Otto Sandoval, M.D., Andrew Blake, Josh Barnes-Livermore, Doug Salvador, M.D., MPH, Brian Jumper, M.D., Jennifer Powers, Moritz Hansen, M.D., and Craig Hawkins, M.D.
Background: A delay of greater than 90 days from diagnosis of muscle-invasive bladder cancer to radical cystectomy is associated with increased pathologic stage and decreased cause-specific survival.
Seventy consecutive surgical candidate patients with T2 muscle-invasive transitional cell carcinoma of the bladder underwent radical cystectomy between 2004 and 2009 at Maine Medical Center in Portland, Maine. Thirty-four eligible patients had preoperative T2 muscle-invasive bladder cancer and did not receive neoadjuvant chemotherapy. Eight patients (24%) had delay greater than 90 days between diagnosis and cystectomy.
Objective: To identify the factors delaying the time between diagnosis of muscle-invasive bladder cancer to cystectomy and develop interventions to achieve 100% of surgeries within 90 days of diagnosis.
Design: Quality improvement, retrospective case series.
Setting: One community / university-associated tertiary care and teaching institution with a multi-state referral base, in the MaineHealth System.
Intervention: Analysis using Clinical Microsystems methodology examining causes of delay and proposed alterations in care pathway to overcome them.
Main outcome measures: The percentage of patients exceeding 90-day interval between diagnosis and surgery.
Results: Six problem categories were identified, with 26 possible points of intervention recognized. The points of intervention were prioritized in terms of the impact and projected efficacy of intervention. The major contributors included scheduling, patient choice factors, and comorbidity evaluation.
Preliminary results after implementation in 2011 indicate construction of a system that allows for 100% of the patients with T2 disease to undergo radical cystectomy within 90 days of diagnosis.
Twenty to 30 percent of newly diagnosed bladder cancer cases are muscle-invasive (T2). Current NCCN (National Comprehensive Cancer Network) guidelines recommend radical cystectomy with consideration of neoadjuvant chemotherapy as the treatment for organ-confined T2 disease in selected patients.
There are no formal recommendations of the timing of cystectomy after diagnosis of T2 disease. Nevertheless, there is general agreement that cystectomy should be performed within 12 weeks of diagnosis based on several studies that showed that delays of more than this period are associated with decreased disease-specific and overall survival as well as advanced pathological stage. (1,2)
Greater than 20 to 30 percent of patients with T2 disease will die of their cancer after suffering metastases or local recurrence, with a five year survival of 66% after cystectomy. (3,4)
Maine Medical Center (MMC) is a busy community / university-associated tertiary care and teaching institution with a multi-state referral base in the MaineHealth System. Maine Medical Partners Urology (MMPU) is the hospital’s outpatient urology practice. Between 2004 and 2009, 25% of our surgery-eligible patients with muscle-invasive (T2) transitional cell carcinoma of the bladder who underwent cystectomy had a delay of greater than 90 days between diagnosis and cystectomy.
To improve the flow of patients, ensuring that every patient with muscle-invasive bladder cancer makes a treatment decision and receives surgical treatment, if desired, within 90 days, we developed an analysis examining causes of delay of delivery of surgical treatment. A voluntary interdisciplinary team identified possible barriers and points of intervention to reach this goal. The group prioritized barriers according to the impact, ease of implementation and projected efficacy of intervention. The main barriers included scheduling, patient choice factors, and comorbidity evaluation.
We recently implemented several strategies/interventions at our practice to reduce the time from diagnosis to treatment to less than 90 days. This study evaluates our early experience with this approach. In this paper we describe a model to analyze and investigate the barriers that increase the time from diagnosis to the delivery of a surgical treatment modality.
The purpose of our improvement project was to improve the consistency of the time from diagnosis to cystectomy to achieve a time to surgery of less than 90 days. We did this through the process of ensuring that every patient with muscle-invasive bladder cancer makes a treatment decision and has surgery expecting them to have improved pathologic staging and cause-specific survival.
Maine Medical Center is a 637-bed hospital located in Portland, Maine. As a tertiary referral center, we see patients from all of Maine as well as parts of Vermont and New Hampshire. Urological services were provided initially by one private practice group composed of six urologists and radical cystectomy procedures were carried out in this facility by two of our urologists in the 2004-2009 period. In 2009 the group became affiliated with Maine Medical Partners and MMC and is now composed of nine urologists. Three perform cystectomies, of which two are fellowship-trained oncologic surgeons. We perform approximately 20 to 30 cystectomies a year. A genitourinary cancer clinical nurse navigator facilitates the process of decision-making, treatment and recovery of patients by providing the appropriate resources and information to patients and physicians. The multidisciplinary team caring for our bladder cancer patients also includes a dedicated genitourinary medical oncologist providing comprehensive medical care.
Planning and intervention
After reviewing performance from 2004 to 2009, 70 consecutive surgical candidate patients with T2 muscle-invasive transitional cell carcinoma of the bladder were identified. Thirty-four eligible patients had preoperative T2 muscle-invasive bladder cancer and did not receive neoadjuvant chemotherapy. Eight patients (24%) had delays greater than 90 days between diagnosis and cystectomy.
