Abstract: Eastern North Carolina (ENC) is home to a rural population that suffers from disparities in breast cancer outcomes. It has been demonstrated that evidence-based clinical pathways can improve quality of cancer care. We sought to use the electronic health record (EHR) as a tool for promoting adherence to clinical pathways to improve the quality of breast cancer care in ENC. A stakeholder team was assembled consisting of representatives from all oncology disciplines within our regional hospital system. A system-wide multidisciplinary Virtual Breast Cancer Conference (VBCC) was operationalized. A standardized VBCC template was purposefully designed to include clinical pathway elements as discrete variables to facilitate rapid analysis and continuous quality improvement. EHR triggers were developed to prompt providers to review the VBCC document and comply with specific elements. Across eight stakeholder meetings, evidence-based clinical pathways and quality metrics for breast cancer care in ENC were developed by multidisciplinary consensus. Complex pathways were broken down into over 75 elements corresponding to individual treatment decisions, and a minimum accepted compliance standard was established for each element. Baseline data analysis revealed subpar compliance with multiple elements. Gemba walks demonstrated that the standardized VBCC template is user-friendly. EHR triggers are currently in the beta testing phase. While VBCC participation by physicians at nonflagship hospitals has not been robust, EHR enhancements are a promising tool for promoting adherence to evidence-based clinical pathways, thereby improving the quality of breast cancer care in ENC.
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People residing in rural regions of the United States are at increased risk for poor health outcomes, including outcomes from cancer.1 Rural residents have lower cancer survival rates than their urban counterparts, even when controlling for possible confounding variables such as distance from a medical facility, race/ethnicity, and socioeconomic status.2 Breast cancer is no exception.2
The eastern region of North Carolina (ENC) is home to a medically underserved, largely rural population known to experience poorer health care outcomes than the rest of North Carolina.3 Patients with breast cancer residing in ENC are more likely to have delays in delivery of adjuvant chemotherapy4 and suffer from higher rates of breast cancer-specific mortality when compared with the rest of the state.5 A regional hospital system that serves this rural constituency is uniquely positioned to address these disparate outcomes.
Evidence-based clinical pathways are supported by the American Society of Clinical Oncology (ASCO) as a mechanism for improving the quality of cancer care.6 Clinical pathways have been demonstrated to improve multiple aspects of care delivery7 as well as patient satisfaction and quality of life.8 We believe that developing, implementing, and ensuring compliance with evidenced-based clinical pathways for breast cancer care within our regional hospital system can minimize variation in care across the health system, facilitate the delivery of high-quality breast cancer care for all patients, and mitigate the effects of rurality on cancer outcomes in ENC.
The overall goal of the collaborative quality improvement project described in this report is to ensure that patients in ENC receive safe, timely, patient-centered, evidence-based, and efficient care for newly diagnosed patients with breast cancer within their local community health care systems. This report describes the development of electronic health record (EHR) enhancements: (1) to integrate evidence-based clinical pathways for breast cancer care into a regional hospital system; and (2) to provide a means for rapid analysis of quality metrics. The structure of this report adheres to the Standards for Quality Improvement Reporting Excellence (SQUIRE) 2.0 guidelines.9
Methods
Background
Our regional hospital health system serves over 1.4 million people across 29 counties in ENC. The system is comprised of eight hospitals with a total of 1447 beds. These hospitals include one academic medical center and three Centers for Medicare & Medicaid Services-designated Critical Access Hospitals. All health care providers employed by our regional hospital system utilize a shared EHR on the Epic platform.
Interventions
A stakeholder team was assembled consisting of representatives from all oncology disciplines within our regional hospital system. The quality improvement initiative was advertised to each of the hospitals, and letters of support were secured from administrators. An open invitation was issued to all the medical oncologists, radiation oncologists, and surgeons at these hospitals. Providers were given the opportunity to contribute to clinical pathway development and/or meaningfully participate in a system-wide multidisciplinary breast cancer conference.
Evidence-based clinical pathways and quality metrics for breast cancer care in our region were developed by multidisciplinary consensus across multiple stakeholder meetings. Pathways were defined for the work-up and treatment of each of the following: ductal carcinoma in situ, early stage invasive disease, inoperable or locally advanced invasive disease, and metastatic breast cancer. Quality metrics were established by breaking down each complex clinical pathway into discrete elements and defining a minimum standard for adherence to each element. Sources of evidence for these pathways and quality metrics included ASCO guidelines,10 National Accreditation Program for Breast Centers standards,11 National Comprehensive Cancer Network guidelines,12 and current literature.
A system-wide Virtual Breast Cancer Conference (VBCC) was operationalized to facilitate multidisciplinary care and adherence to national evidence-based guidelines for breast cancer care. This weekly conference takes place at the flagship hospital’s cancer center and features state-of-the-art video conference equipment to enable seamless participation by and discussions between in-person and remote attendees alike. One of the primary goals of the VBCC is to ensure that breast cancer cases in the region are prospectively discussed by a multidisciplinary team that emphasizes evidence-based breast cancer care at the time of diagnosis, at time of recurrence, and at transitions of care (postoperative or post-neoadjuvant therapy).
