Impact of Narrative Medicine (Workshop Reflexive Writing)

Empathy Clinical Trial

— INAMERE  

Official title:

Impact of an Educational Program 'Narrative Medicine (Workshop Reflexive Writing) ' Dedicated to Medical Students. A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01798069
• Other study ID #: RAV001
• Status: Completed
• Phase: N/A
• First received: February 21, 2013
• Last updated: April 17, 2014
• Start date: December 2012

Study information

• Verified date: February 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Objective: The aim of this study is to assess the impact of an educational program of Narrative Medicine "workshop reflexive writing "dedicated to medical students on the satisfaction of standardized patients.

Design: Randomized Controlled Trial in 2 arms. Participants: Medical students (4th years) of the University Paris Descartes. Methods: Participants will be randomized in two groups. The allocation of participants will be done by a computerized randomization list, the sequence will be created by an independent statistician. Participants will be blinded of the study hypothesis. Allocation concealment will be provided because only the statistician will have access to the randomization list.

A program of Narrative Medicine in Class-led instruction "workshop reflexive writing "vs "workshop reading medical publication".

Outcome: The primary endpoint will be the satisfaction of standardized patient relative to the empathy of the medical students. The secondary endpoints will be the empathy of the medical students; recommendation of the student by the standardized patients to friends or relatives; students' satisfaction.

Potential interests: The investigators believe that the workshop "reflexive writing" can develop the thinking of the student with respect to his behavior with the patient, and so the relation between student and patient.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All students in the fourth year of medical school have chosen for their first 2 quarters to complete an internship in clinical hospital departments (i.e. where direct contact with patients)

Exclusion Criteria:

• All students refusing to participate in the study.

• All students repeaters.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Empathy

Intervention

Behavioral:
• reflective writing
Students allocated to the experimental arm will follow 5 sessions in Class-led instruction of reflexive writing workshops. They will be divided into 12 sub-groups of 8 students. They will write their stories about their own experiences or the experiences of their family / patient.
• reading medical publication workshops

Locations

Country	Name	City	State
France	Centre d'Epidémiologie Clinique, Assistance Publique, Hôtel Dieu	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Interpersonal Reactivity Index	self-administered questionnaire with 4 subscales (Perspective Taking, Empathic Concern, Fantasy, Personal Distress) each containing seven items (a total of 28 items). The items are scored by a Likert scale (0 = Does not describe me well to 4 = Describes me very well).	5 months after randomization (i.e. 1 month after the end of the intervention)	No
Other	students' satisfaction	measure on a numeric scale from 0 (without interest) to 10 (very interesting)	4 months after randomization (i.e. 1 month after the end of the intervention)	No
Other	recommendation of the student by the standardized patient, to friends or relatives	: measure on a numeric scale from 0 (not at all) to 10 (entirely)	5 months after randomization (i.e. 1 month after the end of the intervention)	No
Primary	satisfaction of standardized patient will be assessed through the questionnaire recommended by the American Board of Internal Medicine (ABIM).	It consists of ten questions, denoted by EVGFP scale (excellent = 5, very good = 4, good = 3, fair = 2, poor = 1).	5 months after randomization (i.e. 1 month after the end of the intervention)	No
Secondary	The Jefferson Scale of Physician Empathy	self-administered questionnaire consisting of 20 items scored by a Likert-type scale (strongly agree = 7, strongly disagree = 1): 10 items are rated positively, others 10 items are rated negatively. The total score ranges from 20 to 140.	5 months after randomization (i.e. 1 month after the end of the intervention)	No