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Completed

NCT Number: NCT03458377

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

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.

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Key information

Conditions

Colonic Diseases Digestive System Diseases Educational Problems Gastrointestinal Diseases Intestinal Diseases Nurse-Patient Relations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parc de Salut Mar. Hospital del Mar

Barcelona, 08003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Colonoscopy non-adherence rate

    Time frame: At the moment of colonoscopy

    Ratio of patients do not attend the test

Secondary outcomes

  1. Antiplatelet / anticoagulant rescheduling rate

    Time frame: At the moment of colonoscopy

    Ratio of patients attend the colonoscopy with poor adjustment of antiplatelet / anticoagulant medication so they need rescheduling of the test

  2. Anesthetist rescheduling rate

    Time frame: At the moment of colonoscopy

    Ratio of patients attend the colonoscopy with American Society of Anesthesiologists (ASA) III / IV classification so they need rescheduling of the test under anesthesia

  3. Bowel preparation rescheduling rate

    Time frame: At the moment of colonoscopy

    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

  4. Adenoma detection rate

    Time frame: At the moment of colonoscopy

    Ratio of patients with at least one adenoma in the colon

  5. Cecal intubation rate

    Time frame: At the moment of colonoscopy

    Ratio of successful complete colonoscopies (cecal intubation or in case of previous surgery, ileocolic anastomosis)

  6. Satisfaction of the endoscopic procedure

    Time frame: 30 days after colonoscopy

    Measurement of the overall satisfaction of the colonoscopy with a questionnaire validated by the American Society for Gastrointestinal Endoscopy (ASGE)

  7. Complications related to colonoscopy

    Time frame: 30 days after colonoscopy

    Telephone interview. The patient will be asked about the appearance of perforation, hemorrhage and abdominal symptoms related to the test

  8. Non-adequation colonoscopy cost of patient preparation for colonoscopy

    Time frame: From date of randomization until 30 days before colonoscopy

    Cost derived from non-adequation

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 8, 2018
Registry last updated
Mar 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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