Impact of Narrative Medicine (Workshop Reflexive Writing) (INAMERE)

April 17, 2014 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • 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

      • Paris, France, 75004
        • Centre d'Epidemiologie Clinique, Assistance Publique, Hotel Dieu

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavioral intervention
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.
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.
Active Comparator: behavoral intervention
Students allocated to the active comparator arm will follow 5 sessions in Class-led instruction of reading medical publication workshops. They will be divided into eight subgroups of 12 students. The first and fifth sessions will be presential, and 2nd 3rd and 4th sessions will be homework to do on internet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
satisfaction of standardized patient will be assessed through the questionnaire recommended by the American Board of Internal Medicine (ABIM).
Time Frame: 5 months after randomization (i.e. 1 month after the end of the intervention)
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Jefferson Scale of Physician Empathy
Time Frame: 5 months after randomization (i.e. 1 month after the end of the intervention)
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Interpersonal Reactivity Index
Time Frame: 5 months after randomization (i.e. 1 month after the end of the intervention)
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)
students' satisfaction
Time Frame: 4 months after randomization (i.e. 1 month after the end of the intervention)
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)
recommendation of the student by the standardized patient, to friends or relatives
Time Frame: 5 months after randomization (i.e. 1 month after the end of the intervention)
: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Francois GOUPY, Professeur, Assistance Publique - Hôpitaux de Paris

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

December 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

February 21, 2013

First Submitted That Met QC Criteria

February 22, 2013

First Posted (Estimate)

February 25, 2013

Study Record Updates

Last Update Posted (Estimate)

April 21, 2014

Last Update Submitted That Met QC Criteria

April 17, 2014

Last Verified

February 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • RAV001

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.

Clinical Trials on Empathy

Clinical Trials on reflective writing

Subscribe