DESCRIPTION (provided by applicant): In response to RFA-10-003: AHRQ Clinical and Health Outcomes Initiative in Comparative Effectiveness, the goal of this project is to conduct a randomized controlled multi-center clinical trial to determine whether using the Online Wound Electronic Medical Record (OWEMR) as a clinical intervention tool reduces amputations resulting from diabetic foot ulcers (DFUs) in a variety of healthcare settings. Diabetes is a priority condition that occurs in all racial and ethnic groups but has a higher prevalence among racial and ethnic minority populations and the elderly. Persons with diabetes have a high risk of developing chronic non-healing DFUs that progress to lower-limb amputation, disability and loss of life. Implementation of effective evidence-based DFU treatment guidelines is inhibited by systemic problems with data presentation, clinical care coordination, and loss of continuity of care for patients who are treated by multiple providers in both in- and out-patient settings. The OWEMR is a web-based medical informatics tool that synthesizes data about complex wound problems from multiple sources, identifies information needed to make treatment decisions at the point of care, uses intelligent search features to identify patients who require emergency interventions, and provides evidence- based clinical decision support. The OWEMR was an effective clinical intervention that improved patient outcomes and reduced DFU-related amputations at New York University Medical Center. This project addresses the goals of this RFA: to study an intervention that informs decision-making and improve patient outcomes in a priority condition - diabetes mellitus; to address an established evidence gap in guidelines for achieving effective treatment - the role of glycemic control in promoting DFU healing; and to evaluate designated priority populations - African and Hispanic Americans and elderly and disabled persons. Aim 1 is to conduct a randomized controlled multi-center clinical trial to measure the effectiveness of the OWEMR as an intervention tool to reduce DFU-related lower limb amputations. The 11 participating outpatient foot care centers across the country are either university-affiliated/community medical centers, or Veterans Administration/military healthcare centers. Sites in each of these two categories will be randomly designated as either test sites that will use the OWEMR, or control sites that will use conventional medical record review. All patients will receive the same standard of care. The primary analysis will be the effect of OWEMR use on DFU- related lower limb amputations. Secondary analyses will identify clinical parameters correlated with healing or amputation, and measure the impact of advanced age and race/ethnicity on wound closure and amputation in population subgroups. Aim 2 is to use the comprehensive database generated by a multi-center trial of the OWEMR in Aim 1 to address an evidence gap in diabetes care by evaluating the effect of glycemic control, as measured by plasma HbA1c levels, on DFU-related lower limb amputations.
PUBLIC HEALTH RELEVANCE: The goal of this project is to demonstrate that effective utilization of the Online Wound Electronic Medical Record (OWEMR) can prevent DFU progression to amputation in a variety of healthcare settings. Successful completion of this project will provide level-1 evidence for the effectiveness of the OWEMR as a clinical intervention for reducing DFU-related foot amputations. It also will close a knowledge gap in DFU treatment by defining the effectiveness of long-term glycemic control in reducing DFU-associated amputations. Primary stakeholders in diabetes care - professional associations of wound care specialists and diabetes advocates - will facilitate the translation and dissemination of revised DFU treatment guidelines resulting from this project through their web sites, publications, continuing education programs and conferences.