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This study assesses what impact has on colonoscopy quality the implementation of a telephone educational intervention carried out individually on the patient in the days before the test. Half of the study patients will receive the educational intervention and the other half will not.
A high-quality colonoscopy is an examination in with patients receive an indicated procedure, correct and relevant diagnoses are recognized or excluded, any therapy provided is appropriate, and all steps that minimize risk have been taken.
But quality also refers to pre-procedure and post-procedure quality issues such as information, booking, choice, privacy, dignity, aftercare and satisfaction of patients. All those issues can negatively affect the willingness of patients to perform the test and the possibility of preparing adequately. And what is more, it can diminish the quality of the own exploration, the satisfaction of the patients and their adherence to programs of endoscopic follow-up.
An action on these colonoscopy non-technical issues with a telephone educational intervention performed by the gastrointestinal endoscopy nurse can positively improve all (pre, intra and post-procedure) colonoscopy quality indicators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telephone call group | Experimental | The patient receives the colonoscopy information from the primary care center on the day of the request for the test and a 20 minute educational telephone call 7 days before de procedure. |
|
| Non-telephone call group | No Intervention | The patient only receives the colonoscopy information from the primary care center on the day of the request for the test. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational telephone call | Other | Explanation of the importance of making the test. Guidelines for the usual medication of the patient. Definition of fasting, explanation of colon cleansing adjusted to the presence of predictors of poor basic preparation. Explanation of the endoscopic procedure with the elimination of erroneous concepts of the patient with respect to the procedure. Explanation of norms of action subsequent to the endoscopy. Management of scheduling, destined to improve the adherence of the patient for the test. |
| Measure | Description | Time Frame |
|---|---|---|
| Colonoscopy non-adherence rate | Ratio of patients do not attend the test | At the moment of colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Antiplatelet / anticoagulant rescheduling rate | Ratio of patients attend the colonoscopy with poor adjustment of antiplatelet / anticoagulant medication so they need rescheduling of the test | At the moment of colonoscopy |
| Anesthetist rescheduling rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AgustÃn Seoane Urgorri, MD | Parc de Salut Mar Hospital del Mar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parc de Salut Mar. Hospital del Mar | Barcelona | 08003 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23503044 | Background | Liu X, Luo H, Zhang L, Leung FW, Liu Z, Wang X, Huang R, Hui N, Wu K, Fan D, Pan Y, Guo X. Telephone-based re-education on the day before colonoscopy improves the quality of bowel preparation and the polyp detection rate: a prospective, colonoscopist-blinded, randomised, controlled study. Gut. 2014 Jan;63(1):125-30. doi: 10.1136/gutjnl-2012-304292. Epub 2013 Mar 16. | |
| 17852875 |
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De-identified individual participant data for all primary and secondary outcome measures will be made available.
Data will be available within 6 months of study completion.
Access to the data will be available to the statistician of our institution.
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| ID | Term |
|---|---|
| D003108 | Colonic Diseases |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Reference population: all outpatient referred for the realization of a colonoscopy, regardless of the requesting Service.
Two groups. One of them will receive an complete educational telephone call 7 days before de procedure in addition to the information received from the primary care center on the day of the request for the test. The inclusion in each one of the groups will be done through a randomization sheet.
The intervention includes educational aspects:
Explanation of the importance of making the test. Guidelines for the usual medication of the patient. Definition of fasting, explanation of colon cleansing adjusted to the presence of predictors of poor basic preparation. Explanation of the endoscopic procedure with the elimination of erroneous concepts of the patient with respect to the procedure. Explanation of norms of action subsequent to the endoscopy. Management of scheduling, destined to improve the adherence of the patient for the test.
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The endoscope that performs the colonoscopy and the person in charge of collecting the data of colonoscopy complications and the overall satisfaction of the procedure will be blind to the patient group.
|
Ratio of patients attend the colonoscopy with American Society of Anesthesiologists (ASA) III / IV classification so they need rescheduling of the test under anesthesia |
| At the moment of colonoscopy |
| Bowel preparation rescheduling rate | Ratio of patients attend the colonoscopy with inadequate Boston Bowel Preparation Scale (at least one of the colon segments with less than 2 points) so they need rescheduling of the test | At the moment of colonoscopy |
| Adenoma detection rate | Ratio of patients with at least one adenoma in the colon | At the moment of colonoscopy |
| Cecal intubation rate | Ratio of successful complete colonoscopies (cecal intubation or in case of previous surgery, ileocolic anastomosis) | At the moment of colonoscopy |
| Satisfaction of the endoscopic procedure | Measurement of the overall satisfaction of the colonoscopy with a questionnaire validated by the American Society for Gastrointestinal Endoscopy (ASGE) | 30 days after colonoscopy |
| Complications related to colonoscopy | Telephone interview. The patient will be asked about the appearance of perforation, hemorrhage and abdominal symptoms related to the test | 30 days after colonoscopy |
| Non-adequation colonoscopy cost of patient preparation for colonoscopy | Cost derived from non-adequation | From date of randomization until 30 days before colonoscopy |
| Sola-vera J, Saez J, Laveda R, Girona E, Garcia-Sepulcre MF, Cuesta A, Vazquez N, Uceda F, Perez E, Sillero C. Factors associated with non-attendance at outpatient endoscopy. Scand J Gastroenterol. 2008;43(2):202-6. doi: 10.1080/00365520701562056. |
| 27490086 | Background | Alvarez-Gonzalez MA, Flores-Le Roux JA, Seoane A, Pedro-Botet J, Carot L, Fernandez-Clotet A, Raga A, Pantaleon MA, Barranco L, Bory F, Lorenzo-Zuniga V. Efficacy of a multifactorial strategy for bowel preparation in diabetic patients undergoing colonoscopy: a randomized trial. Endoscopy. 2016 Nov;48(11):1003-1009. doi: 10.1055/s-0042-111320. Epub 2016 Aug 4. |