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

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Residents
All residents will participate in the activity
Other: Education on breaking bad news to family members remotely
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Virginia

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings