Clinical trial NCT00975247: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: VA Greater Los Angeles Healthcare System
Sponsor class: FED
First posted: 2009-09-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* In patient admissions

Primary outcomes:
measure: Bowel preparation quality, as measured by the Ottawa scale.
timeFrame: 3 years
Secondary outcomes:
measure: Adenomatous Polyp Detection
timeFrame: 3 years
measure: Advanced Adenomatous Polyp Detection
timeFrame: 3 years
measure: Cecal Intubation
timeFrame: 3 years
measure: Withdrawal Time
timeFrame: 3 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: West Los Angeles VA Healthcare Center
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System
name: Brennan MR Spiegel, MD, MSHS
role: PRINCIPAL_INVESTIGATOR
References:
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.