Nationalization of clinical care pathways for inflammatory bowel disease management in Canada

Abstract

Background

Inflammatory Bowel Diseases (IBD) are challenging conditions to manage due to the heterogeneity of the disease, diverse treatment options, and nuances of care over a range of ages. Clinical care pathways (CCPs) developed by experts enable health care providers (HCPs) to deliver standardized, high-quality, evidence-based care. In order to remain useful and valuable, these pathways need to evolve alongside changing treatment recommendations. Standardizing IBD care is a priority of Crohn’s Colitis Canada’s Promoting Access and Care through Centres of Excellence (PACE) network.

Aim

To describe the process of nationalizing IBD CCP’s, including development, standardization, maintenance, and dissemination.

Methods

This project was based on a previously developed structured framework for review and maintenance. The CCP team consisted of a leadership group, advisory council and a working group with diverse representation from the country and areas of expertise. The work was tracked with a database with coordination completed by staff of the national organization.

Results

The nationalization process lasted 14 months, with input from 23 HCPs from 14 academic and community institutions across Canada. Sixteen CCPs for IBD care were developed and approved by the CCP team. Challenges encountered included outdated guidelines, differing clinical opinions, and busy clinical schedules of the team members. Translation into French is complete. Support of Crohn’s and Colitis Canada was invaluable.

Conclusion

Despite anticipated challenges, 16 CCPs received approval from the advisory council and are publicly available to HCPs across Canada. Our approach to this undertaking and the lessons learned may be valuable for experts undertaking similar projects for patients with chronic diseases.

Introduction

Inflammatory bowel diseases (IBDs), such as Crohn’s disease (CD) and ulcerative colitis (UC), can have significant impact on the affected individuals, their families, and the healthcare system. In Canada, the burden of IBD continues to grow, with 1 in 91 Canadians expected to be living with IBD by 2035.¹ Between 2018 and 2023, the direct, indirect, and out-of-pocket costs of IBD more than doubled, ballooning from $2.57 billion to $5.38 billion in the five-year period.² As the prevalence of IBD in Canada continues to increase, so will the demand for IBD care. Standardized evidence-based guidelines and recommendations for managing IBD in Canada have the potential to improve patient health outcomes and allow providers to deliver high-quality and holistic care.³

Clinical care pathways (CCPs) are valuable tools that function to standardize clinical practice and optimize evidence-based care.⁴ CCPs adopt recommendations from clinical practice guidelines into specific, actionable processes that consider healthcare system’s unique needs and restrictions.⁴ It has been previously shown that CCPs can positively impact the healthcare systems in which they are implemented by promoting adherence to guidelines and improving documentation.⁵ Evidence suggests that CCPs lead to a higher agreement between providers regarding treatment options and that CCPs can effectively change the professional behavior of providers in the desired direction. Implementing CCPs may also improve the quality and efficacy of patients’ healthcare services.⁵ In the context of Canadian IBD care, the use of CCPs in practice has been shown to reduce emergency department utilization,⁶ increase documentation, and result in appropriate ordering of laboratory investigations.⁷

One of the most significant challenges associated with CCPs is their upkeep⁸ CCPs are dynamic and robust tools. However, to remain valid, CCPs must be updated in real time as new evidence and clinical guidelines come into view.^8,9 This is particularly challenging in the field of IBD as therapeutic advances and treatment options are continuously emerging.¹⁰ Within the Canadian healthcare system, the challenges of implementing up-to-date care are compounded by the limited distribution of healthcare resources and providers in sparsely populated regions. Chappell KD et al. have described a quality-improvement framework (Figure 1) for the renewal of CCPs that uses a matrix to prioritize CCP updates based on modifiable criteria.¹¹ The matrix prioritizes the CCPs based on the risk of change and clinical impact.

Figure 1.

