General Surgical Outcomes Quality Improvement Database (UH-SOCRATES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University Hospitals of Cleveland
Sponsor:
Information provided by (Responsible Party):
Conor Delaney, MD, PhD, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT00622557
First received: February 11, 2008
Last updated: December 11, 2013
Last verified: December 2013
  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 used as a quality improvement tool for analyzing process and outcome measures and to accurately track cases performed by surgeons.


Condition
Colon Cancer
Diverticulitis
Colorectal Polyps
Crohn's Disease
Ulcerative Colitis
Rectal Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: General Surgical Outcomes Quality Improvement Database (UH-SOCRATES)

Resource links provided by NLM:


Further study details as provided by University Hospitals of Cleveland:

Estimated Enrollment: 200000
Study Start Date: May 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Detailed Description:

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:

  1. 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.
  2. 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.

  Eligibility

Ages Eligible for Study:   14 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients receiving surgical, medical, or radiological services at University Hospitals Case Medical Center,Richmond,or Geauga campuses.

Criteria

Inclusion Criteria:

  • All patients receiving surgical,medical,or radiological services at University Hospitals Case Medical Center,Richmond,or Geauga campuses.

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622557

Contacts
Contact: Johnie Rose, MD, PhD 216-844-8649 johnie.rose@UHhospitals.org

Locations
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Bridget Ermlich, RN, MSN    216-844-3602    bridget.ermlich@uhhospitals.org   
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         
Sponsors and Collaborators
University Hospitals of Cleveland
Investigators
Principal Investigator: Conor P. Delaney, MD, PhD University Hospitals of Cleveland
  More Information

No publications provided

Responsible Party: Conor Delaney, MD, PhD, Prinicipal Investigator, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT00622557     History of Changes
Other Study ID Numbers: 04-07-18
Study First Received: February 11, 2008
Last Updated: December 11, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colitis, Ulcerative
Crohn Disease
Diverticulitis
Colitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Inflammatory Bowel Diseases
Colonic Diseases
Intestinal Diseases
Intraabdominal Infections
Infection

ClinicalTrials.gov processed this record on September 18, 2014