Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03887195 |
| Other study ID # |
APHP180446 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2019 |
| Est. completion date |
June 30, 2019 |
Study information
| Verified date |
April 2021 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
Extended description of the protocol, including more technical information (as compared to
the Brief Summary) if desired.
Do not include the entire protocol; do not duplicate information recorded in other data
elements, such as eligibility criteria or outcome measures. (Limit: 32,000 characters)
Example:
Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death, in spite
of recent declines in overall mortality from cardiovascular disease. Existing methods of
emergency resuscitation are inadequate due to time delays inherent in the transport of a
trained responder with defibrillation capabilities to the side of the OOH-CA victim. Existing
Emergency Medical Services (EMS) systems typically combine paramedic Emergency Medical
Technician (EMT) services with some level of community involvement, such as bystander
cardiopulmonary resuscitation (CPR) training. Some communities include automated external
defibrillators (AEDs) at isolated sites or in mobile police or fire vehicles. A
comprehensive, integrated community approach to treatment with AEDs would have community
units served by these volunteer non-medical responders who can quickly identify and treat a
patient with OOH-CA. Such an approach is termed Public Access Defibrillation (PAD). Societal
and medical developments have transformed the relationship between doctors and patients:
several health system reforms, increasing time constraints that strongly impact the exchange
between caregivers and patients, increasing of elderly population and rising prevalence of
chronic diseases, complexification of therapeutic solutions, democratization of medical
information through the media and internet; ... (1, 2).
Different studies point to the fact that there are some gaps in the field of communication.
The doctors themselves recognize that communication with their patients is one of the main
difficulties in the practice of their profession, particularly for patients with chronic
illness who do not adhere to care (9). The multiplication of blogs and discussion forums of
young doctors on this topic is an example (10).
Some problems arising from this situation such as, inter alia, the non-compliance that is
between 30% and 70%, according to different studies and the number of complaints which roses
significantly (70-80% are estimated to be related to communications problems). In the mental
health field, the style of communication influences the ability to detect a problem.
In view of these observations, medical and political authorities want to promote
communication to enhance the doctor-patient relationship. The Royal College of Doctors and
Surgeons of Canada have included it in one of the 7 Essential Skills that every doctor needs
(with medical expertise, collaboration, management, health promotion, erudition and
professionalism). In France, the law of 4 March 2002 on patients' rights and the quality of
the healthcare system includes this point (33).
Numerous studies testify to the influence of communication in the area of health. A review of
21 studies, with a high methodological quality, shows that the quality of communication,
during data collection and discussion of treatment, has a positive effect on patient health
(35). The analyse shows that communication influences in decreasing order: emotional health,
control of symptoms, physiological measures (such as blood glucose and blood pressure) and
pain control (2).
Until recently, this learning was considered related to the practice (2). Different studies
show the limits of practical experience (36-38). Other studies have shown the possibility of
teaching communication skills to health professionals (37, 39-46).
In order to answer these questions, a training module on the therapeutic relationship was
built at Paris Descartes University. This module is organized for 4th year medical students.
The 4th year has been chosen because the students begin the externship, witch confronts
students to the realities of their future profession: suffering, pain, death but also health
inequalities, the precariousness and the power of the doctor. Paradoxically it is at this
period that a fall of their empathy may be observed (48). The aim of this teaching is to
develop the relational and communication skills (know-how and social skills). The pedagogical
approach has been diversified to potentiate the contribution of this module on these three
field: knowledge, well-being and know-how.
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. The
courses are held in small groups to promote the personal investment of each student; they
included six sessions of Therapeutic Relation Training Groups (each lasting one hour and a
half) (49), from October 2018 to May 2019, inspired by the Balint groups (50). The effects of
this groups are gradually clarified, especially in their psycho-affective aspects
(projections, transference and countertransference, representations and beliefs, etc.).
Five role-play sessions are also organized from January to May, in one heure and half 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 a reluctant
patient; management of so-called " abusive requests "; management of aggressiveness and
hostility. After the role-play, a feedback done by the teacher and the group helps to
identify and elaborate what has happened (about verbal and non-verbal communication), to
point out the positive (and also negative ...) and suggest ways to improve.
Finally, a formative assessment will be made during the OCSE (Clinical Objective Structured
Examination), two clinical stations are organized with simulated patients (professional
actors). The feedback is then done by the patients themselves, supervised by the teacher who
provided the role-play training.
Simulation allows the student to train in an environment close to reality, to understand the
complexity and to reflect on his own thoughts, actions, emotions, as well as those of others.
It allows working out a broad range of individual cognitive, relational, affective and
psychomotor skills.
The Balint group is a space for discussion and reflection, supervised by an experienced
professional. It is organized around clinical situations asking questions about the
doctor-patient relationship. Many studies have investigated the impact of a typical Balint
Group (GB), and more particularly, with general doctors, interns and medical students. GB
reported a benefit for their professional life in terms of competence, strengthening their
professional identity and sense of security (59) but not on job satisfaction (60).
