CA2 and CA3 Residents Doing a Two Month Rotation inNCT01522560
Evaluation of Multiscore Feedback in Professionalism for Anesthesia
A study testing Feedback group in people with CA2 and CA3 Residents Doing a Two Month Rotation in and Pediatric Anesthesia Department, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Professionalism is one of the six competences required by The Accreditation for Graduate Medical Education Outcome Project to be taught and evaluated during residency. Anesthesia residents are faced with unique communication challenges in their practice including brief contact time with their patients, operating room… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- CA2 and CA3 Residents Doing a Two Month Rotation in, Pediatric Anesthesia Department
- What is being tested?
- Feedback group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Dec 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- CA2 and CA3 residents doing a two month rotation in Pediatric Anesthesia Department
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Professionalism is one of the six competences required by The Accreditation for Graduate Medical Education Outcome Project to be taught and evaluated during residency. Anesthesia residents are faced with unique communication challenges in their practice including brief contact time with their patients, operating room efficiency pressure, etc. To assess professionalism in Anesthesiology residents is important to obtain evaluations from people with whom they interact including patients, surgeons, colleagues and members of the support team. The Multisource feedback (MSF) approach has been used to evaluate communication skills and professionalism among practicing physicians and residents in a variety of settings. This evaluation model has never been used previously to evaluate anesthesia residents. The investigators propose a randomized controlled trial to validate and evaluate a MSF in professionalism for anesthesia residents. Participants include eighty residents doing two months rotation in Pediatric Anesthesia Department at The Cleveland Clinic Anesthesia Institute from July 1, 2011 and June 30, 2013. MSF questionnaires will be validated using face and content validity methods and comparing them with the current system of evaluation. Residents will be randomly assigned to a feedback group or to the control group. Both groups will receive MSF evaluation from the faculty, patients' parent and coworker. Only the group assigned to feedback is going to have a 'coaching meeting' every month to identify strengths and weaknesses and create strategies for improvement. The investigators are planning to compare the mean values of the baseline evaluations with the mean values obtained after the first and second months from the MSF.
- Being tested
- Feedback group, Control group
- Keywords
- CA2 and CA3 residents, Pediatric Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedback groupOther
Besides the standard evaluation at the end of the rotation, in both groups, residents will receive every week a Multiscore Feedback (MSF) evaluation from the faculty, the patients' parent, and the coworker. Also, for every resident a baseline self assessment will be applied at the beginning and at the end of the rotation.
This group is going to have a 'coaching meeting' every month with the Chairman of Department of Pediatric Anesthesia to identify strengths and weaknesses and create strategies for improvement, based on the Multiscore Feedback (MSF).
Control groupOther
Besides the standard evaluation at the end of the rotation, in both groups, residents will receive every week a Multiscore Feedback (MSF) evaluation from the faculty, the patients' parent, and the coworker. Also, for every resident a baseline self assessment will be applied at the beginning and at the end of the rotation.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Residents will be randomly assigned to a feedback group or to the control group. Besides the standard evaluation at the end of the rotation, in both groups, residents will receive every week a MSF evaluation from the faculty, the patients' parent, and the coworker. Also, for every resident a baseline self assessment will be applied at the beginning and at the end of the rotation. Only the group assigned to feedback is going to have a 'coaching meeting' every month with the Chairman of Department of Pediatric Anesthesia to identify strengths and weaknesses and create strategies for improvement, based on the MSF. Receives: Other: Control group |
| Feedback group | Active comparator | Residents will be randomly assigned to a feedback group or to the control group. Besides the standard evaluation at the end of the rotation, in both groups, residents will receive every week a MSF evaluation from the faculty, the patients' parent, and the coworker. Also, for every resident a baseline self assessment will be applied at the beginning and at the end of the rotation. Only the group assigned to feedback is going to have a 'coaching meeting' every month with the Chairman of Department of Pediatric Anesthesia to identify strengths and weaknesses and create strategies for improvement, based on the MSF. Receives: Other: Feedback group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate Multiscore Feedback (MSF)
To evaluate content validity, copies of the questionnaires will be sent to experts in education in the Anesthesia Institute and Graduate Medical Education at The Cleveland Clinic; they will be asked if the new questionnaires are a good tool to measure professionalism for anesthesia residents
Measured: up to 60 days
Secondary outcomes (1)
secondary goal is to test a Multiscore Feedback (MSF) as a method of evaluation in professionalism for anesthesia residents.
We will assess the impact of feedback using the MSF (versus no feedback) on the professional behavior of anesthesia residents as measured by the MSF. The randomized groups of residents with and without feedback will be compared on mean MSF score after the first and second months of the rotation using a linear mixed effects model to account for the correlation between measurements on the same resident and to adjust for baseline score as a covariate.
