NCT02199210

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

July 21, 2014

Last Update Submit

August 9, 2016

Conditions

Keywords

Massive transfusion protocolsSelf-regulatory learningForethoughtClinical expertiseSimulationEducation

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • Correlation between forethought scores and performance scores.

    Forethought scores and performance scores will be determined within 8 weeks after individuals participated in the study.

Other Outcomes (1)

  • Development and validation of measurement tools for forethought, performance and a tool for prompting forethought.

    Within 4 weeks after completion of Pilot study and Study I.

Study Arms (2)

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.

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.

Interventions

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.

Prompting forethought

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Refusal to take part in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Related Publications (7)

  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 24528463BACKGROUND
  • 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.

    PMID: 21696270BACKGROUND
  • 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.

    PMID: 22691145BACKGROUND
  • 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.

    PMID: 22188866BACKGROUND
  • 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.

    PMID: 19901661BACKGROUND

MeSH Terms

Conditions

Self-Control

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • John G Laffey, MD, FCARCSI

    St. Michael's Hospital, University of Toronto

    PRINCIPAL INVESTIGATOR
  • Charlotte Ringsted, PhD

    The Wilson Center, University Health Network, University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John G Laffey, MD, FCARCSI

CONTACT

Maya J Contreras, PhD, FCARCSI

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2014

First Posted

July 24, 2014

Study Start

August 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 10, 2016

Record last verified: 2016-08

Locations