General Surgical Outcomes Quality Improvement Database (UH-SOCRATES) (SOCRATES)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00622557|
Recruitment Status : Unknown
Verified December 2013 by Conor Delaney, MD, PhD, University Hospitals Cleveland Medical Center.
Recruitment status was: Recruiting
First Posted : February 25, 2008
Last Update Posted : December 12, 2013
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 used as a quality improvement tool for analyzing process and outcome measures and to accurately track cases performed by surgeons.
|Condition or disease|
|Colon Cancer Diverticulitis Colorectal Polyps Crohn's Disease Ulcerative Colitis Rectal Cancer|
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 further develop the General Surgical Outcomes Quality Improvement Database(GSOD)-subsequently renamed UH-SOCRATES-which will track all surgical, medical, and radiological encounters occurring at University Hospitals Case Medical Center(UHCMC)as well as at UH's Richmond and Geauga campuses. This database will have several goals:
- UH-SOCRATES will be used as a quality improvement tool for analyzing process and outcome measures, 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.
- By using hospital coded CPT codes, UH-SOCRATES 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 UH-SOCRATES will also be a powerful resource for formal research into surgical outcomes. Future IRB submissions will be submitted for this purpose. This IRB submission therefore only addresses the quality improvement perspective of the UH-SOCRATES.
|Study Type :||Observational|
|Estimated Enrollment :||200000 participants|
|Official Title:||General Surgical Outcomes Quality Improvement Database (UH-SOCRATES)|
|Study Start Date :||May 2007|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00622557
|Contact: Johnie Rose, MD, PhD||216-844-8649||johnie.rose@UHhospitals.org|
|United States, Ohio|
|University Hospitals Case Medical Center||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Bridget Ermlich, RN, MSN 216-844-3602 email@example.com|
|Principal Investigator: Conor P. Delaney, MD, PhD|
|Sub-Investigator: Jeffrey Ponsky, MD|
|Sub-Investigator: Bridget Ermlich, RN, MSN|
|Sub-Investigator: Johnie Rose, MD|
|Sub-Investigator: Mark Aeder, MD.|
|Sub-Investigator: Brian Jung|
|Sub-Investigator: Achilles Demetriou|
|Principal Investigator:||Conor P. Delaney, MD, PhD||University Hospitals Cleveland Medical Center|