Impact of a Novel Patient Educational Booklet on Colonoscopy Quality

Sponsor

VA Greater Los Angeles Healthcare System (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00975247

Collaborator

(none)

500

Enrollment

Location

Arms

Duration (Months)

9.4

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Colon Cancer Colonoscopy	Other: Receiving an educational booklet	N/A

Study Design

Study Type:

Interventional

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 :

Apr 1, 2008

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Bowel preparation quality, as measured by the Ottawa scale. [3 years]

Secondary Outcome Measures

Adenomatous Polyp Detection [3 years]
Advanced Adenomatous Polyp Detection [3 years]
Cecal Intubation [3 years]
Withdrawal Time [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

In patient admissions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Brennan Spiegel, Associate Professor of Medicine in Residence, VA Greater Los Angeles Healthcare System

ClinicalTrials.gov Identifier:

NCT00975247

Other Study ID Numbers:

IIR 08-310
Project Number 0013

First Posted:

Sep 11, 2009

Last Update Posted:

Dec 10, 2014

Last Verified:

Dec 1, 2014

Keywords provided by Brennan Spiegel, Associate Professor of Medicine in Residence, VA Greater Los Angeles Healthcare System

Polyp detection rates

Colonoscopy completion rates

Scope Withdrawal time

Reduce costs through improving bowel prep quality

Additional relevant MeSH terms:

Colonic Neoplasms

Study Results

No Results Posted as of Dec 10, 2014