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Impact of a Novel Patient Educational Booklet on Colonoscopy Quality

This study has been completed.
Information provided by (Responsible Party):
Brennan Spiegel, VA Greater Los Angeles Healthcare System Identifier:
First received: September 10, 2009
Last updated: December 9, 2014
Last verified: December 2014

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 Intervention
Colon Cancer Colonoscopy Other: Receiving an educational booklet

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Brennan Spiegel, VA Greater Los Angeles Healthcare System:

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

Secondary Outcome Measures:
  • Adenomatous Polyp Detection [ Time Frame: 3 years ]
  • Advanced Adenomatous Polyp Detection [ Time Frame: 3 years ]
  • Cecal Intubation [ Time Frame: 3 years ]
  • Withdrawal Time [ Time Frame: 3 years ]

Enrollment: 500
Study Start Date: April 2008
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
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Please refer to this study by its identifier: 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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Brennan Spiegel, Associate Professor of Medicine in Residence, VA Greater Los Angeles Healthcare System Identifier: NCT00975247     History of Changes
Other Study ID Numbers: IIR 08-310
Project Number 0013
Study First Received: September 10, 2009
Last Updated: December 9, 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 processed this record on September 20, 2017