Telephone Educational Intervention by the Gastrointestinal Endoscopy Nurse. Global Impact on the Quality of Colonoscopy

Educational Problems Clinical Trial

Official title:

Implementation of a Telephone Educational Intervention Performed in Outpatient Patients by the Gastrointestinal Endoscopy Nurse. Study of the Impact on the Pre-procedure, Procedure and Post-procedure Colonoscopy Quality Indicators.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03458377
• Other study ID #: ESTRELLA
• Status: Completed
• Phase: N/A
• Start date: February 20, 2018
• Est. completion date: October 31, 2018

Study information

• Verified date: February 2018
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1534
• Est. completion date: October 31, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All outpatient referred from the Primary Care Centers to perform a colonoscopy in our Digestive Endoscopy Unit, regardless of the applicant's Service.

Exclusion Criteria:

• Hospital patients, patients who refuse inclusion in the study, patients included in another study, impossibility of carrying out the educational intervention and patients who are unable to obtain informed consent will be excluded from the study.

Related Conditions & MeSH terms

• Colonic Diseases
• Educational Problems
• Nurse-Patient Relations

Intervention

Other:
• Educational telephone call
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.

Locations

Country	Name	City	State
Spain	Parc de Salut Mar. Hospital del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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-Zuñiga V. Efficacy of a multifactorial strategy for bowel preparation in diabetic patients undergoing colonoscopy: a randomized trial. Endoscopy. 2016 Nov;48(11):1003-1009. Epub 2016 Aug 4. — View Citation

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. — View Citation

Sola-vera J, Sáez J, Laveda R, Girona E, García-Sepulcre MF, Cuesta A, Vázquez N, Uceda F, Pérez E, Sillero C. Factors associated with non-attendance at outpatient endoscopy. Scand J Gastroenterol. 2008;43(2):202-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colonoscopy non-adherence rate	Ratio of patients do not attend the test	At the moment of colonoscopy
Secondary	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
Secondary	Anesthetist rescheduling rate	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
Secondary	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
Secondary	Adenoma detection rate	Ratio of patients with at least one adenoma in the colon	At the moment of colonoscopy
Secondary	Cecal intubation rate	Ratio of successful complete colonoscopies (cecal intubation or in case of previous surgery, ileocolic anastomosis)	At the moment of colonoscopy
Secondary	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
Secondary	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
Secondary	Non-adequation colonoscopy cost of patient preparation for colonoscopy	Cost derived from non-adequation	From date of randomization until 30 days before colonoscopy