Lucille Lee

Incident Learning and Failure-Mode-and-Effects-Analysis Guided Safety Initiatives in Radiation Medicine

By combining incident learning and process failure-mode-and-effects-analysis (FMEA) in a structure-process-outcome framework we have created a risk profile for our radiation medicine practice and implemented evidence-based risk-mitigation initiatives focused on patient safety. Based on reactive reviews of incidents reported in our departmental incident-reporting system and proactive FMEA, high safety-risk procedures in our paperless radiation medicine process and latent risk factors were identified. Six initiatives aimed at the mitigation of associated severity, likelihood-of-occurrence, and detectability risks were implemented. These were the standardization of care pathways and toxicity grading, pre-treatment-planning peer review, a policy to thwart delay-rushed processes, an electronic whiteboard to enhance coordination, and the use of six sigma metrics to monitor operational efficiencies. The effectiveness of these initiatives over a 3-years period was assessed using process and outcome specific metrics within the framework of the department structure. There has been a 47% increase in incident-reporting, with no increase in adverse events. Care pathways have been used with greater than 97% clinical compliance rate. The implementation of peer review prior to treatment-planning and use of the whiteboard have provided opportunities for proactive detection and correction of errors. There has been a twofold drop in the occurrence of high-risk procedural delays. Patient treatment start delays are routinely enforced on cases that would have historically been rushed. Z-scores for high-risk procedures have steadily improved from 1.78 to 2.35. The initiatives resulted in sustained reductions of failure-mode risks as measured by a set of evidence-based metrics over a 3-years period. These augment or incorporate many of the published recommendations for patient safety in radiation medicine by translating them to clinical practice.

Prospective contouring rounds: A novel, high-impact tool for optimizing quality assurance

PURPOSE This study was designed to present the results of a novel prospective contouring rounds (CR), in which peer review occurs once the contours and written directive are completed but before initiation of treatment planning. METHODS AND MATERIALS Beginning in 2012, all patients undergoing conventionally fractionated radiation therapy at a high-volume academic center were reviewed in a newly initiated daily, prospective, multidisciplinary CR. Cases were scheduled for presentation 2 days after simulation with the expectation that contours would be complete. The clinical suitability of the clinical plan, prescription, contours, and written directive were evaluated and recorded in a prospective database. Treatment planning did not commence until CR approval. Patient information and the prospective database from the first 6 months since program inception, which represented 581 consecutive treatment plans, were pooled and analyzed retrospectively to determine the impact of the prospective peer review at this stage of care delivery. RESULTS Sixty-four percent of cases were completed on time without correction. The remaining 36% of cases required modification before treatment planning was initiated. Incomplete contours, target-volume modifications, and alterations to the written directive were the most common corrections or reasons for delay. Decreasing rates of incomplete contours, contour modifications, and miscellaneous delays were seen over time as the program became established. The percentage of cases that had no delays or modifications increased continuously as the program matured in the first 6 months, from 59% to 70%. CONCLUSIONS Prospective CR is a meaningful and impactful tool in the quality assurance process. More than one-third of cases required contour, directive, or scheduling modification. The establishment of CR improved quality of care, with the percentage of timely, errorless cases increasing steadily over time. The impact of clinical peer review may be optimized by implementation at this early stage of delivery of care rather than at the time of traditional chart rounds.

Development, Implementation, and Compliance of Treatment Pathways in Radiation Medicine

Introduction: While much emphasis on safety in the radiation oncology clinic is placed on process, there remains considerable opportunity to increase safety, enhance outcomes, and avoid ad hoc care by instituting detailed treatment pathways. The purpose of this study was to review the process of developing evidence and consensus-based, outcomes-oriented treatment pathways that standardize treatment and patient management in a large multi-center radiation oncology practice. Further, we reviewed our compliance in incorporating these directives into our day-to-day clinical practice. Methods: Using the Institute of Medicine guideline for developing treatment pathways, 87 disease specific pathways were developed and incorporated into the electronic medical system in our multi-facility radiation oncology department. Compliance in incorporating treatment pathways was assessed by mining our electronic medical records (EMR) data from January 1, 2010 through February 2012 for patients with breast and prostate cancer. Results: This retrospective analysis of data from EMR found overall compliance to breast and prostate cancer treatment pathways to be 97 and 99%, respectively. The reason for non-compliance proved to be either a failure to complete the prescribed care based on grade II or III toxicity (n = 1 breast, 3 prostate) or patient elected discontinuance of care (n = 1 prostate) or the physician chose a higher dose for positive/close margins (n = 3 breast). Conclusion: This study demonstrates that consensus and evidence-based treatment pathways can be developed and implemented in a multi-center department of radiation oncology. And that for prostate and breast cancer there was a high degree of compliance using these directives. The development and implementation of these pathways serve as a key component of our safety program, most notably in our effort to facilitate consistent decision-making and reducing variation between physicians.

