Development of a workflow process mapping protocol to inform the implementation of regional patient navigation programs in breast oncology

Abstract

Background:

Implementing city-wide patient navigation processes that support patients across the continuum of cancer care is impeded by a lack of standardized tools to integrate workflows and reduce gaps in care. We present an actionable workflow process mapping protocol for navigation process planning and improvement based on methods developed for the Translating Research Into Practice (TRIP) study.

Methods:

Key stakeholders at each study site were identified through existing community partnerships, and data on each site’s navigation processes were collected using mixed methods through a series of team meetings. We utilized Health Quality Ontario’s Quality Improvement Guide, service design principles, and key stakeholder input to map the collected data onto a template that is structured according to the case management model.

Results:

Data collection and process mapping exercises resulted in a ten-step protocol that includes: 1) workflow mapping procedures to guide data collection on the series of activities performed by healthcare personnel that comprise a patient’s navigation experience, 2) a site survey to assess program characteristics, 3) a semi-structured interview guide to assess care coordination workflows, 4) a site-level swim lane workflow process mapping template, and 5) a regional high-level process mapping template to aggregate data from multiple site-level process maps.

Conclusion:

Our iterative, participatory approach to data collection and process mapping can be utilized by improvement teams to streamline care coordination, ultimately improving the design and delivery of an evidence-based navigation model that spans multiple treatment modalities and multiple health systems in a metropolitan area. We present this protocol as an actionable toolkit, so the work may be replicated to support other quality improvement initiatives and support efforts to design truly patient-centered breast cancer treatment experiences.

Lay Summary:

Evidence-based patient navigation in breast cancer care requires integration of services through each phase of cancer treatment. The Translating Research Into Practice (TRIP) study aims to implement patient navigation for patients with breast cancer who are at risk for delays and seeking care across six health systems in Boston, MA. We designed a ten-step protocol that outlines procedures and tools that support a systematic assessment for health systems that wish to implement breast cancer patient navigation services for patients at risk for treatment delays.

Precis:

This workflow mapping protocol was designed to support health systems to plan for implementation of a breast cancer patient navigation program to support patients across multiple treatment modalities. This tool may be used to disseminate evidence-based navigation in oncology care.

Background/significance

Patient navigation is an evidence-based model of cancer care delivery that has demonstrated efficacy in improving access to timely breast cancer care among patients who are at risk for delays in care.¹ Patient navigation in the cancer care setting refers to individualized assistance offered to patients, families, and caregivers to help overcome healthcare system barriers and facilitate timely access to quality health and psychosocial care from pre-diagnosis through all phases of the cancer experience.² A foundational principle of navigation is that navigation services should be directed toward patients with low incomes and those experiencing barriers related to care access, who experience disproportionate poor outcomes with cancer and are most likely to benefit from navigation, with the ultimate aim of improving health equity for historically marginalized groups.³ In its 2016 edition of Cancer Program Standards, the American College of Surgeons’ Commission on Cancer (CoC) endorsed patient navigation with its mandate that CoC-accredited programs should establish a patient navigation process as part of continuum of care services “in order to address health care disparities and barriers to cancer care”.⁴ The CoC specifies that prior to establishing the navigation process, the institution should conduct a Community Needs Assessment (CNA) to identify the community and local patient population, health inequities and barriers to care the population of patients with cancer may face, as well as the availability of resources to overcome those barriers.

