Self-regulationNCT02199210
Exploring Self-regulatory Processes in Anesthesiologists During Massive Transfusion
A study testing Prompting forethought in people with Self-regulation and Forethought, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The purpose of the project is to investigate the function of self-regulatory processes in anesthesiologists and how application of these processes influence performance in a crisis situation.The investigators intend to explore specifically the first phase of self-regulation, i.e. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Self-regulation, Forethought, Performance
- What is being tested?
- Prompting forethought
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to Aug 2016
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pilot study: attending anesthesiologists at St. Michael's Hospital , PGY5, PGY2 anesthesia residents at University of Toronto
- Study I: attending anesthesiologists at St. Michael's Hospital, PGY5, PGY2 anesthesia residents at University of Toronto
- Study II: PGY2, PGY3, PGY4 anesthesia residents at University of Toronto
Who cannot join
- Refusal to take part in the study
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
John G Laffey, MD, FCARCSI
Maya J Contreras, PhD, FCARCSI
About this study
Official title: Optimizing Intra-Operative Massive Transfusion: Probing for Forethought
The purpose of the project is to investigate the function of self-regulatory processes in anesthesiologists and how application of these processes influence performance in a crisis situation.The investigators intend to explore specifically the first phase of self-regulation, i.e. the forethought phase which describes processes related to strategic planning, goal setting, goal orientation, and outcome expectation. The investigators hypothesize that prompting forethought before engaging in a simulated massive transfusion crisis situation will result in better task performance in anesthesiologists.
Read the detailed description
The investigators will conduct 3 studies building on each other.
- Pilot Study: the purpose of this study is to develop measurement tools for forethought, performance and a tool for prompting forethought. This study will include 2 attending anesthesiologists and 2 anesthesia residents (PGY2, 5).
- Study I: the purpose of this study is to validate the measurement tools for forethought, performance and the tool for prompting forethought. This will include 6 attending anesthesiologists, 6 PGY5 and 6 PGY2 anesthesia residents.
- Study II: the purpose of this study is to investigate if prompting forethought in anesthesia residents will result in better performance in a simulated massive transfusion than no prompting.
- Conditions
- Self-regulation, Forethought, Performance
- Being tested
- Prompting forethought
- Keywords
- Massive transfusion protocols, Self-regulatory learning, Forethought, Clinical expertise, Simulation, Education
- Medical subject headings
- Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prompting forethoughtOther
Participants will be asked questions which elicit specific forethought elements related to the given clinical situation. These are elements that relate to strategic planning, goal setting, goal orientation, imagery, outcome expectation. These context specific questions will be determined in the Pilot study and validated in Study I.
| Study group | Role | What they receive |
|---|---|---|
| Prompting forethought | Experimental | A demographic questionnaire will be filled out by each participant. After randomization, participants will be presented with the background information of the simulated scenario.Subsequently:
* participants forethought will be prompted and each participant will be asked to report his/her forethought,
* participants then will be asked to manage a simulated massive transfusion scenario,
* at completion of the scenario, each participant will undergo individualized debriefing and a syllabus on massive transfusion will be briefly discussed with them and also provided as a reading material for learning. Receives: Other: Prompting forethought |
| No prompting | No intervention | A demographic questionnaire will be filled out by each participants. After randomization, participants will be presented with the background information of the simulated scenario.Subsequently: * participants will sit and wait for a predetermined time before entering into the simulator, * participants then will be asked to manage a simulated massive transfusion scenario, * at completion of the scenario, each participant will be interviewed about their thought process before entering to the simulation room, * each participant will undergo individualized debriefing and a syllabus on massive transfusion will be briefly discussed with them and also provided as a reading material for learning. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance in managing simulated massive transfusion scenario
Task specific performance tool will be developed in the Pilot study and will be validated in Study I. Each performance will be video recorded and two independent, blinded rater will evaluate the videos and assess performance. Performance assessment tool will be numerical including a 1-5 point scale for each performance element and a Global Rating Scale. Difference between massive transfusion management performance will be compared in anesthesia residents whose forethought is prompted to residents who don't receive prompting.
Measured: Each individual's performance will be video recorded and subsequently evaluated within 8 weeks.
Secondary outcomes (1)
Correlation between forethought scores and performance scores.
The investigators will determine if quality of forethought relates to quality of performance in anesthesia residents managing the simulated massive transfusion scenario. The Pilot study and Study I will be used to develop and validate a scoring form for forethought. This will include scores (1-5) for each forethought elements (strategic planning, goal setting, goal orientation, imaginary, outcome expectation) and a GRS (1-5).
