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Breaking Bad News in Obstetrics: A Trial of Simulation-Debrief Based Education

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02168192
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : March 17, 2016
Information provided by (Responsible Party):
Montefiore Medical Center

Brief Summary:

The purpose of this study is to assess the utility of training in Breaking Bad News (BBN) skills. We hypothesize that given little or no formal training in breaking bad news, obstetric providers will benefit from a curriculum of teaching breaking bad news techniques, but will benefit more from a simulation teaching technique than from a lecture in breaking bad news techniques.

The investigators also hypothesize that providers who have undergone breaking bad news simulation will receive improved scores after the simulation debriefing compared to their pre-simulation scores, and their improvement with be greater than the control group.

Condition or disease Intervention/treatment Phase
Breaking Bad News Skills Communications Skills Medical Education Obstetrics Simulation Behavioral: Simulation-Debrief Behavioral: Traditional lecture Not Applicable

Detailed Description:

The investigators' study is part of a planned educational initiative on breaking bad news communication skills, planned for house staff in the department of Obstetrics and Gynecology. All subjects will undergo both a baseline and post-education simulation. The investigators' study intervention is a personalized review and debriefing of the simulation, as compared with a conventional lecture in order to assess the best curriculum for teaching this skill set.

The investigators' study design will be described, consent obtained and consenting house staff will be randomized to participate in a simulation-based education session/debrief or to attend lecture. Randomization will be achieved using sequential opaque envelopes containing allocation cards, designating group assignment. A physician who is not involved in the study will randomly insert allocation cards into the envelopes and group assignment will be concealed until after enrollment is complete.

Subjects will be assigned a study number. The list of subject identifiers and study numbers will be kept separate from other study data, and destroyed after all phases of the study are complete. All other study data will have identifying information deleted, and will be stored in a password protected database.

The investigators plan to have subjects assess baseline characteristics and breaking bad news skills using a self-assessment tool. Subsequently all house staff will be evaluated on their management of breaking bad news through a baseline SP scenario, with assessments by physician-teachers as well as the SPs . These SPs are non-physicians, and do not have supervisory control over the study subjects. The physician-teachers are the co-investigators on this study: Drs. Chazotte, Dayal, Landsberger, Bernstein, Goffman, and Karkowsky.

After this baseline assessment, the intervention group will debrief their baseline simulation with a physician educator. The control group will instead undergo a conventional lecture about "Breaking Bad News" techniques. Finally, both groups will undergo a second simulation, which will be assessed by SPs and physician-teachers

After this step, subjects will fill out self-assessment tools on BBN. House staff who did not undergo the conventional curriculum will then attend the lecture; similarly, those subjects who were not in the intervention group will then have the opportunity to review their simulation in a personal debriefing session.

Six months after the study, we plan to have all subjects fill out a self-assessment form to assess if any long-term change to their BBN skills has been sustained.

SPs will be formally trained in the scenario and in their responses, as well as in standardized assessment of the subjects.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Breaking Bad News in Obstetrics: A Trial of Simulation-Debrief Based Education
Study Start Date : November 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : July 2013

Arm Intervention/treatment
Placebo Comparator: Traditional Lecture
These subjects received a 10 minute power point lecture on BBN skills.
Behavioral: Traditional lecture
Control group underwent lecture for approximately 10 minutes reviewing BBN skills.

Experimental: Simulation-Debrief
These subjects received a formal debrief process, reviewing their prior baseline simulation.
Behavioral: Simulation-Debrief
Subjects underwent a formal debrief, reviewing the BBN skills exhibited in their prior simulation of an obstetrical communication skills scenario.

Primary Outcome Measures :
  1. BBN skills [ Time Frame: Immediate ]
    As evaluated by IRB-approved evalution

Secondary Outcome Measures :
  1. Subject BBN confidence [ Time Frame: Immediately and 6 months post-intervention ]
    Subject BBN confidence about their communications skills in the setting of Breaking Bad news was evaluated immediately post-intervention and 6-months post-intervention

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

-Montefiore Medical Center Obstetrics/Gynecology department house staff.

Exclusion Criteria:

  • House staff that were unable to attend at least two sessions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02168192

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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Montefiore Medical Center
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Principal Investigator: Cynthia Chazotte, MD Montefiore Medical Center
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Responsible Party: Montefiore Medical Center Identifier: NCT02168192    
Other Study ID Numbers: 10-08-275
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016
Keywords provided by Montefiore Medical Center:
Breaking bad news skills
Communications skills
Medical education