about neuropathy, our pathways would branch to an alternative on-pathway option of FOLFIRI (folinic acid [leucovorin calcium], fluorouracil, irinotecan hydrochloride) instead of FOLFOX (folinic acid [leucovorin calcium], fluorouracil, and oxaliplatin [eloxatin]).
There is some concern about the transparency of pathways in terms of the evidence upon which they are built and the processes used to develop them. Can you tell us how your pathways were originally developed and how they are maintained to incorporate updated information?
DJ: There are several aspects to the notion of transparency with regards to the creation of clinical pathways: transparency around who is involved in the process; transparency around any conflicts of interest around that involvement; and transparency around the reasons why specific therapies are included or excluded from the pathways.
Regarding the first two issues, we have been clear about who specifically has been involved in the creation of these pathways: the corresponding disease center experts for each type of cancer. Furthermore, our institution imposes regulations and keeps records of each faculty member’s potential conflicts of interest.
Regarding each treatment choice, we try to provide citations that justify why a given treatment was chosen, wherever and whenever appropriate. Throughout the process, we have also been clear to state the primacy of patient outcomes (efficacy, toxicity) in determining the structure of our pathways. We want to be sensitive to issues of cost, particularly in those situations where two treatments are otherwise considered equivalent in efficacy and toxicity or in situations where there may be a significant out-of-pocket cost to the patient. However, we have not designed our pathways with cost-savings as the primary goal.
You have described your clinical pathways as being an “electronic road map” for the best treatment of different cancer types. Can you describe how the system works and how physicians interact with it?
DJ: Our pathways system is a web-based platform that is powered by Via Oncology, although the actual content has been fully customized by our Dana-Farber physicians. When providers access the system electronically, they have to supply those pieces of information that are relevant to the decision-making process, such as histology, stage, performance status, and line of therapy. In addition, the system captures pertinent tumor genomic information—for example, EGFR status in non-small cell lung cancer or BRAF status in melanoma—to help drive appropriate decision-making. Once a provider navigates through the system, he or she is first presented with pertinent and available clinical trial options. If a trial is not pursued, the system records the reason why and then presents the non-trial, on-pathway options. As noted previously, these may involve several granular choices that might take into account specific toxicities or comorbidities, common patient concerns, or even aspects such as treatment schedule or out-of-pocket patient costs.
Our system is designed to be sufficient and navigable as a stand-alone platform, which is important for any members of our greater network who do not share our electronic medical records (EMR). Nonetheless, we are actively working on interfaces between pathways and key systems. We have created an interface between our pathways platform and our clinical trial management software so that trial availability will be updated within pathways in real time. Furthermore, after a recent switch to a new EMR system in Boston, we are actively developing an interface that will bring pathways directly into that environment.
What incentives, if any, do you use to encourage physicians to adhere to the pathways?
DJ: We have been clear from the onset of our pathways program that we would not offer bonuses or disincentives, financial or otherwise, that are tied to staying “on-pathway.” For each treatment decision, we always want to empower our providers to treat patients with whatever they see as the most appropriate therapy.
However, we do request that our physicians use the pathways system, regardless of what treatment they choose, because using the system allows us to track the actual care we are delivering in order to learn and improve. One of the highlights of the system is the data we are able to obtain from it. We are able to collect data not only about utilization but also about clinical characteristics, frequency of regimen use, clinical trial enrollment, etc. It also allows us to understand when and why physicians decide to go off-pathway; in turn, this can inform subsequent considerations about revising that pathway.
We are incredibly lucky to have the medical staff that we do, dedicated to extraordinary patient care and scientific discovery. If anything, the ultimate incentive that drives their use of pathways isn’t going to be a bonus or a penalty; it’s going to be the opportunity to collect and learn from the data we derive, the chance to improve clinical trial accrual, and the assurance that the platform can serve as a way to disseminate information and expertise to every exam room and infusion unit in our network.
Is there a concern that pathway usage could reduce the role of the patient in decision-making? How can clinical pathways be used in a way that is patient-centered?
CKD: That hasn’t been a concern we have encountered. It is our intention that through these pathways, we are able to provide more patient-centric care. Not only do we incorporate the nuances of an individual’s disease, but we also use the system to highlight clinical trials that would be of interest to the patient. The system itself is able to capture data that indicates patient choice. For example, if a clinical trial is indicated but a patient is not interested, the system captures that. In addition, if a patient chooses to select a more aggressive therapy or a different route of care, our system is able to capture that as well. In the future, we also plan to use the system to collect patient-reported outcomes related to the treatment they are receiving.
DJ: Our intention hasn’t been to reduce the role of the patient (or the physician, for that matter) in treatment decision-making. Rather, created and implemented properly, pathways have the potential to improve patient involvement. First, for a patient, I think there is something empowering about knowing that a panel of disease-specific experts from our institution think that a given treatment is the best that we have to offer. Second, we have tried to create pathways that incorporate some of the fundamental elements, such as performance status, key comorbidities, and toxicities (eg, neuropathy, hair loss), that frequently drive patient choices in specific settings. We’ve also tried to create branching options in selected situations around treatment schedule or out-of-pocket cost and availability. For example, in certain situations, while a targeted oral therapy may be the first choice, our pathways may try to provide guidance over what to do when that therapy is unattainable or infeasible for whatever reason. Having pathways that act on several levels is important for patients.
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