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Surgery Checklist and Process Improvement Surrounding Endoscopic Sinus Surgery

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ClinicalTrials.gov Identifier: NCT01499719
Recruitment Status : Completed
First Posted : December 26, 2011
Last Update Posted : March 29, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this clinical trial is to evaluate the effectiveness of a new surgical checklist in the setting of sinus surgery for patients with chronic rhinosinusitis (CRS) and to measure the frequency of compliance by surgical personnel at OHSU with specific daily safety protocols before and after introduction of the checklist. The investigators hypothesized that the use of an ESS specific surgical checklist will improve the frequency of compliance by surgical personnel at OHSU to internal safety concerns and protocols.

Condition or disease Intervention/treatment
Chronic Rhinosinusitis Behavioral: Checklist introduction / Pause

Detailed Description:
A total of 200 unidentified, non-randomized endoscopic sinus surgery cases will be observed and reviewed by research personnel (T.L.S, J.C.) within the Oregon Sinus Center, located within the Center for Health and Healing on the South Waterfront Campus of OHSU, under the direction of Timothy L. Smith, MD, MPH (PI). The first 100 surgical cases will be evaluated as "pre-intervention" cases by research personnel while the second 100 surgical cases will be evaluated as "post-intervention" cases after the introduction and discussion of the surgical checklist to operating room staff.

Study Design

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surgery Checklist and Process Improvement Surrounding Endoscopic Sinus Surgery
Study Start Date : December 2011
Primary Completion Date : December 2012
Study Completion Date : December 2012
Groups and Cohorts

Group/Cohort Intervention/treatment
Surgical checklist
Compliance for surgical checklist
Behavioral: Checklist introduction / Pause
Operating room staff will be introduced to a new checklist specifically designed to address concerns around protocols for endoscopic sinus surgery to raise awareness and attention to 11 specific areas of interest.


Outcome Measures

Primary Outcome Measures :
  1. Sinus surgery checklist [ Time Frame: 6 months ]
    11 dichotomous questions regarding observed operating room protocols for internal process improvement.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Resident and fellow surgeons.
Criteria

Inclusion Criteria:

  • CRS defined by 2007 Adult Sinusitis Guidelines.13
  • Unidentified adult patients electing endoscopic sinus surgery for the treatment of CRS.

Exclusion Criteria:

  • Unable to complete surgical procedures due to perioperative complications.
Contacts and Locations

Information from the National Library of Medicine

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): NCT01499719


Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
More Information

Responsible Party: Dr. Timothy L. Smith, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01499719     History of Changes
Other Study ID Numbers: checklist pause
First Posted: December 26, 2011    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: March 2016

Keywords provided by Dr. Timothy L. Smith, Oregon Health and Science University:
Sinusitis
Disease
Chronic
Sinonasal