Abstract
Abstract
Background
Clostridioides difficile
infection (CDI) is the most common cause of health care–associated infectious diarrhea; however, variability in laboratory testing results in uncertainty in diagnosis and clinical decision-making. Recurrent CDI (rCDI), defined as the return of infection following initial treatment, continues to present significant clinical challenges due to limited therapeutic options. Although health care providers are familiar with vancomycin as first-line therapy for CDI, many are less familiar with fecal microbiota transplantation (FMT), despite its recommendation in clinical guidelines for rCDI management. Consequently, primary care providers (PCPs) may experience uncertainty regarding diagnostic test interpretation, treatment selection, and referral for FMT, highlighting the need for practical clinical tools to support evidence-based management.
Objective
This study will support the standardization of care and improve patient treatment experiences in Alberta by identifying barriers and facilitators encountered by PCPs in managing CDI and rCDI, using these findings to codevelop a provincial rCDI clinical pathway.
Methods
This qualitative study investigated the codevelopment process of a provincial rCDI clinical pathway between the study team and intended end users. A draft pathway was developed by the study team comprising gastroenterology and infectious disease specialists, followed by an iterative end user–centered design approach. PCP participants completed 2 rounds of 60‐ to 90-minute virtual, one-on-one, semistructured interviews incorporating scenario-based usability testing with standardized clinical cases. Using a think-aloud approach, participants evaluated the pathway’s clarity, diagnostic decision-making, treatment recommendations, referral processes, and integration into clinical workflows. Feedback was analyzed using thematic analysis, informed iterative revisions were made to the pathway and accompanying user guide, and they were reevaluated in a second round of interviews.
Results
Out of 30 invited PCPs, 3 (10%) participated in this study. During the first round of interviews, participants identified challenges interpreting PCR-positive vs toxin-positive test results, navigating the pathway layout, locating embedded hyperlinks, and understanding FMT referral processes. Iterative, feedback-driven revisions addressed these barriers by improving diagnostic guidance, simplifying navigation, increasing hyperlink visibility, and clarifying referral timing with a user guide. During the second round of interviews, all participants reported that modifications improved CDI test result interpretation, streamlined navigation, enhanced workflow integration, and increased confidence in applying the pathway to clinical scenarios. The final version of this pathway was well received for its clarity, readability, and clinical utility, and was viewed as a valuable educational resource for supporting evidence-based management of CDI.
Conclusions
This study demonstrated the feasibility and value of codeveloping a provincial clinical pathway with physician partners for managing CDI and rCDI. The resulting tool was clear, practical, and aligned with primary care workflows. This iterative, user-centered design was useful for developing clinically relevant decision support tools. Future research should evaluate the pathway’s implementation and impact on physician practice, patient care, and clinical outcomes using quantitative and qualitative methods.