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startJul 2011
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CA2 and CA3 Residents Doing a Two Month Rotation inStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nelson Riveros, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522560
- Sponsor's protocol ID
- 11-473
- Status last verified
- Aug 2017
- First submitted
- 27 Jan 2012
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Multiscore Feedback in Professionalism for Anesthesia
- ClinicalTrials.gov ID
- NCT01522560
- Acronym / sponsor ID
- 11-473
- Keywords
- CA2 and CA3 residents, Pediatric Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 31 Jan 2012 (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.
Professionalism is one of the six competences required by The Accreditation for Graduate Medical Education Outcome Project to be taught and evaluated during residency. Anesthesia residents are faced with unique communication challenges in their practice including brief contact time with their patients, operating room efficiency pressure, etc. To assess professionalism in Anesthesiology residents is important to obtain evaluations from people with whom they interact including patients, surgeons, colleagues and members of the support team. The Multisource feedback (MSF) approach has been used to evaluate communication skills and professionalism among practicing physicians and residents in a variety of settings. This evaluation model has never been used previously to evaluate anesthesia residents. The investigators propose a randomized controlled trial to validate and evaluate a MSF in professionalism for anesthesia residents. Participants include eighty residents doing two months rotation in Pediatric Anesthesia Department at The Cleveland Clinic Anesthesia Institute from July 1, 2011 and June 30, 2013. MSF questionnaires will be validated using face and content validity methods and comparing them with the current system of evaluation. Residents will be randomly assigned to a feedback group or to the control group. Both groups will receive MSF evaluation from the faculty, patients' parent and coworker. Only the group assigned to feedback is going to have a 'coaching meeting' every month to identify strengths and weaknesses and create strategies for improvement. The investigators are planning to compare the mean values of the baseline evaluations with the mean values obtained after the first and second months from the MSF.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: Control groupResidents will be randomly assigned to a feedback group or to the control group. Besides the standard evaluation at the end of the rotation, in both groups, residents will receive every week a MSF evaluation from the faculty, the patients' parent, and the coworker. Also, for every resident a baseline self assessment will be applied at the beginning and at the end of the rotation. Only the group assigned to feedback is going to have a 'coaching meeting' every month with the Chairman of Department of Pediatric Anesthesia to identify strengths and weaknesses and create strategies for improvement, based on the MSF. |
| Feedback group | Active comparator | Other: Feedback groupResidents will be randomly assigned to a feedback group or to the control group. Besides the standard evaluation at the end of the rotation, in both groups, residents will receive every week a MSF evaluation from the faculty, the patients' parent, and the coworker. Also, for every resident a baseline self assessment will be applied at the beginning and at the end of the rotation. Only the group assigned to feedback is going to have a 'coaching meeting' every month with the Chairman of Department of Pediatric Anesthesia to identify strengths and weaknesses and create strategies for improvement, based on the MSF. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- CA2 and CA3 residents doing a two month rotation in Pediatric Anesthesia Department
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Feedback groupBesides the standard evaluation at the end of the rotation, in both groups, residents will receive every week a Multiscore Feedback (MSF) evaluation from the faculty, the patients' parent, and the coworker. Also, for every resident a baseline self assessment will be applied at the beginning and at the end of the rotation. This group is going to have a 'coaching meeting' every month with the Chairman of Department of Pediatric Anesthesia to identify strengths and weaknesses and create strategies for improvement, based on the Multiscore Feedback (MSF). | Other | Feedback group |
| Control groupBesides the standard evaluation at the end of the rotation, in both groups, residents will receive every week a Multiscore Feedback (MSF) evaluation from the faculty, the patients' parent, and the coworker. Also, for every resident a baseline self assessment will be applied at the beginning and at the end of the rotation. | Other | Control Group |
Primary outcome
Validate Multiscore Feedback (MSF)
Time frame: up to 60 days
To evaluate content validity, copies of the questionnaires will be sent to experts in education in the Anesthesia Institute and Graduate Medical Education at The Cleveland Clinic; they will be asked if the new questionnaires are a good tool to measure professionalism for anesthesia residents
1 secondary outcome
secondary goal is to test a Multiscore Feedback (MSF) as a method of evaluation in professionalism for anesthesia residents.
Time frame: up to 18 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 9 Feb 2018.
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.
Nelson Riveros, M.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feedback group in people with CA2 and CA3 Residents Doing a Two Month Rotation in and Pediatric Anesthesia Department, run by The Cleveland Clinic at 1 site in United States.
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 9 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 United States. 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. Some participants in this study may receive a placebo. 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?
Validate Multiscore Feedback (MSF) (time frame: up to 60 days). 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 9 Feb 2018.