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Completed

NCT Number: NCT02168192

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montefiore Medical Center

The Bronx, New York, 10461, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

-Montefiore Medical Center Obstetrics/Gynecology department house staff.

Exclusion criteria

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

Treatment and study plan

Simulation-Debrief

Behavioral

Subjects underwent a formal debrief, reviewing the BBN skills exhibited in their prior simulation of an obstetrical communication skills scenario.

Traditional lecture

Behavioral

Control group underwent lecture for approximately 10 minutes reviewing BBN skills.

Primary outcomes

  1. BBN skills

    Time frame: Immediate

    As evaluated by IRB-approved evalution

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2013
First posted
Jun 20, 2014
Registry last updated
Mar 17, 2016

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.

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