Development of a Low Resource Tool for Optimizing Head and Neck Cancer Treatment Delivery Within an Integrated Health Care Delivery System

Abstract: The Veterans Health Administration is the largest nationally integrated health care delivery system in the United States, making it an ideal environment for development of tools designed to streamline cancer diagnosis and treatment. Head and neck cancer squamous cell carcinoma (HNSCC) remains a difficult disease to diagnose and treat. Objective: To develop an efficient approach to improving treatment metrics for HNSCC patients. Methods: We developed a prospective tracking tool available to providers and clinic staff to track patients from initial referral through diagnosis and treatment completion and used it to evaluate clinical care delivery between June 2016 and October 2018. Results: Utilization of the tracking tool and closed-loop communication facilitated rapid treatment initiation (diagnosis-treatment mean=44 days) and delivery. Compliance with treatment package time <100 days was 88%; compliance with initiation of adjuvant radiation within 6 weeks of surgery was 75%. Conclusion: Timely initiation and delivery of multimodality cancer treatment can be facilitated by integration among participating services and by the presence of a fully integrated health care delivery system.

Head and neck squamous cell carcinoma (HNSCC) presents a difficult challenge for patients and providers due to disease complexity, vague symptoms at presentation, and requirements for integrated, multimodality treatment for advanced stage disease.^1-3 This problem is rapidly increasing in scope due in large part to the nearly exponential increase in human papilloma virus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC) incidence.^4-6 Although most attention is currently focused on development of novel treatments for HNSCC, it has become clear over the last 2 decades that adequate delivery of existing, standard-of-care treatment can have a dramatic impact on disease-free and overall patient survival.⁷ Perhaps nowhere is this clearer than in evaluating the impact of timing of postoperative radiotherapy (PORT) initiation on survival. Delivery of PORT within a total treatment package time of 100 days has repeatedly been associated with a significant (~20%) improvement in patient survival.⁸ This effect size is more than double the relative effect size of adding concurrent chemotherapy to radiation in the setting of advanced stage head and neck cancers.⁹ Additionally, metrics such as time to diagnosis, diagnosis to treatment, and streamlined delivery of multimodality treatment have been shown to critically impact oncologic outcomes in head and neck cancer.^1-3,10

Advanced stage head and neck cancer requires not only multiple treatment modalities, but also necessitates that these modalities be appropriately temporally integrated; multiple patient, disease, and health care delivery system characteristics can impact timely initiation and completion of care. However, assigning specific reasons for delays has proven very difficult using retrospective analyses.¹ Since there are no prospective data which address this problem, it remains difficult to substantially improve these metrics within US institutions.

We had previously conducted a retrospective analysis of treatment delivery within a tertiary-care Veterans Health Administration (VHA) facility.¹ Despite the existence of an established and functional multidisciplinary tumor board, and in the context of a horizontally and vertically integrated health delivery system, we identified concerning trends related to time from diagnosis to treatment initiation, as well as timely completion of multimodality treatment.¹ Data by Graboyes et al using National Cancer Database analysis indicate that our difficulties are not unique and present a significant challenge at the population level throughout the United States.¹¹ 

In the present study, based on this historical experience, we instituted a quality control (QC)/quality improvement (QI) project aimed at tracking and optimizing treatment related metrics within a tertiary VHA institution. Our primary goal was to maximize compliance with metrics related to PORT delivery. Our secondary goal was to determine whether prospective data collection regarding treatment delivery metrics can provide increased granularity for analysis compared with retrospectively collected data.

Methods

Patient Cohort

Following approval from the Baylor College of Medicine and Michael E. DeBakey VA Medical Center (MEDVAMC) Institutional Review Boards, we performed an analysis of prospectively collected data acquired over a 2-year QC/QI project (2016-2018) designed to streamline and optimize time from diagnosis to treatment initiation, rendering timely delivery of multimodality treatment for head and neck cancer patients. Dates of patient referral, tissue-based diagnosis (biopsy), presentation at multidisciplinary board, treatment initiation, and completion were recorded along with tumor site and stage. All patients discussed at the Head and Neck Multidisciplinary Tumor Board (HNMDTB) of the MEDVAMC were analyzed, including those with diagnoses of HNSCC, head and neck melanoma, salivary gland malignancies, and advanced nonmelanoma skin cancers.

