PROJECT SUMMARY ABSTRACT While other diabetes complications decreased, amputations (combined major and minor) due to foot ulcers increased 63%, reaching a 20-year peak. More than two million Americans develop a foot ulcer annually, placing them at risk of limb loss. Even worse, rural patients face a 37% greater risk of above-ankle, major amputation compared to urban counterparts, a health disparity identified by our group and others. We urgently need interventions to address this grave rural disparity and escalating amputation rate. Our systematic review of 33 studies spanning four continents reported that urban integrated care models reduce major amputation by approximately 40%. Urban integrated care models work by co-locating multiple specialists in the same clinic and using algorithms to address four physiologic factors: 1) poor glycemic control, 2) vascular disease, 3) mechanical complications, and 4) secondary infection. However, the urban integrated care model has never been adapted to rural, primary care settings. We engineered the first integrated care model for rural patients with diabetic foot ulcers, which is innovative in supporting both rural primary care and care that bridges rural and urban settings. To do so, we partnered with a HRSA-awarded Cooperative of 43 rural healthcare systems with a nationally recognized focus on improving rural diabetes care. Together, we identified the #1 health system barrier to rural, integrated care: poor collaboration across the rural-urban health system divide. Without co-location, rural providers and urban specialists struggle to manage the highest risk patients―those with ischemia and infection. Next, we co- designed an integrated care model to promote cross-setting collaboration without co-location. Our model includes two tools: 1) a care algorithm and 2) a referral checklist. The care algorithm supports rural primary care in providing high quality, local care to most patients. It also addresses obstacles to collaborating with urban specialists by providing a priori agreed upon referral criteria including timeframes, clinical indications, and pre-consultation diagnostics for severe disease. The referral checklist will support rural clinic schedulers, who place referrals to urban specialty clinics, by providing schedulers with a list of documents that should be included, reducing barriers of time-consuming triage and disjointed electronic health records. This early-stage-investigator proposal answers NIDDK’s call for small R01 pilot/feasibility trials in preparation for a statewide trial. We aim to: 1) build recruitment and retention strategies that work across diverse, rural clinics, and 2) evaluate the potential of our integrated care model to reduce major amputations by examining its impact on guideline-concordant care processes, including urban specialty referral. These aims 1) address the top reasons clinical trials fail―poor recruitment and retention, and 2) generate preliminary evidence of ...