Impact of a Novel Patient Educational Booklet on Colonoscopy Quality
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
| 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 |
Inclusion Criteria:
- Any patient scheduled to undergo outpatient colonoscopic CRC screening or surveillance in VAGLA
Exclusion Criteria:
- In patient admissions
Contacts and Locations| Contact: Jennifer Talley, MSPH | 310-268-3240 | jtalley@mednet.ucla.edu |
| Contact: Evelyn Alvarez, MPH | 310-478-3711 ext 41898 | evalvarez@mednet.ucla.edu |
| 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 | |
| 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 |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 22, 2013