Treatment Delivery

Historical patterns of treatment delivery were previously published by our group.¹ At the MEDVAMC, all necessary clinical and ancillary services for the treatment and management of head and neck cancer patients were available throughout the study period and did not change. Analysis of clinical patterns by the multidisciplinary team identified common aspects of cancer diagnosis and treatment within the HNMDTB. These patterns of clinical care are summarized in Figure 1A for both surgical and nonsurgical patients. Following analysis of our treatment patterns and identification of areas of possible time use inefficiencies, we generated three major paradigm changes in clinical practice within the multidisciplinary treatment team (Figure 1B).

First, parallel clinical processes or pathways were integrated horizontally wherever possible. Specifically, although referrals to medical and radiation oncology services remained dependent on confirmation of pathologic tissue diagnosis, referral to ancillary services, such as dental medicine, and orders for staging imaging were initiated at the time of clinical diagnosis, prior to return of pathology to expedite appointments and studies necessary in treatment planning. Dental extractions, which were often relegated to after surgical resection due to delayed coordination, were incorporated into the surgical planning process and were performed at the time of definitive oncologic surgery. Second, a protocol of dissemination of secure closed-loop communications detailing the treatment plans of all patients following tumor board discussion to the multidisciplinary team was implemented via the electronic medical record (EMR), requiring co-signature of participating services. This ensured clarity in the treatment plan within the entire team while also facilitating supplemental EMR-based communications regarding individual patients.  

Third, a patient tracking database using existing, approved institutional resources available to all authorized providers, was constructed to track patients from time of initial clinical presentation to first post-treatment imaging and generation of individualized Survivorship Care Plans. This tracking tool allowed for rapid review of progression of individual patients through the diagnostic and therapeutic phases of treatment delivery and was used to generate regular summaries and reports for the treatment team during the study period. Data from the tracking database was reviewed by treatment teams twice per week to ascertain individual patient progress through the various diagnostic and therapeutic steps of the overall process. Communication regarding individual patients were then carried out via secure closed-loop communication either through the EMR or institutional secure email function.

No new personnel were added to the treatment team during the study period. Services were available prior to and following initiation of the current QC/QI project. No new services were generated. Staffing levels for all services within the multidisciplinary team remained variable throughout the study period and were not controlled for. Case complexity increased during the study period compared with our historical data. For example, during the 2-year period included in the current study, 21 oncologic surgical resections for HNSCC (15%) were accompanied by microvascular free flap reconstruction compared with <10 for oncologic procedures performed during our historical comparison period (3%). Descriptive statistics were performed using SPSS (v25, IBM). For all statistics, P values were considered to be statistically significant if below a threshold of .05 (2-sided).

Results

Patient and Treatment Characteristics

A total of 300 patients were presented to the HNMDTB during the study period. Of these, 14 refused treatment and 33 opted for treatment at another institution, leaving 253 who received treatment at the MEDVAMC. Of these, 6 patients died prior to or during treatment delivery, 10 opted for observation, and 15 opted for palliative systemic treatment. 

A total of 212 patients received curative intent treatment during the study period. For these patients, the interval from referral to treatment initiation averaged 63 days (median = 50 days), while the interval from diagnosis to treatment initiation averaged 47 days (median = 40 days)
(Table 1). One hundred thirty patients were treated surgically of which 57 patients (44%) received PORT. For this group of patients, which received multimodality treatment, time from surgery to PORT initiation averaged 43 days (median = 41 days). A majority (47/55; 85%) patients were treated within a 100-day treatment package time (TPT) and 37/57 (65%) initiated PORT within 6 weeks of surgery.

HNSCC Treatment Delivery

A total of 142 patients were diagnosed with HNSCC; 121 (85%) patients were compliant with treatment recommendations for treatment selection, intensity and timeframe (Table 2). Among new, previously not evaluated patients, the most common reason for referral was a mass or abnormal imaging (n=63), followed by hoarseness (n=25), and dysphagia/odynophagia (n=16). Only 3 patients had a known cancer diagnosis at the time of referral to Oto-HNS. Compliance was defined as: (1) agreeing to one of the HNMDTB treatment options presented to the patient and (2) compliance with diagnostic and therapeutic appointments designed to initiate timely care. Among all HNSCC patients, time from diagnosis to treatment initiation averaged 46 days (median = 41 days); for compliant patients, time from diagnosis to treatment initiation decreased to 44 days (median = 40 days). Among compliant HNSCC patients, 54 were treated surgically, followed by PORT in 24 patients. Of these 21/24 had a TPT of 100 days, and 18/24 initiated PORT within 6 weeks of surgery. For the 3 patients whose TPT extended past 100 days, 1 patient required unexpected extractions postoperatively, 1 had an acute episode of cholecystitis that required treatment at an outside hospital, and 1 presented with a concomitant visual stroke that required intervention prior to adjuvant treatment initiation. With the exception of these 3 patients, all other patients, 21/24 initiated PORT within 7 weeks of surgery.

A majority of all compliant HNSCC (67/121) patients were treated nonsurgically, and most (n = 52) were treated with concurrent chemo-radiation. Among these patients, time from referral to treatment initiation averaged 64 days (median = 63 days), and time from diagnosis to treatment initiation averaged 52 days (median = 49 days). For patients with early stage disease who underwent radiation alone, time from diagnosis to treatment initiation was substantially reduced (mean = 38 days, median = 33 days). Overall, patients who underwent surgical treatment were able to initiate treatment faster compared to patients who underwent radiation-based treatment (diagnosis – treatment mean = 36 days vs 49 days; P < .05). This effect was maintained even for patients who required PORT (40 days vs 49 days; P < .05).

We next evaluated treatment initiation and delivery parameters as a function of disease site and stage. Patients with a diagnosis of laryngeal/hypopharyngeal SCC had mean time from referral to treatment of 65 days (median= 62 days) and mean time from diagnosis to treatment of 34 days (median= 33 days). Patients with a diagnosis of oropharyngeal cancer had a mean time from referral to treatment for 60 days (median= 56 days) and time from diagnosis to treatment of 49 days (median= 48 days). Patients who required radiation alone had a shorter diagnosis to treatment time compared with patients who required chemo-radiation (P < .01). Nodal status (N0 vs N+) was associated with increased diagnosis to treatment time (P < .01), but site (larynx/hypopharynx vs oropharynx) and T-classification were not (P = .48, P = 0.11, respectively). For patients which underwent surgical treatment, site (larynx/hypopharynx vs oral cavity/oropharynx) was associated with shorter time from diagnosis to treatment (24 vs 43 days; P = .02). Need for adjuvant treatment, nodal status, and T classification were not associated to differential time from diagnosis to treatment intervals (P = 0.39, P = .82, P = .73, respectively).

Data were available from 11 HNSCC patients (2 nasopharynx, 8 oropharynx, 1 larynx) which received chemo-radiation with curative intent at a non-MEDVAMC facility during the study period arranged through the Veteran Choice Program (VCP) during the study period. For these patients, mean time from diagnosis to treatment was 70 days (median= 73 days), and time from HNMDTB to treatment initiation was 65 days (median= 64 days). 

Discussion

In our study, utilization of the tracking tool and closed-loop communication facilitated rapid treatment initiation (diagnosis-treatment mean=44 days) and delivery. Compliance with treatment package time <100 days was 88%; compliance with initiation of adjuvant radiation within 6 weeks of surgery was 75%. Timely initiation and delivery of multimodality cancer treatment can be facilitated by integration among participating services and by the presence of a fully integrated health care delivery system.

Successful diagnosis and treatment of a single advanced stage HNSCC patient generally requires between 12 and 15 specialty trained individuals (physicians, speech pathologists, radiation physicists, registered dietitians, etc) generating an extremely complex clinical challenge. In a fragmented health care system, such as that encountered by the majority of the US population, this process can sometimes become an insurmountable challenge. Published literature demonstrates an escalating crisis for a majority of HNSCC patients treated in the United States as it relates to treatment-related metrics.^1,8,10,11 This is particularly problematic given the proven impact of treatment delays, treatment breaks, and incomplete treatment delivery on HNSCC outcomes.^10,12-14 Most recent datasets indicate that the effect sizes associated with these parameters easily dwarf gains in HNSCC survival obtained from technological and scientific advances in surgical techniques, radiation techniques, and development of novel systemic therapeutic strategies for this disease.^9,15-18

Fragmentation of cancer care has been associated with substandard HNSCC treatment delivery and remains common even in the United States.^19-21 However, we have found that diagnosis and timely treatment of HNSCC, even within an integrated health delivery system with all components of a multidisciplinary team and a single EMR within a physical plant, still remains challenging.¹ However, integrated health systems provide a unique opportunity, both for study and to improve treatment-related metrics. Over the study period, delivery of multimodality treatment within 100 day TPT occurred in 88% of patients compared with our historical comparator of 68%.¹ Compliance with a 6-week interval between surgery and PORT of 75% was substantially higher than our historical comparator of 42%.¹ These numbers also compare favorably to data from national US databases, but remain significantly below our expectations as a multidisciplinary treatment group.^11,22,23 In addition to these basic metrics, we observed several patterns of treatment delivery that can be used to further refine and improve diagnostic and therapeutic strategies.

Surgical patients consistently demonstrate the fastest time from referral to treatment and diagnosis to treatment of any group of patients. This pattern remains consistent even when patients present with advanced stage disease that require adjuvant treatment. Several factors likely contribute to this. First, HNSCC cancer referrals at our institution are initiated through the surgical team (Oto-HNS). Second, surgical teams (Oto-HNS ablative, Oto-HNS reconstructive, OMFS) are able to coordinate surgical care in an expeditious manner. Third, planning associated with patient disposition and nutritional requirements (ie, gastrostomy placement) can be facilitated during the inpatient postoperative period. In contrast, for patients receiving nonsurgical treatment, there are multiple interventions that all must occur prior to treatment initiation (ie, dental extractions, gastrostomy placement). This can be particularly difficult in patients with advanced stage disease who require chemo-radiation. Despite our efforts to date, we have been unable to reduce mean time from diagnosis to treatment for this group to under 45 days, which is our current goal. Patients which require single modality radiation treatment can generally initiate treatment rapidly; this is particularly true for patients with early stage laryngeal disease who do not generally require dental extractions or evaluation for gastrostomy placement.

Utilization of the VCP can play an important role for patients that live far away from their primary VHA institution, but it does not improve treatment metrics and may actually delay treatment initiation, since it requires additional work-up and evaluation at the secondary institution. This is to be expected since utilization of  VCP will often lead to fragmentation of care, particularly for chemo-radiation based regimens that are resource and facility intensive. We contend that, rather than relying on VCP, additional efforts and resources within the VHA should be dedicated toward facilitating transportation, coordination of care delivery, and housing for patients who are otherwise VCP candidates.

Moreover, utilization of a real-time tracking tool and closed-loop communication allows for rapid interventions for individual patients, coordination of appointments, and minimization of diagnostic and treatment delays. At an institutional level, utilization of the tracking tool allows us to generate quarterly and yearly reports for the entire multidisciplinary treatment team, track progress in real time, and discuss performance with institutional administration to optimize resource utilization and allocation. 

There are 2 natural follow-up questions regarding implementation of such an approach. First, what are the relative costs associated with implementation? Implementation of the described approach was specifically designed to obviate the need for additional personnel (ie, dedicated patient navigator) since manpower is a significant cost generator and notoriously difficult to secure across various medical care delivery systems. No additional testing was implemented as part of the described approach, which could impact cost. Second, what are the benefits with regard to oncologic outcomes secondary to implementation? Our data are not mature enough (we do not have 2-year follow-up on the entire patient cohort) and our dataset large is not yet large enough to definitively answer this question. Since oncologic outcomes are site and stage specific, we will need to acquire a substantially larger patient dataset prior to measuring improvements in outcomes compared with our historical controls. However, the published datasets for head and neck cancer from other groups have shown a very substantial gain in survival as a function of treatment package time.²³

Across all patient subsets, time from referral to diagnosis ranges from 10 to 14 days. Our institutional goal is to reduce this time frame to 5 working days, through additional coordination of in-clinic and same-day biopsy via sampling of primary tumor and/or fine needle aspiration of cervical nodes. In addition, streamlined referral patterns are essential to expediting evaluation through development of clinical pathways designed to identify cancer patients among the wide variety of etiologies which present with similar initial symptoms.^24-27 Further coordination of treatment can incorporate development of true multidisciplinary clinics, which have been shown to impact both care delivery and survival.²⁸ However, this requires significant buy-in and coordination of multiple distinct services, which can remain difficult in the current clinical environment. These processes will require dedicated Lean Six Sigma methodology to be incorporated into our tracking tool and development of a parallel resource utilization and cost analysis designed to provide systemic optimization.

Conclusion

We developed a prospective tracking tool available to providers and clinic staff to track patients from initial referral through diagnosis and treatment completion and used it to evaluate clinical care delivery. This resulted in timely initiation and delivery of multimodality cancer treatment via integration among participating services and by the presence of a fully integrated health care delivery system.

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