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Impact of a Novel Patient Educational Booklet on Colonoscopy Quality

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ClinicalTrials.gov Identifier: NCT00975247
Recruitment Status : Completed
First Posted : September 11, 2009
Last Update Posted : December 10, 2014
Information provided by (Responsible Party):
Brennan Spiegel, 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.

Condition or disease Intervention/treatment
Colon Cancer Colonoscopy Other: Receiving an educational booklet

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Impact of a Novel Patient Educational Booklet on Colonoscopy Quality
Study Start Date : April 2008
Primary Completion Date : September 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Received Booklet
Patients who have received colonoscopy preparation booklet
Other: Receiving an educational booklet
Patients who receive an educational booklet will be considered to be receiving an intervention
Other Name: Quality improvement
No Intervention: Did not receive booklet
Patients who did not receive colonoscopy preparation booklet

Primary Outcome Measures :
  1. Bowel preparation quality, as measured by the Ottawa scale. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • In patient admissions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975247

United States, California
West Los Angeles VA Healthcare Center
Los Angeles, California, United States, 90073
Sponsors and Collaborators
VA Greater Los Angeles Healthcare System
Principal Investigator: Brennan MR Spiegel, MD, MSHS VA Greater Los Angeles Healthcare System

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brennan Spiegel, Associate Professor of Medicine in Residence, VA Greater Los Angeles Healthcare System
ClinicalTrials.gov Identifier: NCT00975247     History of Changes
Other Study ID Numbers: IIR 08-310
Project Number 0013
First Posted: September 11, 2009    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: December 2014

Keywords provided by Brennan Spiegel, VA Greater Los Angeles Healthcare System:
Quality Improvement
Colon Cancer
Polyp detection rates
Colonoscopy completion rates
Scope Withdrawal time
Reduce costs through improving bowel prep quality

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases