Screening ColonoscopiesNCT02690779
Bowel Preparation Quality for Screening Colonoscopy
A study testing Educational intervention and Routine Care Instructions in people with Screening Colonoscopies, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The study will consist of a prospective observational period performed in the GI Endoscopy Lab. The objective is to document the quality of bowel preps in patients undergoing a screening colonoscopy with and without an educational intervention. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Screening Colonoscopies
- What is being tested?
- Educational intervention and Routine Care Instructions
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Nov 2015
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective outpatient procedures performed for diagnostic purposes:
- screening colonoscopy
- surveillance colonoscopy
Who cannot join
- Colonoscopy for diagnosis/therapy of acute gastrointestinal hemorrhage or for planned therapeutic intervention
- Colonoscopy performed on hospital inpatients
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Impact of a Patient Educational Video on Bowel Preparation Quality for Screening Colonoscopy: a Quality Assurance Project
The study will consist of a prospective observational period performed in the GI Endoscopy Lab. The objective is to document the quality of bowel preps in patients undergoing a screening colonoscopy with and without an educational intervention.
Read the detailed description
The educational intervention will consist of a 2-3 minute video demonstrating video images of adequate and inadequate bowel preps, and reviewing instructions for split dose prep administration. This video will be posted on YouTube. Group 1 will consist of 30 subjects who will be instructed to view this video prior to beginning their colonoscopy preparation. Information to access the YouTube video will be provided to the patients by endoscopy nurse assessment staff when contacting the patients as per standard practice to review appointment scheduling and procedure-day logistics. Group 2 will consist of 30 subjects who will not receive instructions to view the video.
Nursing staff will be asked to grade bowel preps according to the Boston Bowel Preparation Scale (BBPS), a validated and reliable instrument for assessing quality of bowel preparation [6]. Using the BBPS, a four point scoring system is applied to each of the three broad regions of the colon: the right side of the colon (including the cecum and ascending colon), the transverse section of the colon (including the hepatic and splenic flexures), and the left side of the colon (including the descending colon, sigmoid colon, and rectum). The points are assigned as follows: (0), unprepared colon segment, (1), portion of the mucosa of the colon segment seen, (2), minor amount of residual staining, (3), entire mucosa of colon segment seen well. The three segment scores are then summed for a total BBPS score, which ranges from 0 to 9. The maximum BBPS score for a perfectly clean colon without any residual liquid is 9, and the minimum BBPS score for an unprepared colon is 0. The endoscopy nurse who is in the procedure room will be scoring the bowel preparation. This protocol has been employed previously in the VUMC Endoscopy Lab and the endoscopy nurses at Vanderbilt have completed a detailed in-service training session on using the BBPS scoring system. Prior to initiation of this current study protocol, the endoscopy nurses will have a BBPS scoring system review session to ensure continued reliable and valid BBPS scores. The endoscopy nurses will be blinded to whether the patient viewed the video or not.
- Conditions
- Screening Colonoscopies
- Being tested
- Educational intervention, Routine Care Instructions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational interventionOther
2-3 minute video demonstrating video images of adequate and inadequate bowel preps, and reviewing instructions for split dose prep administration.
Routine Care InstructionsOther
patients will follow routine care and instructions
| Study group | Role | What they receive |
|---|---|---|
| Patients watching educational video | Experimental | The educational intervention will consist of a 2-3 minute video demonstrating video images of adequate and inadequate bowel preps, and reviewing instructions for split dose prep administration. This video will be posted on YouTube. Group 1 will consist of 30 subjects who will be instructed to view this video prior to beginning their colonoscopy preparation. Information to access the YouTube video will be provided to the patients by endoscopy nurse assessment staff when contacting the patients as per standard practice to review appointment scheduling and procedure-day logistics. Receives: Other: Educational intervention |
| Patients not watching educational video | Sham comparator | Group 2 will consist of 30 subjects who will not receive instructions to view the video. They will be given routine care instructions for bowel prep. Receives: Other: Routine Care Instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate bowel preparation as defined by the Boston Bowel Preparation Scale (total score ≥6 with no score less than 2)
Measured: At time of colonoscopy
Secondary outcomes (1)
Bowel preparation quality as defined by the Boston Bowel Preparation Scale (total and segment scores)
Measured: At time of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startAug 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Screening ColonoscopiesStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith Obstein, Vanderbilt University Medical Center
- Investigators
- Keith Obstein, MD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690779
- Sponsor's protocol ID
- 131668
- Status last verified
- Mar 2017
- First submitted
- 19 Jan 2016
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Patient Educational Video on Bowel Preparation Quality for Screening Colonoscopy: a Quality Assurance Project
- ClinicalTrials.gov ID
- NCT02690779
- Acronym / sponsor ID
- 131668
- Conditions
- Screening Colonoscopies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 24 Feb 2016 (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.
