Colon CancerNCT00975247
Impact of a Novel Patient Educational Booklet on Colonoscopy Quality
A study testing Receiving an educational booklet in people with Colon Cancer and Colonoscopy, run by VA Greater Los Angeles Healthcare System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Colonoscopy
- What is being tested?
- Receiving an educational booklet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient scheduled to undergo outpatient colonoscopic CRC screening or surveillance in VAGLA
Who cannot join
- In patient admissions
Trial locations and contacts
1 site in 1 country.
United States1 site
West Los Angeles VA Healthcare Center
Los Angeles, California, 90073
About this study
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.
Read more
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.
- Conditions
- Colon Cancer, Colonoscopy
- Being tested
- Receiving an educational booklet
- Keywords
- Quality Improvement, Colonoscopy, Screening, Colon Cancer, Polyp detection rates, Colonoscopy completion rates, Scope Withdrawal time, Reduce costs through improving bowel prep quality
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receiving an educational bookletOther
Also called Quality improvement
Patients who receive an educational booklet will be considered to be receiving an intervention
| Study group | Role | What they receive |
|---|---|---|
| Received Booklet | Active comparator | Patients who have received colonoscopy preparation booklet Receives: Other: Receiving an educational booklet |
| Did not receive booklet | No intervention | Patients who did not receive colonoscopy preparation booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel preparation quality, as measured by the Ottawa scale.
Measured: 3 years
Secondary outcomes (4)
Adenomatous Polyp Detection
Measured: 3 years
Advanced Adenomatous Polyp Detection
Measured: 3 years
Cecal Intubation
Measured: 3 years
Withdrawal Time
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startApr 2008
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Greater Los Angeles Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Brennan Spiegel, VA Greater Los Angeles Healthcare System
- Investigators
- Brennan MR Spiegel, MD, MSHS, Principal investigator, VA Greater Los Angeles Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975247
- Sponsor's protocol ID
- IIR 08-310
- Other IDs
- Project Number 0013
- Status last verified
- Dec 2014
- First submitted
- 10 Sep 2009
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21483463
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Novel Patient Educational Booklet on Colonoscopy Quality
- ClinicalTrials.gov ID
- NCT00975247
- Acronym / sponsor ID
- IIR 08-310
- Conditions
- Colon Cancer, Colonoscopy
- Keywords
- Quality Improvement, Colonoscopy, Screening, Colon Cancer, Polyp detection rates, Colonoscopy completion rates, Scope Withdrawal time, Reduce costs through improving bowel prep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- VA Greater Los Angeles Healthcare SystemUS federal agency
- Study start
- Apr 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 11 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Received Booklet | Active comparator | Other: Receiving an educational bookletPatients who have received colonoscopy preparation booklet |
| Did not receive booklet | No intervention | –Patients who did not receive colonoscopy preparation booklet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient scheduled to undergo outpatient colonoscopic CRC screening or surveillance in VAGLA
Key exclusion criteria (1 listed)
- In patient admissions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Receiving an educational bookletAlso: Quality improvementPatients who receive an educational booklet will be considered to be receiving an intervention | Other | Received Booklet |
Primary outcome
Bowel preparation quality, as measured by the Ottawa scale.
Time frame: 3 years
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
- Derived from this study: PubMed 21483463Spiegel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brennan MR Spiegel, MD, MSHS principal investigator
VA Greater Los Angeles Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Receiving an educational booklet in people with Colon Cancer and Colonoscopy, run by VA Greater Los Angeles Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel preparation quality, as measured by the Ottawa scale. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00975247, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2014.