Colonic Neoplasms, Colonic Polyps
Conditions
Keywords
colonoscopy, bowel preparation, patient education, polyp detection
Brief summary
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.
Detailed description
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.
Interventions
OTHEREducational card
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.
Sponsors
Boston Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Outpatients * 18 years old or older * Referred and scheduled for an elective screening colonoscopy
Exclusion criteria
* Inpatients * Prisoners * Cognitively impaired patients * Legally blind patients * Patients allergic to polyethylene glycol electrolyte lavage solution
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Boston Bowel Preparation Scale Score | 2 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Advance Colonoscope From Anus to Tip of Cecum. | 2 years | time in minutes to advance colonoscope from anus to tip of cecum during insertion phase of colonoscopy. |
| Time to Withdraw Colonoscope From Tip of Cecum to Anus. | 2 years | Time in minutes to withdraw colonoscope from tip of cecum to anus during withdrawal phase of colonoscopy |
| Number of Repeat Procedures Recommended Due to Inadequate Bowel Preparation. | 2 years | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Educational Card Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions. | 477 |
| Control Patients in this arm will be given the standard pre-endoscopy instructions. | 492 |
| Total | 969 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | did not keep appointment | 522 | 509 |
Baseline characteristics
| Characteristic | Educational Card | Control | Total |
|---|---|---|---|
| Age Continuous | 57 years STANDARD_DEVIATION 8 | 57 years STANDARD_DEVIATION 7 | 57 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 477 participants | 492 participants | 969 participants |
| Sex: Female, Male Female | 279 Participants | 287 Participants | 566 Participants |
| Sex: Female, Male Male | 198 Participants | 205 Participants | 403 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 477 | 0 / 942 |
| serious Total, serious adverse events | 0 / 477 | 0 / 492 |
Outcome results
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
Time frame: 2 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Educational Card | Boston Bowel Preparation Scale Score | 6 units on a scale |
| Control | Boston Bowel Preparation Scale Score | 6 units on a scale |
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.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Educational Card | Number of Repeat Procedures Recommended Due to Inadequate Bowel Preparation. | 51 participants who had a colonoscopy |
| Control | Number of Repeat Procedures Recommended Due to Inadequate Bowel Preparation. | 49 participants who had a colonoscopy |
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.
Time frame: 2 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Educational Card | Time to Advance Colonoscope From Anus to Tip of Cecum. | 7 time in minutes |
| Control | Time to Advance Colonoscope From Anus to Tip of Cecum. | 7 time in minutes |
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
Time frame: 2 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Educational Card | Time to Withdraw Colonoscope From Tip of Cecum to Anus. | 8 Time in minutes |
| Control | Time to Withdraw Colonoscope From Tip of Cecum to Anus. | 7 Time in minutes |