Palliative treatment directives for bone metastases: A quality-directed approach to guiding institutional practice.

188 Background: The efficacy of single fraction (fx) radiation treatment (RT) has proven to have equipoise for palliation of bone metastases when compared to courses of 10 fx or more. Despite these data, there has been a slow adoption of this practice in the US and worldwide. Examination of our multicenter practice from 2004 - 2016 showed that single fx RT utilization has remained at 17% and hypofractionationed (HFX) courses (1 or 5 fx) have remained at 71% since 2009. We hypothesized that evidence-based, treatment-guiding directives could improve HFX utilization in this population. METHODS Institutionally, palliative bone metastasis treatments are routinely tracked by a Quality Assurance committee. In 2/2016, two consensus-driven and evidence-based clinical directives were created within our electronic health system for use with either simple or complicated bone metastasis, irrespective of primary histology. The simple and complex directives had default prescriptions of 8 Gy/1fx or 20 Gy/5fx, respectively. The directives were reviewed with physician staff to improve compliance; directives were allowed to be edited at the physicians discretion if an alternative fx was indicated. The chi-square test was used for analysis. RESULTS From 1/2009-5/2016, there were 1,781 treatment courses of palliative external beam RT. Following implementation in 2/2016, the new clinical directives were used for 96% of cases and were modified in 12 cases (n = 72). Single fx use increased from 17% to 36% among palliative bone metastasis treatments (p ≤ 0.001) and HFX (1 or 5 fx) utilization increased from 71% to 92% compared to other fractionation schemes (10 fx or other) (p = 0.001). CONCLUSIONS The institution-wide adoption of evidence-based, treatment directives proved to be a straightforward and successful intervention which allowed for rapid adoption and increased utilization of the standard of care. Our early data suggests that this may be a useful approach in the setting of reticence to new treatment paradigms. Further examination of evidence based directives is warranted to address issues of overtreatment in palliation and in standardizing oncologic care.

Radiation Therapy: Brachytherapy

Prostate brachytherapy is an interventional procedure that is highly safe and effective for the treatment of localized prostate cancer. Brachytherapy offers equivalent to superior biochemical outcomes when compared to external beam radiation therapy and radical prostatectomy but offers an attractive toxicity prolife, improved quality of life, and preservation of sexual function when compared to these modalities. Modern prostate brachytherapy has benefitted significantly from the integration of advanced radiologic technologies, which have led to significant advances in the diagnosis and staging of prostate cancer, in the intraoperative imaging and placement of radioactive sources, and in the dosimetric assessment and toxicity management of patients undergoing prostate brachytherapy.

Implementation of clinical practice guidelines in a multicenter radiation oncology department.

117 Background: Recent reports suggest that less than 20% of cancer care is based upon level I evidence. As a result, the majority of cancer care tends to be ad-hoc. Furthermore, deviations from established standards-of-care are associated with worse clinical outcomes. Systematic and evidence-based approaches to cancer care are widely regarded as an effective way of improving quality and value in oncology, yet their implementation remains broadly circumspect. In our multicenter radiation medicine department, we developed clinical practice guidelines (CPGs) that encourage consistent care in order to minimize variations in patient treatment, outcome, and experience. We hypothesized that CPGs would also improve efficiency, performance, and cost. METHODS We developed a system for prioritizing value in radiation oncology (Smarter Radiation Oncology) comprising three pillars - quality, evidence-based care, and patient experience. We created 87 unique, evidence-based and consensus-driven electronic CPGs that apply to the majority of patients undergoing radiation therapy in our department. Each CPG delineates an evidence-based treatment approach for a specific cancer site and stage, as well as many technical components such as simulation, treatment planning, quality assurance, clinical care requirements and survivorship. RESULTS Overall compliance to CPGs was >88%. Six-sigma Z-scores indicated improvement in efficiency and compliance. Treatment delays decreased and patients reported more favorable ratings on a variety of measures, including likelihood to recommend, wait times, understanding of treatment, and physician sensitivity. For breast and prostate cancer, adherence to CPG treatment resulted in 20% and 15% average lower costs than standard, non-CPG treatment. CONCLUSIONS We demonstrate that consensus- and evidence-based CPGs can be successfully implemented in a multicenter department, with high adherence rates. CPGs improve safety and reduce costs by minimizing variation and deviations from standards-of-care. In an era of rising cancer spending, CPGs can be expanded beyond radiation oncology to the entire oncologic care process, thereby improving value for all cancer patients.