Through collaboration with an established EHR Advisory Group, the clinical pathways were integrated into the EHR through multiple approaches. First, standardized VBCC templates comprised of clinical pathway elements were developed and made live within the EHR. These templates were purposefully designed to enable rapid data collection and real-time analysis of variance from minimum quality standards. Each element included in the templates was designed to be analyzable as a discrete variable via use of checkboxes and drop-down menus or as a qualitative variable via use of free-response text boxes. This design allows for rapid extraction of data elements via EHR queries. In addition, specific EHR triggers were developed to encourage compliance with clinical pathways and VBCC recommendations.
Study of the Interventions
The impact of this quality improvement initiative can be evaluated by comparing rates of compliance with quality metrics before and after the implementation of various interventions.
Baseline data were collected via retrospective review of records of patients diagnosed with breast cancer within our regional hospital system in the 2 years preceding the initiation of this project (2016 and 2017). Eligible patients were identified from our institutional cancer registry. The first comparative analysis will be performed 3 months after the completion of all EHR enhancements.
Measures
To measure meaningful participation by stakeholders, minimum standards for multidisciplinary conference attendance were established. The following are measured: (1) overall rates of clinical pathway adherence; (2) rates of compliance with defined quality metrics for each element of the pathway; and (3) rates of provider response to EHR triggers designed to promote compliance.
Analysis
Qualitative methods include Gemba walks to evaluate the ease of use of standardized VBCC templates by real-time users. Quantitative methods include use of the student t test to compare compliance rates before and after implementation of the entire quality improvement initiative.
Results
Table 1 illustrates the timeline of key action steps in our quality improvement project.
Formal commitments were obtained from administrators at the flagship hospital and two of the seven remaining hospitals within our regional health care system. Following an open invitation to all oncology stakeholders in our hospital system, medical oncologists from five institutions (62.5%), surgeons from three institutions (37.5%), and radiation oncologists from two of four facilities with this service (50%) agreed to participate in this quality improvement initiative. These physicians agreed to contribute to clinical pathway development and to meaningfully participate in our system-wide VBCC.
Through multidisciplinary discussion across eight stakeholder meetings, evidence-based clinical pathways were developed. These clinical pathways encompass all aspects of breast cancer care including screening, diagnostic approaches, treatment algorithms, and survivorship care. These complex pathways were broken down into over 75 elements corresponding to individual treatment decisions. A minimum accepted compliance standard was established for each clinical pathway element. Final clinical pathways and quality metrics were compiled into a formal Breast Cancer Standards, Goals, and Pathways document, which will be available to all breast cancer providers in our regional hospital system via the hospital intranet (Supplementary Materials).
The VBCC was operationalized after the opening of a new cancer center at the flagship hospital in the third month of this project. Baseline attendance included two surgeons, 1 to 2 medical oncologists, 1 to 2 radiation oncologists, one pathologist, and 2 to 3 breast imagers. After the VBCC was operationalized, a third surgeon and third radiation oncologist began to attend regularly, and additional physicians started to attend periodically via remote access. However, we have not had consistent participation by regional network medical oncologists, radiation oncologists, or surgeons.
Several EHR changes were made, as shown in the project timeline (Table 1). First, standardized VBCC templates were created for patients at the time of diagnosis, at time of recurrence, and at transitions of care (postoperative and post-neoadjuvant therapy). These templates will allow the collection of discrete data elements. Gemba walks demonstrated that after a brief learning curve, users can navigate the templates with ease and feel that they are a manageable addition to their clinical workflow. In addition, two EHR triggers have been developed. A “Best Practice Alert” trigger encourages oncology providers to review the VBCC recommendations upon opening a patient’s chart, and a “Required Element Completion” trigger prompts providers to enter a clinical stage as soon as “breast cancer” is added to the Problem List. These triggers are currently in the beta phase of testing.
To analyze baseline compliance, 435 new breast cancer cases diagnosed in the 2 years prior to the initiation of this quality improvement project were reviewed with respect to several key quality metrics. These results highlight multiple areas for improvement and demonstrate significant variability in compliance rates between the flagship hospital and the remainder of the hospitals in the system (Table 2).
Three months following the go-live date for final EHR enhancements, we will run an EHR query to generate our first post-implementation quality report. The impact of the quality improvement project on adherence to clinical pathway elements will be evaluated via quantitative analysis of established quality metrics. These results will be discussed in a stakeholder meeting and an action plan will be agreed upon to allow the completion of the first Plan-Do-Study-Act (PDSA) cycle. Thereafter, reports will be generated every 3 months and discussed at regular stakeholder meetings to ensure completion of a PDSA cycle every quarter. In the spirit of continuous quality improvement, quality metrics and minimum standards will be routinely re-evaluated on a quarterly basis at stakeholder meetings.
Discussion
The overall goal of this quality improvement project is to ensure that patients in ENC receive safe, timely, evidence-based, equitable, and high-quality breast cancer care within their local community health care systems. We proposed to accomplish this overall goal by using health system-wide, evidence-based breast cancer clinical pathways. This report describes the use of the EHR as a tool for promoting adherence to clinical pathways and facilitating continuous quality improvement. Purposeful design of EHR templates not only enables standardized documentation of multidisciplinary conference recommendations, but also allows for real-time analysis of categorical quality metrics via rapid EHR queries. EHR-based approaches to measuring quality of care are therefore both robust and efficient.
The quality improvement approach described herein may be generalizable to many health care settings and may translate to diseases beyond breast cancer. One challenge to the universal adoption of our approach is fragmentation of care across multiple health care systems. If institutions share a common EHR platform, however, they may be able to network to overcome this obstacle; for example, the Epic platform offers inter-system connectivity via the “Care Everywhere” feature. Institutions with different EHR platforms or without EHR capabilities may benefit from web-based tools for quality improvement. Flores and colleagues utilized a cloud-based technology platform to successfully develop and disseminate clinical pathways for cancer, pulmonary/critical care, and cardiovascular medicine across a multisite health care system.13 Although breast centers can participate in an established web-based national quality improvement program via the National Quality Measures for Breast Centers,14 clinical pathways offer quality improvement benefits beyond what can be realized by this tool.6 Furthermore, developing clinical pathways via multidisciplinary consensus of stakeholders within a health care system ensures that quality metrics will be appropriate for the cultural context of the system’s patient population. Another approach to avoiding the limitations of varied EHRs across different institutions is utilization of a network-wide EHR. For example, evidence-based clinical pathways have been incorporated into the US Oncology Network’s iKnowMed EHR through a quality tool called Clear Value Plus.15
Standardized EHR templates for multidisciplinary conferences can improve quality of breast cancer care. Farrugia and colleagues reported improved adherence rates for two of three national quality metrics established by the American College of Surgeons Commission on Cancer’s Rapid Quality Reporting System following a simple modification of their institution’s multidisciplinary breast cancer conference EHR note template.16 Despite promising initial results, their project did not continue beyond the pilot phase due to time and personnel constraints. Generation of quality reports required labor-intensive chart abstraction by dedicated staff. In contrast, our VBCC template was purposefully designed to enable efficient data extraction via rapid EHR queries. As some template-derived data represents multidisciplinary recommendations that may or may not be followed, we plan to verify adherence using administrative data such as Current Procedural Terminology codes or Treatment Plans codes (eg for systemic therapy and radiation therapy). Our methodology, therefore, minimizes the need for retrospective chart review and facilitates sustainability.
Some chart review will still be necessary. Although our hospital system benefits from an institutional cancer registry, there is a brief time lag in the availability of registry data relative to EHR-derived data. Work is ongoing to design a system that will allow for efficient importation of both EHR-derived data and registry-derived data into a shared database, such as our institutional research database application, Research Electronic Data Capture (REDCap).17 The feasibility of integrating institutional data and state data has been demonstrated: the Oncoshare database successfully combined EHR data from two health care organizations and data from the California Cancer Registry.18 When our two datasets are merged, it will be important to select the correct metrics for evaluation and comparison. For example, the VBCC template includes a discrete variable that classifies patients as meeting or not meeting criteria for postmastectomy radiation and the cancer registry collects treatment data, but it remains to be determined how to best measure pathway compliance. Potential metrics include start of radiation therapy within a specific time frame postoperatively, completion of all treatment sessions without delays, or receipt of the full recommended dose, among other options. If the ideal metric is not readily analyzable from raw cancer registry data, stakeholders will need to decide whether there are sufficient resources to perform the chart review necessary to obtain additional data or whether an alternative metric is more feasible.
As compliance is the rate-limiting step for successful implementation of clinical pathways, effective approaches for promoting compliance are essential. We anticipate that our EHR triggers will successfully improve compliance because similar triggers have been demonstrated to be effective mechanisms for identifying deviations from quality standards in cancer care.19 We intentionally limited the number of triggers to two in an effort to prevent “click fatigue,” which is associated with increased patient safety hazards and physician burnout.20 Once beta testing is complete and the triggers go live, we will solicit feedback from providers about the perceived benefits of the EHR triggers relative to the additional burden on their workflow. This feedback will be considered in the context of the results of the first post-implementation report with the goal of maximizing the utility of the EHR triggers in future PDSA cycles.
Initiation of this project required convincing key stakeholders of the relative advantage of compliance with clinical pathways in breast cancer care. Although physicians from all oncologic subspecialties contributed to the development of the Breast Cancer Standards, Goals, and Pathways document, VBCC participation by physicians at non-flagship hospitals has not been robust. Based on feedback from nonparticipating physicians, scheduling conflicts are the primary reason for their lack of participation in the weekly VBCC. n effort was made to identify a more suitable time, but poll results showed that the current schedule enables participation by a maximal number of providers. Participation of regular VBCC attendees in separate multidisciplinary conferences held at nonflagship hospitals may allow for improved collaboration and greater buy-in for this quality improvement project.
Conclusion
In summary, EHR enhancements are a promising tool for promoting adherence to evidence-based clinical pathways, thereby improving the quality of cancer care in ENC.
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