The model that we used involves the assignment of a nurse coordinator to each patient referred to the head and neck clinic. Once the patient is referred, the patient’s coordinator makes an appointment at the clinic within 2 days. If the patient does not yet have a definitive diagnosis, one is made using the various modalities available: imaging, fine-needle aspiration biopsy, or panendoscopy with biopsy. Pending this diagnosis, the patient is discussed at a multidisciplinary tumor board meeting that convenes every Thursday. Here, the head and neck cancer specialists, radiation oncologists, medical oncologists, and speech pathologists determine the formal treatment recommendation that will be offered to the patient. The following day, the patient returns to clinic to discuss treatment options. Ideally, this entire process occurs within 2 weeks of the initial referral.
The interval from first presentation to the head and neck clinic to treatment recommendation was plotted as a scatterplot showing the distribution of each individual patient. The red line indicates our aspirational goal of a 14-day interval from presentation to treatment recommendation. The longer and shorter horizontal black lines represent the mean (SD) of 18.8 (37.4) days. A total of 47 of 93 patients received treatment recommendations within 14 days. The interval was within 1 standard deviation of the mean for 83 patients and within 2 standard deviations of the mean for 89 patients.
Ohlstein JF, Brody-Camp S, Friedman S, Levy JM, Buell JF, Friedlander P. Initial Experience of a Patient Navigation Model for Head and Neck Cancer. JAMA Otolaryngol Head Neck Surg. 2015;141(9):804-809. doi:10.1001/jamaoto.2015.1467
Specific temporal goals for treatment of head and neck cancer (HNC) are common in Europe but not in the United States. We implemented a patient-centric navigation model with an aspirational goal that all patients will receive treatment recommendations within 2 weeks of presentation as a means to improve outcomes in our patients with HNC.
To assess the temporal impact of using an aspirational goal in a patient-centric navigation system on the time from presentation to formulation of treatment planning for patients with HNC.
Design, Setting, and Participants
Retrospective review of 100 consecutive patients treated for squamous cell carcinoma of the head and neck at a tertiary referral center between 2011 and 2014. Patients were assessed to determine the efficiency of a patient-centric navigational model in delivering cancer treatment recommendations. This model was designed with an aspirational goal of providing treatment recommendations within a 2-week period.
Starting in 2011, patient-centric navigation model including the assignment of a nurse who acts as a patient navigator.
Main Outcomes and Measures
The time interval between presentation to clinic and definitive treatment recommendations, as well as factors associated with delay.
Of the 93 patients who met inclusion requirements, most were white (81 [87%]) males (74 [80%]) with a mean (SD) age of 63.4 (10.8) years insured by Medicare or Medicaid (64 [69%]). Forty-seven (51%) received treatment recommendations within the 2-week period, with median and mode values of 15 and 14 days, respectively. The mean (SD) interval was 18.8 (18.6) days. Outliers included 2 patients with synchronous lung nodules (72 and 85 days) and 2 patients with psychosocial barriers (107 and 86 days). There were no significant differences seen for the mean (SD) time interval with respect to patient race (blacks, 17.6 [15.7] vs whites, 22.5 [30.0]; P = .20), sex (males, 18.3 [18.1] vs females, 20.4 [19.7]; P = .13), insurance status (insured, 16.3 [10.2] vs uninsured, 19.8 [21.0]; P = .24), and stage at presentation (stage I, 14.4 [17.0] vs stage II, 11.0 [5.3] vs stage III, 14.7 [8.6] vs stage IV, 21.2 [20.2]; P = .40).
Conclusions and Relevance
The goal of treatment recommendations for HNC within 2 weeks was shown to be reasonable and attainable. Further research should address the delays encountered by patients with psychosocial barriers and those with synchronous lung nodules.
