NCT02170818

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

87
On Track

Trial Health Score

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

Enrollment
310

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
Last Updated

June 23, 2014

Status Verified

June 1, 2014

Enrollment Period

6.2 years

First QC Date

June 17, 2014

Last Update Submit

June 20, 2014

Conditions

Keywords

EducationCurriculumAnesthesiologyOperating Rooms

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

EXPERIMENTAL

Educational Workshop on Speaking-Up Before Simulated Case

Other: Educational Workshop on Speaking-Up

Unrelated Education

SHAM COMPARATOR

Unrelated Education (CPR) before simulated case (Educational Workshop on Speaking-up after case and debriefing)

Other: Unrelated Education (CPR)

Interventions

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

Educational Workshop on Speaking-Up

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

Unrelated Education

Eligibility Criteria

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

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

Location

MeSH Terms

Interventions

Cardiopulmonary Resuscitation

Intervention Hierarchy (Ancestors)

ResuscitationEmergency TreatmentTherapeutics

Study Officials

  • Daniel B Raemer, Ph.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

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

Locations