SupervisionVSINCT05075278
Supervision Models in Training Environments
A study testing Survey in people with Supervision and Anesthesia, run by Rhode Island Hospital at 1 site in United States.
Trial summary
Attending physicians often supervise novice junior residents in a direct one-to-one format. Alternatively, a senior resident can be paired with a new trainee under the non-direct (but immediately available) supervision of an attending physician. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Supervision, Anesthesia
- What is being tested?
- Survey
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2021to 30 Jul 2022
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New incoming anesthesia residents assigned to healthy patients (ASA physical status classifications of 1 or 2).
Who cannot join
- New incoming anesthesia residents assigned to patients with ASA physical status classifications 3 or greater.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: Assessing the Quality and Effectiveness of Two Common Supervision Models in Training Environments Using a Validated Supervision Instrument
Attending physicians often supervise novice junior residents in a direct one-to-one format. Alternatively, a senior resident can be paired with a new trainee under the non-direct (but immediately available) supervision of an attending physician. Resident supervision has been considered an important step towards independent practice. Both models are ubiquitous in the United States, but no study to date has been performed if one model is better than the other with respect to supervision scores.
Read the detailed description
Supervision of residents is a cornerstone of ACGME accreditation and a critical focus of any training program. A nine-faceted, validated survey has been used to assess quality and effectiveness of supervision in training environments. Residents that assign poor scores for faculty members also tend to poorly evaluate the department-at-large. Further, residents that evaluate supervisors unfavorably also tend to report more patient safety mishaps in the context of a less safe work environment. Previous literature that used this supervision scale concluded that residents who reported mean department-wide supervision scores less than 3 (frequent) reported significantly more frequent occurrences of mistakes with negative consequences to patients and medication errors.
Attending physicians often supervise novice junior residents in a direct one-to-one format. Alternatively, a senior resident can be paired with a new trainee under the non-direct (but immediately available) supervision of an attending physician. Resident supervision has been considered an important step towards independent practice.. Both models are ubiquitous in the United States, but no study to date has been performed if one model is better than the other with respect to supervision scores.
- Conditions
- Supervision, Anesthesia
- Being tested
- Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyBehavioural
A survey will be completed by the participants at the conclusion of each day.
| Study group | Role | What they receive |
|---|---|---|
| Attending physician for direct 1:1 supervision | Active comparator | Participants will be assigned to an attending physician for direct 1:1 supervision. The participants will fill out a survey at the end of the day for 16 consecutive days. Receives: Behavioral: Survey |
| Senior resident for direct 1:1 supervision | Experimental | Participants will be assigned to an senior resident as a direct supervisor with oversight from an attending physician (in accordance with CMS/ACGME staffing criteria). The participants will fill out a survey at the end of the day for 16 consecutive days. Receives: Behavioral: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Supervision evaluation questionnaire
A series of questions pertaining to planning perianesthesia care, feedback, availability, opportunities, stimulating patient based learning, professionalism, interpersonal skills, presence, and safety. It questions are scored using a 4-point Likert scale (never = 1, rarely = 2, frequently = 3, and always = 4). A score less than 3 is associated with more frequent occurrences of mistakes.
Measured: At the conclusion of each day for 16 consecutive days
Secondary outcomes (1)
Spielberger State-Trait Anxiety Inventory Short Form
(Strongly agree=5, Agree=4, Neither=3, Disagree=2, Strongly Disagree=1).
Measured: At the conclusion of each day for 16 consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start7 Jul 2021
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SupervisionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Malgieri, MD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075278
- Sponsor's protocol ID
- 1734757
- Acronym
- VSI
- Status last verified
- Jan 2023
- First submitted
- 29 Sep 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Oliveira GS Jr, Rahmani R, Fitzgerald PC, Chang R, McCarthy RJ. The association between frequency of self-reported medical errors and anesthesia trainee supervision: a survey of United States anesthesiology residents-in-training. Anesth Analg. 2013 Apr;116(4):892-7. doi: 10.1213/ANE.0b013e318277dd65. Epub 2013 Feb 5.
PubMed 23385057De Oliveira GS Jr, Dexter F, Bialek JM, McCarthy RJ. Reliability and validity of assessing subspecialty level of faculty anesthesiologists' supervision of anesthesiology residents. Anesth Analg. 2015 Jan;120(1):209-213. doi: 10.1213/ANE.0000000000000453.
PubMed 25268396Riveros Perez E, Jimenez E, Yang N, Rocuts A. Evaluation of Anesthesiology Residents' Supervision Skills: A Tool to Assess Transition Towards Independent Practice. Cureus. 2019 Feb 26;11(2):e4137. doi: 10.7759/cureus.4137.
PubMed 31058020de Oliveira Filho GR, Dal Mago AJ, Garcia JH, Goldschmidt R. An instrument designed for faculty supervision evaluation by anesthesia residents and its psychometric properties. Anesth Analg. 2008 Oct;107(4):1316-22. doi: 10.1213/ane.0b013e318182fbdd.
PubMed 18806047
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Quality and Effectiveness of Two Common Supervision Models in Training Environments Using a Validated Supervision Instrument
- ClinicalTrials.gov ID
- NCT05075278
- Acronym / sponsor ID
- VSI / 1734757
- Conditions
- Supervision, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 12 Oct 2021 (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.
Attending physicians often supervise novice junior residents in a direct one-to-one format. Alternatively, a senior resident can be paired with a new trainee under the non-direct (but immediately available) supervision of an attending physician. Resident supervision has been considered an important step towards independent practice. Both models are ubiquitous in the United States, but no study to date has been performed if one model is better than the other with respect to supervision scores.
Detailed description
Supervision of residents is a cornerstone of ACGME accreditation and a critical focus of any training program. A nine-faceted, validated survey has been used to assess quality and effectiveness of supervision in training environments. Residents that assign poor scores for faculty members also tend to poorly evaluate the department-at-large. Further, residents that evaluate supervisors unfavorably also tend to report more patient safety mishaps in the context of a less safe work environment. Previous literature that used this supervision scale concluded that residents who reported mean department-wide supervision scores less than 3 (frequent) reported significantly more frequent occurrences of mistakes with negative consequences to patients and medication errors.
Attending physicians often supervise novice junior residents in a direct one-to-one format. Alternatively, a senior resident can be paired with a new trainee under the non-direct (but immediately available) supervision of an attending physician. Resident supervision has been considered an important step towards independent practice.. Both models are ubiquitous in the United States, but no study to date has been performed if one model is better than the other with respect to supervision scores.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attending physician for direct 1:1 supervision | Active comparator | Behavioral: SurveyParticipants will be assigned to an attending physician for direct 1:1 supervision. The participants will fill out a survey at the end of the day for 16 consecutive days. |
| Senior resident for direct 1:1 supervision | Experimental | Behavioral: SurveyParticipants will be assigned to an senior resident as a direct supervisor with oversight from an attending physician (in accordance with CMS/ACGME staffing criteria). The participants will fill out a survey at the end of the day for 16 consecutive days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- New incoming anesthesia residents assigned to healthy patients (ASA physical status classifications of 1 or 2).
Key exclusion criteria (1 listed)
- New incoming anesthesia residents assigned to patients with ASA physical status classifications 3 or greater.
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 |
|---|---|---|
| SurveyA survey will be completed by the participants at the conclusion of each day. | Behavioural | Attending physician for direct 1:1 supervision, Senior resident for direct 1:1 supervision |
Primary outcome
Supervision evaluation questionnaire
Time frame: At the conclusion of each day for 16 consecutive days
A series of questions pertaining to planning perianesthesia care, feedback, availability, opportunities, stimulating patient based learning, professionalism, interpersonal skills, presence, and safety. It questions are scored using a 4-point Likert scale (never = 1, rarely = 2, frequently = 3, and always = 4). A score less than 3 is associated with more frequent occurrences of mistakes.
1 secondary outcome
Spielberger State-Trait Anxiety Inventory Short Form
Time frame: At the conclusion of each day for 16 consecutive days
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 8 Feb 2023.
- Background: PubMed 23385057De Oliveira GS Jr, Rahmani R, Fitzgerald PC, Chang R, McCarthy RJ. The association between frequency of self-reported medical errors and anesthesia trainee supervision: a survey of United States anesthesiology residents-in-training. Anesth Analg. 2013 Apr;116(4):892-7. doi: 10.1213/ANE.0b013e318277dd65. Epub 2013 Feb 5.
- Background: PubMed 25268396De Oliveira GS Jr, Dexter F, Bialek JM, McCarthy RJ. Reliability and validity of assessing subspecialty level of faculty anesthesiologists' supervision of anesthesiology residents. Anesth Analg. 2015 Jan;120(1):209-213. doi: 10.1213/ANE.0000000000000453.
- Background: PubMed 31058020Riveros Perez E, Jimenez E, Yang N, Rocuts A. Evaluation of Anesthesiology Residents' Supervision Skills: A Tool to Assess Transition Towards Independent Practice. Cureus. 2019 Feb 26;11(2):e4137. doi: 10.7759/cureus.4137.
- Results publication: PubMed 18806047de Oliveira Filho GR, Dal Mago AJ, Garcia JH, Goldschmidt R. An instrument designed for faculty supervision evaluation by anesthesia residents and its psychometric properties. Anesth Analg. 2008 Oct;107(4):1316-22. doi: 10.1213/ane.0b013e318182fbdd.
- Individual participant dataSharing planned: No
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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.
Christopher Malgieri, MD principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey in people with Supervision and Anesthesia, run by Rhode Island Hospital 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 8 Feb 2023. 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. 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?
Supervision evaluation questionnaire (time frame: At the conclusion of each day for 16 consecutive days). 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 NCT05075278, which also lists 4 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 8 Feb 2023.