Improving Faculty's Ability to Speak Up to Others in the Operating Room
1 other identifier
interventional
310
1 country
1
Brief Summary
Importance Team members speaking-up by raising concerns about inappropriate or unsafe actions of others within the team can have direct, immediate, and preventive effect on adverse outcomes. However, little is known about the hurdles and enablers of this behavior in healthcare, especially within the operating room setting. Objective 1\. Determine if an educational workshop would improve speaking-up behaviors of practicing anesthesiologists when presented with realistically-simulated clinical situations. 2.Describe speaking-up behaviors addressed to a surgeon, a nurse, and a colleague. 3. Identify the self-reported hurdles and enablers for speaking-up in those situations encountered. Design Randomized controlled experiment of an educational workshop intervention on communication behaviors in a simulated case. Qualitative analysis of debriefing conversations following the simulated case. Setting Established academic simulation center Participants Seventy-one practicing anesthesiologists from four academic medical centers and one community hospital Intervention Fifty minute educational workshop on speaking-up that included rationale, conversational techniques, a rubric for speaking-up, and role-play.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 17, 2014
CompletedFirst Posted
Study publicly available on registry
June 23, 2014
CompletedJune 23, 2014
June 1, 2014
6.2 years
June 17, 2014
June 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Speaking-Up Behavior
Subjects were assessed by trained raters as to whether they spoke-up when safety related errors were made during a realistic simulation case.
Immediate
Secondary Outcomes (2)
Speaking-up Behaviors
Immediate
Self-reported hurdles and enablers of speaking-up
1 hour
Study Arms (2)
Educational Workshop on Speaking-Up
EXPERIMENTALEducational Workshop on Speaking-Up Before Simulated Case
Unrelated Education
SHAM COMPARATORUnrelated Education (CPR) before simulated case (Educational Workshop on Speaking-up after case and debriefing)
Interventions
Educational workshop including lecture, discussion, role-play Concepts include: 2-challenge rule, pairing advocacy and inquiry
Unrelated Education (CPR workshop) including: lecture, discussion Topics covered: Cardiac Life Support algorithms, CPR, Medications
Eligibility Criteria
You may qualify if:
- Attending Anesthesiologist
You may not qualify if:
- Prior exposure to test case
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02139, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel B Raemer, Ph.D.
Massachusetts General Hospital
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
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Anaesthesia
Study Record Dates
First Submitted
June 17, 2014
First Posted
June 23, 2014
Study Start
March 1, 2008
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
June 23, 2014
Record last verified: 2014-06