While the CoC acknowledges navigation as a process, the CNA elements it describes assess only the characteristics of a community’s needs. The CNA as described does not include an assessment of the interrelated steps in care delivery through which a patient must be navigated. The importance of mapping processes to enhance patient experiences within a given oncology program is well-justified; however, mapping processes within a single institution does little to address treatment interruptions related to transfer of care between institutions.^5,6 Patients with breast cancer who are Black and classified as lower socioeconomic status are 2–3 times more likely to experience these interruptions, which can impact survival outcomes.^7,8

Despite its well-recognized promise for improving breast health equity among historically marginalized racial groups and low-income patient populations that may face systemic barriers to care, the implementation of patient navigation processes within even a single oncology program can be challenging.^1,9 One barrier is a lack of standardized tools to facilitate the organization and optimization of navigation activities within and across healthcare settings.^10,11 The care management or case management model, which is a foundational concept in the science of patient navigation, is comprised of four components that offer a practical template for mapping the navigation process across the treatment continuum.¹² As described by the Patient Navigation Research Program, the first step is case identification, which is a systematic approach to identifying and prioritizing new patients with cancer.¹² The second is identifying individual barriers to receiving care and health-related social needs. Third, navigators should develop an individualized action plan to address the barriers and needs identified by the patient. The fourth step is tracking, which includes longitudinal follow-up with the patient throughout transitions between treatment modalities until treatment completion or navigation services are no longer needed. Evidence on the outcomes associated with treatment delays suggests that this follow-up should occur not only during transitions within an oncology program, but also during transitions to other oncology programs.⁸

To address this gap, we adapted the practice of process mapping by integrating it with the case management model and applying it to the oncology navigation setting, and present the products of this exercise as a protocol for navigation process planning and improvement. This paper describes the development of these tools within the context of the Translating Research Into Practice (TRIP) intervention and parent protocol, and presents actionable steps for replication of this work to support other large-scale patient navigation programs.

Methods

IRB Approval

The parent study received institutional review board approval from the Boston University Medical Center/Boston Medical Center Institutional Review Board (IRB# H-37314). The workflow mapping data collection protocol was developed as part of the study’s formative work under a Non-Human Subjects Research designation with the goal of creating a generalizable protocol for city-wide navigation process planning and improvement.

Translating Research into Practice (TRIP)

TRIP is a hybrid type I effectiveness-implementation trial which deploys a standardized patient navigation intervention across six Boston academic medical centers to address racial and socioeconomic disparities in receipt of timely breast cancer treatment.¹³ The collaborative, systems-level intervention incorporates a city-wide patient navigation protocol, use of a shared regional patient registry, and a standardized assessment and referral process for addressing patients’ barriers to care.

The TRIP study has three strategic aims to 1) design, 2) execute, and 3) disseminate the integrated, evidence-based navigation intervention. A community-engaged approach is embedded throughout the TRIP study to achieve these aims, which values equitable decision-making and long-term commitment to the partnership process, emphasizes the development of trusting relationships, and employs iterative and cyclical processes.¹⁴ The workflow process mapping protocol was developed during formative work for TRIP when designing the intervention. It was developed through collaboration by multiple TRIP sites and used to assess the continuity of navigation processes at all of the TRIP sites.

Conceptual Approach to Formative Work

Our conceptual approach to formative work for the TRIP intervention draws from service design principles and human-centered approaches, which aim to improve experiences by optimizing an organization’s operations to better support the individuals being served.¹⁵ The user experience design and service design fields are known for placing user needs at the center of improvement initiatives, and this ethos of human-centered design (HCD) is taking hold in healthcare and as a way to ensure that increasingly complex healthcare systems center patient needs as opposed to other priorities.¹⁶ HCD approaches can support effective and equitable community-based participatory research (CBPR), particularly in projects like TRIP which aim to address complex public health problems, utilize transdisciplinary teams, and address power inequities that exist between academic research teams and community partners.^17,18,19 We identified process mapping, a tool used in both healthcare quality improvement and service design initiatives, as a methodology with promising applications in the oncology setting.^5,6,20,21 It has increasingly been used in healthcare to identify the sequence of steps in a process, understand the relationships between processes, encourage mutual understanding of process details among stakeholders, clarify roles and responsibilities, and identify bottlenecks and unnecessary complexity.²² The study team recognized the translational potential of service design principles to improve navigator and patient experiences and identified the Quality Improvement Guide from Health Quality Ontario as a practical framework for applying process mapping in healthcare quality improvement.²³ This Guide was selected for its useful comparison of multiple types of process maps and instructions for their application in healthcare. The study team integrated this guide with well-known healthcare organizational concepts, specifically the case management model, with input from key stakeholders. The outcome of this exercise resulted in an interview guide for conducting the qualitative workflow assessment (Table 3) to ensure that activities associated with each component of the case management model were systematically recorded.

