Faculty, MedicalNCT02170818
Improving Faculty's Ability to Speak Up to Others in the Operating Room
A study testing Educational Workshop on Speaking-Up and Unrelated Education (CPR) in people with Faculty, Medical, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Faculty, Medical
- What is being tested?
- Educational Workshop on Speaking-Up and Unrelated Education (CPR)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Attending Anesthesiologist
Who cannot join
- Prior exposure to test case
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02139
About this study
Official title: 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
Read more
- 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.
Read the detailed description
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.
- Conditions
- Faculty, Medical
- Being tested
- Educational Workshop on Speaking-Up, Unrelated Education (CPR)
- Keywords
- Education, Curriculum, Anesthesiology, Operating Rooms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Workshop on Speaking-UpOther
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
| Study group | Role | What they receive |
|---|---|---|
| Educational Workshop on Speaking-Up | Experimental | Educational Workshop on Speaking-Up Before Simulated Case Receives: 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) Receives: Other: Unrelated Education (CPR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediate
Secondary outcomes (2)
Speaking-up Behaviors
Anesthesiologist subject's behavior in speaking-up to a surgeon, nurse, and colleague during a realistic simulation case were assessed descriptively.
Measured: 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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startMar 2008
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Faculty, MedicalStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Anesthesia Patient Safety Foundation
- Responsible party
- Principal investigator, Daniel Raemer, Ph.D., Massachusetts General Hospital
- Investigators
- Daniel B Raemer, Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170818
- Sponsor's protocol ID
- 2008P001015
- Status last verified
- Jun 2014
- First submitted
- 17 Jun 2014
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Faculty's Ability to Speak Up to Others in the Operating Room: A Simulation Based Randomized Controlled Trial of an Educational Intervention
- ClinicalTrials.gov ID
- NCT02170818
- Acronym / sponsor ID
- 2008P001015
- Conditions
- Faculty, Medical
- Keywords
- Education, Curriculum, Anesthesiology, Operating Rooms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Anesthesia Patient Safety Foundation
- Study start
- Mar 2008
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Detailed description
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Workshop on Speaking-Up | Experimental | Other: Educational Workshop on Speaking-UpEducational Workshop on Speaking-Up Before Simulated Case |
| Unrelated Education | Sham comparator | Other: Unrelated Education (CPR)Unrelated Education (CPR) before simulated case (Educational Workshop on Speaking-up after case and debriefing) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Attending Anesthesiologist
Key exclusion criteria (1 listed)
- Prior exposure to test case
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Workshop on Speaking-UpEducational workshop including lecture, discussion, role-play Concepts include: 2-challenge rule, pairing advocacy and inquiry | Other | Educational Workshop on Speaking-Up |
| Unrelated Education (CPR)Unrelated Education (CPR workshop) including: lecture, discussion Topics covered: Cardiac Life Support algorithms, CPR, Medications | Other | Unrelated Education |
Primary outcome
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.
2 secondary outcomes
Speaking-up Behaviors
Time frame: Immediate
Self-reported hurdles and enablers of speaking-up
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel B Raemer, Ph.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Workshop on Speaking-Up and Unrelated Education (CPR) in people with Faculty, Medical, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speaking-Up Behavior (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2014.