The study will consist of a prospective observational period performed in the GI Endoscopy Lab. The objective is to document the quality of bowel preps in patients undergoing a screening colonoscopy with and without an educational intervention.
Detailed description
The educational intervention will consist of a 2-3 minute video demonstrating video images of adequate and inadequate bowel preps, and reviewing instructions for split dose prep administration. This video will be posted on YouTube. Group 1 will consist of 30 subjects who will be instructed to view this video prior to beginning their colonoscopy preparation. Information to access the YouTube video will be provided to the patients by endoscopy nurse assessment staff when contacting the patients as per standard practice to review appointment scheduling and procedure-day logistics. Group 2 will consist of 30 subjects who will not receive instructions to view the video.
Nursing staff will be asked to grade bowel preps according to the Boston Bowel Preparation Scale (BBPS), a validated and reliable instrument for assessing quality of bowel preparation [6]. Using the BBPS, a four point scoring system is applied to each of the three broad regions of the colon: the right side of the colon (including the cecum and ascending colon), the transverse section of the colon (including the hepatic and splenic flexures), and the left side of the colon (including the descending colon, sigmoid colon, and rectum). The points are assigned as follows: (0), unprepared colon segment, (1), portion of the mucosa of the colon segment seen, (2), minor amount of residual staining, (3), entire mucosa of colon segment seen well. The three segment scores are then summed for a total BBPS score, which ranges from 0 to 9. The maximum BBPS score for a perfectly clean colon without any residual liquid is 9, and the minimum BBPS score for an unprepared colon is 0. The endoscopy nurse who is in the procedure room will be scoring the bowel preparation. This protocol has been employed previously in the VUMC Endoscopy Lab and the endoscopy nurses at Vanderbilt have completed a detailed in-service training session on using the BBPS scoring system. Prior to initiation of this current study protocol, the endoscopy nurses will have a BBPS scoring system review session to ensure continued reliable and valid BBPS scores. The endoscopy nurses will be blinded to whether the patient viewed the video or not.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients watching educational video | Experimental | Other: Educational interventionThe educational intervention will consist of a 2-3 minute video demonstrating video images of adequate and inadequate bowel preps, and reviewing instructions for split dose prep administration. This video will be posted on YouTube. Group 1 will consist of 30 subjects who will be instructed to view this video prior to beginning their colonoscopy preparation. Information to access the YouTube video will be provided to the patients by endoscopy nurse assessment staff when contacting the patients as per standard practice to review appointment scheduling and procedure-day logistics. |
| Patients not watching educational video | Sham comparator | Other: Routine Care InstructionsGroup 2 will consist of 30 subjects who will not receive instructions to view the video. They will be given routine care instructions for bowel prep. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective outpatient procedures performed for diagnostic purposes:
Key exclusion criteria (2 listed)
- Colonoscopy for diagnosis/therapy of acute gastrointestinal hemorrhage or for planned therapeutic intervention
- Colonoscopy performed on hospital inpatients
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 |
|---|---|---|
| Educational intervention2-3 minute video demonstrating video images of adequate and inadequate bowel preps, and reviewing instructions for split dose prep administration. | Other | Patients watching educational video |
| Routine Care Instructionspatients will follow routine care and instructions | Other | Patients not watching educational video |
Primary outcome
Adequate bowel preparation as defined by the Boston Bowel Preparation Scale (total score ≥6 with no score less than 2)
Time frame: At time of colonoscopy
1 secondary outcome
Bowel preparation quality as defined by the Boston Bowel Preparation Scale (total and segment scores)
Time frame: At time of colonoscopy
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 27 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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.
Keith Obstein, MD, MPH principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention and Routine Care Instructions in people with Screening Colonoscopies, run by Vanderbilt University Medical Center 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 3 inclusion and 2 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 27 Mar 2017. 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. Some participants in this study may receive a placebo. 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?
Adequate bowel preparation as defined by the Boston Bowel Preparation Scale (total score ≥6 with no score less than 2) (time frame: At time of colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2017.