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Improving Colonoscopy Quality for Colorectal Cancer Screening in the National VA Healthcare System

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: NCT04389957
Recruitment Status : Enrolling by invitation
First Posted : May 15, 2020
Last Update Posted : December 24, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
High quality screening colonoscopy is critical for colorectal cancer (CRC) prevention in Veterans. There is significant variability in colonoscopy quality in VA that is directly linked to differences in CRC incidence and death. The investigators developed the VA Endoscopy Quality Improvement Program (VA-EQuIP) that the National GI program office will implement using centralized quality measurement and reporting for adenoma detection rates (ADR), bi-annual audit and feedback with provider benchmarking to local and national performance, and collaborative learning to support colonoscopy quality improvement. Using a cluster randomized controlled trial, the investigators will study the implementation of VA-EQuIP and determine the efficacy of its intervention on adenoma detection rates, which are directly linked to CRC incidence and death.

Condition or disease
Colorectal Neoplasms

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Study Type : Observational
Estimated Enrollment : 500000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Improving Colonoscopy Quality for Colorectal Cancer Screening in the National VA Healthcare System
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine


Group/Cohort
Providers
The quantitative surveys will be delivered to the identified local quality stewards (N=73) and providers (N=657) for each enrolled site via the Research Electronic Data Capture (REDCap) platform at baseline (prior to VA-EQuIP) and 12 months following completion of the VA-EQuIP intervention. We will incorporate established methods of maximizing web survey responses, including multiple, carefully-timed, integrated email contacts.
Patients
We expect 69 sites with 571 providers seeing 135,517 patients/year, corresponding to 95 providers/wave and 59 patients/provider/quarter. Patient data is retrospective and informs the primary outcome of provider adenoma detection rate. There is not a direct intervention for patients.



Primary Outcome Measures :
  1. Provider Adenoma detection rate (for all colonoscopies) [ Time Frame: Based on our stepped wedge design and 3 year time frame of project, the average follow up will be 20 months ]
    Adenoma detection rate is a provider level quality metric. For individual endoscopy providers, the numerator is the number of patients undergoing colonoscopy for any indication in which one or more adenomatous polyps were removed. The denominator is the total number of patients undergoing colonoscopy for each individual provider. Data will be obtained from our operational database for quality measurement and reporting.

  2. Provider Screening Adenoma detection rate (Sceening colonoscopies only) [ Time Frame: Based on our stepped wedge design and 3 year time frame of project, the average follow up will be 20 months ]
    Screening Adenoma detection rate is a provider level quality metric. For individual endoscopy providers, the numerator is the number of patients undergoing colonoscopy for colon cancer screening in which one or more adenomatous polyps were removed. The denominator is the total number of patients undergoing colonoscopy for colon cancer screening each individual provider. Data will be obtained from our operational database for quality measurement and reporting (VA-EQuIP).


Secondary Outcome Measures :
  1. Cecal intubation rate (provider level) [ Time Frame: Based on our stepped wedge design and 3 year time frame of project, the average follow up will be 20 months ]
    Cecal intubation is a provider level quality metric. The cecal intubation rate is the proportion of colonoscopies with cecal intubation documented in the procedure note.

  2. Bowel Preparation Quality (provider level) [ Time Frame: based on our stepped wedge design and 3 year time frame of project, the average follow up will be 20 months ]
    Bowel preparation quality is determined by each endoscopist for bowel cleanliness allowing polyp visualization and removal. Bowel preparation quality is measured as Adequate or Inadequate by our quality reporting system. For each provider, bowel preparation quality will be calculated with the numerator equal to all colonoscopies with "adequate" preparation quality divided by the denominator of all colonoscopies performed by the provider.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Surveys and interviews will be delivered to identified local endoscopists and GI section chiefs responsible for endoscopy services potentially eligible VA sites. Researchers will recruit section chiefs and endoscopists.
Criteria

Inclusion Criteria:

  • Quantitative surveys will be delivered to endoscopy or GI section chiefs responsible for endoscopy services for each enrolled site.
  • Qualitative interviews will be conducted with GI section chiefs and individual endoscopists at participating facilities.
  • A list of criteria for selection of participants in the clinical study, provided in terms of inclusion and exclusion criteria is suitable for assisting potential participants in identifying clinical studies of interest.

Exclusion Criteria:

-VA facilities without existing colonoscopy procedure or pathology notes in our operational database will not be included in the study.


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): NCT04389957


Locations
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United States, California
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121
United States, Utah
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States, 84148
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Andrew Gawron, MD MS VA Salt Lake City Health Care System, Salt Lake City, UT
Principal Investigator: Tonya R. Kaltenbach San Francisco VA Medical Center, San Francisco, CA
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04389957    
Other Study ID Numbers: SDR 18-148
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Quality Improvement
Adenoma
Colonoscopy
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases