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Impact of a Novel Patient Educational Booklet on Colonoscopy Quality

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00975247
First Posted: September 11, 2009
Last Update Posted: December 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Brennan Spiegel, VA Greater Los Angeles Healthcare System
  Purpose

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

  Eligibility

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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • In patient admissions
  Contacts and Locations
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


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

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 Submitted: September 10, 2009
First Posted: September 11, 2009
Last Update Posted: December 10, 2014
Last Verified: December 2014

Keywords provided by Brennan Spiegel, VA Greater Los Angeles Healthcare System:
Quality Improvement
Colonoscopy
Screening
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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases