EmpathyNCT01837706
The Impact of Emergency Physician Empathy on Litigation Propensity
An observational study of Empathy, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this study is to observe whether people would report being less likely to sue a physician who shows more empathy when giving a patient potentially bad news regarding their medical condition. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Empathy
- How many people
- 437 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 2013
- Phase
- Observational
- 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
Study population: Emergency room patients
Who may be able to join
- Emergency Room Patient
Who cannot join
- Non-English speaking
- Not healthy enough to be in waiting room
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Emergency Department
Loma Linda, California, 92354
About this study
The purpose of this study is to observe whether people would report being less likely to sue a physician who shows more empathy when giving a patient potentially bad news regarding their medical condition.
Read the detailed description
The investigators hypothesized that patients will have less propensity to sue emergency physicians after a poor outcome if the physician demonstrated empathy by verbalizing that they recognize the patient is concerned about their symptoms, and that the patient knows their typical state of health better than a physician seeing them for the first time. Accordingly, the investigators will assess whether the presence or absence of emergency physician empathetic statements in videotaped simulated encounters will alter patient propensity towards litigation. Secondary objectives are to assess whether the presence or absence of empathetic statements alters patient perceptions of discharge instruction clarity, physician expertness, physician caring, and physician desirability.
- Conditions
- Empathy
- Keywords
- Empathy, Communication, Physician litigation
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Emergency Room Patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intention to sue
This outcome will be assessed by asking "Would you sue this doctor?" after viewing a short video. Items will be measured on a 5-point scale (1=Definitely no to 5=Definitely yes).
Measured: Immediately after viewing
Secondary outcomes (4)
Assessment of physician expertise
This outcome will be assessed by asking "Do you believe this physician is an expert?" after viewing a short video. Items will be measured on a 5-point scale (1=Definitely no to 5=Definitely yes).
Measured: Immediately after viewing
Assessment of physician caring
This outcome will be assessed by asking "Do you think this doctor cared about the patient?" after viewing a short video. Items will be measured on a 5-point scale (1=Definitely no to 5=Definitely yes).
Measured: Immediately after viewing
Assessment of whether subject would want to be physician's patient
This outcome will be assessed by asking "Would you want this physician as your doctor?" after viewing a short video. Items will be measured on a 5-point scale (1=Definitely no to 5=Definitely yes).
Measured: Immediately after viewing
Assessment of clarity of physician instructions
This outcome will be assessed by asking "Did you understand the instructions the doctor gave the patient?" after viewing a short video. Items will be measured on a 5-point scale (1=Definitely no to 5=Definitely yes).
Measured: Immediatley after viewing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmpathyStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dustin Smith, Loma Linda University
- Investigators
- Dustin Smith, MD, Principal investigator, Loma Linda UniversityEllen Reibling, PhD, Study director, Loma Linda UniversityJesse Kellar, MD, Study director, Loma Linda UniversitySteve Green, MD, Study director, Loma Linda UniversityElizabeth Walters, MD, Study director, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837706
- Sponsor's protocol ID
- RS-5120206
- Status last verified
- Oct 2014
- First submitted
- 18 Apr 2013
- Last updated
- 3 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Smith DD, Kellar J, Walters EL, Reibling ET, Phan T, Green SM. Does emergency physician empathy reduce thoughts of litigation? A randomised trial. Emerg Med J. 2016 Aug;33(8):548-52. doi: 10.1136/emermed-2015-205312. Epub 2016 Mar 21.
PubMed 27002161
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Emergency Physician Empathy on Litigation Propensity
- ClinicalTrials.gov ID
- NCT01837706
- Acronym / sponsor ID
- RS-5120206
- Conditions
- Empathy
- Keywords
- Empathy, Communication, Physician litigation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 23 Apr 2013 (estimated)
- 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.
The purpose of this study is to observe whether people would report being less likely to sue a physician who shows more empathy when giving a patient potentially bad news regarding their medical condition.
Detailed description
The investigators hypothesized that patients will have less propensity to sue emergency physicians after a poor outcome if the physician demonstrated empathy by verbalizing that they recognize the patient is concerned about their symptoms, and that the patient knows their typical state of health better than a physician seeing them for the first time. Accordingly, the investigators will assess whether the presence or absence of emergency physician empathetic statements in videotaped simulated encounters will alter patient propensity towards litigation. Secondary objectives are to assess whether the presence or absence of empathetic statements alters patient perceptions of discharge instruction clarity, physician expertness, physician caring, and physician desirability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency Room Patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency room patients
Key inclusion criteria (1 listed)
- Emergency Room Patient
Key exclusion criteria (2 listed)
- Non-English speaking
- Not healthy enough to be in waiting room
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intention to sue
Time frame: Immediately after viewing
This outcome will be assessed by asking "Would you sue this doctor?" after viewing a short video. Items will be measured on a 5-point scale (1=Definitely no to 5=Definitely yes).
4 secondary outcomes
Assessment of physician expertise
Time frame: Immediately after viewing
Assessment of physician caring
Time frame: Immediately after viewing
Assessment of whether subject would want to be physician's patient
Time frame: Immediately after viewing
Assessment of clarity of physician instructions
Time frame: Immediatley after viewing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2014.
- Derived from this study: PubMed 27002161Smith DD, Kellar J, Walters EL, Reibling ET, Phan T, Green SM. Does emergency physician empathy reduce thoughts of litigation? A randomised trial. Emerg Med J. 2016 Aug;33(8):548-52. doi: 10.1136/emermed-2015-205312. Epub 2016 Mar 21.
Related trials for Empathy
Not yet recruiting
Culturally-Tailored AI Chatbot Simulation for Therapeutic Communication and Empathy in Psychiatric Nursing Students
Therapeutic Communication
Active, not recruiting
AI Ambient Scribe in Psychiatry
Therapeutic Alliance, Empathy
Not yet recruiting
Psychosocial Effects of Empathy-Based Midwifery Education on Midwifery Students and Pregnant Women
Empathy, Anxiety
Recruiting
Reducing Mental Health Stigmatization Among Healthcare Workers and Students Using a Virtual Reality Protocol: The VIRTUS Protocol
Schizophrenia Disorder
Not yet recruiting
Development of the '1 Situation-5 Minutes' Game and Evaluation of Its Impact on Care Awareness and Empathy: A Mixed-Methods Study
Nursing Students' Care Awareness and Empathy
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.
Dustin Smith, MD principal investigator
Loma Linda University
Ellen Reibling, PhD study director
Loma Linda University
Jesse Kellar, MD study director
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Empathy, run by Loma Linda University 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 1 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: finished, as of the sponsor's last update on 3 Oct 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intention to sue (time frame: Immediately after viewing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01837706, which also lists 1 linked publication.
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 3 Oct 2014.