Based on this, a quality improvement initiative was proposed to the practice-based clinical microsystems team and the group committed to achieving 100% compliance in having cT2 bladder cancer patients undergo cystectomy within 90 days of diagnosis. The Clinical Microsystems approach at Maine Medical Center is the model with which to assess inpatient and outpatient system efficiency and coordination [5,6]. Several members of the urology practice had been trained in clinical microsystems tools through a medical center learning collaborative and the improvement tools were used by the group to redesign processes over the previous two years. A microsystems team was created composed of 11 members, including a urologist; a genitourinary cancer clinical nurse navigator; an oncology systems coordinator; an office visit scheduler; an office OR scheduler; an office manager; an office administrator; nurses from the OR, post anesthesia care and inpatient floor; and an administrator (urology program manager).
Biweekly meetings were held to analyze the different factors that could potentially represent barriers which would be improved upon to achieve the less than 90 days time from diagnosis to surgery in our patients. The team analyzed the current process using brainstorming, multi-voting, process mapping and cause effect diagrams (Fishbone).
Six problem categories were identified and 26 possible barriers and points of intervention were recognized. These barriers were prioritized by the group according to their impact, perceived ease of implementation of measures to counteract them and projected efficacy of intervention to overcome them. We approached all barriers at the same time, with different teams looking at each of the areas.
The problem categories identified included the outside referral process to our practice, issues with the scheduling and with the actual post diagnosis first visit, issues with the ease of involvement of our nurse navigator, issues with events in the period between the recommendation to have surgery and the actual surgery (2nd opinions, neoadjuvant chemotherapy) and issues with the surgery scheduling process. The main barriers (problems) were felt to be the ones regarding scheduling issues, patient choice factors, and comorbidity evaluation.
The proposed quality improvement interventions to overcome these barriers were composed of five primary components: adjustment of OR scheduling; enhanced patient navigation; changes in the management of referrals; milestone alerts through the outpatient electronic medical record (EMR) for the patients’ providers; and modification of the scheduling process.
1. One of main components of our analysis was to assess and revise the operating room scheduling process to prevent scheduling delays. Cystectomies are lengthy procedures (4-6+ hrs) and therefore require extended OR times, and availability and presence of ancillary personnel familiar with the procedure. When limited access to the OR was recognized as a barrier to our process, data on the urologic utilization of the OR was obtained and a request was brought to the OR committee advocating for more OR time based on our improved survival data with bringing patients to surgery in less than 90 days after diagnosis. Another intervention was to move potential outpatient operations to our day surgery facility rather than the main inpatient hospital to maximize access to open surgery time at our main campus.
2. Although patient navigators have been in place in several clinical settings in our institution, they were underutilized for patients diagnosed with invasive bladder cancer. A preliminary review of medical charts revealed that a primary reason for delay for cystectomy, after the recommendation for surgery, was related to patient indecision or delay in moving through different treatment modalities. Thus we chose to more rigorously apply patient navigation to bladder cancer patients. This would systematize referral to the navigator and standardize patient education and navigation milestones to better assist patients in achieving informed decisions about their treatment in a timely fashion. Interventions included staff meetings to reinforce the need for referral and education of all our staff (including the physicians) about the role of our nurse navigator.
The model for a patient navigator is to provide supplemental education about treatment risks, benefits and alternatives, and to assist the patient in navigating the individual steps from referral, second opinion, treatment and recovery. The nurse navigator would receive a referral upon diagnosis of T2 invasive bladder cancer and contact the patient by phone to review the treatment risks and benefits, answer any additional questions, and facilitate efficient decision-making. Facilitating efficient decision-making may be achieved through patient education alone, or by facilitating referrals for second opinions or contact with a patient who has undergone a similar treatment. The navigator would conduct periodic follow-up calls to ensure that the patient is progressing toward a final decision and initiation of treatment. Also, in the case of patients receiving a course of neoadjuvant therapy first, follow-up calls will be used to transition efficiently from chemotherapy to subsequent surgery. By involving our nurse navigator, and thus providing prompt and early education to our patients, our patients will come to a timely decision thereby reducing the interval from diagnosis to surgery.
3. Regarding our referral pattern issues, our interventions included revising our internal referral directly to a single scheduler (schedulers had jointly handled all urology scheduling previously) paired to our nurse navigator to ensure all the pertinent information from outside referrals is available for our surgeon to evaluate. When information is incomplete, schedulers actively collect information prior to the scheduled visit. This new process required specialization of scheduling staff.
4. A new flow sheet was implemented through the outpatient electronic medical record (EPIC). The flow sheet appears as a single tab in the outpatient EMR and as milestones are reached, alerts are generated, so that the surgeon, navigator and schedulers are made aware of the time remaining before reaching the 90-day mark so that the appropriate scheduling procedures are undertaken as follows: as soon as a patient’s TURBT indicates T2 invasive bladder cancer, an alert is sent to the patient navigator and to the surgeon’s office prompting a visit with the surgeon to be scheduled. The next alert is sent to the patient navigator prompting patient contact once a treatment recommendation has been made; either for neoadjuvant therapy followed by cystectomy or for cystectomy directly. Finally, alerts to the patient navigator are generated at regular intervals from the date of treatment recommendation to ensure that patients finalize decisions in a timely manner.
