NCT03887195

Brief Summary

Background: Empathic skills of medical students decrease during their studies. Besides, communication skills training is French context. In this context doctor-patient relationship training was built at Paris Descartes University for the 4th year medical students. Implementation of this training aims at maintaining or even increasing empathic and emotional skills of students. Objective: to evaluate effectiveness of this training on medical students skills, knowledge and attitudes. Methodology: Interventional and longitudinal monocentric study Pre/post-test auto-assessment for

  • empathic skills score assessed with the Jefferson Scale of Physician Empathy- Medical Student Version (JSPE-MS)
  • emotional intelligence's score assessed with the Emotional Expressivity Scale (EES)
  • students' declarative knowledge of the doctor-patient relationship assessed with multiple choice question. Post-test assessement for:
  • empathic skills assessed by simulated patients with CARE grid during the Objective Structured Clinical Examination (OSCE).
  • satisfaction auto-questionnaire.
  • socio-demographic and education data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
403

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

29 days

First QC Date

March 15, 2019

Last Update Submit

March 3, 2026

Conditions

Keywords

empathyemotional intelligenceMedical studentEducational programPhysician-Patient Relations

Outcome Measures

Primary Outcomes (1)

  • Jefferson Scale of Physician Empathy- Medical Student Version (JSPE-MS)

    The evolution of students' empathy will be evaluated by the JSPE-MS which is a self-related questionnaire assessing empathy specifically in the doctor-patient relationship; JSPE focuses more specifically on the cognitive component of empathy.

    The week before the beginning of intervention (first Balint group) and immediately after the end of the formative OSCE, up to 6 months later

Secondary Outcomes (3)

  • Emotional Expressivity Scale (EES)

    The week before the beginning of intervention (first Balint group) and immediately after the end of the formative OSCE, up to 6 months later

  • Multiple choice questions

    The week before the beginning of intervention (first Balint group) and immediately after the end of the formative OSCE, up to 6 months later

  • CARE grid

    Immediately after the end of the formative OSCE, up to 6 months later

Study Arms (1)

students

The clinical sample is made up of 501 students (male and female) in the 4th year of medicine at Paris Descartes University, participating at the obligatory training module during the 2018-2019 academic year : this constitutes the entire population concerned by the intervention.

Other: Training mandatory module about the therapeutic relationship

Interventions

The training programme is composed by: * 2 lectures (optional) * 6 supervision sessions by Balint type groups (5 of which are mandatory); * 5 role-plays (all required); * 2 OSCE with patient actors (all required). This teaching is initiated by two lectures on the relationship, the awareness, the listening, the empathy, the therapeutic distance, and the personal impacts that affect the relationship. It included six sessions of Therapeutic Relation Training Groups inspired by the Balint groups. Five role-play sessions are also organized from January to May, the students could play the doctor or the patient. The scenarios are about the following themes: announcement of bad news; accompaniment of chronic disease; management of aggressiveness and hostility; etc. After the role-play, a feedback done by the teacher and the group helps to elaborate what has happened. Finally, a formative assessment will be made during the Clinical Objective Structured Examination.

students

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Undergraduate medical fourth-years student of Paris Descartes University

You may qualify if:

  • Age \> to 18 years old
  • Undergraduate medical fourth-year student of Paris Descartes University
  • Taking part in an obligatory doctor-patient relationship training
  • French language
  • Agreement

You may not qualify if:

  • Refusal of agreement
  • Not speaking French

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paris Descartes University, Sorbonne Paris City, Faculty of Medicine

Paris, 75014, France

Location

Related Publications (11)

  • Starfield B, Wray C, Hess K, Gross R, Birk PS, D'Lugoff BC. The influence of patient-practitioner agreement on outcome of care. Am J Public Health. 1981 Feb;71(2):127-31. doi: 10.2105/ajph.71.2.127.

    PMID: 7457681BACKGROUND
  • Maguire P, Fairbairn S, Fletcher C. Consultation skills of young doctors: I--Benefits of feedback training in interviewing as students persist. Br Med J (Clin Res Ed). 1986 Jun 14;292(6535):1573-6. doi: 10.1136/bmj.292.6535.1573.

    PMID: 3719282BACKGROUND
  • Beckman HB, Markakis KM, Suchman AL, Frankel RM. The doctor-patient relationship and malpractice. Lessons from plaintiff depositions. Arch Intern Med. 1994 Jun 27;154(12):1365-70.

    PMID: 8002688BACKGROUND
  • Marvel MK, Epstein RM, Flowers K, Beckman HB. Soliciting the patient's agenda: have we improved? JAMA. 1999 Jan 20;281(3):283-7. doi: 10.1001/jama.281.3.283.

    PMID: 9918487BACKGROUND
  • Ormel J, Koeter MW, van den Brink W, van de Willige G. Recognition, management, and course of anxiety and depression in general practice. Arch Gen Psychiatry. 1991 Aug;48(8):700-6. doi: 10.1001/archpsyc.1991.01810320024004.

    PMID: 1883252BACKGROUND
  • Arborelius E, Bremberg S. What does a human relationship with the doctor mean? Scand J Prim Health Care. 1992 Sep;10(3):163-9. doi: 10.3109/02813439209014056.

    PMID: 1410945BACKGROUND
  • Beaulieu MD, Leclere H, Bordage G. Taxonomy of difficulties in general practice. Can Fam Physician. 1993 Jun;39:1369-75.

    PMID: 8324406BACKGROUND
  • Novel A-S. Baptiste Beaulieu : " J'ai parfois l'impression que ma vie passe sans moi ". Le Monde.27.03.2015

    BACKGROUND
  • DiMatteo MR, Haskard-Zolnierek KB, Martin LR. Improving patient adherence: a three-factor model to guide practice. Health Psychology Review. 2012;6(1):74-91.

    BACKGROUND
  • DiMatteo MR. The physician-patient relationship: effects on the quality of health care. Clin Obstet Gynecol. 1994 Mar;37(1):149-61. doi: 10.1097/00003081-199403000-00019. No abstract available.

    PMID: 8194205BACKGROUND
  • Chauvel H, Santini C, Layat Burn C, Jilet L, Abdoul H, Billon G, Jaunay LB, Jaury J, Buffel du Vaure C, Piot MA. Évolution de l'empathie d'étudiants en 4e année de médecine après un module obligatoire de formation à la relation thérapeutique. Annales Médico-psychologiques, revue psychiatrique. 2023 Dec;181(10):871-879.

    RESULT

Study Officials

  • Marie-Aude PIOT, D, PhD candidate

    Institut National de la Santé Et de la Recherche Médicale, France

    PRINCIPAL INVESTIGATOR
  • Céline Buffel du Vaure, MD, PhD, MCU

    University of Paris 5 - Rene Descartes

    STUDY CHAIR
  • Louis Baptiste Jaunay, MD, CCU

    University of Paris 5 - Rene Descartes

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2019

First Posted

March 22, 2019

Study Start

June 1, 2019

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

All data will be shared with research team.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
All data will be completed at the end of data collection (at the end of june of 2019).
Access Criteria
All researchers involved in this research would be allowed to access to results.

Locations