Founded in 2016, the Clinical Pathways Forum is a community of pathways professionals—now totaling 15 institutions from across the United States—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.
Stephen B Edge, MD, FACS, FASCO, vice president, System Quality and Outcomes, and professor of surgery at Roswell Park Comprehensive Cancer Center (RP; Buffalo, NY), and professor of surgery at the University at Buffalo spoke at the Forum on December 15, 2020 about the clinical pathways program at RP, with a focus on evaluation and review of care administered off-pathway (“off-pathway adjudication process”).
Key Drivers for Oncology Clinical Pathways Use
RP implemented a pathways program in 2015 to support five key drivers: care quality, clinical research, patient experience, care coordination, and payer relations. RP’s initial pathways program used the Moffitt Cancer Center model and methodology1 to develop multidisciplinary care paths that included seven major cancer types and “cross-cutting” pathways that follow the patient across service lines, such as neutropenic fever and spinal metastases. The original pathways were static reference documents that were accessible from within the electronic health record (EHR) and included clinical trials and drug list pricing for each treatment option. As the program grew, the manual process of maintaining concordance measures and pathway content became unsustainable, and so RP looked for a vendor solution. Ultimately, ClinicalPath by Elsevier (formerly Via Pathways by Via Oncology) was chosen for its clinical trial support and EHR integration features. RP uses Allscripts for its EHR.
RP uses pathways as a tool to document quality of care, assess appropriate and inappropriate variation in care, enable audit and feedback with providers, and to compare care provided across the network at multiple sites. Pathways support research programs at RP by providing clinicians with information about available trials and provide patients with written documentation with individualized information about their cancer type and treatment plan. Care coordination is facilitated by using pathway data to identify individuals with advanced cancer and promote goals of care and hospice use. Finally, RP uses pathways as a pay-for-performance measure with payers to provide benchmarks and data on treatment patterns.
Clinical Trial Management
Trials open at RP are embedded into the pathway and are presented to the provider based upon patient presentation. This helps to increase awareness and accrual, particularly in the community affiliates. It also provides valuable data to support clinical research services. Pathways data is frequently used to assess trial feasibility for prospective trials and to assess performance of individual trials in practice. “We can give them information for how many patients might be available for a trial by looking at how many patients we have treated with a certain disease presentation over the last year,” Dr Edge explained.
Pathways as Tool to Enhance Patient-Provider Goals-of-Care Discussions
Historically, clinical pathways have been focused on drug regimens and were used behind the scenes to assist exclusively in clinical decisions. Dr Edge stated, “One of the hallmarks of our pathways program is that we are trying to use the pathways to reach beyond the treatment decision. RP uses pathways as a key element of patient education. We want these to be as patient-facing as we can…we think it’s important to tell the patients about pathways.” RP developed a graphic for display in the exam rooms that explains how and why pathways are used. The graphic highlights key pathway features, such as how they combine the doctor’s expertise, best standards, clinical trials, and patients’ personal needs to result in the best care for them (Image 1). By positioning pathways in this way for patients, pathways can be used to prompt goals-of-care (GOC) discussions for patients and show them the potential trajectory of their disease and care journey. For example, in patients with metastatic cancer, the pathways algorithm may prompt a discussion on how to enhance quality of life as patients approach end of life. By linking pathway data to the EHR, patients who have had a documented GOC discussion can be identified. 
Dr. Edge and his team are now looking at ways to leverage the pathway to improve the GOC with patient-specific provider prompts to foster these discussions. Dr Edge explained, “We are looking at this as an opportunity to use the pathways to identify people early in their course of metastatic cancer and give the doctor a prompt on the day of clinic that there is no documentation of GOC in the medical record. They can then use their judgement as to whether today is the day to do that.”
Providers are also prompted to respond to the “Surprise Question” for patients who have advanced cancer. A unique feature in the RP pathways program, the Surprise Question asked is, “Would you be surprised if this patient died within the next 12 months?” This thought-provoking question is a tool to remind providers to think about palliative services, counseling, and advanced directives.2 Dr Edge explained that the Surprise Question, which had not been previously well-tested in cancer, is a sensitive method of defining the prognosis in metastatic cancer, as RP demonstrated in a 2020 publication using pathways data.3
Review of Care Using Pathways: What is the Optimal Rate of Pathway Concordance?
