Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav), a randomized controlled trial - Project Summary Up to one-third of 37 million people living with diabetes in the United States (US) will experience a diabetic foot ulcer (DFU) in their lifetime resulting in an annual cost of $78 billion. Poor DFU healing is the leading cause of the 100,000 diabetes-related amputations that occur annually in the US. DFU pathophysiology is complex and effective care revolves around four key pillars: glycemic control, wound management, vascular disease treatment, and infection therapy. A multidisciplinary approach is essential to improve DFU healing and prevent amputations. While there are existing multidisciplinary DFU programs, they are not equipped with tools to mitigate the impact of adverse social determinants of health to deliver high quality DFU care to those who need it most. A strategy to facilitate multidisciplinary DFU care and support patients in their healing journey that can be widely implemented is essential to improve DFU healing rates and curb the diabetes-related limb loss pandemic, particularly for underserved and high-risk populations. Patient navigators are healthcare personnel who mitigate barriers to care by facilitating care logistics, connecting patients to available resources, and promoting patient engagement. While navigators have been shown to improve diabetes outcomes, their effectiveness in improving DFU care and promoting healing remains untested. Informed by extensive preliminary data and community input, we developed the CARE-D-Foot-Nav (Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation) program and will launch the first randomized controlled trial to assess if a comprehensive navigator program improves DFU care. In CARE-D-Foot-Nav, a certified diabetes educator, serving as a navigator, will meet patients weekly starting immediately after hospital discharge to deliver personalized care coordination, education, social support, and transportation assistance. We will randomize 270 participants hospitalized with a DFU to CARE-D-Foot-Nav versus usual care (1:1 ratio) for 20 weeks post-hospital discharge. To minimize attrition and recall bias, the usual care group will receive monthly research retention phone calls. Our overarching hypothesis is that the CARE-D-Foot-Nav program will increase linkage to multidisciplinary DFU care and patient engagement thus leading to improved healing. AIM 1: To assess the effectiveness of CARE-D-Foot as compared to usual care on 20-week DFU healing (primary outcome). DFU healing will be adjudicated by blinded independent assessors. AIM 2: To evaluate fidelity to and acceptability of the CARE-D-Foot-Nav program using mixed methods. AIM 3: To perform a CARE-D-Foot-Nav cost-effectiveness analysis (CEA). To carry out these aims, we have assembled a team of DFU experts with RCT trial experience along with leaders in implementation science, patient navigation, and health economics. If successful, CARE-D-Foot-Nav has the potential to revolutionize how we deliver DFU care and promote limb salvage.
