Surgery Checklist and Process Improvement Surrounding Endoscopic Sinus Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Timothy L. Smith, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01499719
First received: December 21, 2011
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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 Intervention
Chronic Rhinosinusitis
Behavioral: Checklist introduction / Pause

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Surgery Checklist and Process Improvement Surrounding Endoscopic Sinus Surgery

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Sinus surgery checklist [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    11 dichotomous questions regarding observed operating room protocols for internal process improvement.


Enrollment: 100
Study Start Date: December 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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: NCT01499719

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

No publications provided

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
Study First Received: December 21, 2011
Last Updated: April 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Sinusitis
Disease
Chronic
Sinonasal

ClinicalTrials.gov processed this record on September 30, 2014