- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01304030
Improving Empathy and Relational Skills
February 23, 2011 updated by: Massachusetts General Hospital
Improving Empathy and Relational Skills in Resident Physicians: A Randomized Controlled Trial
Our research hypothesis is that residents who participate in the empathy and relational skills training modules will significantly improve in these skills as compared to a control group of residents who receive residency training as usual that includes the current standard training in the doctor-patient relationship.
To evaluate this hypothesis, we will use a two-pronged approach to assessment.
The first prong is the residents' self assessment of empathy and the second is from the patients' perspective.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study design is a randomized controlled trial assigning resident physicians (N=100) to either: (a) empathy and relational skills training; or (b) control group receiving standard residency training as usual.
Over the course of six weeks, each resident physician in the experimental group will receive three 60-minute training sessions focused on empathy and relational skills (the residents assigned to the control condition will receive standard residency training as usual).
The emerging neuroscience of emotions and empathy has provided the neurobiological and physiological bases for our Empathy Training Modules to enhance patient-doctor communication.
These innovative modules provide the basic science and video modeling for empathy training.
Based on cutting edge mirror neuron research, our training modules offer a novel approach to empathy and relational skills training that teaches physicians about the neurobiology and physiology of emotions in difficult or stressful patient interactions.
We have developed professionally produced high definition training modules that portray difficult patient-physician interactions.
Importantly, these videos also include physiological displays of emotion for both members of the dyad so that one can easily observe the degree to which patient and physician are physiologically concordant or discordant with one another.
The empathy training is conducted at a deeper level of physiological awareness and regulation that promises to be more effective than traditional didactic teaching by integrating the technology of psychophysiology.
The goal of raising awareness of physiologic indices during a patient-doctor interaction is to present an objective measure of emotional response to both explicit and implicit stimuli, which promises to be a powerful teaching tool to enhance empathic physician behaviors.
Study Type
Interventional
Enrollment (Actual)
99
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 Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 021114
- Massachusetts General Hospital
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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
20 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
All medical and surgical residents who are based at Massachusetts General Hospital will be eligible to participate in the study.
Exclusion Criteria:
Residents who are rotating at sites other then Massachusetts General Hospital Residents who are on rotations that do not include clinical care
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
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Experimental Group
The experimental group receives Empathy Training.
The control Group receives residency training as usual
|
The Empathy Training Modules utilize translational research in emotion expression basic science, physiology of emotions, decoding facial expressions and self-regulation skills as pertaining to management of medical and surgical patients.
Other Names:
|
|
ACTIVE_COMPARATOR: Control Group
The control group receives residency training as usual
|
Residents will receive their typical didactic and clinical education
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Consultation and Relational Empathy Measure (CARE) measure
Time Frame: Up to 5 weeks (this is an average)
|
At baseline: (1) Residents will complete the CARE measure (2) 10 patients in each resident's clinic will rate their encounter using the CARE Measure; (3) Residents will receive the Empathy and Relational Training Modules or residency training as usual.
At the six-week endpoint: (4) residents will complete the CARE measure and (5) patients will complete the CARE measure after the clinic visit.
|
Up to 5 weeks (this is an average)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Jefferson Empathy Scale Mehrabian Balanced Emotional Empathy Scale (BEES) (30 items) 2.Jefferson Empathy Scale (20 items 3. Neuroscience of Emotions Assessment 4. Ekman Facial Expression Decoding Assessment
Time Frame: Prospective
|
The Mehrabian BEES Measures baseline empathy.
The Jefferson Scale measures physician attitudes about the importance of empathy in clinical medical care.
The Neuroscience of Emotions Test measures knowledge of basic science of emotions.
The Ekman test measures ability to decode subtle facial expressions.
|
Prospective
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Helen Riess, MD, Massachusetts General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Riess H. Empathy in medicine--a neurobiological perspective. JAMA. 2010 Oct 13;304(14):1604-5. doi: 10.1001/jama.2010.1455. No abstract available.
- Riess H, Kelley JM, Bailey R, Konowitz PM, Gray ST. Improving empathy and relational skills in otolaryngology residents: a pilot study. Otolaryngol Head Neck Surg. 2011 Jan;144(1):120-2. doi: 10.1177/0194599810390897.
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
February 1, 2010
Primary Completion (ACTUAL)
December 1, 2010
Study Completion (ACTUAL)
December 1, 2010
Study Registration Dates
First Submitted
February 19, 2011
First Submitted That Met QC Criteria
February 23, 2011
First Posted (ESTIMATE)
February 25, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
February 25, 2011
Last Update Submitted That Met QC Criteria
February 23, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2009P001599
- P001599 (OTHER_GRANT: Risk Management Foundation)
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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