Impact of a Novel Patient Educational Booklet on Colonoscopy Quality

Colon Cancer Clinical Trial

Official title:

Impact of a Novel Patient Educational Booklet on Colonoscopy Quality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00975247
• Other study ID #: IIR 08-310
• Secondary ID: Project Number 0
• Status: Completed
• Phase: N/A
• First received: September 10, 2009
• Last updated: December 9, 2014
• Start date: April 2008
• Est. completion date: September 2012

Study information

• Verified date: December 2014
• Source: VA Greater Los Angeles Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• In patient admissions

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Colon Cancer
• Colonoscopy

Intervention

Other:
• Receiving an educational booklet
Patients who receive an educational booklet will be considered to be receiving an intervention

Locations

Country	Name	City	State
United States	West Los Angeles VA Healthcare Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Greater Los Angeles Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel preparation quality, as measured by the Ottawa scale.		3 years	No
Secondary	Adenomatous Polyp Detection		3 years	No
Secondary	Advanced Adenomatous Polyp Detection		3 years	No
Secondary	Cecal Intubation		3 years	No
Secondary	Withdrawal Time		3 years	No