A roundtable discussion: home healthcare-not a hospital in the home.

Home healthcare is vital for a large percentage of the population. According to data from the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control (CDC), 7 million people in the United States receive home healthcare annually. The use of medical devices in the home and other nonclinical environments is increasing dramatically. By the year 2050, an estimated 27 million people will need continuing care in the home or in the community and not in a controlled clinical environment. 1 The FDA recently announced its Home Use Devices Initiative and issued the document, "Draft Guidance for Industry and FDA Staff-Design Considerations for Devices Intended for Home Use" on Dec. 12, 2012. 2 The Center for Devices and Radiological Health (CDRH) regulates medical devices, but that regulatory authority alone is not enough to ensure safe and effective use of devices in the home. To address these and other issues, AAMI and FDA will co-host a summit on healthcare technology in nonclinical settings Oct. 9-10, 2013.

Successful patient diabetes education in the emergency department.

PURPOSE: The purpose of this study was to examine the effect of diabetes self-management education (DSME) provided in a large urban emergency department (ED) by a certified diabetes educator using a "learner-centered" approach to teaching survival skills. It was hypothesized that an intervention providing learner-centered education in the ED would significantly improve diabetes knowledge and self-management skills. METHODS: Participants were patients who presented to the ED with uncontrolled blood glucose with type 2 diabetes mellitus (T2DM). A learner-centered DSME approach was developed. Baseline knowledge and skills were assessed in the ED with a 5-question test and a request to demonstrate meter and insulin injection technique. Education focused on identified gaps in knowledge and skills and incorporated an opportunity for the patient to exercise control in the treatment process. At outpatient follow-up, knowledge retention was assessed with the same 5-question test, and skills again were tested. RESULTS: Patients with T2DM who were provided learner-centered DSME in the ED demonstrated a significant increase in knowledge-related test scores on all questions at follow-up. Significantly fewer patients required meter and insulin injection instruction postintervention, compared to the baseline. CONCLUSION: Study results provide evidence supporting the effectiveness of learner-centered DSME delivered in the ED at imparting critical knowledge and skills to patients with T2DM.

Designing Real-time Decision Support for Trauma Resuscitations.

BACKGROUND: Use of electronic clinical decision support (eCDS) has been recommended to improve implementation of clinical decision rules. Many eCDS tools, however, are designed and implemented without taking into account the context in which clinical work is performed. Implementation of the pediatric traumatic brain injury (TBI) clinical decision rule at one Level I pediatric emergency department includes an electronic questionnaire triggered when ordering a head computed tomography using computerized physician order entry (CPOE). Providers use this CPOE tool in less than 20% of trauma resuscitation cases. A human factors engineering approach could identify the implementation barriers that are limiting the use of this tool. OBJECTIVES: The objective was to design a pediatric TBI eCDS tool for trauma resuscitation using a human factors approach. The hypothesis was that clinical experts will rate a usability-enhanced eCDS tool better than the existing CPOE tool for user interface design and suitability for clinical use. METHODS: This mixed-methods study followed usability evaluation principles. Pediatric emergency physicians were surveyed to identify barriers to using the existing eCDS tool. Using standard trauma resuscitation protocols, a hierarchical task analysis of pediatric TBI evaluation was developed. Five clinical experts, all board-certified pediatric emergency medicine faculty members, then iteratively modified the hierarchical task analysis until reaching consensus. The software team developed a prototype eCDS display using the hierarchical task analysis. Three human factors engineers provided feedback on the prototype through a heuristic evaluation, and the software team refined the eCDS tool using a rapid prototyping process. The eCDS tool then underwent iterative usability evaluations by the five clinical experts using video review of 50 trauma resuscitation cases. A final eCDS tool was created based on their feedback, with content analysis of the evaluations performed to ensure all concerns were identified and addressed. RESULTS: Among 26 EPs (76% response rate), the main barriers to using the existing tool were that the information displayed is redundant and does not fit clinical workflow. After the prototype eCDS tool was developed based on the trauma resuscitation hierarchical task analysis, the human factors engineers rated it to be better than the CPOE tool for nine of 10 standard user interface design heuristics on a three-point scale. The eCDS tool was also rated better for clinical use on the same scale, in 84% of 50 expert-video pairs, and was rated equivalent in the remainder. Clinical experts also rated barriers to use of the eCDS tool as being low. CONCLUSIONS: An eCDS tool for diagnostic imaging designed using human factors engineering methods has improved perceived usability among pediatric emergency physicians.

Reducing healthcare-associated infections in an ambulatory dialysis unit: Identification and alignment of work system factors.

BACKGROUND: Patients undergoing hemodialysis have experienced a 43% increase in rate of hospitalization due to infection during the past 20 years. Research in other industries has shown that safe systems are achieved by considering the entire system to enable performance specifications to be met. METHOD: A sociotechnical systems framework was applied through the Macroergonomic Analysis and Design method to evaluate a 54-chair ambulatory dialysis unit to decrease healthcare-associated infections. Fifty-seven system discrepancies across 6 healthcare-associated infection risk factors were identified. A multicomponent intervention was developed to address 44 of the variances across 4 of the risk factors. RESULTS: Access-related bloodstream infections and access site infections did not improve. Bacterial surface contamination decreased. Process measures for the individual components of the intervention demonstrated varying adherence to the intervention. CONCLUSIONS: Inconsistent compliance with interventions is hypothesized to be due to organizational and external environment factors.

Defining the pharmaceutical system to support proactive drug safety.

The military, aviation, nuclear, and transportation industries have transformed their safety records by using a systems approach to safety and risk mitigation. This article creates a preliminary model of the U.S. pharmaceutical system using available literature including academic publications, policies, and guidelines established by regulatory bodies and drug industry trade publications. Drawing from the current literature, the goals, roles, and individualized processes of pharmaceutical subsystems will be defined. Defining the pharmaceutical system provides a vehicle to assess and address known problems within the system, and provides a means to conduct proactive risk analyses, which would create significant pharmaceutical safety advancement.