Measured: Forethought scores and performance scores will be determined within 8 weeks after individuals participated in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Self-regulationStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Sponsor
- Investigators
- John G Laffey, MD, FCARCSI, Principal investigator, St. Michael's Hospital, University of TorontoCharlotte Ringsted, PhD, Principal investigator, The Wilson Center, University Health Network, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199210
- Sponsor's protocol ID
- SIMPROJECT-MT
- Status last verified
- Aug 2016
- First submitted
- 21 Jul 2014
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Zimmermann BJ. Development of adaptation of expertise: The role of self-regulatory processes and beliefs. In: Ericsson KA, ed. The Cambridge Handbook of Expertise and Expert Performance: Cambridge Unicersity Press 2006:705-22.
Ericsson KA. Protocol analysis and expert thought: concurrent verbalisations of thinking during experts' performance on representative tasks. In: Ericsson KA, ed. The Cambridge Handbook of Expertise and Expert Performance: Cambridge University Press 2006:223-41.
Artino AR Jr, Cleary TJ, Dong T, Hemmer PA, Durning SJ. Exploring clinical reasoning in novices: a self-regulated learning microanalytic assessment approach. Med Educ. 2014 Mar;48(3):280-91. doi: 10.1111/medu.12303.
PubMed 24528463Cleary TJ, Sandars J. Assessing self-regulatory processes during clinical skill performance: a pilot study. Med Teach. 2011;33(7):e368-74. doi: 10.3109/0142159X.2011.577464.
PubMed 21696270Brydges R, Nair P, Ma I, Shanks D, Hatala R. Directed self-regulated learning versus instructor-regulated learning in simulation training. Med Educ. 2012 Jul;46(7):648-56. doi: 10.1111/j.1365-2923.2012.04268.x.
PubMed 22691145Dzik WH, Blajchman MA, Fergusson D, Hameed M, Henry B, Kirkpatrick AW, Korogyi T, Logsetty S, Skeate RC, Stanworth S, MacAdams C, Muirhead B. Clinical review: Canadian National Advisory Committee on Blood and Blood Products--Massive transfusion consensus conference 2011: report of the panel. Crit Care. 2011;15(6):242. doi: 10.1186/cc10498. Epub 2011 Dec 8.
PubMed 22188866Cotton BA, Dossett LA, Au BK, Nunez TC, Robertson AM, Young PP. Room for (performance) improvement: provider-related factors associated with poor outcomes in massive transfusion. J Trauma. 2009 Nov;67(5):1004-12. doi: 10.1097/TA.0b013e3181bcb2a8.
PubMed 19901661
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Intra-Operative Massive Transfusion: Probing for Forethought
- ClinicalTrials.gov ID
- NCT02199210
- Acronym / sponsor ID
- SIMPROJECT-MT
- Conditions
- Self-regulation, Forethought, Performance
- Keywords
- Massive transfusion protocols, Self-regulatory learning, Forethought, Clinical expertise, Simulation, Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- Aug 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 24 Jul 2014 (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.
The purpose of the project is to investigate the function of self-regulatory processes in anesthesiologists and how application of these processes influence performance in a crisis situation.The investigators intend to explore specifically the first phase of self-regulation, i.e. the forethought phase which describes processes related to strategic planning, goal setting, goal orientation, and outcome expectation. The investigators hypothesize that prompting forethought before engaging in a simulated massive transfusion crisis situation will result in better task performance in anesthesiologists.
Detailed description
The investigators will conduct 3 studies building on each other.
- Pilot Study: the purpose of this study is to develop measurement tools for forethought, performance and a tool for prompting forethought. This study will include 2 attending anesthesiologists and 2 anesthesia residents (PGY2, 5).
- Study I: the purpose of this study is to validate the measurement tools for forethought, performance and the tool for prompting forethought. This will include 6 attending anesthesiologists, 6 PGY5 and 6 PGY2 anesthesia residents.
