Colonic DiseasesNCT03458377
Telephone Educational Intervention by the Gastrointestinal Endoscopy Nurse. Global Impact on the Quality of Colonoscopy
A study testing Educational telephone call in people with Colonic Diseases and Nurse-Patient Relations, run by Parc de Salut Mar at 1 site in Spain.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Diseases, Nurse-Patient Relations, Educational Problems
- What is being tested?
- Educational telephone call
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,534 participants
- Where
- 1 siteSpain
- Study dates
- 20 Feb 2018to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All outpatient referred from the Primary Care Centers to perform a colonoscopy in our Digestive Endoscopy Unit, regardless of the applicant's Service.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Being tested
- Educational telephone call
- Keywords
- Colonoscopy, Quality, Telephone intervention
- Medical subject headings
- Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational telephone callOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonoscopy non-adherence rate
Ratio of patients do not attend the test
Measured: At the moment of colonoscopy
Secondary outcomes (8)
Antiplatelet / anticoagulant rescheduling rate
Ratio of patients attend the colonoscopy with poor adjustment of antiplatelet / anticoagulant medication so they need rescheduling of the test
Measured: At the moment of colonoscopy
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
Measured: At the moment of colonoscopy
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
Measured: At the moment of colonoscopy
Adenoma detection rate
Ratio of patients with at least one adenoma in the colon
Measured: At the moment of colonoscopy
Cecal intubation rate
Ratio of successful complete colonoscopies (cecal intubation or in case of previous surgery, ileocolic anastomosis)
Measured: At the moment of colonoscopy
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)
Measured: 30 days after colonoscopy
Complications related to colonoscopy
Telephone interview. The patient will be asked about the appearance of perforation, hemorrhage and abdominal symptoms related to the test
Measured: 30 days after colonoscopy
Non-adequation colonoscopy cost of patient preparation for colonoscopy
Cost derived from non-adequation
Measured: From date of randomization until 30 days before colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start20 Feb 2018
- Primary completion1 Sep 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colonic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 1,534 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agustín Seoane Urgorri, MD, Principal investigator, Parc de Salut Mar Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458377
- Sponsor's protocol ID
- ESTRELLA
- Status last verified
- Feb 2018
- First submitted
- 16 Feb 2018
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
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 23503044Sola-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 17852875Alvarez-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
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03458377
- Acronym / sponsor ID
- ESTRELLA
- Keywords
- Colonoscopy, Quality, Telephone intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,534 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 8 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Telephone call group | Experimental | Other: Educational telephone callThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All outpatient referred from the Primary Care Centers to perform a colonoscopy in our Digestive Endoscopy Unit, regardless of the applicant's Service.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational telephone callExplanation 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. | Other | Telephone call group |
Primary outcome
Colonoscopy non-adherence rate
Time frame: At the moment of colonoscopy
Ratio of patients do not attend the test
8 secondary outcomes
Antiplatelet / anticoagulant rescheduling rate
Time frame: At the moment of colonoscopy
Anesthetist rescheduling rate
Time frame: At the moment of colonoscopy
Bowel preparation rescheduling rate
Time frame: At the moment of colonoscopy
Adenoma detection rate
Time frame: At the moment of colonoscopy
Cecal intubation rate
Time frame: At the moment of colonoscopy
Satisfaction of the endoscopic procedure
Time frame: 30 days after colonoscopy
Complications related to colonoscopy
Time frame: 30 days after colonoscopy
Non-adequation colonoscopy cost of patient preparation for colonoscopy
Time frame: From date of randomization until 30 days before colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Background: PubMed 23503044Liu 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.
- Background: PubMed 17852875Sola-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.
- Background: PubMed 27490086Alvarez-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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agustín Seoane Urgorri, MD principal investigator
Parc de Salut Mar Hospital del Mar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational telephone call in people with Colonic Diseases and Nurse-Patient Relations, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colonoscopy non-adherence rate (time frame: At the moment of colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03458377, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.