NCT01304030

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
Last Updated

February 25, 2011

Status Verified

February 1, 2011

Enrollment Period

10 months

First QC Date

February 19, 2011

Last Update Submit

February 23, 2011

Conditions

Keywords

Empathy

Outcome Measures

Primary Outcomes (1)

  • Consultation and Relational Empathy Measure (CARE) measure

    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 Outcomes (1)

  • 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

    Prospective

Study Arms (2)

Experimental Group

EXPERIMENTAL

The experimental group receives Empathy Training. The control Group receives residency training as usual

Behavioral: Empathy Training Modules

Control Group

ACTIVE COMPARATOR

The control group receives residency training as usual

Behavioral: Residency Training as usual

Interventions

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.

Also known as: E.M.P.A.T.H.Y. (TM)
Experimental Group

Residents will receive their typical didactic and clinical education

Also known as: Residency Training
Control Group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All medical and surgical residents who are based at Massachusetts General Hospital will be eligible to participate in the study.

You may not qualify if:

  • Residents who are rotating at sites other then Massachusetts General Hospital Residents who are on rotations that do not include clinical care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 021114, United States

Location

Related Publications (2)

  • 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.

    PMID: 20940387BACKGROUND
  • 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.

    PMID: 21493400BACKGROUND

Study Officials

  • Helen Riess, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2011

First Posted

February 25, 2011

Study Start

February 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 25, 2011

Record last verified: 2011-02

Locations