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

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

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.

Study Overview

• Status: Completed
• Conditions: Faculty, Medical
• Intervention / Treatment: Other: Educational Workshop on Speaking-Up; Other: Unrelated Education (CPR)

Detailed Description

Main Outcomes and Measures

1. 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.

• Study Type: Interventional
• Enrollment (Actual): 310
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02139
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Attending Anesthesiologist

Exclusion Criteria:

• Prior exposure to test case

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Educational Workshop on Speaking-Up; Educational Workshop on Speaking-Up Before Simulated Case	Other: Educational Workshop on Speaking-Up; Educational workshop including lecture, discussion, role-play Concepts include: 2-challenge rule, pairing advocacy and inquiry
Sham Comparator: Unrelated Education; Unrelated Education (CPR) before simulated case (Educational Workshop on Speaking-up after case and debriefing)	Other: Unrelated Education (CPR); Unrelated Education (CPR workshop) including: lecture, discussion Topics covered: Cardiac Life Support algorithms, CPR, Medications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speaking-up Behaviors	Anesthesiologist subject's behavior in speaking-up to a surgeon, nurse, and colleague during a realistic simulation case were assessed descriptively.	Immediate
Self-reported hurdles and enablers of speaking-up	A qualitative analysis of stated hurdles or enablers for speaking-up or not was conducted from video recordings of a post-case structured debriefing.	1 hour

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Anesthesia Patient Safety Foundation
• Investigators: Principal Investigator: Daniel B Raemer, Ph.D., Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: June 17, 2014
• First Submitted That Met QC Criteria: June 20, 2014
• First Posted (Estimate): June 23, 2014

Study Record Updates

• Last Update Posted (Estimate): June 23, 2014
• Last Update Submitted That Met QC Criteria: June 20, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Education; Anesthesiology; Operating Rooms; Curriculum
• Other Study ID Numbers: 2008P001015