Framework for CCP review as described in Chappell KD et al.¹¹

In collaboration with the University of Calgary, the IBD Team (gastroenterologists, nurses, pharmacists, and administrative support) at the University of Alberta devised a set of CCPs between 2014 and 2016. These CCPs were based on a comprehensive search of existing evidence, with topics being selected by the IBD Team based on team consensus. CCPs consist of algorithms and checklists that standardize clinical and organizational elements and guarantee consistent IBD management in an ambulatory environment. Since April 2016, Crohn’s and Colitis Canada’s Promoting Access and Care through Centers of Excellence (PACE) Network has supported this initiative. In 2020, a comprehensive strategy was developed to sustain and nationalize these pathways by launching the PACE Clinical Care Pathways Program, ensuring optimal care delivery to all Canadians with IBD.

The aim of this paper is to describe the process of nationalizing CCPs to support the delivery of IBD care in Canada. Herein, we report the challenges faced and solutions found for this work to help standardize the delivery of evidence-based IBD care.

Methodology

Application of the review framework

A structured framework and timeline to assess whether the CCPs to align with the most up-to-date evidence-based recommendations in IBD care (Chappell KD et al.) served as the basis for this project. Using this framework, CCPs categorized as high risk for change are expected to undergo updates based on new evidence within 1-2 years. In contrast, CCPs categorized as low risk are unlikely to change within the next three years. High clinical impact CCPs are considered imperative for IBD care, while those with low clinical impact are recommended but not essential for optimal IBD care. Currently, all 16 CCPs available are assigned a level and a review interval.

Roles of the review team and stakeholder involvement

A diverse team of reviewers from across Canada was chosen to ensure the applicability of the CCPs nationwide. Invitations were extended to multidisciplinary experts in IBD, including gastroenterologists, colorectal surgeons, IBD nurses, and community physicians supporting IBD patients. Invitees were selected based on recommendations from Crohn’s and Colitis Canada leadership and based on recommendations from the project leads and co-leads. Reviewers were assigned CCPs based on their self-identified area of expertise and interest.

For a thorough and balanced review process, a primary and secondary reviewer were assigned for each CCP to assess the content and incorporate emerging evidence. Two reviewers were invited to bring diverse perspectives and facilitate the cohesiveness of responsibilities and workloads, considering their clinical duties. Reviewers could request to review a CCP of a certain topic, if it aligned with their area of interest. If there were no volunteers, then the project leads would reach out to clinicians with areas of practice focused on the CCP topic and invite them to review the content.

The primary reviewer’s responsibilities include evaluating CCPs and recommending necessary updates or revisions. These recommendations for revisions could range from minor to major adjustments, often including literature reviews to incorporate the latest evidence-based data. The secondary reviewer’s key responsibility involves closely collaborating with and supporting the primary reviewer in their duties. Team members can also propose the development of new CCPs based on emerging evidence or identified gaps in clinical practice.

To ensure evidence-based decision-making, an Advisory Council consisting of diverse stakeholders within the field of IBD care was also established. This council comprises academic and community gastroenterologists, colorectal surgeons, IBD nurses, and patient partners. The co-lead of the CCP program serves as the advisory council chair. To uphold impartiality and ensure expert input, none of the Advisory Council members are involved in the initial drafting or subsequent reviews of the CCPs. Their responsibilities focus on assessing proposed modifications to the CCPs and providing feedback regarding evidence statements on new CCPs.

The Advisory Council and the primary and secondary reviewers form the working group, while the project leads oversee and engage this group. Figure 2 outlines the structure of the IBD CCP team.

Figure 2.

Clinical care pathways team structure.

Consensus-building and approval process

The working group convenes biannually, virtually or in person, to review proposed revisions and recommendations to update the CCPs. Upon completion of the Advisory Council’s review of the proposed changes, the Council retains the final authority to approve or reject any amendments. The integration of edits and the subsequent dissemination of the updated CCPs are contingent upon the Council’s consensus.

The reviewers and Advisory Council members are also consulted via email as needed to provide timely advice on CCP activities and output.

