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Grant Funded Clinical Trials and Research ProjectsCurrent Grants Inguinal Hernia Management: Watchful Waiting vs. Operation Inguinal hernia is one of the most common worldwide afflictions of men. Because the presence of an inguinal hernia is usually considered an indication for its repair, little is known about the natural history of this abnormality in minimally symptomatic patients. Approximately 700,000 herniorrhaphies are performed in the U.S. each year, with large direct costs of surgical care and indirect costs to the economy resulting from time-off from work, school, or usual activities. The indications for surgical repair of a minimally symptomatic hernia are vague, and it is not known whether patients with inguinal hernias can safely delay surgical treatment and if they will accept Watchful Waiting (WW) as the method of management for their hernia. This multi-center collaborative project between the American College of Surgeons, Northwestern University, and the VA Cooperative Studies Program, proposes to enroll 753 men with asymptomatic or minimally symptomatic inguinal hernias, either primary or recurrent. Patients will be recruited at 5 community and academic sites over a 2.5 year period with follow-up for a minimum of two years and an average of 3.25 years. WW will be compared with tension-free open repair (TFH). Primary outcome measurements will be: (1) Pain or discomfort limiting usual activities; (2) Changes in the Physical Component Summary score of the SF-36. Secondary outcome comparisons include cost, complications (including hernia accident and recurrence), satisfaction, and the incidence of any hernia-related operation. The role of age and comorbidity and their interactions in influencing the patient-centered outcome of hernia management will be determined. This trial will substantially increase knowledge of the natural history of inguinal hernia in men, provide useful information on medical, patient-centered, and cost outcomes of the various treatment options, and guide selection of the appropriate treatment of this common surgical disease. National Surgical Quality Improvement Program
Safety-related adverse events after major surgical operations are a major contributor to the incidence of morbidity and mortality for patients. In the National Surgical Quality Improvement Program (NSQIP), a risk-adjusted adverse event reporting system for major surgical operations in the Department of Veterans Affairs, the rates of adverse events (30-day post-operative morbidity and mortality) have been compared annually since 1994. All the surgical programs have been ranked anonymously by the ratio of observed to expected (O/E) adverse events. The information derived is provided to each hospital annually, and each year's performance is compared to the last. Post-operative surgical morbidity and mortality have declined 43% and 28%, respectively, since the initiation of the program. The aim of this demonstration project is to achieve similar improvements in adverse event rates after major operations in a sample of nonfederal hospitals by applying the methodology of NSQIP. The hypothesis, that NSQIP methods can be successfully integrated into nonfederal hospitals and that feedback of comparative risk-adjusted adverse event data will produce improvement in the rates of post-operative adverse events in these hospitals, will be tested in 10 selected institutions. The interventions that will be tested are: (1) ongoing feedback of performance data in the form of comparative rates of adverse events (O/E ratios); (2) structured site visits to low and high outlier institutions focusing on the systems issues, latent process failures, and processes and structures that promote patient safety and reduce preventable adverse events; (3) identification of safe systems and human factors issues that contribute to the reduction of preventable adverse events found in institutions with consistently low adverse event rates and dissemination of this information to institutions that have consistently high rates of adverse events; and (4) analysis of cases of low-risk patients who experience an unexpected adverse event to detect latent errors in patient safety systems in surgery. Educating Surgeons in Patient Safety The office provides grant administration support and technical assistance to the Division of Education for this project. The American College of Surgeons (ACS) will demonstrate innovative approaches to educate surgeons in advances in patient safety, including those found in ongoing and new research studies originating from ACS. Strategies to avoid errors and improve quality of surgical care, including dissemination of best practices identified through studies conducted by the ACS, are essential educational components of the programs described in this proposal. In this project, the ACS has two specific aims:
Committee on Trauma ASBI In 2003, alcohol-related fatalities accounted for 40% of all motor vehicle fatalities in the United States. NTHSA set three priorities for addressing impaired driving: 1) high visibility enforcement, 2) supporting prosecution, adjudication and sentencing, and 3) promoting screening and brief intervention. The purpose of this cooperative agreement award between the ACS and NHTSA is to develop and adapt screening and brief intervention materials for use by trauma center personnel to identify and address alcohol use problems in trauma patients. National Sample Project Phase, II The ACS National Trauma Data Bank (NTDB) is the largest compilation of trauma injury data ever assembled. It currently contains over 1.4 million records voluntarily provided by over 500 U.S. trauma centers. Because the NTDB does not capture data about every trauma patient at every trauma center, the data cannot be used to determine national estimates of rates for clinical measures of trauma care. The National Sample Project (NSP) addresses this through the development of a nationally representative sample of US trauma patients at Level I and II facilities. The NSP will provide detailed clinical indicators and other trauma care information that are not available in other data systems. The project will include a survey of all NSP hospitals to help assess differences in case definitions and help determine a standard case definition for reporting national estimates of trauma care. The internal database management system will be developed to maintain the de-identified NTDB-NSP data files, and provide user-friendly methods for timely access to NSP data by interested clinical and injury researchers. National Trauma Registry Standardization Project Data collection is the foundation for building effective statewide trauma programs. Data is a principal driver in trauma systems strategic planning and in trauma care improvement. Trauma data quantifies the magnitude of the injury problem. Unfortunately, most states do not have a comprehensive trauma registry from which to measure the severity of the problem, costs, personnel needs, and the like. Additionally, it is essential to determine the quality of health care delivered and to evaluate patient outcomes. In FY2005, the HRSA Trauma-EMS Systems Program Grant Guidance will place special emphasis on the importance of data collection and effective statewide trauma registries. The ACS NTDB, under HRSA contract 03-0234P, has convened a group of national experts and stakeholders to research and refine the elements and definitions of trauma care data fields. The result of their work will be a minimum standard trauma care dataset for use on the national level, data definitions, and inclusion/exclusion criteria for trauma care. These results will be presented to a larger, national group for consensus and ultimate adoption into trauma registries. Trauma Systems Consultation Planning and Evaluation Projects Title XII of the Public Health Services Act requires the Federal program to assist the States with enhancing the quality of trauma care as well as promoting the number of States with statewide, effective trauma systems. HRSA has partnered with the ACS Committee on Trauma in an effort to improve the quality of trauma care and to promote trauma system improvements through 1) provision of specialized expert technical assistance consultation and recommendations through a multidisciplinary process as established by the ACS; 2) orientation of additional experts by becoming trainees for the program to be able to offer consulting services to the States; 3) convening, attending, and participating in various national trauma centered meetings and events; and 4) provision of detailed data analysis of the extracted existing databases within the ACS Committee on Trauma. Completed Grants Palliative Care Workgroup The purpose of the Workgroup is to facilitate introduction of the precepts and techniques of palliative care to surgical practice and education in the United States and Canada. The Workgroup will do this by bringing together surgeons with demonstrated interest in palliative care to share resources, strategies and expertise, and in doing so act as a catalyst for change.
Work Conditions of Surgery Residents and Quality of Care Graduate surgical education in the United States emphasized attainment of graded authority and increasing responsibility for surgery residents as experience is gained. Factors such as personal stress, fatigue or sleep deprivation, work load, and adequacy of supervision and support services may adversely affect the resident's judgment and performance and threaten patient safety. Changes in the delivery of surgical care, such as short hospital stays and outpatient surgical care, have increased the acuity of patients in the hospital where surgery residents are primarily based and have increased their workload. Simultaneous cost-cutting measures by hospitals, such as elimination or reduction of support staff, have placed additional work burdens on surgery residents. Changes in nursing staffing patterns have impaired the development of teamwork and adversely affect communication between residents and nurses. The principle of education as the top priority of a surgery residency program is threatened by an increasing need for service. The influence of each of these factors on quality of care and patient safety is unknown. To study these issues and determine the relative importance of stress factors on surgery resident performance and patient safety, we propose to develop surveys for residents, attending staff, and nurses on surgery and anesthesiology services. The surveys will assess teamwork, collaboration, safety culture, organizational culture, and stress. Additional survey items specific for surgery residents will assess working hours, indebtedness, family issues and support services, the balance of service versus education, and attitudes and behavior. Correlation and linkage of survey results with documentation of adverse events in the institution and an analysis of preventable adverse events will provide information concerning the relative effects of various resident stress factors on patient safety. Human Subjects Grant The American College of Surgeons proposes to accomplish the following specific aims:
Trauma Data Bank and Consultation Program Continuous Quality Improvement (formerly the Office of Evidence-Based Surgery) has been providing grant oversight and technical assistance on an award to the Trauma Department from the National Highway Traffic Safety Administration. Grant funds were awarded to:
Revised January 18, 2006
Continuous Quality Improvement
by the American College of Surgeons, Chicago, IL 60611-3211 |
