Exploring Self-regulatory Processes in Anesthesiologists During Massive Transfusion

Performance Clinical Trial

Official title:

Optimizing Intra-Operative Massive Transfusion: Probing for Forethought

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02199210
• Other study ID #: SIMPROJECT-MT
• Status: Recruiting
• Phase: N/A
• First received: July 21, 2014
• Last updated: August 9, 2016
• Start date: August 2014
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: St. Michael's Hospital, Toronto
• Contact: John G Laffey, MD, FCARCSI
• Phone: (416) 864-5071
• Email: laffeyj[@]smh.ca
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Refusal to take part in the study

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Forethought
• Performance
• Self-regulation

Intervention

Other:
• Prompting forethought
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.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (7)

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. — View Citation

Brydges 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. — View Citation

Cleary 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. — View Citation

Cotton 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. — View Citation

Dzik 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. Review. — View Citation

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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Development and validation of measurement tools for forethought, performance and a tool for prompting forethought.	In the Pilot study, think-aloud protocol will be used to identify forethought elements in experts (attending anesthesiologists) and non-expert (anesthesia residents). The real-time interviews will be used to design the measurement tool for forethought and also to develop a tool for prompting forethought. Equally, performance in a simulated massive transfusion scenario in experts and non-experts will be used to develop a scoring format for performance. The provisional scoring format then will be reviewed by experts and the research group. Study I will determine construct and predictive validity and reproducibility (inter-rater reliability) of these measurement scores.	Within 4 weeks after completion of Pilot study and Study I.	No
Primary	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.	Each individual's performance will be video recorded and subsequently evaluated within 8 weeks.	No
Secondary	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).	Forethought scores and performance scores will be determined within 8 weeks after individuals participated in the study.	No