Continuous maintenance of CCPs

Once the Advisory Council approves the changes, the pathways are updated to reflect the latest revisions.

A dedicated database, managed and maintained by the PACE network, tracks renewal dates for each CCP based on their assigned risk of change and clinical impact. This system ensures that the CCP team remains on track and facilitates the timely revision of pathways as per their designated level in the review framework.¹¹

Results

The process to nationalize the IBD CCPs took place over fourteen months. During this time, 23 HCPs from 14 academic and community institutions in Canada provided input. The HCPs engaged in the project worked in a variety of roles including academic physicians, community physicians, surgeons, nurses, and patient-partners. Both Western and Eastern Canada were represented, although none of the HCPs were practicing in the maritime provinces at the time. Membership of the CCP Team has changed over time, with stability provided through support of the leadership team.

Renewal timelines and risk stratification

In the initial meeting, the working group held a detailed discussion on renewing the 13 CCPs that had originally been developed in Alberta between 2014 and 2016. Furthermore, the team proposed topics for new CCPs based on the gaps identified in standardized care for IBD. This collaborative dialogue was designed to enhance the effectiveness and relevance of the CCPs in meeting specific patient needs. The group agreed to renew all 13 existing CCP topics and set a goal to enhance their applicability throughout Canada. Additionally, they recognized the necessity to develop three new CCPs (Table 1).

Table 1.

Clinical care pathway topics and their assigned levels following the voting.

Clinical care pathway	Final assigned level
Existing CCP topics
Colon dysplasia surveillance	Level 2
Crohn’s disease therapy decision tree	Level 4
IBD in preconception or pregnant individuals	Level 4
Induction of advanced therapies*	Level 4
Maintenance of advanced therapies*	Level 4
Initiation and tapering of Corticosteroids	Level 2
Initiation of immunomodulators	Level 2
Iron sucrose infusion	Level 1
Management of perianal penetrating Crohn’s disease	Level 4
Postoperative Crohn’s management	Level 4
Suspected IBD outpatient flare	Level 2
Ulcerative colitis therapy decision tree	Level 4
Vitamin D replacement	Level 1
New CCP topics
Health maintenance in an individual with IBD	Level 1
Loss of response or partial response for patients on advanced therapies	Level 2
Vaccination guide for patients with IBD	Level 4

Level 1: Low risk to change, low clinical impact; Level 2: Low risk to change, high clinical impact; Level 3: High risk to change, low clinical impact; Level 4: High risk to change, high clinical impact.

^*Note: “Advanced Therapy” has replaced “Biologic Therapy” from earlier versions.

All participants utilized the previously developed renewal matrix¹¹ to assess and assign a level to the CCPs. This process was instrumental in determining the timeline for the subsequent round of updating and renewing the CCPs. When consensus was not achieved, the more conservative option (ie, the high risk to change/high clinical impact) was adopted (Table 1). There were no disagreements with regards to the assignment of levels for the national CCPs. To ensure completeness and quality of the final CCPs, all members of the CCP team had to approve the final versions.

Challenges in national implementation and lessons learned to date

Stakeholder engagement to update the existing CCPs, develop new CCPs, and nationalize them was expected to last six months. Nevertheless, unforeseen modifications in the review panel exceeded the initially projected time period. Furthermore, aligning the schedules of reviewers and Advisory Council members for meetings proved challenging.

The development of most CCPs necessitated multiple iterations before achieving consensus, with some pathways undergoing at least three revisions before attaining final approval for dissemination. The need for multiple revisions was often due to the primary and secondary reviewers themselves making changes in one version and then deciding more clarification was needed in the subsequent version. The Advisory Council also requested clarification on changes in some instances, which resulted in an extra round of revisions. In other cases, the need for multiple revisions was due to variations in medication access and disease monitoring processes within different provinces; the goals was for the pathways to be able to be used in any province in Canada, and so province-specific processes were avoided. A lack of up-to-date guidelines further delayed the renewal of the pathways. As Canada has both English and French as official languages and Crohn’s and Colitis Canada is a national organization, translation of all CCPs into French was necessary, this added complexity and delay in dissemination.

Coordination of this project and the iterative work of CCP renewal requires a dedicated team to keep the work on track is imperative. Crohn’s and Colitis Canada has worked tirelessly to make this work a success.

Nationalizing the IBD CCPs entailed an extensive assessment of the existing protocols, engaging stakeholders in IBD care, and disseminating these up-to-date, evidence-based pathways for managing IBD patients throughout Canada.

A total of 23 healthcare professionals representing academic and community settings from 14 different institutions and clinics took part in the meticulous review, update, and development of 16 CCPs. The dedicated support of the staff of Crohn’s and Colitis Canada has been key to the success over this process of nationalization.

Virtual meeting platforms have been instrumental in allowing real-time collaboration across Canada.

Dissemination and adoption of CCPs

Dissemination of the CCPs is a central component of the nationalization effort and has been planned through multiple coordinated channels. The vision for developing the CCPs was to seamlessly integrate these clinical support tools into electronic medical records (EMRs), enabling real-time tracking of CCP usage and providing best practice advisory alerts. However, the diversity of EMR systems across the country limited the feasibility of integrating the CCPs into EMRs. Therefore, the CCPs are hosted on Alberta’s IBD clinic website (https://ibdclinic.ca/) and Crohn’s and Colitis Canada’s website where they are freely accessible to healthcare professionals and the general public, which may include patients and caregivers. On Crohn’s and Colitis Canada’s platform, a pop-up form is included that prompts users to identify their role (eg, gastroenterologist, nurse, allied health professional, researcher or others), allowing monitoring users accessing the tools. Quarterly web analytics are reviewed to assess engagement and reach. To complement analytics, an embedded user online feedback survey is used to gather qualitative insights on usability and content relevance.

All CCPs are translated into French to maximize accessibility across Canada’s francophone healthcare community. In addition to static CCP documents, Crohn’s and Colitis Canada is also in preparation to develop interactive versions of the CCPs that can be accessed online. These will include clickable algorithms and user-friendly features to facilitate real-time application during clinical encounters, with the goal of enhancing adoption and integration into practice.

To ensure that these resources are effectively disseminated and implemented, knowledge translation (KT) activities are guided by the working group members in partnership with Crohn’s and Colitis Canada. Dissemination at national and international conferences, mentoring sessions, educational workshops, and professional association meetings (eg, nursing associations, resident associations, and family physician groups) is supported through the Advisory Council members and reviewers. In these settings, they are encouraged to incorporate a slide on the CCP program, featuring a QR code linking to the webpages, when the topic of their presentation is relevant. To support these activities, Crohn’s and Colitis Canada prepares standardized promotional materials such as slides and infographics that can be adapted for specific audiences. This also ensures consistency in messaging.

Additionally, short articles and blurbs are submitted to newsletters of national and provincial professional organizations (eg, gastroenterology, nursing, and family physician associations), and manuscripts are targeted to relevant journals. Crohn’s and Colitis Canada’s community newsletters are also used to highlight the availability of CCPs to patients, empowering them to raise awareness with their care teams.

Evaluation of dissemination and implementation activities is multi-pronged. Metrics include website analytics (page views, active users, engagement time), survey feedback, and stakeholder reports of KT activities. Annual Advisory Council and reviewer meetings include dedicated agenda items on dissemination, where members are invited to share where and how they promoted the CCPs (eg, at conferences, organizational channels, publications).

The success in nationalizing the CCPs is assessed through indicators of HCP access (captured by website analytics supplemented by role identification through an embedded feedback form), dissemination through multiple professional organizations (eg, via newsletters, conferences, and journals), and incorporation of user feedback (via surveys) into ongoing CCP renewal.

