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

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ClinicalTrials.gov Identifier: NCT03458377
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
Parc de Salut Mar

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.

Condition or disease Intervention/treatment Phase
Colonic Diseases Nurse-Patient Relations Educational Problems Other: Educational telephone call Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 1534 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Single (Investigator)
Masking Description: 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.
Primary Purpose: Supportive Care
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.
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Colonoscopy non-adherence rate [ Time Frame: At the moment of colonoscopy ]
    Ratio of patients do not attend the test


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458377


Contacts
Contact: Agustín Seoane Urgorri, MD 932483000 ext 3057 92847@parcdesalutmar.cat

Locations
Spain
Parc de Salut Mar. Hospital del Mar Recruiting
Barcelona, Spain, 08003
Contact: Agustín Seoane Urgorri, MD    932483000 ext 3057    92847@parcdesalutmar.cat   
Principal Investigator: Agustín Seoane Urgorri, MD         
Sponsors and Collaborators
Parc de Salut Mar
Investigators
Principal Investigator: Agustín Seoane Urgorri, MD Parc de Salut Mar Hospital del Mar

Publications:
Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT03458377     History of Changes
Other Study ID Numbers: ESTRELLA
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Statistical Analysis Plan (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.
URL: https://www.imim.es/sct/amib/amib.html

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Parc de Salut Mar:
Colonoscopy
Quality
Telephone intervention

Additional relevant MeSH terms:
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases