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

Status

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

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

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

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 (Actual)

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.
99

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 Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 021114
        • Massachusetts General Hospital

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

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

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.
EXPERIMENTAL: Experimental Group
The experimental group receives Empathy Training. The control Group receives residency training as usual
Behavioral: Empathy Training Modules
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:
  • E.M.P.A.T.H.Y. (TM)
ACTIVE_COMPARATOR: Control Group
The control group receives residency training as usual
Behavioral: Residency Training as usual
Residents will receive their typical didactic and clinical education
Other Names:
  • Residency Training

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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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

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, 2010

Primary Completion (ACTUAL)

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.
December 1, 2010

Study Completion (ACTUAL)

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.
December 1, 2010

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).
February 19, 2011

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.
February 23, 2011

First Posted (ESTIMATE)

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.
February 25, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

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.
February 25, 2011

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.
February 23, 2011

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.
February 1, 2011

More Information

Terms related to this study

Keywords

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.
  • 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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