Breaking Bad News to Family Members in a Pandemic

April 26, 2021 updated by: Linda R Duska, University of Virginia
Resident education on breaking bad news and conducting end of life conversations has been shown to improve comfort levels with having these conversations. Interventions with OB/GYN residents specifically have used a combination of didactics, resident role-playing and ultimately interaction with standardized patients with feedback from palliative care specialists. These interventions can be costly and also are not practical during the pandemic training environment where resident has transitioned to a virtual curriculum. While the didactics portions of this previously proven curriculum can be done virtually, the standardized patient interactions are challenging to replicate. Additionally, one of the key changes to patient care that has emerged during the pandemic is restrictive hospital and clinic visitor policies. Care providers must now have the ability to have difficult conversations and break bad news to family members over the phone rather than in person. Additionally, there has been an increasing reliance on telehealth visits. There are no currently studied training interventions in obstetrics and gynecology that address these skills.

Study Overview

Detailed Description

First residents will be asked to participate. After giving consent, they will complete a pre-study questionnaire regarding their education and experience with end of life and breaking bad news conversations: They will be queried on basic demographic information: Age, Sex, Year of Residency, Intended specialty, prior education on end of life and breaking bad news: (0 hrs, 1-3 hours, 4-10 hours, 10-40 hrs, > 40 hrs), prior palliative or hospice rotation, have you had interaction with palliative care providers during training, have you experienced the death of a close family member or friend?, have you experienced a personally life threatening diagnosis?. We also will query the number of times residents have participated in code discussions, breaking bad news, discussion about prognosis, discussion about care at the end of life and discussion about hospice. They will also rate their own ability and comfort with the following topics : self-assessed preparation and attitudes about end-of life communication. First will be asked to review "Discussing Resuscitation Preferences with Patients: Challenges and Rewards" There will be a didactic session during which we will review the article and discuss strategies for breaking bad news to family members. A faculty member from General OB/GYN, MFM and Gynecologic Oncology will each give a brief 10 min lecture on how they have difficulty conversations with patients and family members in their specific field (post-operative complications , pre-viable delivery, and hospice/end of life/withdrawal of car). The lecture will be taped for those unable to attend. Two sessions will be held during didactics via Zoom in two different months to encompass those on night shifts and vacations. Residents will be split into groups of 3 with a faculty member in each group. They will role-play three scenarios one specific to each of the subspecialties- 1) Pre-viable delivery, 2) Discussion of withdrawal of care for a patient with advanced gynecologic malignancy who can no longer make their own medical decisions, and 3) Telling a family member about a surgical complication requiring an emergent return to the operating room. One resident will play the part of the family member receiving the phone call. To better mimic phone conversation, video will be turned off during this portion. The faculty member will score the interaction based on the following criteria and also give specific feedback regarding what went well and what should be improved. After receiving feedback from the role playing session, residents will then sign up for a recorded session with an actor playing a family member. They will be randomly assigned to one of the three topics and will then be assessed by a faculty member with the same criteria. After each of the three sections of teaching, residents will be asked to rate on a 1 to 5 scale their experience with the content and if it improved their ability to have end of life conversations. 3 months following the intervention, residents will be queried with the same questions asked previously to assess changes in their comfort with these conversations

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • residents in University of Virginia's residency in Obstetrics and Gynecology
  • able to provide informed consent

Exclusion Criteria:

  • under age 18
  • inability to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Residents
All residents will participate in the activity
Participants will receive a combination of surveys, pre- and post-tests, lectures and didactics to increase their awareness of techniques to communicate difficult topics with patients remotely as well as skill building exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pre vs. post test scores
Time Frame: 4 years
Increase in self-reported comfort levels post education sessions compared to the "Bad News" pre-test questionnaire with ranking comfort level for a variety of breaking bad news scenarios from 1 to 5 with 5 indicating very comfortable and 1 indicating very uncomfortable.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

January 1, 2026

Study Registration Dates

First Submitted

October 11, 2020

First Submitted That Met QC Criteria

November 15, 2020

First Posted (Actual)

November 20, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 3977

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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