The Balint Group increase psychological medicine skills and it also have a positive effect on
the attitude towards patients with psychosomatic problems. The GB specifically augment
significantly and uniquely the clinical empathy (66). It could be helpful to improve skills
of medical students (71, 72) by promoting stress and anxiety management, self-awareness and a
different view of the doctor-patient relationship (71).
Many studies show the impact of empathy on the doctor-patient relationship, a recent review
(74) shows that empathy increases patient satisfaction. It improves the relationship skills
by better control of patient anxiety, better communication (including psycho-social problems,
better adherence to treatment and the reduction of certain symptoms). (74) For the doctor,
improvement in empathy enhances the sense of personal accomplishment by improving his-own
well-being (76).
However, during medical studies, clinical empathy decreases (48) especially from the third
year, when students start to meet patients. A recent systematic review (77) explains this
fall, which continues during the internship. This phenomenon also occurs in other health
disciplines.
Neumann & al. hypothesize that the cause could be to live the experience of vulnerability at
the beginning of the clinical practice; they also mention the role of idealized beliefs of
the role of the doctor, as well as the high level of stress of some students (such as
burnout, depression ...) (77).
The good influence of teaching on empathy has been shown, especially in hospital or in
liberal cabinet (78, 79). However, insufficient lessons are organized to develop this skill.
A systematic review of 18 interventions to teach empathy to medical students, from 2003 to
2012, despite methodological biases, concludes that trainings to support student empathy are
effective (80). A recent meta-analysis of 18 randomized controlled trials (81) confirms these
findings.
Among the effective techniques, the simulation is highlighted as "experiential learning" and
"theatre". Other studies also show the value of teaching empathy for interns (82) and doctors
(83). Different pedagogies raise an interest in the teaching of empathy; including
communication techniques (verbal and non-verbal), lessons based on the study of videotaped
consultations, theoretical lessons in ethics and empathy, role playing and simulation with
standardized patients (84), exchange groups and therapeutic relationship training groups
(85), including Balint-type groups (86).
A first pilot study evaluating the evolution of the empathy of a part of the medical
students, during the role plays was conducted during the 2017-2018 academic year, in order to
evaluate the feasibility and relevance of this research, extended to the entire promotion of
4th year students.
The competency-based approach now constitutes a new frame of reference in education; who
tries to go beyond pedagogy by objective (87). Emotional Intelligence is defined as "the
ability to perceive, access and generate emotions to support thought, to understand emotions,
and to promote emotional and intellectual growth."(88). As it now stands, the scientific
literature has not been able to establish whether it was a personal trait, an acquired skill,
or both (89). But a recent review indicates a correlation between medical education and the
acquisition of emotional skills (69). It could be of great support in resolving some
conflicting aspects of the doctor-patient relationship (69).
Indeed, the doctor-patient relationship is considered to be of significant "emotional risk";
because of the negative emotions expressed by the patient, such as pain, anxiety, despair ...
(90). Paying attention to the emotions of the patient has a beneficial impact for both the
patient and the doctor (prevention of the fall of empathy, greater professionalism, greater
job satisfaction, and the last but not the least : well-being ...) (91, 92 ).
The increasing recognition of the notion of competence in the construction of medical
professionalism (54), particularly in the area of doctor-patient relationship and
communication (32), stimulate the organization of pedagogical devices. The FRT module
attempts to respond to this approach. However, empathy and emotional intelligence appear as
fundamental skills in the acquisition of these communicative and relational skills. This
study aims to evaluate mainly the impact of this module of FRT on the maintenance or even the
effective acquisition of certain skills and know-how (empathy and emotional intelligence)
centrals in the construction of communication and relational skills.
In order to do that the analyse is focused to assess the evolution of the student's empathy
score with the Jefferson Scale of Physician Empathy- Medical Student Version (JSPE-MS), and
with the emotional intelligence's score by the Emotional Expressivity Scale (EES). Theses
scores are collected at the beginning and the end of the module.
The empathic skills will be assessed by simulated patients with CARE grid during the
Objective Structured Clinical Examination (OSCE).
This work investigates likewise the evolution of students' knowledge of the doctor-patient
relationship with multiple choice questions.
At the end of the training students will be also asked to complete a satisfaction
questionnaire. For the group baseline socio-demographic and education data will be collected.
This is a twofold study, quantitative and qualitative and the results about empathy and
emotional intelligence are going to be put into perspective with the data about the
acquisition of knowledge.
The statistical analysis evaluative intervention epidemiology:
-Quantitative : Scores collected before and after the training (JSPE-MS, EES,questionnaire
about the knowledge) or just at the end of the module ( OSCE and satisfaction questionnaire)
The evolution of students' empathy will be evaluated by the JSPE-MS witch is a
self-questionnaire assessing empathy specifically in the doctor-patient relationship. JSPE
focuses more specifically on the cognitive component of empathy.
