Colorectal CancerNCT02428907
Simulation Training of Endoscopy Staff to Improve Patient Experience in Colonoscopy
An observational study of Colorectal Cancer, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
Some patients experience a degree of pain and discomfort during endoscopic examination of the large bowel. Sedatives and analgesics may be administered in low doses. Excessive dosage or intense pain may lead to hypotension and impaired level of consciousness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- simulation training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 539 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2012to Apr 2013
- Phase
- Observational
- 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
Study population: All patients for colonoscopy under minimal sedation
Who may be able to join
- All patients for colonoscopy under minimal sedation who are able to understand imformation
Who cannot join
- Unable to understand information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Simulation Based Team Training of Endoscopy Staff May Improve Patients' Perception of Colonoscopy
Some patients experience a degree of pain and discomfort during endoscopic examination of the large bowel. Sedatives and analgesics may be administered in low doses. Excessive dosage or intense pain may lead to hypotension and impaired level of consciousness. The purpose of the present study was to determine if simulation training of endoscopy staff in preventing pain and handling acute complications through effective teamwork could improve the quality of colonoscopy from the patients' perspective.
Read the detailed description
The study was carried out in a surgical department, where colonoscopies were performed on an out-patient basis under minimal sedation. The intervention consisted of a simulation based course for endoscopy staff. All endoscopy nurses and doctors participated (n=43). The course consisted of three short lectures followed by simulation training. The lectures dealt with technical aspects of colonoscopy, usage of medication and management of unexpected emergency events during the procedure, and finally with interprofessional teamwork and team communication. The lectures were followed by in situ simulation in an endoscopy room. For 2 months before and after the course a questionnaire based survey was carried out. The respondents were consecutive patients who had undergone colonoscopy under minimal sedation or no sedation (according to their own preference ). The questionnaire was filled out when the patient was fully recovered after sedation and ready to go home. The relevant nursing staff and doctor for the procedure also filled out their part of the questionnaire. Patients were invited to participate and gave written consent after oral and written information according to the Helsinki declaration .
- Conditions
- Colorectal Cancer
- Being tested
- simulation training
- Keywords
- simulation training, minimal sedation, colonoscopy, patient satisfaction, teamwork, team training, patient safety
- Medical subject headings
- Colorectal Neoplasms, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulation trainingBehavioural
teamtraining of endoscopy staff
What is being measured
The primary outcome is the main question the study is designed to answer.
patient perception of colonoscopy
comparison of patient satisfaction aspects of colonoscopy before and after a simulation, course for staff. The patients fill out a questionnaire: Pain score on a visual analogue scale, Wiilingness to return for a repeat colonoscopy if necessary on a visual analogue scale, assessmment of doctor's and nurse's behaviour on a scale from 1 - 10 regarding empathy, quality of information. Staff answer a questionnaire where they assess the quality of teamwork on a scale from 1-10. They also assess the patients perceived pain on a visual analogue scale.
Measured: 3 months
Secondary outcomes (1)
Staff perception of teamwork
comparison of staff's perception of quality of teamwork before and after a simulation course
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startOct 2012
- Primary completionFeb 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 539 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen L Larsen, m.d., Principal investigator, Medical Doctor and head of department at Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428907
- Sponsor's protocol ID
- 2008-58-0028
- Status last verified
- Feb 2018
- First submitted
- 18 Feb 2015
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation Based Team Training of Endoscopy Staff May Improve Patients' Perception of Colonoscopy
- ClinicalTrials.gov ID
- NCT02428907
- Acronym / sponsor ID
- 2008-58-0028
- Conditions
- Colorectal Cancer
- Keywords
- simulation training, minimal sedation, colonoscopy, patient satisfaction, teamwork, team training, patient safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 539 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 29 Apr 2015 (estimated)
- 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.
Some patients experience a degree of pain and discomfort during endoscopic examination of the large bowel. Sedatives and analgesics may be administered in low doses. Excessive dosage or intense pain may lead to hypotension and impaired level of consciousness. The purpose of the present study was to determine if simulation training of endoscopy staff in preventing pain and handling acute complications through effective teamwork could improve the quality of colonoscopy from the patients' perspective.
Detailed description
The study was carried out in a surgical department, where colonoscopies were performed on an out-patient basis under minimal sedation. The intervention consisted of a simulation based course for endoscopy staff. All endoscopy nurses and doctors participated (n=43). The course consisted of three short lectures followed by simulation training. The lectures dealt with technical aspects of colonoscopy, usage of medication and management of unexpected emergency events during the procedure, and finally with interprofessional teamwork and team communication. The lectures were followed by in situ simulation in an endoscopy room. For 2 months before and after the course a questionnaire based survey was carried out. The respondents were consecutive patients who had undergone colonoscopy under minimal sedation or no sedation (according to their own preference ). The questionnaire was filled out when the patient was fully recovered after sedation and ready to go home. The relevant nursing staff and doctor for the procedure also filled out their part of the questionnaire. Patients were invited to participate and gave written consent after oral and written information according to the Helsinki declaration .
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients for colonoscopy under minimal sedation
Key inclusion criteria (1 listed)
- All patients for colonoscopy under minimal sedation who are able to understand imformation
Key exclusion criteria (1 listed)
- Unable to understand information
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 |
|---|---|---|
| simulation trainingteamtraining of endoscopy staff | Behavioural | – |
Primary outcome
patient perception of colonoscopy
Time frame: 3 months
comparison of patient satisfaction aspects of colonoscopy before and after a simulation, course for staff. The patients fill out a questionnaire: Pain score on a visual analogue scale, Wiilingness to return for a repeat colonoscopy if necessary on a visual analogue scale, assessmment of doctor's and nurse's behaviour on a scale from 1 - 10 regarding empathy, quality of information. Staff answer a questionnaire where they assess the quality of teamwork on a scale from 1-10. They also assess the patients perceived pain on a visual analogue scale.
1 secondary outcome
Staff perception of teamwork
Time frame: 3 months
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 5 Feb 2018.
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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.
Karen L Larsen, m.d. principal investigator
Medical Doctor and head of department at Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Aalborg University Hospital at 1 site in Denmark.
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 5 Feb 2018. 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 Denmark. 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?
patient perception of colonoscopy (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2018.