Impact of a Novel Patient Educational Booklet on Colonoscopy Quality
NCT ID: NCT00975247
Last Updated: 2014-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
500 participants
INTERVENTIONAL
2008-04-30
2012-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
QUADRUPLE
Study Groups
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Received Booklet
Patients who have received colonoscopy preparation booklet
Receiving an educational booklet
Patients who receive an educational booklet will be considered to be receiving an intervention
Did not receive booklet
Patients who did not receive colonoscopy preparation booklet
No interventions assigned to this group
Interventions
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Receiving an educational booklet
Patients who receive an educational booklet will be considered to be receiving an intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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VA Greater Los Angeles Healthcare System
FED
Responsible Party
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Brennan Spiegel
Associate Professor of Medicine in Residence
Principal Investigators
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Brennan MR Spiegel, MD, MSHS
Role: PRINCIPAL_INVESTIGATOR
VA Greater Los Angeles Healthcare System
Locations
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West Los Angeles VA Healthcare Center
Los Angeles, California, United States
Countries
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References
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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.
Other Identifiers
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Project Number 0013
Identifier Type: -
Identifier Source: secondary_id
IIR 08-310
Identifier Type: -
Identifier Source: org_study_id