Development of Quality Indicators and Quality Improvement... | NCT02385552

Studies
Development of Quality Indicators and Quality Improvement Plan of Colonoscopy in Experienced Endoscopist

NCT02385552

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Apr 18, 2016Estimated

Enrollment

17Estimated

Phase

Not provided

Conditions

Colonic Polyps
Colonic Neoplasms

Interventions

Feedback

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Mar 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Mar 1, 2015

First Submission Date that Met QC Criteria

Mar 5, 2015

First Posted Date

Mar 11, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2016

Last Update Posted Date

Apr 18, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Su Jin Chung, Associate Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine clinical factors affecting quality indicators of colonoscopy including adenoma detection rate, and whether quality of colonoscopy could be elevated by improving related factors.

Detailed Description

This study is an extension of quality assurance program in Seoul National University Hospital Healthcare System Gangnam Center. This study is composed of five periods. First, quality indicators of colonoscopy in experienced endoscopists will be analyzed retrospectively from January 2011 to december 2014. Individual differences and changes of quality indicators in every endoscopist will be verified. In second period, from January 2015 to March 2015, quality assurance program will be activated. Endoscopists will be educated by EQUIP (Endoscopic Quality Improvement Program). Also split-regimen bowel preparation instead of same-day regimen and Boston bowel preparation scale will be introduced to standardize disparity of grading. Third, prospective trial starts from April 2015 to March 2018. All endoscopists will receive feedbacks of their own adenoma detection rates in every 3 months. Changes of quality indicators for each endoscopist will be investigated, and annually monitored by institutional review board. If there is a significant improvement of quality indicators in interim assessment, prospective trial will be extended until April 2018. Fourth is wash-out period from April 2018 to march 2019. Feedbacks will be stopped and adenoma detection rates and quality indicators of endoscopists will be compared with those from prospective period. Finally, cumulative rate and mortality rate of colorectal cancers will be investigated until December 2019.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

8 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

17Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experienced endoscopists		All of the experienced endoscopists will receive feedbacks from investigators about their own adenoma detection rate every 3 months	Behavioral: Feedback

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Feedback	Behavioral	Experienced endoscopists will receive feedbacks from investigators about their own adenoma detection rates.	Experienced endoscopists

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adenoma detection rate	(total, right, transverse, left)	8 years

Secondary Outcomes

Measure	Description	Time Frame
Colonoscopy performance indicators	Colonoscopy withdrawal time in negative complete colonoscopy	8 years
Colonoscopy performance indicators	The number of taken pictures in negative complete colonoscopy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Customers who received colonoscopy in Seoul National University Hospital Healthcare System Gangnam Center from 2011 to 2019.

Exclusion Criteria:

Age <18 years
Customers who refused to offer their health check up data
History of inflammatory bowel disease
History of familial adenomatous polyposis
Customers who received Incomplete colonoscopy
History of previous colorectal resection

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Customers who received colonoscopy in Seoul National University Hospital Healthcare System Gangnam Center from 2011 to 2019.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ji Yeon Seo, M.D.	Contact	82-2-2112-5641		sjy@snuh.org
Changhyun Lee, M.D.	Contact	82-2-2112-5578		mdchlee@snuh.org

Overall Officials

Name	Affiliation	Role
Su Jin Chung, M.D., Ph.D.	Department of Internal Medicine and Healthcare Research Institute, Healthcare System Gangnam Center, Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Healthcare System Gangnam Center, Seoul National University Hospital	Recruiting	Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003111	Colonic Polyps
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D007417	Intestinal Polyps
D011127	Polyps
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided