Impact of a Novel Patient Educational Booklet on Colonoscopy Quality
Recruitment status was Recruiting
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.
|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|
- Bowel preparation quality, as measured by the Ottawa scale. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- 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 ]
|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)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00975247
|Contact: Jennifer Talley, MSPHfirstname.lastname@example.org|
|Contact: Evelyn Alvarez, MPH||310-478-3711 ext email@example.com|
|United States, California|
|West Los Angeles VA Healthcare Center||Recruiting|
|Los Angeles, California, United States, 90073|
|Contact: Jennifer Talley, MSPH 310-268-3240 firstname.lastname@example.org|
|Principal Investigator: Brennan MR Spiegel, MD, MSHS|
|Principal Investigator:||Brennan MR Spiegel, MD, MSHS||VA Greater Los Angeles Healthcare System|