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OpenTrials
Completed

NCT Number: NCT02170818

Improving Faculty's Ability to Speak Up to Others in the Operating Room

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.

Completed

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02139, United States

About this study

Main Outcomes and Measures

  • Observed communication in a simulated case that included a surgeon falling asleep during surgery, inappropriate activation of a speakerphone by a nurse, and an incorrect treatment order by a colleague in response to a venous air embolism. 2. Transcribed conversation during a structured debriefing, analyzed for hurdles and enablers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Attending Anesthesiologist

Exclusion criteria

  • Prior exposure to test case

Treatment and study plan

Educational Workshop on Speaking-Up

Other

Educational workshop including lecture, discussion, role-play Concepts include: 2-challenge rule, pairing advocacy and inquiry

Unrelated Education (CPR)

Other

Unrelated Education (CPR workshop) including: lecture, discussion Topics covered: Cardiac Life Support algorithms, CPR, Medications

Primary outcomes

  1. Speaking-Up Behavior

    Time frame: Immediate

    Subjects were assessed by trained raters as to whether they spoke-up when safety related errors were made during a realistic simulation case.

Secondary outcomes

  1. Speaking-up Behaviors

    Time frame: Immediate

    Anesthesiologist subject's behavior in speaking-up to a surgeon, nurse, and colleague during a realistic simulation case were assessed descriptively.

  2. Self-reported hurdles and enablers of speaking-up

    Time frame: 1 hour

    A qualitative analysis of stated hurdles or enablers for speaking-up or not was conducted from video recordings of a post-case structured debriefing.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Anesthesia Patient Safety Foundation

Registry information

Official study title

Improving Faculty's Ability to Speak Up to Others in the Operating Room: A Simulation Based Randomized Controlled Trial of an Educational Intervention

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Jun 23, 2014
Registry last updated
Jun 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.