This study describes the process of cocreating a provincial clinical pathway to support physicians in the management of patients with CDI (including rCDI) in Alberta, Canada, while highlighting key aspects of CDI care, including diagnosis, treatment, and referral processes.

Ethics approval was obtained from the University of Alberta Research Ethics Board (Pro00130489). All participants signed a written consent form and agreed to be video recorded during the interviews.

A purposive sampling strategy was applied to recruit participants. PCPs were identified with the support of the Alberta Health Services (AHS) Primary Health Care Integration Network, interested primary care networks, the Alberta Medical Association, and the academic Department of Family Medicine at the University of Alberta. From this pool, PCPs with experience referring rCDI patients were contacted via email to assess their interest in participating. The FMT nurse navigator distributed consent forms and coordinated interviews.

We used a qualitative methodology to gather empirical data on the optimal format and clinical content of the proposed pathway. The draft provincial rCDI clinical pathway was first developed by the study team consisting of specialists in gastroenterology and infectious diseases in collaboration with the University of Alberta’s Physician Learning Program. To facilitate use in clinical practice, the pathway incorporated direct links to existing provincial and Canadian clinical resources, including the Alberta Referral Directory, Bugs & Drugs [15], and other relevant guidance documents, allowing clinicians to access additional information as needed. This draft served as a low-fidelity prototype intended for iterative testing and refinement according to feedback from the end users. A user-centered design approach was also taken, as scenario-based usability testing and iterative prototyping can reveal cognitive and workflow mismatches that are not readily apparent through guideline development alone. Codevelopment activities consisted of 2 rounds of scenario-based usability testing conducted through one-on-one virtual 60‐ to 90-minute interview sessions with PCPs. The sessions followed a semistructured format, framed by an interview guide with case scenarios in addition to open-ended questions. A separate interview guide was designed for each respective interview.

Prior to the first interview, PCPs were provided with the initial draft of the provincial rCDI pathway. During the interview, participants were asked to apply the draft pathway to 2 standardized patient case scenarios representing common but clinically challenging rCDI presentations. Using a think-aloud approach, PCPs described how they interpreted pathway steps, made treatment decisions, and determined referral appropriateness while navigating the tool.

The interviewer probed for clarity, decision confidence, points of hesitation, perceived ambiguities, and workflow misalignments. Particular attention was paid to how physicians interpreted diagnostic test results (PCR vs toxin), distinguished recurrent cases from new infections, and identified when to reassess for alternative causes of diarrhea.

Following the first interview, usability findings were synthesized into structured summary tables and task success matrices capturing decision points, areas of confusion, drop-off locations within the pathway, and suggested revisions. These artifacts were used to guide iterative pathway redesign, including modifications to terminology, visual hierarchy, navigation cues, hyperlink visibility, and referral timing.

The revised pathway and an accompanying user guide were then retested with the same end user PCPs in a second round of interviews to assess whether prior usability issues had been resolved and to validate improvements in clarity, workflow integration, and clinical feasibility.

The AHS Health System Knowledge and Evaluation team, acting as additional independent qualitative analysts, collaborated with the research team to design interview guides including sample case scenarios, facilitate interviews, and conduct data analysis. Verbatim transcripts generated from Microsoft Teams recordings were analyzed using a thematic analysis framework. To ensure methodological rigor, coding was conducted independently by a member of the study team and a member of the external AHS Health System Knowledge and Evaluation team. Discrepancies in code applications were resolved through consensus and consultation with the broader study team rather than using formal quantitative interrater reliability measures.

Theme derivation followed an inductive approach, progressing from initial open coding to group codes into broader, descriptive categories representing specific workflow barriers or design challenges. These categories were then structured into overarching thematic maps (Figures S1 and S2 in Multimedia Appendix 1) to visually map the relationships between diagnostic interpretation, pathway navigation, clinical workflow, and implementation feasibility.

In addition to thematic qualitative analysis, usability data were analyzed using task-based evaluation methods commonly used in human-centered design. Task success and failure were documented alongside qualitative observations and participant quotations. This dual analytic approach enabled triangulation between what physicians reported, how they navigated the pathway, and where design-related barriers emerged. Findings were iteratively mapped back to pathway revisions to ensure that identified usability issues directly informed design changes rather than remaining descriptive only.

Of the 30 PCPs invited, 3 provided consent and subsequently participated in one-on-one interviews. Participant gender and practice history are presented in Table 1.

Physician partners in our study identified important gaps in the current CDI clinical workflow, including inconsistencies in referral patterns and challenges in accessing consistent information. Through an iterative co-creation process with PCPs, we developed a physician-centered pathway to guide diagnosis, management, and referral for rCDI. The resulting pathway was perceived by participants as clinically relevant, practical, and easy to use, highlighting the feasibility of using a co-creation framework to design practical, end user–aligned clinical pathways. However, our participating physicians were all highly engaged, academically affiliated, and had prior experience referring rCDI patients, and results may differ if we had included participants in rural practices or those without prior experience with rCDI patients. Nevertheless, as a regional, qualitative development study, our results demonstrate the value of the co-design process. Future studies should evaluate pathway uptake and impact on clinical practice, referral patterns, health care utilization, and patient outcomes.

