NCT00975247

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

December 10, 2014

Status Verified

December 1, 2014

Enrollment Period

4.4 years

First QC Date

September 10, 2009

Last Update Submit

December 9, 2014

Conditions

Colon CancerColonoscopy

Keywords

Quality ImprovementColonoscopyScreeningColon CancerPolyp detection ratesColonoscopy completion ratesScope Withdrawal timeReduce costs through improving bowel prep quality

Outcome Measures

Primary Outcomes (1)

  • Bowel preparation quality, as measured by the Ottawa scale.

    3 years

Secondary Outcomes (4)

  • Adenomatous Polyp Detection

    3 years

  • Advanced Adenomatous Polyp Detection

    3 years

  • Cecal Intubation

    3 years

  • Withdrawal Time

    3 years

Study Arms (2)

Received Booklet

ACTIVE COMPARATOR

Patients who have received colonoscopy preparation booklet

Other: Receiving an educational booklet

Did not receive booklet

NO INTERVENTION

Patients who did not receive colonoscopy preparation booklet

Interventions

Receiving an educational bookletOTHER

Patients who receive an educational booklet will be considered to be receiving an intervention

Also known as: Quality improvement
Received Booklet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • In patient admissions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Los Angeles VA Healthcare Center

Los Angeles, California, 90073, United States

Location

Related Publications (1)

  • Spiegel BM, Talley J, Shekelle P, Agarwal N, Snyder B, Bolus R, Kurzbard N, Chan M, Ho A, Kaneshiro M, Cordasco K, Cohen H. Development and validation of a novel patient educational booklet to enhance colonoscopy preparation. Am J Gastroenterol. 2011 May;106(5):875-83. doi: 10.1038/ajg.2011.75. Epub 2011 Apr 12.

    PMID: 21483463DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Quality Improvement

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

EngineeringTechnology, Industry, and AgricultureQuality of Health CareHealth Services Administration

Study Officials

  • Brennan MR Spiegel, MD, MSHS

    VA Greater Los Angeles Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine in Residence

Study Record Dates

First Submitted

September 10, 2009

First Posted

September 11, 2009

Study Start

April 1, 2008

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

December 10, 2014

Record last verified: 2014-12

Locations

US(1)