Regarding the electronic medical record per se, it will aid with the tracking of milestones from diagnosis to surgery, automatic referral, automatic reminders and reporting and enhancement of completeness of information. Maine Medical Center has implemented a single electronic medical record tool for all services system wide.
Our chart review analysis revealed that another major cause of delay in receipt of treatment after recommendation for surgery related to the office and/or operating room scheduling and the coordination between the outpatient and inpatient systems. The flow sheet embedded in the EPIC EMR is used to a) combine and track data in a single location and b) generate alerts to the patient navigator, surgeon and hospital for patient tracking and efficient scheduling of treatment.
5. The scheduling process was altered to implement protected office block time for in-depth discussion about treatment options; a dedicated scheduler for oncology cases only; and protocol defined visits with nurse navigator, medical oncology, as well as early reservation of operating room time.
The scheduler was also tasked with booking the patient’s first post-diagnosis visit along with holding an OR block for potential cystectomy even prior to the patient decision. In selected patients, simultaneous appointment with medical oncology was booked to ensure prompt evaluation and possible implementation of neoadjuvant therapy if indicated.
Patients with bladder cancer are assigned to protected office blocks for cystectomy surgeons for their initial visits and follow up. As with our referral process, a primary oncology scheduler was assigned to our patients with bladder cancer, to centralize their flow through our system. Also, when a patient was identified to have muscle-invasive cancer, the patient would be assigned to his primary surgeon (if they did cystectomies) or to another cystectomy surgeon depending on the availability of a cystectomy surgeon’s open OR time availability. Regarding the latter, the process would be facilitated by presentation of all our patients to our multidisciplinary tumor board to allow for transfer of care to an available cystectomy surgeon.
Planning Study of the Intervention
The specific aim of this project was to identify the factors delaying the time between diagnosis of muscle-invasive bladder cancer to cystectomy and implement interventions to achieve 100% of surgeries within 90 days of diagnosis.
The primary outcome was the number of patients achieving surgery within 90 days of diagnosis, measured with real-time alerts in our EMR. To confirm ultimate compliance with the interventions, on a quarterly basis, the urology program manager and the oncology systems coordinator generate reports detailing T2 bladder cancer patients’ time from diagnosis to surgery. This will be an ongoing project with no defined end date.
Impact to Date
With all our planned interventions implemented by December 2010, patient flow was tracked and results indicate that all patients since have met the milestones towards meeting the 90-day window for surgical treatment. A system redesign to achieve 100% of the patients with T2 disease to undergo radical cystectomy within 90 days of diagnosis is feasible and achievable.
(1 ) Gore, J. ; Lai, J. ; Setodji, C. ; et al. Mortality increases when radical cystectomy is delayed more than 12 weeks. Cancer, 2009; 115; 988-996.
(2) Sanchez-Ortiz, R.F. ; Huang, W.C. ; Mick, R. ; et al. An interval longer than 12 weeks between the diagnosis of muscle invasion and cystectomy is associated with worse outcome in bladder carcinoma. Journal of Urology, 2003; 169: 110-115.
(3) Herr, H.; Dotan, Z.; Donat, S.; et al. Defining optimal therapy for muscle invasive bladder cancer. Journal of Urology, 2007:177: 437-443.
(4) Stein, J.P.; Lieskovsky, G.; Cote, R.; et al: Radical cystectomy in the treatment of invasive bladder cancer: long-term results in 1,054 patients. Journal of Clinical Oncology, 2001; 19(3): 666-675.
(5) Nelson, E.C.; Godfrey, M.M.; Batalden, P.B.; et al: Clinical Microsystems, Part 1. The Building Blocks of Health Systems. The Joint Commission Journal on Quality and Patient Safety, 2008; 34(7): 367-378.
(6) Nelson, E.C.; Batalden, P.B.; and Godfrey, M.M. Quality By Design: A Clinical Microsystems Approach. San Francisco: John Wiley & Sons: 2007.
Otto Sandoval, M.D.
Urology Resident, Maine Medical Center
22 Bramhall Street, Portland, ME 04102
Oncology Systems Coordinator, Maine Medical Center Cancer Institute
100 Campus Drive, Scarborough, ME 04074
Urology Program Manager
Maine Medical Center
Doug Salvador, M.D., MPH
Vice President, Quality and Patient Safety, Maine Medical Center
Assistant Professor of Medicine, Tufts University School of Medicine
Brian Jumper, M.D.
Director of Pediatric Urology, Maine Medical Partners Urology
Assistant Clinical Professor, Tufts University School of Medicine
100 Brickhill Avenue, South Portland, ME 04106
Oncology Nurse Navigator
Maine Medical Center Cancer Institute
Moritz Hansen, M.D.
Co-Director, Division of Urology, Maine Medical Partners Urology
Assistant Clinical Professor, Tufts University School of Medicine
Craig Hawkins, M.D.
Maine Medical Partners Urology, Assistant Clinical Professor