Impact of a Novel Patient Educational Booklet on Colonoscopy Quality
|ClinicalTrials.gov Identifier: NCT00975247|
Recruitment Status : Completed
First Posted : September 11, 2009
Last Update Posted : December 10, 2014
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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|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 :||April 2008|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
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
- Bowel preparation quality, as measured by the Ottawa scale. [ Time Frame: 3 years ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975247
|United States, California|
|West Los Angeles VA Healthcare Center|
|Los Angeles, California, United States, 90073|
|Principal Investigator:||Brennan MR Spiegel, MD, MSHS||VA Greater Los Angeles Healthcare System|