- Study II: the purpose of this study is to investigate if prompting forethought in anesthesia residents will result in better performance in a simulated massive transfusion than no prompting.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prompting forethought | Experimental | Other: Prompting forethoughtA demographic questionnaire will be filled out by each participant. After randomization, participants will be presented with the background information of the simulated scenario.Subsequently: * participants forethought will be prompted and each participant will be asked to report his/her forethought, * participants then will be asked to manage a simulated massive transfusion scenario, * at completion of the scenario, each participant will undergo individualized debriefing and a syllabus on massive transfusion will be briefly discussed with them and also provided as a reading material for learning. |
| No prompting | No intervention | –A demographic questionnaire will be filled out by each participants. After randomization, participants will be presented with the background information of the simulated scenario.Subsequently: * participants will sit and wait for a predetermined time before entering into the simulator, * participants then will be asked to manage a simulated massive transfusion scenario, * at completion of the scenario, each participant will be interviewed about their thought process before entering to the simulation room, * each participant will undergo individualized debriefing and a syllabus on massive transfusion will be briefly discussed with them and also provided as a reading material for learning. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Pilot study: attending anesthesiologists at St. Michael's Hospital , PGY5, PGY2 anesthesia residents at University of Toronto
- Study I: attending anesthesiologists at St. Michael's Hospital, PGY5, PGY2 anesthesia residents at University of Toronto
- Study II: PGY2, PGY3, PGY4 anesthesia residents at University of Toronto
Key exclusion criteria (1 listed)
- Refusal to take part in 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 |
|---|---|---|
| Prompting forethoughtParticipants will be asked questions which elicit specific forethought elements related to the given clinical situation. These are elements that relate to strategic planning, goal setting, goal orientation, imagery, outcome expectation. These context specific questions will be determined in the Pilot study and validated in Study I. | Other | Prompting forethought |
Primary outcome
Performance in managing simulated massive transfusion scenario
Time frame: Each individual's performance will be video recorded and subsequently evaluated within 8 weeks.
Task specific performance tool will be developed in the Pilot study and will be validated in Study I. Each performance will be video recorded and two independent, blinded rater will evaluate the videos and assess performance. Performance assessment tool will be numerical including a 1-5 point scale for each performance element and a Global Rating Scale. Difference between massive transfusion management performance will be compared in anesthesia residents whose forethought is prompted to residents who don't receive prompting.
1 secondary outcome
Correlation between forethought scores and performance scores.
Time frame: Forethought scores and performance scores will be determined within 8 weeks after individuals participated in the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
- BackgroundZimmermann BJ. Development of adaptation of expertise: The role of self-regulatory processes and beliefs. In: Ericsson KA, ed. The Cambridge Handbook of Expertise and Expert Performance: Cambridge Unicersity Press 2006:705-22.
- BackgroundEricsson KA. Protocol analysis and expert thought: concurrent verbalisations of thinking during experts' performance on representative tasks. In: Ericsson KA, ed. The Cambridge Handbook of Expertise and Expert Performance: Cambridge University Press 2006:223-41.
- Background: PubMed 24528463Artino AR Jr, Cleary TJ, Dong T, Hemmer PA, Durning SJ. Exploring clinical reasoning in novices: a self-regulated learning microanalytic assessment approach. Med Educ. 2014 Mar;48(3):280-91. doi: 10.1111/medu.12303.
- Background: PubMed 21696270Cleary TJ, Sandars J. Assessing self-regulatory processes during clinical skill performance: a pilot study. Med Teach. 2011;33(7):e368-74. doi: 10.3109/0142159X.2011.577464.
- Background: PubMed 22691145Brydges R, Nair P, Ma I, Shanks D, Hatala R. Directed self-regulated learning versus instructor-regulated learning in simulation training. Med Educ. 2012 Jul;46(7):648-56. doi: 10.1111/j.1365-2923.2012.04268.x.
- Background: PubMed 22188866Dzik WH, Blajchman MA, Fergusson D, Hameed M, Henry B, Kirkpatrick AW, Korogyi T, Logsetty S, Skeate RC, Stanworth S, MacAdams C, Muirhead B. Clinical review: Canadian National Advisory Committee on Blood and Blood Products--Massive transfusion consensus conference 2011: report of the panel. Crit Care. 2011;15(6):242. doi: 10.1186/cc10498. Epub 2011 Dec 8.
- Background: PubMed 19901661Cotton BA, Dossett LA, Au BK, Nunez TC, Robertson AM, Young PP. Room for (performance) improvement: provider-related factors associated with poor outcomes in massive transfusion. J Trauma. 2009 Nov;67(5):1004-12. doi: 10.1097/TA.0b013e3181bcb2a8.
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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.
John G Laffey, MD, FCARCSI principal investigator
St. Michael's Hospital, University of Toronto
Charlotte Ringsted, PhD principal investigator
The Wilson Center, University Health Network, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prompting forethought in people with Self-regulation and Forethought, run by Unity Health Toronto at 1 site in Canada.
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 3 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: status not confirmed, as of the sponsor's last update on 10 Aug 2016. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John G Laffey, MD, FCARCSI ((416) 864-5071, laffeyj@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance in managing simulated massive transfusion scenario (time frame: Each individual's performance will be video recorded and subsequently evaluated within 8 weeks.). 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 NCT02199210, which also lists 7 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 10 Aug 2016.