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Impact of a Novel Patient Educational Booklet on Colonoscopy Quality

V

VA Greater Los Angeles Healthcare System

Status

Completed

Conditions

Colon Cancer
Colonoscopy

Treatments

Other: Receiving an educational booklet

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00975247
IIR 08-310
Project Number 0013

Details and patient eligibility

About

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.

Enrollment

500 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • In patient admissions

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

500 participants in 2 patient groups

Received Booklet
Active Comparator group
Description:
Patients who have received colonoscopy preparation booklet
Treatment:
Other: Receiving an educational booklet
Did not receive booklet
No Intervention group
Description:
Patients who did not receive colonoscopy preparation booklet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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