Discussion

High-quality care requires individualized and standardized care choices.¹² While individualized care considers a patient’s circumstances, needs, and preferences, standardized care helps ensure that care is efficient, evidence-based, and safe for most patients.^12,13 Standardized care can also help provide treatment and management suggestions for healthcare providers who may not frequently encounter patients with specific complex, rare, or specialized diseases.¹⁴ Our initiative aimed to develop standardized pathways enabling healthcare providers across Canada to use evidence-based treatment and management strategies to deliver the highest quality of care to individuals with IBD.

To our knowledge, our initiative is one of the first of its kind in IBD. Challenges expected in developing standardized CCPs included Canada’s federated government model, which has resulted in inconsistencies in available resources and healthcare practice regulations amongst the provinces and territories. Other barriers to developing and updating CCPs were time commitments needed to conduct literature searches and reviews, consolidating guidelines and project managing the review teams to ensure timeline review and updates to the CCPs. Despite the distinct practices of Canadian IBD providers, they continuously engage in unifying and collaborative research projects and quality improvement initiatives to improve patient care. This is facilitated through the support of organizations such as the Canadian Association of Gastroenterology and Crohn’s and Colitis Canada, who organize frequent meetings that encourage cooperation and provide administrative support in coordinating these projects.

With funding and administrative support from Crohn’s and Colitis Canada’s PACE research initiative, several anticipated barriers to CCP development were effectively mitigated. Common challenges in projects of this scope include difficulties in securing and sustaining external funding, coordinating input from a large multidisciplinary group of providers, and maintaining reviewer engagement given competing clinical responsibilities. The dedicated resources and project management support provided through PACE helped address these challenges, enabling sustained momentum and prolonged provider engagement. Nonetheless, delays in obtaining reviewer feedback and incorporating revisions remained ongoing obstacles, reflecting the realities of clinical workload.¹⁵ We found that the reviewer’s flexibility, open communication, and increased accountability helped the CCPs progress.⁴ Other strategies to consider are monthly check-ins with reviewers and offering a ‘chat’ channel to allow them to ask questions and share thoughts informally. For future initiatives, partnering with national organizations such as Crohn’s and Colitis Canada may be critical to ensuring the funding and administrative infrastructure needed for success.

Our process had several strengths and limitations. Although we succeeded in including a range of stakeholders in our advisory committee, adding advisory members representing the interests of trainees, pharmacists, primary care providers, and non-GI endoscopists may be beneficial in the future. This would contribute to more well-rounded CCPs and may facilitate the dissemination and promotion of the CCPs within more stakeholder groups. Another limitation is our choice not to use a rigorous method of collecting feedback, such as the Delphi method.¹⁶ Although the Delphi method may have provided more certainty concerning the opinions of the Advisory Council members, we felt that allowing discussion between members was important, especially considering how quickly evidence can evolve for treating and managing IBD.¹⁷ Since our goal is to renew the CCPs continually, our decision to use a less time-consuming feedback collection method allowed us to update the CCPs relatively quickly and with less coordination required from the advisory members.

Conclusion

In summary, our national initiative demonstrates how a CCP renewal framework can be used to update existing CCPs and develop new ones. We also demonstrated how partnerships with national organizations can be leveraged to facilitate this process and ensure its advancement. Using these strategies, we successfully nationalized and renewed 16 CCPs for IBD. Future initiatives will include regular updates of the CCPs according to their assigned levels and the promotion of the CCPs to improve clinical care.

Funding

The National Clinical Care Pathways is funded through Crohn’s and Colitis Canada’s Promoting Access and Care through Centers of Excellence (PACE) initiative.

This work was supported by Crohn’s and Colitis Canada through their Promoting Access and Care through Centres of Excellence (PACE) Network.

Conflicts of interest

Conflict of interest disclosure forms (ICMJE) have been collected for all co-authors and can be accessed as supplementary material.

Data availability

The data underlying this article are available in the article and in its online supplementary material.