Telephone Educational Intervention by the Gastrointestinal Endoscopy Nurse. Global Impact on the Quality of Colonoscopy
Primary Purpose
Colonic Diseases, Nurse-Patient Relations, Educational Problems
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Educational telephone call
Sponsored by
About this trial
This is an interventional supportive care trial for Colonic Diseases focused on measuring Colonoscopy, Quality, Telephone intervention
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.
Sites / Locations
- Parc de Salut Mar. Hospital del Mar
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Telephone call group
Non-telephone call group
Arm Description
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.
The patient only receives the colonoscopy information from the primary care center on the day of the request for the test.
Outcomes
Primary Outcome Measures
Colonoscopy non-adherence rate
Ratio of patients do not attend the test
Secondary Outcome Measures
Antiplatelet / anticoagulant rescheduling rate
Ratio of patients attend the colonoscopy with poor adjustment of antiplatelet / anticoagulant medication so they need rescheduling of the test
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
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
Adenoma detection rate
Ratio of patients with at least one adenoma in the colon
Cecal intubation rate
Ratio of successful complete colonoscopies (cecal intubation or in case of previous surgery, ileocolic anastomosis)
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)
Complications related to colonoscopy
Telephone interview. The patient will be asked about the appearance of perforation, hemorrhage and abdominal symptoms related to the test
Non-adequation colonoscopy cost of patient preparation for colonoscopy
Cost derived from non-adequation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03458377
Brief Title
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
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 20, 2018 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Parc de Salut Mar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Diseases, Nurse-Patient Relations, Educational Problems
Keywords
Colonoscopy, Quality, Telephone intervention
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
1534 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telephone call group
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-telephone call group
Arm Type
No Intervention
Arm Description
The patient only receives the colonoscopy information from the primary care center on the day of the request for the test.
Intervention Type
Other
Intervention Name(s)
Educational telephone call
Intervention Description
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 Outcome Measure Information:
Title
Colonoscopy non-adherence rate
Description
Ratio of patients do not attend the test
Time Frame
At the moment of colonoscopy
Secondary Outcome Measure Information:
Title
Antiplatelet / anticoagulant rescheduling rate
Description
Ratio of patients attend the colonoscopy with poor adjustment of antiplatelet / anticoagulant medication so they need rescheduling of the test
Time Frame
At the moment of colonoscopy
Title
Anesthetist rescheduling rate
Description
Ratio of patients attend the colonoscopy with American Society of Anesthesiologists (ASA) III / IV classification so they need rescheduling of the test under anesthesia
Time Frame
At the moment of colonoscopy
Title
Bowel preparation rescheduling rate
Description
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
Time Frame
At the moment of colonoscopy
Title
Adenoma detection rate
Description
Ratio of patients with at least one adenoma in the colon
Time Frame
At the moment of colonoscopy
Title
Cecal intubation rate
Description
Ratio of successful complete colonoscopies (cecal intubation or in case of previous surgery, ileocolic anastomosis)
Time Frame
At the moment of colonoscopy
Title
Satisfaction of the endoscopic procedure
Description
Measurement of the overall satisfaction of the colonoscopy with a questionnaire validated by the American Society for Gastrointestinal Endoscopy (ASGE)
Time Frame
30 days after colonoscopy
Title
Complications related to colonoscopy
Description
Telephone interview. The patient will be asked about the appearance of perforation, hemorrhage and abdominal symptoms related to the test
Time Frame
30 days after colonoscopy
Title
Non-adequation colonoscopy cost of patient preparation for colonoscopy
Description
Cost derived from non-adequation
Time Frame
From date of randomization until 30 days before colonoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agustín Seoane Urgorri, MD
Organizational Affiliation
Parc de Salut Mar Hospital del Mar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parc de Salut Mar. Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.imim.es/sct/amib/amib.html
Citations:
PubMed Identifier
23503044
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.
Results Reference
background
PubMed Identifier
17852875
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.
Results Reference
background
PubMed Identifier
27490086
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.
Results Reference
background
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Telephone Educational Intervention by the Gastrointestinal Endoscopy Nurse. Global Impact on the Quality of Colonoscopy
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