Breaking Bad News in Obstetrics: A Trial of Simulation-Debrief Based Education
NCT ID: NCT02168192
Last Updated: 2016-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
36 participants
INTERVENTIONAL
2010-11-30
2013-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Assessment of Postpartum Education to Improve Compliance
NCT04486170
Navigating New Motherhood 2
NCT03922334
Testing Feasibility of Care Coordination and Motivational Interviewing for Women With a Recent Preterm Birth
NCT05120843
Postpartum Video Education in High Risk Populations
NCT06310720
Pilot Randomized Control Trial to Assess the Impact of Video Education on Postpartum Care Knowledge and Attendance Among Pregnant Individuals With Diabetes
NCT07009106
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Traditional Lecture
These subjects received a 10 minute power point lecture on BBN skills.
Traditional lecture
Control group underwent lecture for approximately 10 minutes reviewing BBN skills.
Simulation-Debrief
These subjects received a formal debrief process, reviewing their prior baseline simulation.
Simulation-Debrief
Subjects underwent a formal debrief, reviewing the BBN skills exhibited in their prior simulation of an obstetrical communication skills scenario.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Simulation-Debrief
Subjects underwent a formal debrief, reviewing the BBN skills exhibited in their prior simulation of an obstetrical communication skills scenario.
Traditional lecture
Control group underwent lecture for approximately 10 minutes reviewing BBN skills.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Montefiore Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Cynthia Chazotte, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Montefiore Medical Center
The Bronx, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10-08-275
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.