Impact of a Novel Patient Educational Booklet on Colonoscopy Quality

Not Applicable

Completed

• Conditions: Colonoscopy; Colon Cancer
• Interventions: Other: Receiving an educational booklet

• 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

Arm && Interventions

Group	Intervention	Description
Received Booklet	Receiving an educational booklet	Patients who have received colonoscopy preparation booklet

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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