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CompletedNCT03458377Updated Mar 20, 2019

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

An interventional study of Educational telephone call in Colonic Diseases, Nurse-Patient Relations and Educational Problems, sponsored by Parc de Salut Mar. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-20.

Sponsored by Parc de Salut Mar · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
1,534
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Colonic Diseases
  • Nurse-Patient Relations
  • Educational Problems

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Keywords

  • Colonoscopy
  • Quality
  • Telephone intervention
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
1,534 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • OtherEducational 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.

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What researchers measure

Primary outcomes

  1. Colonoscopy non-adherence rate

    Ratio of patients do not attend the test

    Time frame: At the moment of colonoscopy

Secondary outcomes

  1. Antiplatelet / anticoagulant rescheduling rate

    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

  2. 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

    Time frame: At the moment of colonoscopy

  3. 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

    Time frame: At the moment of colonoscopy

  4. Adenoma detection rate

    Ratio of patients with at least one adenoma in the colon

    Time frame: At the moment of colonoscopy

  5. Cecal intubation rate

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

    Time frame: At the moment of colonoscopy

  6. 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)

    Time frame: 30 days after colonoscopy

  7. Complications related to colonoscopy

    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

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

    Cost derived from non-adequation

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

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Study locations

1 site
  • Parc de Salut Mar. Hospital del Mar
    Barcelona, 08003, Spain
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References and documents

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. PubMed 23503044 ↗
  • 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. PubMed 17852875 ↗
  • 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. PubMed 27490086 ↗

Individual participant data

Plan to share: Yes — De-identified individual participant data for all primary and secondary outcome measures will be made available.

Supporting information: Sap

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Registry details

Key details

Study ID
NCT03458377
Lead sponsor
Parc de Salut Mar
Responsible party
Sponsor
First posted
Mar 8, 2018
Start date
Feb 20, 2018
Primary completion
Sep 1, 2018
Completion
Oct 31, 2018
Last update
Mar 20, 2019

Study contacts

Agustín Seoane Urgorri, MD
principal investigator · Parc de Salut Mar Hospital del Mar

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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