Back to resultsImpact of a Novel Patient Educational Booklet on Colonoscopy Quality
Primary Purpose
Colon Cancer, Colonoscopy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Receiving an educational booklet
Sponsored by
About this trial
This is an interventional health services research trial for Colon Cancer focused on measuring Quality Improvement, Colonoscopy, Screening, Colon Cancer, Polyp detection rates, Colonoscopy completion rates, Scope Withdrawal time, Reduce costs through improving bowel prep quality
Eligibility Criteria
Inclusion Criteria:
- Any patient scheduled to undergo outpatient colonoscopic CRC screening or surveillance in VAGLA
Exclusion Criteria:
- In patient admissions
Sites / Locations
- West Los Angeles VA Healthcare Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Received Booklet
Did not receive booklet
Arm Description
Patients who have received colonoscopy preparation booklet
Patients who did not receive colonoscopy preparation booklet
Outcomes
Primary Outcome Measures
Bowel preparation quality, as measured by the Ottawa scale.
Secondary Outcome Measures
Adenomatous Polyp Detection
Advanced Adenomatous Polyp Detection
Cecal Intubation
Withdrawal Time
Full Information
NCT ID
NCT00975247
First Posted
September 10, 2009
Last Updated
December 9, 2014
Sponsor
VA Greater Los Angeles Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT00975247
Brief Title
Impact of a Novel Patient Educational Booklet on Colonoscopy Quality
Official Title
Impact of a Novel Patient Educational Booklet on Colonoscopy Quality
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Greater Los Angeles Healthcare System
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background: Achievement of colonoscopy outcomes depends on high-quality bowel preparation by patients; yet inadequate preparation is common.
Objective: To develop and test an educational booklet to improve bowel preparation quality.
Design: "Before-and-after" study followed by randomized controlled trial.
Setting: Veteran Affairs medical center.
Patients: Patients undergoing outpatient colonoscopy
Measurements: The investigators first performed cognitive interviews to identify knowledge and belief barriers to high-quality colonoscopy preparation. The investigators then created a patient educational booklet addressing patient barriers to improve preparatory behaviors. The investigators tested the booklet in 2 sequential studies: (1) controlled "before-and-after" study in patients undergoing colonoscopy during 2 consecutive months: 1 without and 1 with the booklet; (2) randomized controlled trial. The outcome in both studies was bowel preparation quality measured on a 6-point Likert scale (>5="good"). In each study the investigators compared the proportion achieving a "good" preparation between groups and performed logistic regression to measure the effect of the booklet on preparation quality while adjusting for the purgative received.
Limitations: Unknown impact on polyp yield and cancer reduction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Colonoscopy
Keywords
Quality Improvement, Colonoscopy, Screening, Colon Cancer, Polyp detection rates, Colonoscopy completion rates, Scope Withdrawal time, Reduce costs through improving bowel prep quality
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Received Booklet
Arm Type
Active Comparator
Arm Description
Patients who have received colonoscopy preparation booklet
Arm Title
Did not receive booklet
Arm Type
No Intervention
Arm Description
Patients who did not receive colonoscopy preparation booklet
Intervention Type
Other
Intervention Name(s)
Receiving an educational booklet
Other Intervention Name(s)
Quality improvement
Intervention Description
Patients who receive an educational booklet will be considered to be receiving an intervention
Primary Outcome Measure Information:
Title
Bowel preparation quality, as measured by the Ottawa scale.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Adenomatous Polyp Detection
Time Frame
3 years
Title
Advanced Adenomatous Polyp Detection
Time Frame
3 years
Title
Cecal Intubation
Time Frame
3 years
Title
Withdrawal Time
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any patient scheduled to undergo outpatient colonoscopic CRC screening or surveillance in VAGLA
Exclusion Criteria:
In patient admissions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brennan MR Spiegel, MD, MSHS
Organizational Affiliation
VA Greater Los Angeles Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Los Angeles VA Healthcare Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21483463
Citation
Spiegel BM, Talley J, Shekelle P, Agarwal N, Snyder B, Bolus R, Kurzbard N, Chan M, Ho A, Kaneshiro M, Cordasco K, Cohen H. Development and validation of a novel patient educational booklet to enhance colonoscopy preparation. Am J Gastroenterol. 2011 May;106(5):875-83. doi: 10.1038/ajg.2011.75. Epub 2011 Apr 12.
Results Reference
derived
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Impact of a Novel Patient Educational Booklet on Colonoscopy Quality
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