Table 3:

Workflow assessment sample questions structured according to the case management model

Section 1: Navigation Overview	How long have you been a navigator? Who is your immediate supervisor? Who are the most important healthcare team members in your navigation work? At what point during treatment do you begin the navigation of breast cancer patients? Describe your relationship with MDs, nurses, and social workers. What metrics or data do you review regularly?
Section 2: Identifying Eligible Patients	What criteria make a patient eligible for navigation? How are patients that require navigation services identified? Is there anything that makes identifying patients for navigation easy or difficult? If so, please elaborate. What criteria do you use to determine which patients have the most urgent need for assistance? How many different software applications and/or computer systems do you need to log in to in order to identify and navigate patients each day? Please tell me the name and purpose of each of these platforms/computer systems. How many patients are you currently actively navigating? In the past 12 months, how often have you been unable to navigate a new patient because you had too many existing patients? If a patient transferred care to your institution from another hospital, do you have any way of knowing about their navigation experience or if they were navigated at the previous hospital? If yes, how?
Section 3: Longitudinal Patient Tracking and Follow-Up	Once a patient has been identified for navigation, how do you keep track of their appointments? How often do you reach out to the patients you are assisting? How often do your patients reach out to you? In the past 12 months what has been your preferred method of following up with patients? If a patient becomes unresponsive to your outreach, what strategy do you employ to attempt further assistance or determine why they are unresponsive? In your opinion, what is the greatest barrier to patient retention?
Section 4: Identifying Barriers to Care	Do you have a systematic way of screening people for social needs that are barriers to care? Once you have identified barriers to care, where do you log information on each patient’s most important barriers? What are the 3 most common social barriers to care you identify? When and how often do you screen patients for barriers to care? How do you document the information gathered on barriers?
Section 5: Addressing Barriers to Care	Which method of connecting patients with resources to address health related social needs has been the most successful in the past 12 months? Of the resources/referral organizations you have identified, which were most successful in assisting patients? In the past 12 months, how often have patients utilized the organizations they were referred to?

Creating the Protocol: Adapting Process Mapping to the Oncology Setting with Key Stakeholders

The Quality Improvement Guide from Health Quality Ontario identifies process mapping as a fundamental tool for identifying where problems in a process occur.²³ To collect data on the process of navigation at each of the TRIP hospitals, the study team utilized an existing community stakeholder group, the Boston Breast Cancer Equity Coalition (the Coalition), to identify clinical champions and navigation program administrators across Boston who would receive a web-based survey. The clinical champions are medical or surgical oncologists from each site’s breast oncology program, and would ultimately serve as co-investigators and on the study’s Clinical Advisory Panel (CAP). This group was charged not only with improving the continuity of navigation services at their respective institutions, but also doing so in a manner that would support the systematization of inter-hospital navigation processes regionally. The CAP assisted the study team in identifying the navigators, navigator supervisors, and other key personnel involved in navigation work at each site. These stakeholder groups, described in Table 1, convened through a series of multidisciplinary stakeholder meetings to collect and analyze data on each site’s navigation processes.

Table 1:

Stakeholders involved in the workflow mapping process

	Stakeholder Groups	Members	Role
Process Improvement Team	Study team	Researchers from 4 academic medical centers	Plan and conduct workflow mapping Synthesize findings
	Clinical champions, aka Clinical Advisory Panel (CAP)	Medical or surgical oncologists from clinical sites’ breast oncology programs	Provide knowledge of institution’s oncology program Identify appropriate staff to carry out navigation protocol Work with study team to iteratively improve implementation of navigation at site based on QI opportunities identified in process mapping
	Navigators	Nurse or lay navigators at clinical sites’ breast oncology programs	Provide knowledge of institution’s oncology program and patient touch points Carry out navigation protocol
	Navigator supervisors	Supervisors of navigation programs	Provide knowledge of institution’s oncology program Carry out navigation protocol
Community Stakeholders	Boston Breast Cancer Equity Coalition	Boston area academic researchers, breast oncologists, patient advocates, cancer survivors, public health officials	Identify clinical champions and navigation program administrators across Boston Advise study team

Results

The TRIP study team developed a protocol, summarized in Figure 1, to create standardized workflow maps for each study site, and presents this process as a protocol designed to complement the Community Needs Assessment required by the CoC by mapping an institution’s breast cancer patient navigation process across oncology departments. Users may adopt one or more tools, outlined in Table 2, to meet the unique needs of their program, depending on resource availability and project scope.

Figure 1:

Overview of the workflow mapping process

Table 2:

Components of the Workflow Process Mapping Protocol

Tool	Intended Use	Target Audience
Workflow Mapping Guide	Instructions for administering the site survey and semi-structured interview and presenting data on process maps	Process improvement team
Site Survey	Assess (1) staff composition, funding, and infrastructure of existing navigation program, (2) tools used by patient navigation personnel, (3) existing processes for addressing the social determinants of health	Site clinical champion(s)
Semi-Structured Interview (workflow assessment)	Identify specific people and processes involved in four key components of care coordination: (1) identifying patients; (2) tracking and following patients over time; (3) characterizing barriers to care; (4) and addressing barriers to care	Full breast oncology navigation team, which may include: patient navigator(s), patient navigator supervisor(s), and designated clinical champion(s).
Site-Level Swimlane Workflow Process Mapping Template	Template for visualizing workflow assessment data onto a site-level swimlane workflow process map	Process improvement team
Regional High-Level Process Map Template	Template for aggregating data from multiple site-level process maps to a single high-level regional process map	Process improvement team

Overview

To create a site-level and/or regional workflow map:

1. Identify clinical champions at each participating site.

   1. Identify individuals who have knowledge of the staffing composition and allocation of responsibility within the oncology programs they represent.
2. Survey the identified clinical champions to assess core navigation program characteristics:

   1. Staff composition, funding, and infrastructure of existing navigation program
   2. Web-based and physical tools used by patient navigation personnel to accomplish daily tasks
   3. Existing processes for addressing the social determinants of health and documenting patients’ individual barriers to care
3. Conduct a workflow assessment to identify care coordination strengths and opportunities within the navigation program, staff relationships with one another, and the sequence of steps in their work with one another and their patients. The workflow assessment takes the form of a semi-structured interview. This tool expands upon the basic characteristics of the oncology program assessed through the survey, and provides a more nuanced understanding four navigation components based on the Case Management Model⁵: (1) identifying patients; (2) identifying barriers to care; (3) addressing barriers to care; and (4) tracking and following patients over time. This exercise is intended to simulate a walkthrough of the staff’s interactions with a patient and other navigation personnel from diagnosis through the patient’s completion or transfer of care. Table 3 outlines sample questions in the workflow assessment by topic.

