Impact of a Novel Patient Educational Booklet on Colonoscopy Quality

December 9, 2014 updated by: Brennan Spiegel, VA Greater Los Angeles Healthcare System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90073
        • West Los Angeles VA Healthcare Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • In patient admissions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • Quality improvement
No Intervention: Did not receive booklet
Patients who did not receive colonoscopy preparation booklet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bowel preparation quality, as measured by the Ottawa scale.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Adenomatous Polyp Detection
Time Frame: 3 years
3 years
Advanced Adenomatous Polyp Detection
Time Frame: 3 years
3 years
Cecal Intubation
Time Frame: 3 years
3 years
Withdrawal Time
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Greater Los Angeles Healthcare System

Investigators

  • Principal Investigator: Brennan MR Spiegel, MD, MSHS, VA Greater Los Angeles Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

September 10, 2009

First Submitted That Met QC Criteria

September 10, 2009

First Posted (Estimate)

September 11, 2009

Study Record Updates

Last Update Posted (Estimate)

December 10, 2014

Last Update Submitted That Met QC Criteria

December 9, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 08-310
  • Project Number 0013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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