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

NCT03458377 | Completed

• 1 other identifier: ESTRELLA
• Study Type: interventional
• Target: 1,534
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Diseases; Nurse-Patient Relations; Educational Problems

Keywords

Colonoscopy; Quality; Telephone intervention

Outcome Measures

Primary Outcomes (1)

• Colonoscopy non-adherence rate

  Ratio of patients do not attend the test

  At the moment of colonoscopy

Secondary Outcomes (8)

• Antiplatelet / anticoagulant rescheduling rate

  At the moment of colonoscopy

• Anesthetist rescheduling rate

  At the moment of colonoscopy

• Bowel preparation rescheduling rate

  At the moment of colonoscopy

• Adenoma detection rate

  At the moment of colonoscopy

• Cecal intubation rate

  At the moment of colonoscopy

Study Arms (2)

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.

Other: Educational telephone call

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.

Interventions

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.

Telephone call group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Parc de Salut Mar. Hospital del Mar

Barcelona, 08003, Spain

Location

Related Publications (3)

• 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.

  PMID: 23503044 BACKGROUND

• 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.

  PMID: 17852875 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.

  PMID: 27490086 BACKGROUND

MeSH Terms

Conditions

Colonic Diseases

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Agustín Seoane Urgorri, MD

  Parc de Salut Mar Hospital del Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: March 8, 2018
• Study Start: February 20, 2018
• Primary Completion: September 1, 2018
• Study Completion: October 31, 2018
• Last Updated: March 20, 2019

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Data will be available within 6 months of study completion.
• Access Criteria: Access to the data will be available to the statistician of our institution.

Locations

ES (1)