   1. Observe power dynamics and what staff are comfortable sharing, as power dynamics within the room may inhibit sharing and tamper the success of community-engaged research efforts.²⁰ Note items that may warrant individual follow-up in a subsequent meeting.
   2. The workflow assessment should be held at a mutually agreeable meeting space and time, and audio-recorded and transcribed.
4. Using information from the surveys and workflow assessments, create the site-level swim lane workflow process map as follows:

   1. Outline all departments offering breast oncology diagnosis and treatment services at the site (e.g., radiology, imaging center, pathology, surgical oncology, medical oncology, radiation oncology). Create a 2-column table, with one row for each department involved in breast cancer diagnosis and treatment. List department names in each cell of the left column.
   2. Identify which of the oncology departments in Step 1 offer patient navigation services. In the right column of the table, create a box for each staff member involved in providing navigation services for the given department.
   3. Identify which personnel in the departments outlined in Step 2 perform navigation activities. Add names and titles to the box in the right-hand column for the department staff work in. Departments that do not have personnel responsible for performing navigation activities will have a blank box with no personnel listed.
   4. Write in the navigation activities performed by each personnel to the right of the box with their name.
   5. Identify the patient handoffs between personnel. Draw arrows between boxes to indicate handoffs.
   6. Identify the mechanism of patient handoff between departments (i.e., email, phone call, a note in the electronic medical record, in-person conversation). Write down the mechanisms used for hand-offs on the arrows added in Step 5. Care transitions between departments that do not have a hand-off mechanism will not have an arrow. (Figure 2)
5. Meet with the site’s oncology navigation team to present the workflow assessment data back to them, using the workflow process map as a visualization.

   1. Verify that the sequence of steps in navigation workflow is accurately captured. Welcome edits and input.
6. Incorporate all suggested changes to ensure that the workflow process map visualizes the site’s navigation workflow accurately.

   1. The workflow process map should reflect navigation services across oncology departments as they currently are, not how they ought to be.²³

7. Meet as a team and discuss gaps, bottlenecks, and areas for standardization and process improvement using the workflow process map to facilitate the discussion. Maintain a focus on patient handoff between treatment modalities.

8. If the site’s process improvement initiative is part of a regional effort toward standardization in navigation processes, repeat data collection for all sites involved.

9. Aggregate all site-level process maps into a regional-level process map. The regional high-level process map can be used for multi-site process improvement initiatives in which stakeholders across multiple institutions seek to improve continuity of navigation care delivery by facilitating a “warm handoff” for patients who transfer their care during cancer treatment. The template presented in Figure 3 represents an anonymized, regional patient navigation high-level process map. This template may be utilized to illustrate the scope of navigation services offered across multiple institutions within the same region, and can be created by aggregating the data from each institution’s site-level swim lane workflow process map. The site in Figure 1 is represented as Site 1 in Figure 2 below. The template visualization in Figure 2 reveals that only two of the six sites offer navigation services across the entire spectrum of breast cancer treatment, from diagnosis through all treatment modalities. Furthermore, one site only offers navigation services in surgical oncology. In regions where many patients transfer care throughout the course of breast cancer treatment, patients are at risk for lacking access to crucial services that help identify and address barriers to care.

10. Convene stakeholders from all sites to discuss gaps, bottlenecks, and areas for regional standardization and process improvement using the regional-level process map to facilitate knowledge translation and action planning.

Figure 2:

Template of the patient navigation swimlane workflow process map, by oncology department Caption: This template displays an example of a site in which navigation activities are only offered in radiology and surgical oncology. While there is a “warm handoff” from radiology to surgical oncology, there are no personnel responsible for navigation to receive patients in either medical oncology or radiation oncology. This visualization illustrates a need to identify personnel in these two departments who can perform navigation activities and support multi-disciplinary care coordination throughout a patient’s treatment experience.

Figure 3:

Template of the Regional Patient Navigation High-Level Process Map, by site

Discussion

We adapted service design tools and HCD approaches with community engagement to plan a multi-site patient navigation process improvement initiative. By utilizing an iterative, participatory approach to tool design and data collection, process improvement teams may effectively utilize community partnerships and a site survey to stakeholders within a site and assess basic program structures and competencies. Building from this, teams may conduct a successful workflow assessment to systematically assess the breadth of navigation activities across departments that may not traditionally collaborate in process improvement initiatives. Finally, teams may present these data in an actionable way via workflow process maps. Discussion of logistical steps, roles, and responsibilities should be accompanied by an emphasis on ensuring that patients’ action plans for addressing their identified barriers to care transition seamlessly as patients move through different treatment modalities.

