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The purpose of this study is to determine whether adding a simple educational card to standard pre-procedure instructions improves the quality of bowel preparation for colonoscopy.
Despite written instructions, many patients do not understand the importance of bowel preparation as they prepare for colonoscopy. This often leads to poor compliance with preparation protocol and therefore inadequate bowel preparation. Our goal is to include a simple educational card which will hopefully improve the quality of bowel preparation by providing a visual component with the preparation instructions. This card will stress the importance of drinking the entire bowel preparation and provide representative images of a dirty and clean colon. We will specifically target patients directly booked for screening colonoscopy (those without a pre-procedure office visit). In a randomized fashion, patients in the control group will receive the standard bowel preparation instructions and patients in the intervention group will receive the educational card along with the standard bowel preparation instructions. The primary outcome will be the endoscopist's assessment of the quality of preparation using a standardized bowel preparation scale. Secondary outcomes will include the number and types of polyps found, colonoscope insertion and withdrawal time, and patient satisfaction with the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions. |
|
| B | No Intervention | Patients in this arm will be given the standard pre-endoscopy instructions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational card | Other | A 4x6 inch educational card containing a photo of an unprepared colon and a clean colon with the caption: "Drinking all the bowel cleaning medicine as described in the enclosed instructions lets the doctor see your colon better during your colonoscopy." |
| Measure | Description | Time Frame |
|---|---|---|
| Boston Bowel Preparation Scale Score | An ordinal scale. 0=fully unprepared colon and 9=perfectly clean colon. Higher values represent a better outcome. For reference please see: Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointestinal Endoscopy 2009;69:620-625. PMCID: PMC2763922 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Advance Colonoscope From Anus to Tip of Cecum. | time in minutes to advance colonoscope from anus to tip of cecum during insertion phase of colonoscopy. | 2 years |
| Time to Withdraw Colonoscope From Tip of Cecum to Anus. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian C Jacobson, MD, MPH | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University Medical Center | Boston | Massachusetts | 02118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21168840 | Derived | Calderwood AH, Lai EJ, Fix OK, Jacobson BC. An endoscopist-blinded, randomized, controlled trial of a simple visual aid to improve bowel preparation for screening colonoscopy. Gastrointest Endosc. 2011 Feb;73(2):307-14. doi: 10.1016/j.gie.2010.10.013. Epub 2010 Dec 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Educational Card | Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions. |
| FG001 | Control | Patients in this arm will be given the standard pre-endoscopy instructions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Educational Card | Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions. |
| BG001 | Control | Patients in this arm will be given the standard pre-endoscopy instructions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Boston Bowel Preparation Scale Score | An ordinal scale. 0=fully unprepared colon and 9=perfectly clean colon. Higher values represent a better outcome. For reference please see: Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointestinal Endoscopy 2009;69:620-625. PMCID: PMC2763922 | Posted | Median | Inter-Quartile Range | units on a scale | 2 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Educational Card | Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Jacobson, MD, Principal Investigator | Boston Medical Center | 6176386563 | brian.jacobson@bmc.org |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Time in minutes to withdraw colonoscope from tip of cecum to anus during withdrawal phase of colonoscopy
| 2 years |
| Number of Repeat Procedures Recommended Due to Inadequate Bowel Preparation. | The number of times a colonoscopist recommended that the bowel was too unclean to qualify as an acceptable colonoscopy and therefore recommended repeating the procedure after better cleansing. This is both the number of participants with an inadequate preparation and the number of inadequate procedures. These are synonymous. | 2 years |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
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| Secondary | Time to Advance Colonoscope From Anus to Tip of Cecum. | time in minutes to advance colonoscope from anus to tip of cecum during insertion phase of colonoscopy. | Posted | Median | Inter-Quartile Range | time in minutes | 2 years |
|
|
|
| Secondary | Time to Withdraw Colonoscope From Tip of Cecum to Anus. | Time in minutes to withdraw colonoscope from tip of cecum to anus during withdrawal phase of colonoscopy | Posted | Median | Inter-Quartile Range | Time in minutes | 2 years |
|
|
|
| Secondary | Number of Repeat Procedures Recommended Due to Inadequate Bowel Preparation. | The number of times a colonoscopist recommended that the bowel was too unclean to qualify as an acceptable colonoscopy and therefore recommended repeating the procedure after better cleansing. This is both the number of participants with an inadequate preparation and the number of inadequate procedures. These are synonymous. | Posted | Number | participants who had a colonoscopy | 2 years |
|
|
|
| 0 |
| 477 |
| 0 |
| 477 |
| EG001 | Control | Patients in this arm will be given the standard pre-endoscopy instructions. | 0 | 492 | 0 | 942 |
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| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |