In Support of a Patient Navigator Program for Diabetic Foot Ulcer Care: A Qualitative Thematic Analysis and Pilot Studies.

Objective: The primary objective of this study was to inform and assist in planning the design of a patient navigator randomized controlled trial. We explored patient perceptions and preferences for the proposed intervention and their broader care experiences with diabetic foot ulcer (DFU) care. We additionally conducted a retrospective chart review to investigate if patient navigator phone calls are associated with increased clinic attendance and a pilot study of a 30-day post discharge navigator program for people with DFU. Methods: This qualitative study involved two semi-structured focus group discussions (FDGs) with a total of 13 English-speaking patients with DFUs. Participants were recruited from an urban hospital in Atlanta (Grady Memorial Hospital). A deductive thematic analysis was performed on the discussion transcripts using a codebook structured around 20 prioritized constructs from the Consolidated Framework for Implementation Research (CFIR). We reviewed medical records for patients hospitalized with a DFU at Grady Memorial Hospital between January 2016 and December 2022 and compared post-hospital discharge DFU-related outpatient clinic attendance rates stratified by receipt or no receipt of a patient navigator phone call. The pilot study was a DFU navigator program with a primary outcome of 30-day post-hospital discharge clinic attendance (n=12). Results: The thematic analysis revealed two primary domains shaping the patient experience: "Communication Gaps and Inconsistency" and "System Fatigue and Erosion of Trust." The overall theme reflected a significant loss of confidence, with participants expressing skepticism and concerns that care sometimes seemed more focused on financial gain than on patient well-being. From these experiences, participants articulated a clear desire for a patient navigator who serves to advocate, coordinate, educate, and provide emotional support. Among 1285 patients hospitalized with a DFU, 153 (12%) received a post-hospital discharge patient navigator phone call. The 30-day post-hospital discharge DFU-related outpatient clinic attendance rate among those that did and did not receive a patient navigator phone call was 90% and 50%, respectively (p<.01). In the pilot navigator program, all 12 participants attended a DFU-related outpatient visit within 30 days of hospital discharge. Conclusion: The proposed intervention of a patient navigation program directly addresses the foundational issues raised by participants of mistrust and fragmentation in DFU care. The findings indicate that trust-building, transparency, and reliable care coordination are essential requirements for successful patient navigation programs and, ultimately, for improved clinical outcomes in DFU care. The retrospective study and the pilot study demonstrate that high rates of outpatient clinic attendance are possible.