Pathways are used to evaluate the actual treatment in relation to the pathway recommendation. The treatment can be on-pathway, on a clinical trial (also considered on-pathway), or off-pathway. Dr Edge emphasized that a treatment being listed within National Comprehensive Cancer Network (NCCN) Guidelines does not necessarily mean that it is “on-pathway.” He says that the value of on-pathway care is to help identify optimal treatment in terms of efficacy and toxicity, and potentially with reduced cost. It also provides decision support, patient assurance that they are getting the best care, and end-of-life decision support.
The widely accepted target rate for concordance to pathways is 80% to 85% (ie, about 15%-20% of choices will or should be appropriately off-pathway to account for individual patient factors). Dr Edge posed the question, “Is there really an optimal rate for being on pathway? I would contend that we don’t really know what the rate should be. Should it be 65%, 75%, 85%, 90%? I would say that any rate that one chooses is arbitrary, because there really is no validation of these rates.” He went on to explain that there are many reasons for variation. The rate may vary based on the cancer type, the patient’s disease status (eg, adjuvant vs metastatic), rate of change of the standards, and other reasons. While pathways aim to cover a majority of best options for patients, knowing when to deviate from the pathway is critical.
RP’s Off-Pathway Adjudication Process
RP reviews every case of off-pathway care. This process allows for correction of discrepancy issues via direct reports from the pathways system. Sometimes providers navigate the system incorrectly and select an off-pathway treatment that was really on-pathway—this happens approximately 3% to 5% of the time. The adjudication process also allows RP to evaluate and validate the reasons for off-pathway care, which is used for feedback to the provider, communication with internal or external stakeholders (eg, payers), and quality management. RP worked with Elsevier to customize the ClinicalPath within RP’s system so that, in addition to the drop-down list for off-pathway care, providers are required to enter in a free-text reason for going off-pathway. A senior nurse-led team then reviews the reasons to determine if the pathway was navigated correctly and if the rationale for
off-pathway care is clearly stated and supported in the medical record. Cases without clear documentation are referred to the treating oncologist and/or multidisciplinary team for review. Off-pathway reasons are assigned an adjudication category (Box 1).
Dr Edge explained that RP is uncomfortable reporting unreviewed data to external stakeholders because the reports may include on-pathway end points beyond the key treatment decision, and the reports do not account for misuse or mis-navigation. He stated, “It also doesn’t identify the good care that doctors provide off-pathway and the rationale for that care.” Dr Edge referred to a recent article, where RP did a retrospective review of all off-pathway care for one year and found that most off-pathway care is justified and appropriate.4
In conclusion, Dr Edge commented on the workload involved for providers to complete pathways as part of their clinical documentation. The group at RP recognizes that pathways slightly add to the significant burden of EHR documentation, but they feel it is necessary and of real value. RP still feels a real commitment to continually look for ways to make it easier to complete and more valuable to the provider and the patient. Dr Edge stated, “I don’t have a problem asking people to spend a few minutes to document the reasons why they are starting a medical treatment, be that chemotherapy, surgery or radiation, that will be life-altering and potentially life-threatening for the patient and potentially cost upward of a hundred thousand dollars or more.”
Finally, he urged others to consider doing reviews of off-pathway care. There are programs that do this prospectively—off-pathway treatment cannot start until approved by a Pharmacy &Therapeutics Committee member. Retrospective review is equally valuable. It provides for correction of entry mistakes, allows the program to identify opportunities for improvement of care, and potentially improvement in the pathways. Dr Edge added, “Honestly, it also allows demonstration to all internal and external stakeholders the quality of care provided, and the thoughtfulness and patient-centeredness of care given by our oncologists.”
References
1. Edge SB, Liu L, Stefaniak N, et al. Going off pathway: problem or good care? J Clin Oncology. 2020;38(suppl 15):7014. doi:10.1200/JCO.2020.38.15_suppl.7014
2. Del Signore A. An in-depth look at Moffitt Cancer Center’s clinical pathways program.
J Clin Pathways. March 5, 2019. Accessed March 1, 2021. https://www.journalofclinicalpathways.com/depth-look-moffitt-cancer-centers-clinical-pathways-program-and-use-payer-strategies-part-i
3. Downar J, Goldman R, Pinto R, Englesakis NM, Adhikari NKJ. The “surprise question” for predicting death in seriously ill patients: a systematic review and meta-analysis. CMAJ. 2017;189(13):e484-e493. doi:10.1503/cmaj.160775
4. Edge SB, Liu L, Case AA, et al. Value of oncologist generated surprise question in predicting survival in metastatic cancer. J Clin Oncol. 2020;38(suppl 15):12082. doi:10.1200/JCO.2020.38.15_suppl.12082
