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

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.

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.

Study Overview

• Status: Completed
• Conditions: Colonic Diseases; Nurse-Patient Relations; Educational Problems
• Intervention / Treatment: Other: Educational telephone call

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.

• Study Type: Interventional
• Enrollment (Actual): 1534
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Parc de Salut Mar. Hospital del Mar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telephone call group; 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.	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.
No Intervention: Non-telephone call group; The patient only receives the colonoscopy information from the primary care center on the day of the request for the test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colonoscopy non-adherence rate	Ratio of patients do not attend the test	At the moment of colonoscopy

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Parc de Salut Mar
• Investigators: Principal Investigator: Agustín Seoane Urgorri, MD, Parc de Salut Mar Hospital del Mar

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2018
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: February 16, 2018
• First Submitted That Met QC Criteria: March 1, 2018
• First Posted (Actual): March 8, 2018

Study Record Updates

• Last Update Posted (Actual): March 20, 2019
• Last Update Submitted That Met QC Criteria: March 19, 2019
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Colonoscopy; Quality; Telephone intervention
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Colonic Diseases
• Other Study ID Numbers: ESTRELLA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
• IPD Sharing Time Frame: Data will be available within 6 months of study completion.
• IPD Sharing Access Criteria: Access to the data will be available to the statistician of our institution.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No