In the era of the Affordable Care Act, substantial changes have occurred in treating institutions and, frequently, the practice patterns for the management of head and neck cancer (HNC). A recent study confirmed that during the period from 2002 to 2010, the proportion of patients with HNC receiving treatment in an academic medical center has steadily increased from 61.7% to 79.8%.1 Several factors contributing to this practice shift included the complexity of care rendered, the comorbidities of these patients, and the predominant funding source and level associated with these patients.1- 3 This same concentration of care within well-defined health care systems allowed for an expanded opportunity to study the patient population and to improve the quality and efficiency of care for these patients. One quality measure included the standardization of patient evaluation and efficient approaches to health care planning.4,5
Effective management of cancer and, in particular, HNC poses a substantial challenge to a health care system. The majority of patients with HNC present with advanced disease, in conjunction with substantial medical comorbidities, and frequently concurrent low socioeconomic status.1 High-risk patient groups that have previously been identified include those with African American race, governmental insurance, and lower socioeconomic status. The most challenging factor to contend with has been the treatment of patients of lower socioeconomic status.2 Caring for this patient population is frequently labor intensive and resource exhaustive, with these patients at highest risk for poorer outcomes.1
Patient navigation has been previously identified and extensively proposed as a principal strategy to improve the outcomes for these at-risk populations for cancer and other medical conditions.6 Harold Freeman was an early investigator in public health who pioneered patient navigation more than 3 decades ago in Harlem. Freeman7 embraced and later refined the concepts of a community-based initiative in which volunteers would help patients belonging to groups that were historically marginalized from the health care system. The central premise was that even the most health care–literate patient would have difficulty navigating the multistep complexities of diagnostic, treatment, and surveillance algorithms inherent in cancer care and that this difficulty would only further be compounded for health care–illiterate patients.6
After Hurricane Katrina, inner-city New Orleans experienced a substantial reduction in clinicians. During the first year after Katrina, our group recognized that a substantial proportion of high-risk patients with HNC were presenting with more advanced disease than expected. To attempt to reach out to the community during this period, we proposed and formed a faith- and community-based partnership (Healing Hands Across the Divide) with a focus on prevention, early detection, and effective management of HNC. This partnership opened a dialogue between the community, its leaders, and clinicians. Through a series of forums, the community identified the need for a more efficient and patient-centric care system. It was agreed that this patient-centric approach would concentrate on more timely and efficient diagnosis, with the specific goal of formulating a treatment plan shortly after the patient entered the health care system.8
During our community interactions, we became familiar with the concept of aspirational goals. This concept appeared in the literature during the last decade, most frequently in the psychological literature.9 An aspirational goal is defined as an agreed health care goal established through partnerships between stakeholders including community leaders, patients, and clinicians. Aspirational goals have been adopted more commonly in European Union countries but are often “soft targets” rarely met.10 Taking these aspirational goals seriously would be a crucial step toward a true partnership between all stakeholders, necessitating cooperation among patients, community leaders, and the medical community.9 We believed that the aspirational goal concept would be critical in our formulation of a novel health care plan for HNC.
Using our past interactions, we redesigned our HNC treatment system, adopting an aspirational goal–driven patient-centric navigation model. In collaboration with our stakeholders, the team committed to the aspirational goal that all patients who presented with head and neck tumors would be evaluated, receive a diagnosis, and receive treatment recommendations within a 2-week period. On the basis of this aspirational goal, a health care platform was developed with a nurse coordinator serving as an intake nurse, as well as patient navigator. The patient navigator would work with patients and the head and neck service to coordinate imaging studies, referrals, and surgery. To ensure the achievement of our aspirational goal, a weekly multidisciplinary treatment planning conference was instituted where all new patients and current patients under active treatment would be discussed. We hypothesized that such a health care delivery system would meet our aspirational goal in the majority of cases.
We identified the first 100 consecutive patients who received a diagnosis of presumed primary squamous cell HNC who presented to the Tulane University School of Medicine Head and Neck Clinic between 2011 and 2014, after the 2011 initiation of our aspirational goal–driven patient-centered navigation system. Inclusion criteria consisted of new patients presenting to the Head and Neck Clinic for evaluation of a neck mass or other symptoms related to HNC such as dysphagia or hoarseness. Patients with disease recurrence, benign tumors, or tumors of the thyroid or parotid glands were excluded. Demographic data including insurance type, race, age, sex, tobacco use, primary tumor site, and stage were collected. Staging was according to National Comprehensive Cancer Network guidelines, with early stage including stages I and II and late stage including stages III and IV. Patients presented with various levels of diagnostic workup. At our institution, previous diagnostic procedures and studies were reviewed to formulate treatment recommendations.