Process mapping is an effective exercise for promoting an aligned understanding among stakeholders of how a process actually works compared to how it is thought to work, and has been successfully translated from the engineering and user experience fields to be applied in a variety of complex care coordination settings.²⁵ Specifically, the study identified swim lane process maps as the most suitable medium for presenting navigator workflow data. The swim lane approach allows for the representation of the multiple departments involved in care coordination,²² and is used to identify patient handoffs between departments and keep track of which personnel are responsible for navigation activities throughout a patient’s breast cancer treatment. While process mapping has proven useful in a variety of single- and multi-site healthcare delivery contexts,^26–34 it has primarily been utilized in oncology to map processes within a single treatment modality.^35–39 The literature reveals a notable gap in describing the application of process mapping to streamline interdisciplinary processes in cancer care delivery and patient navigation, and a dearth of evidence on best practices for collaborative regional process improvement in oncology.⁷

Limitations to this process include the absence of a mechanism to determine whether any key stakeholders were omitted from the tool development process. Utilizing an existing community stakeholder group (the Coalition) allowed us to partner with a variety of stakeholders representing multiple academic medical centers, but it is possible that stakeholders not affiliated with the Coalition were excluded. Additionally, using all parts of the protocol can be a resource-intensive process, and particularly demanding for staff whose oncology programs lack infrastructure for routine multidisciplinary team meetings. Surveys, semi-structured interviews, and feedback meetings all require time from practitioners, which can be hard to find in a busy practice environment. Given that the timing and frequency of patient handoffs between treatment modalities may be subject to the nature of care required based on a given patient’s diagnosis, the process mapping protocol does not explicitly account for handoff frequency; this may be a subject for further consideration by process improvement teams. Additionally, while data on implementation outcomes such as acceptability and adoption would support the effectiveness of the process mapping protocol, these data will not be available until the conclusion of the study and will be reported on in future manuscripts. Furthermore, this process was developed and used only in Boston area academic medical centers, and may face limitations when applied in regions with different healthcare environments. Finally, the provider-centered nature of the processes being mapped is a significant limitation. The tools produced by this study are crucial for understanding patient care pathways in oncology navigation, but the patient perspective is essential to design effective, equitable healthcare delivery processes.

Process mapping is an important tool for improving care coordination, however, future research should prioritize including the voices of patients and caregivers in quality improvement to undertake truly patient-centered quality improvement initiatives.^40–42 Patient journey maps can be used to illustrate the patient’s ‘touch points’ with the healthcare service, and visualizes both the functional steps undertaken by the patient as well as their emotional journey, which includes feelings, behavior, motivation, and attitudes across the episodes of care.⁴³ Patient journey mapping, while not yet widely used in oncology, has demonstrated success in Canada by improving service integration in cancer care, stakeholder communication, and ultimately patients’ healthcare experiences.^44–46 Additional research, including patient journey mapping, is recommended to optimize the delivery of patient navigation services within and across academic medical centers while centering patient needs and perspectives. With this approach, providers of oncology care may design a truly human-centered experience that meets the logistical, psychosocial, and cultural needs of patients.

By utilizing the Workflow Process Mapping Protocol, oncology programs may systematically plan and implement evidence-based navigation services into their existing health system. This process-oriented approach will help quality improvement teams within and across healthcare settings identify and address gaps in navigation by mapping their navigation landscape, assessing existing assets and needs, and designing a patient navigation program to fit their existing organizational and regional structure while maintaining compliance with CoC standards. In the era of accountable care, process improvement tools are critical to design effective regional, systems-level navigation programs that support patients at risk for treatment delays through all phases of breast cancer treatment.