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OpenTrials
Completed

NCT Number: NCT00975247

Impact of a Novel Patient Educational Booklet on Colonoscopy Quality

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.

Completed

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colonoscopy Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Los Angeles VA Healthcare Center

Los Angeles, California, 90073, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • In patient admissions

Treatment and study plan

Receiving an educational booklet

Other

Patients who receive an educational booklet will be considered to be receiving an intervention

Other names: Quality improvement

Primary outcomes

  1. Bowel preparation quality, as measured by the Ottawa scale.

    Time frame: 3 years

Secondary outcomes

  1. Adenomatous Polyp Detection

    Time frame: 3 years

  2. Advanced Adenomatous Polyp Detection

    Time frame: 3 years

  3. Cecal Intubation

    Time frame: 3 years

  4. Withdrawal Time

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

VA Greater Los Angeles Healthcare System

Fed

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Sep 11, 2009
Registry last updated
Dec 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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