Seven patients were excluded from the original sample population, reducing the study population to 93 patients. Reasons for the 7 exclusions included (1) 1 tumor that was later reviewed and found to be benign, (2) 3 patients whose disease was subsequently found to be recurrent, and (3) 3 patients who were lost to follow-up. The remaining patients’ records were reviewed to identify intervals from first symptom onset to presentation, presentation to biopsy, and biopsy to treatment recommendation and treatment initiation. For this study, treatment recommendation is defined as the date that a physician discussed the diagnosis and provided the patient with treatment options. Treatment recommendations were only provided after the patient staging and biopsy results were discussed at tumor board. Treatment start date was defined as the date when either the patient underwent surgery or a chemotherapy and/or radiation therapy regimen was initiated.
All patient information and data were collected and protected in accordance with guidelines set forth by the Tulane Institutional Review Board and Health Insurance Portability and Accountability Act regulations. The study was approved by the Tulane Institutional Review Board, and informed consent was waived secondary to the retrospective nature of the study.
The navigation model that was used included the assignment of a nurse who acts as a patient navigator for each patient who is sent to the head and neck clinic. Our navigator also functioned as a clinic nurse, thus minimizing costs and increasing efficiency. Once a patient is referred, the navigator establishes clinic care within 2 days. Previous diagnostic test results are obtained and reviewed prior to clinic presentation. After the patient’s initial visit, additional tests, biopsies, and panendoscopies are scheduled as clinically necessary. After comprehensive evaluation, the patient is discussed at a multidisciplinary tumor board meeting that convenes weekly. Here, the HNC specialists, radiation oncologists, medical oncologists, and speech pathologists determine the formal treatment recommendation(s) that will be offered to the patient. The following day, the patient returns to clinic to determine their treatment choice. The process is designed to occur within 2 weeks of initial referral (Figure 1).
Study population characteristics and information were analyzed using the Fisher exact test, independent t test, and χ2 tests as appropriate. Time from presentation to the head and neck clinic to treatment disposition was dichotomized between those who met our 14-day aspirational goal and those who did not. Stage at presentation was also dichotomized into early (stages I and II) and late (stages III and IV) categories. P < .05 was considered to be statistically significant. Data and statistical analysis were performed using SAS software, version 9.4 (SAS Institute), and Prism 6 (Graphpad Software).
The study population presenting to the Tulane Head and Neck Clinic was quite homogenous. The majority of the patients were white (81 [87%]) males (74 [80%]) with a mean (SD) age of 63.4 (10.8) years insured by Medicare or Medicaid (64 [69%]). Tobacco use was also prevalent, with 72 (78%) of the patients reporting a history of cigarette smoking. Patients were found to present at an advanced stage, with the majority (67 [81%]) of biopsies revealing stage III or IV disease. Cancer of the oral cavity and/or oropharynx was the most common tumor site, seen in 63 patients (70%). Routes of presentation were also considered, with the majority of our patients (66 [73%]) being referred by outside ear, nose, and throat specialists for further evaluation, followed by referrals from dentists or oral surgeons (14 [16%]), followed by patients from the emergency department (6 [6%]) and those directly referred by their primary care physician (4 [4%]) (Table 1).
There were no significant differences seen for the time interval from presentation at clinic to receipt of treatment recommendations for patients with respect to patient race (blacks, 17.6 [15.7] vs whites, 22.5 [30.0]; P = .20), sex (males, 18.3 [18.1] vs females, 20.4 [19.7]; P = .13), insurance status (insured, 16.3 [10.2] vs uninsured, 19.8 [21.0]; P = .24), and stage at presentation (stage I, 14.4 [17.0] vs stage II, 11.0 [5.3] vs stage III, 14.7 [8.6] vs stage IV, 21.2 [20.2]; P = .40) (Table 1). There was marked variation in the time from onset of patient symptoms to presentation to our head and neck clinic: mean (SD), 129 (164.7) days (Table 2).
The majority of patients who required biopsy received tissue diagnosis within 7 days of their original office visit. Variations were seen in the time to biopsy: mean (SD), 12.1 (13.4) days, with a mode of 5 days (Table 2).
The aspirational goal of treatment recommendation within 2 weeks of presentation was achieved for 47 patients (51%). The mean (SD) interval was 18.8 (18.6) days, with a median interval of 15 days (Table 2). Additionally, of the 93 patients, 83 received treatment recommendations within 1 standard deviation and 89 within 2 standard deviations of the mean interval. Of the 4 outliers identified, 2 patients had psychosocial barriers that prevented them from achieving care in a timely manner and 2 also received a diagnosis of lung nodules that extended their treatment course (Figure 2).
In the United States today, patients with HNC frequently present with advanced disease, resulting in disparate outcomes.11 Currently, more than 60% of patients with HNC present and receive a diagnosis of advanced-stage (III or IV) lesions with a mean 5-year survival rate of 50%.11,12 This is in contrast to patients with a diagnosis of early-stage disease, for whom the 5-year survival rate is in excess of 80%.12 Our current data mirror this trend, with more than 80% of our patients presenting at an advanced stage.
This void of progress prompts the question, What modifications in the health care system can be made to improve patient outcomes? A recent meta-analysis indicated that diagnostic delay—excess time between onset of a patient’s first symptom and receipt of a definitive diagnosis—was a contributing factor to inferior outcomes. A recent study by Cleveland and Thornton-Evans11 indicated that patients with oral cancer who experienced a diagnostic delay frequently incurred a significantly higher incidence of advanced disease. These data indicate that an intervention that uses a system-based approach to minimize or eliminate diagnostic delays may result in a decrease in the incidence of advanced-stage presentation and improve outcomes of patients with HNC.
At present, there are limited studies in the United States defining the optimal time from onset of a patient’s first sign or symptom through diagnosis and eventual start of therapy.5 The majority of studies evaluating temporal goals are from European and Asian centers.12 In the United States, patients with HNC are treated through a variety of health care delivery systems. These potential entry points into the health care system include solo practitioners, community-based cancer centers, regional health care systems, and national health care systems. Unfortunately, few data have been reported on patient and clinician delays outside academic medical centers. The clearest analysis of temporal progression emerges from a retrospective study of patients treated for oral cancer in which Peacock et al13 identified a mean time from symptom onset to treatment initiation of 206 days. This study identified patient delay as the largest contributing factor, with a mean delay of 104.7 days. However, clinician delay was also frequent and lengthy, with delays occurring for patients awaiting (1) primary care physician recognizing the need for either biopsy or specialist referral (mean, 35.9 days), (2) specialist visit (mean, 17.7 days), (3) additional testing (mean, 10.1 days), (4) presentation at a head and neck tumor board (mean, 20.7 days), and (5) initiation of treatment (mean, 16.6 days).13 Patel and Brennan14 reported data concerning the efficiency of health care delivery at an inner city hospital, reporting a mean time from presentation to treatment recommendations of 23 days. In this study, patients with early-stage tumors were noted to have shorter intervals between presentation and treatment planning compared with those presenting with later-stage disease.14 This was in contrast to our data in which there was no significant difference in time intervals for those with early versus advanced disease.
Delay in patient presentation and subsequent definitive therapy has been linked to inferior patient outcomes.15 Advanced stage at presentation has also been associated with increased cost of care compared with patients presenting with earlier-stage disease. These facts have drawn substantial attention and have illuminated several areas for intervention including patient awareness, screening programs, and minimizing clinician delays.16 Health care systems in Europe are typically run by national governments. McKie et al10 report on a government-centered model using aspirational goals to attempt to reduce clinician delays. In the United Kingdom, the National Health Service has developed a 2-week referral route that allows efficient referral from primary care physician to subspecialist. Although this route exists, only 21.4% of patients with HNC who received a diagnosis between 2004 and 2006 used this pathway.10 In 2004, the Netherlands established the aspirational goal of a 30-day interval from first visit to a specialist to the initiation of treatment. The platform introduced in the Netherlands included a health care system in which nearly all patients with a diagnosis of HNC are referred to a head and neck clinic for treatment. Despite this formulated and mature system, only 7% of patients with laryngeal cancer, 13% of patients with pharyngeal cancer, and 41% of patients with oral carcinomas were able to obtain definitive care within the timeframe of this aspirational goal.4 The health care system in the United States is far less integrated, with multiple insurers and greater numbers of clinicians in the health care delivery systems who frequently do not communicate with each other. This disparate health care delivery system has not developed patient care driven by aspirational goals.