Prior to this project, no provincial clinical pathway existed for CDI management in Alberta. While CDI practice guidelines have been published by professional societies, access to FMT in Canada remains limited, and most practitioners do not know when or how to access this treatment [16]. Clinical pathways may address these gaps by translating evidence into practice and improving access to emerging treatments. Integration of pathway content into electronic health records has been proposed as a low-effort strategy to enhance awareness [17], which informed the development of our clinical pathway.

Co-creation is gaining recognition as a valuable way to bring together stakeholders to promote collaboration, support knowledge dissemination, and exchange perspectives [18]. In practice, coordinating multiple health care professionals during pathway development can be challenging. The complexity of the clinical problem, intervention, and implementation, including the need to align pathway goals across members of the health care team and ensure stakeholder engagement, may either facilitate or hinder both pathway development and implementation [19]. Also, a lack of leadership and limited intrinsic motivation can be barriers in a clinical setting [19]. Therefore, involving a specialist in a relevant health care field is essential for providing guidance and structure in the initial development of care pathways [20]. Across specialties, pathways have demonstrated effectiveness in standardizing patient care, improving timeliness, and reducing costs while not negatively affecting overall patient health outcomes [12,21]. For effective knowledge mobilization, particularly between specialists and PCPs, codevelopment provides an important mechanism for generating tools that are relevant and acceptable to stakeholders, more usable, and more likely to be successfully implemented within health care settings [22,23].

Embedding human-centered design methods allowed us to translate physician feedback into iterative refinements that improved our pathway’s clarity and usability. Although the initial draft was developed by the multidisciplinary research team using existing evidence and specialist expertise, repeated engagement with PCPs allowed their perspectives to inform iterative pathway refinement. Future work could involve PCPs earlier in pathway conceptualization, enabling them to shape pathway content from the outset while further strengthening stakeholder ownership and supporting implementation.

The existing literature examining the co-creation of clinical pathways with PCPs is limited. However, studies evaluating clinical pathways more broadly demonstrate that their implementation can yield numerous positive outcomes across the journey of care, from diagnosis to treatment. One study assessing the impact of a clinical pathway reported a marked reduction in health care–associated CDI rates following the introduction of a mandatory pathway [24]. The investigators attributed this reduction to decreased rates of misdiagnosis, reducing the use of resources and health care costs and promoting the delivery of appropriate patient care.

Evidence from other studies further emphasizes the utility of clinical pathways in other areas. A study conducted in the United States found that implementing clinical pathways for nutritional management and lower airway inflammation in patients with cystic fibrosis resulted in more standardized and uniform care [25]. Additionally, a systematic review from Europe reported that care pathways enhanced health care staff knowledge, improved interprofessional documentation, and strengthened both communication and team relationships [26]. Across these studies, a recurring theme was the necessity of a multidisciplinary approach in developing and implementing care pathways, which can effectively support collaboration within interprofessional teams and enhance the quality of patient care [25,26].

A key limitation in this study is the low number of participants. Potential participants may have been discouraged by the required time commitment of up to 4 hours, which can be a significant challenge for a busy clinician. Selection bias may also have been introduced in this exploratory codevelopment study; as participants were recruited through professional and academic networks, all 3 PCPs were academically affiliated and had prior experience treating and referring rCDI patients. Self-selection bias was also a concern, as those who agreed to participate may have held stronger opinions regarding clinical pathways or a greater interest in quality improvement initiatives. Although this small sample size was appropriate for iterative pathway development, the findings may not fully reflect the perspectives of physicians practicing in other settings, those who have not managed rCDI patients, or other potential end users such as nurses, pharmacists, or patients. A greater diversity of participants may have provided valuable perspectives for further refining this pathway and its implementation. A higher number of participants would also permit specific feedback to be quantified to substantiate our qualitative analyses. As such, the findings should be viewed as exploratory and may not be transferable to community-based, rural-based, or less academically engaged practitioners and allied health care team members.

Supporting PCP engagement in research is essential to developing systemic interventions that mitigate clinical burdens and foster robust, interdisciplinary support networks across medical specialties [27,28]. Enhancing future PCP research participation requires a multipronged approach, which may include equitable financial compensation, reduced interference with daily practice routines, and enhanced institutional backing [29,30]. Future pathway refinement should also incorporate perspectives from additional stakeholders, including nurses, pharmacists, and a more diverse group of physicians, to strengthen the pathway implementation and transferability.

Methodological limitations should also be noted. The interview guides were not pilot tested, potentially limiting our ability to assess and refine the validity of their content [31]. Interviews are a valuable method for gathering information; however, the quality of data obtained through interviews can vary considerably depending on the researcher’s qualifications, skills, and familiarity with the research topic.

The co-creation of clinical pathways with physician partners represents a feasible approach for developing clinically relevant decision support tools for the management of rCDI. Future research should explore the acceptability and effectiveness of alternative formats for the pathway to ensure these resources remain accessible and relevant across diverse primary care settings. As the rCDI clinical pathway is introduced into the provincial referral directory, prospective evaluation will be critical to assess its impact on clinical decision-making, referral practices, implementation, and patient outcomes, while informing future refinement of the pathway.