It is composed of 2O items, decomposable into 3 groups (Nuguyen Trong, 2016):
ten items focus on the " perspective talking " : adopting the patient's point of view (items
2, 4, 5, 9, 10, 13, 16, 17, 20) eight items relate to the "care component": the attention to
the emotional experience of the patient (items 1, 7, 8, 11, 12, 14, 18, 19) two items
represent "the ability to stand in the patient's shoes" (Items 3, 6) Each item is rated from
1 to 7 (Lickert scale). There is a specific version validated for students, the JSPE-MS that
the investigators will use for this study.
The second self-related questionnaire is the EES (93), it is about the emotional
expressivity. The French version was translated and submitted to the author. It evaluates the
disposition to express emotions. This scale contains 17 proposals listing different forms of
emotional expression, such as "I am able to cry in front of other people". The frequency of
these situations, from "never true" to "always true" is rated from 1 to 6 on a Lickert scale.
Self-questionnaires about declarative knowledge are also submitted to students in order to
complete the assessment of the skills acquired in this module, and to compare them with the
empathic and emotional expressivity skills measured.
The multiple-response questionnaire it's proposed by the Sides platform, preparing students
for the National Examination Grading (ECN) competition. The content will focus on part of the
ECN Question No. 1, on "The doctor-patient relationship". Answers will be constructed from
the National College of Psychiatry's reference system for psychiatry.
The last self-related questionnaire is submitted only at the end of the module, it's a
student satisfaction questionnaire, taken from the WHO report on evaluation of educational
devices (94). Student satisfaction is an important parameter in the acceptability of teaching
and his investment (54). These results will be compared with the data of empathy and
emotional expressiveness, to determine correlations.
At the end of the module, during the Objective Structured Clinical Examination (OSCE),
students' empathy is measured by the evaluation by patients standardized. As the current
pedagogical module can not allow pre / post-test evaluation of this measure, the post-test
evaluation alone is proposed as representative of the skills of the cohort of students at the
end of this module.
Finally, socio-demographic data will be collected, in order to relate the measures of empathy
with these informations(96-98): age, sex, parents' level of education, living conditions of
the students, internships done during the module, medical-psychiatric history (or has already
done psychotherapy), specialty (s) desired after the internship: 1st, 2nd and 3rd choice.
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 training module during the 2018-2019
academic year: this constitutes the entire population concerned by the intervention.
The study will be presented to students at the university's opening discours. The
presentation will be made by one of the main pedagogical leaders of this module: Professor
Jaury, who will show the benefits and "risks" of the study, the terms of participation
(questionnaires) and the terms of consent or refusal An information note will be sent by
email via the addresses transmitted to each student, with the same informations.
The questionnaires and a consent form will be made available to students on the Moodle
platform, in the part where they access by their personal identifiers, before the beginning
of the training and at the end of the module.
A new e-mail will be sent at the end of the year to the students to specify the modalities of
this evaluation, its aim of research (and not sanctioning), to encourage to complete the
self-questionnaires post-test, and to recall the benefits and risk of research, terms of
consent and refusal.
The collection of pre-training data (JSPE-MS, EES) and socio-demographic data will be on the
Moodle platform in the days preceding the start of the role plays.
The collection of post-training data will be done by filling the self-questionnaires
immediately after the training OSCE, via the Moodle platform. A single entry will be made,
via the Moodle platform, and will then be reported in a table for analysis, by Chiara
Santini, one of the corresponding researchers.
Descriptive analyses will be performed to check for missing and / or outliers and to verify
the normality of the variables and to decide which hypothesis tests to use.
All the data collected during the evaluation will be described in order to obtain a precise
profile of the people participating in the study.
Quantitative variables will be described with confidence interval according to their mean,
standard deviation, median, minimum and maximum.
The qualitative variables will be described according to their size and the percentage. The
qualitative data analysis will follow a content analysis.
To check the differences between the two groups (pre and post-training), the analysis of
variance, the Student's paired tests or the chi-squared test, will be done as some
non-parametric tests (Kruskall-Wallis test or Wilcoxon-Mann-Whitney test ) may be used. Post
hoc analysis will be conducted if necessary.
In order to know the relations between the quantitative variables the investigators will
realize simple linear correlations (Pearson's R, or rho coefficient values for the Spearman
correlation).
Multivariate analyses will be performed using multiple regressions. They will test the
existence or not of a relationship between the predictive variables and the dependent
variables considering the other confounding variables. The multivariate analyses will also
make it possible to estimate whether each of the variables contributes significantly to the
prediction of the dependent variable.
The statistics will be compiled and analyzed using the SPSS and R computer software. A
significance level of 0.05 will be retained.