In designing our navigational model, we chose an initial goal of efficient treatment recommendation to meet the patient’s perceived needs of a responsive health care system. In this study, we present our data on an initial experience with an aspirational goal for delivering multidisciplinary treatment recommendations within 14 days of patient presentation to the health care system. Despite buy-in from community and clinician stakeholders, we were only able to achieve this goal for a slight majority of our patients. Even with this shortfall in our desired outcome, our initial experience achieved our goal more frequently than previously reported studies from European centers. Fortunately, most patients were within 1 standard deviation of this aspirational goal. In addition, once patients entered into our navigation model, we found no statistically significant difference in time interval from presentation to diagnosis on the basis of stage at presentation, race, or insurance status. This finding may benefit the uninsured and those of African American race, who have been reported to typically have outcomes worse than those of their counterparts.17- 19 We propose that our navigation system might help address these disparities by helping patients to access reliable and timely care. Expanded studies in the future will be needed to test this hypothesis.
This initial experience with an aspirational goal also provided important insight into system failures, identifying 2 outlier groups: (1) those with substantial psychosocial concerns and inadequate social support and (2) those with lung nodules. Psychosocial needs are more frequently encountered in high-risk patients, as was the case in our HNC population. Inadequately treated mental illness and lack of social support frequently contribute to both patient and clinician delay in not only HNC but most disease processes. Early identification of these barriers can prompt the use of mental health care professionals and networks to more effectively serve these populations. Future prospective studies will be needed to assess the impact of early interventions on these outliers.
Patients with synchronous lung nodules were also found to be outliers. This finding may reflect the complexity of these patients’ disease and diagnostic evaluation that contribute to clinician delay. We currently are designing a navigation protocol tailored to these patients. Future studies will determine the efficacy of this approach.
Limitations of this study include lack of comparison to a control group (historical or concurrent), focus on a narrow window of time in the spectrum of diagnosis and treatment, single-site design with lower power, and the homogeneity of the patient population. As stated, we chose to focus on the evaluation of head and neck squamous cell carcinoma from presentation to treatment recommendation. This initial period has been shown to be a crucial point in the management of HNC.18,19 In this study, we were able to achieve efficient delivery of treatment recommendations in the study population. The external validity, as well as the applicability to at-risk populations, is unknown and will need to be determined in future multisite studies.
With the introduction of a patient-centric navigation system driven by an aspirational goal, the clinic was able to render treatment recommendations for the majority of patients with HNC within 2 weeks of presentation. Variations of timeliness of treatment were still seen in this patient population, but most patients received treatment recommendations within 3 weeks of presentation. Stage at presentation, race, and insurance status did not have a statistical effect on temporal outcomes. Furthermore, we identified 2 subgroups who experienced substantial delay: those lacking in psychosocial support and those with synchronous lung nodules. Further investigation will be necessary to determine external validity and applicability to high-risk populations.
Submitted for Publication: March 30, 2015; final revision received May 29, 2015; accepted June 9, 2015.
Corresponding Author: Paul Friedlander, MD, Department of Otolaryngology, Tulane University School of Medicine, 1430 Tulane Ave, SL-59, New Orleans, LA 70112-2699 (email@example.com).
Published Online: August 27, 2015. doi:10.1001/jamaoto.2015.1467.
Author Contributions: Dr Friedlander had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: All authors.
Acquisition, analysis, or interpretation of data: Ohlstein, Brody-Camp, Friedman, Buell, Friedlander.
Drafting of the manuscript: Ohlstein, Brody-Camp, Friedman, Buell, Friedlander.
Critical revision of the manuscript for important intellectual content: Ohlstein, Brody-Camp, Levy, Buell, Friedlander.
Statistical analysis: Ohlstein, Buell.
Administrative, technical, or material support: Levy, Buell, Friedlander.
Study supervision: Levy, Buell, Friedlander.
Conflict of Interest Disclosures: None reported.