Impact of a Novel Patient Educational Booklet on Colonoscopy Quality

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by VA Greater Los Angeles Healthcare System.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
VA Greater Los Angeles Healthcare System
ClinicalTrials.gov Identifier:
NCT00975247
First received: September 10, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 VA Greater Los Angeles Healthcare System:

Primary Outcome Measures:
  • Bowel preparation quality, as measured by the Ottawa scale. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adenomatous Polyp Detection [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Advanced Adenomatous Polyp Detection [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Cecal Intubation [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Withdrawal Time [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: April 2008
Estimated Study Completion Date: September 2012
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975247

Contacts
Contact: Jennifer Talley, MSPH 310-268-3240 jtalley@mednet.ucla.edu
Contact: Evelyn Alvarez, MPH 310-478-3711 ext 41898 evalvarez@mednet.ucla.edu

Locations
United States, California
West Los Angeles VA Healthcare Center Recruiting
Los Angeles, California, United States, 90073
Contact: Jennifer Talley, MSPH    310-268-3240    jtalley@mednet.ucla.edu   
Principal Investigator: Brennan MR Spiegel, MD, MSHS         
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

No publications provided by VA Greater Los Angeles Healthcare System

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brennan Spiegel, MD, MSHS / Principal Investigator, VA Greater Los Angeles Healthcare System
ClinicalTrials.gov Identifier: NCT00975247     History of Changes
Other Study ID Numbers: IIR 08-310, Project Number 0013
Study First Received: September 10, 2009
Last Updated: September 10, 2009
Health Authority: United States: Federal Government

Keywords provided by 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

ClinicalTrials.gov processed this record on October 23, 2014