Resident Education, Patient Communication, Breaking Bad News to Patients Remotely, TelemedicineNCT04638530
Breaking Bad News to Family Members in a Pandemic
A study testing Education on breaking bad news to family members remotely in people with Resident Education, Patient Communication, Breaking Bad News to Patients Remotely, Telemedicine, run by University of Virginia at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Resident Education, Patient Communication, Breaking Bad News to Patients Remotely, Telemedicine
- What is being tested?
- Education on breaking bad news to family members remotely
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- residents in University of Virginia's residency in Obstetrics and Gynecology
- able to provide informed consent
Who cannot join
- under age 18
- inability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Rachel Lacy, MPH, 434-243-0126, rmc9p@virginia.edu
Linda Duska, MD
About this study
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.
Read the 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
- Conditions
- Resident Education, Patient Communication, Breaking Bad News to Patients Remotely, Telemedicine
- Being tested
- Education on breaking bad news to family members remotely
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education on breaking bad news to family members remotelyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Residents | Other | All residents will participate in the activity Receives: Other: Education on breaking bad news to family members remotely |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pre vs. post test scores
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start1 Feb 2021
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resident Education, Patient Communication, Breaking Bad News to Patients Remotely, TelemedicineStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda R Duska, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638530
- Sponsor's protocol ID
- 3977
- Status last verified
- Apr 2021
- First submitted
- 11 Oct 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breaking Bad News to Family Members in a Pandemic
- ClinicalTrials.gov ID
- NCT04638530
- Acronym / sponsor ID
- 3977
- Conditions
- Resident Education, Patient Communication, Breaking Bad News to Patients Remotely, Telemedicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Residents | Other | Other: Education on breaking bad news to family members remotelyAll residents will participate in the activity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- residents in University of Virginia's residency in Obstetrics and Gynecology
- able to provide informed consent
Key exclusion criteria (2 listed)
- under age 18
- inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education on breaking bad news to family members remotelyParticipants 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. | Other | Residents |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education on breaking bad news to family members remotely in people with Resident Education, Patient Communication, Breaking Bad News to Patients Remotely, Telemedicine, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rache l M Lacy, MPH (434-243-0126, rmc9p@hscmail.mcc.virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pre vs. post test scores (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.