Impact of a Novel Patient Educational Booklet on Colonoscopy Quality

Not Applicable

Completed

• Conditions: Colonoscopy; Colon Cancer

• Registration Number: NCT00975247
• Lead Sponsor: VA Greater Los Angeles Healthcare System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-09-10
• Study First Submitted QC: 2009-09-10
• Study First Posted: 2009-09-11
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-09
• Last Update Posted: 2014-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Any patient scheduled to undergo outpatient colonoscopic CRC screening or surveillance in VAGLA

Exclusion Criteria

• In patient admissions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bowel preparation quality, as measured by the Ottawa scale.	3 years

Secondary Outcome Measures

Name	Time	Method
Adenomatous Polyp Detection	3 years
Cecal Intubation	3 years
Advanced Adenomatous Polyp Detection	3 years
Withdrawal Time	3 years

Trial Locations

Locations (1)

West Los Angeles VA Healthcare Center; 🇺🇸 Los Angeles, California, United States