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General Surgical Outcomes Quality Improvement Database (UH-SOCRATES)


N/A
14 Years
95 Years
Open (Enrolling)
Both
Colon Cancer, Diverticulitis, Colorectal Polyps, Crohn's Disease, Ulcerative Colitis, Rectal Cancer

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Trial Information

General Surgical Outcomes Quality Improvement Database (UH-SOCRATES)


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.


Inclusion Criteria:



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

Exclusion Criteria:

- None

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Conor P. Delaney, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospitals of Cleveland

Authority:

United States: Institutional Review Board

Study ID:

04-07-18

NCT ID:

NCT00622557

Start Date:

May 2007

Completion Date:

March 2013

Related Keywords:

  • Colon Cancer
  • Diverticulitis
  • Colorectal Polyps
  • Crohn's Disease
  • Ulcerative Colitis
  • Rectal Cancer
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colitis
  • Colitis, Ulcerative
  • Crohn Disease
  • Diverticulitis
  • Ulcer
  • Colonic Polyps

Name

Location

University Hospitals Case Medical Center Cleveland, Ohio  44106