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General Surgical Outcomes Quality Improvement Database (GSOD)(SOCRATES) - NCT00622557-44106(Clinical Trial 578098)



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City:  Cleveland
State:  
OH
Zip Code: 44106
Conditions: Colon Cancer - Diverticulitis - Colorectal Polyps - Crohn's Disease - Ulcerative Colitis - Rectal Cancer
Purpose: A database has been established to track the outcomes of all cases performed in the University Hospitals Department of Surgery in an effort to improve quality of surgical performance and case management. Specifically, the purpose of the database will be to support resident training, provide opportunities for quality improvement and an ability to accurately track cases.
Study summary: Since the Institute of Medicine report, titled "To Err is Human", there has been an increasing trend to evaluate outcomes in healthcare. While optimal outcomes in delivery of healthcare are something that hospitals and their medical, nursing and administrative staff have always tried to achieve, this has often been attempted without having much information to assess the outcomes that actually occur. For this reason, programs such as NSQIP (the National Surgical Quality Improvement Project) have been brought from the VA system into private and academic healthcare systems, to sample surgical outcomes and provide hospitals with benchmarks that can be achieved, as well as informing them where they rank in the overall results. Unfortunately, systems such as NSQIP are based on sampling a percentage of cases performed each week, but do not track all cases or all providers. Many cases are therefore not tracked in any way. Certain centers have now established databases to track their own surgical outcomes. These are usually specific to certain surgical specialties, and provide an opportunity to perform quality improvement. These also have the added value of being useful tools for maintenance of certification and for clinical research. Primary goals of this study: We propose to establish a General Surgical Outcomes Quality Improvement Database (GSOD) which will track all cases performed by the Department of Surgery. This database will have several goals: 1. The GSOD will be used to support the Mortality and Morbidity conference and directly support quality improvement and resident training. 2. The GSOD will also be used for more advanced forms of quality improvement, for example being able to evaluate patients with prolonged length of stay so that cases can be defined and evaluated for specific risk factors or in-hospital events. 3. By using hospital coded CPT and DRG codes, the GSOD will be able to accurately track cases performed by surgeons for maintenance of certification purposes. All of these goals are related to quality improvement and assessment, and are considered "not human subjects research" under 45 CFR 46. In the future it is hoped that the GSOD will also be a powerful resource for formal research into surgical outcomes, and also for identification and tracking of cases in prospective and retrospective research trials. Future IRB submissions will be submitted for this purpose at a future time and this IRB submission therefore only addresses the quality improvement perspective of the GSOD.
Criteria: Inclusion Criteria: - All patients undergoing surgical procedures in the Department of Surgery of University Hospitals of Cleveland. Exclusion Criteria: - None
Study is available at: University Hospitals Case Medical Center
Cleveland, OH 44106
United States

Primary Contact:
Bridget Ermlich, RN, MSN
Email: bridget.ermlich@uhhospitals.org
Phone: 216-844-3602

Secondary Contact:
Johnie Rose, MD, PhD
Email: johnie.rose@UHhospitals.org
Phone: 216-844-8649
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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