Clinical trial NCT03458377: Telephone Educational Intervention by the Gastrointestinal Endoscopy Nurse. Global Impact on the Quality of Colonoscopy
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Diseases
Nurse-Patient Relations
Educational Problems
Keywords: Colonoscopy
Quality
Telephone intervention
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 1534
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Colonoscopy non-adherence rate
timeFrame: At the moment of colonoscopy
Secondary outcomes:
measure: Antiplatelet / anticoagulant rescheduling rate
timeFrame: At the moment of colonoscopy
measure: Anesthetist rescheduling rate
timeFrame: At the moment of colonoscopy
measure: Bowel preparation rescheduling rate
timeFrame: At the moment of colonoscopy
measure: Adenoma detection rate
timeFrame: At the moment of colonoscopy
measure: Cecal intubation rate
timeFrame: At the moment of colonoscopy
measure: Satisfaction of the endoscopic procedure
timeFrame: 30 days after colonoscopy
measure: Complications related to colonoscopy
timeFrame: 30 days after colonoscopy
measure: Non-adequation colonoscopy cost of patient preparation for colonoscopy
timeFrame: From date of randomization until 30 days before colonoscopy
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Parc de Salut Mar. Hospital del Mar
Study officials:
affiliation: Parc de Salut Mar Hospital del Mar
name: Agustín Seoane Urgorri, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.