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Impact of Narrative Medicine (Workshop Reading Diaries) (INAMEDI)

This study is currently recruiting participants.
Verified November 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01798290
First received: February 21, 2013
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

Objective: The aim of this study is to assess the impact of an educational program of Narrative Medicine "workshop reading diaries" dedicated to medical students on their empathy.

Design: Randomized Controlled Trial in 2 arms. Participants: Medical students (4th years) of the University Paris Descartes. Methods: participants will be randomized in 2 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 with lesson in small group of "workshop reading patients' diaries " vs "workshop reading literature".

Outcome: The primary endpoint will be a first measure of the empathy of the medical students. The secondary endpoints will be a second measure of the empathy of the medical student; satisfaction of the student relative to the educational program .

Potential interests: We believe that the workshop "reading patients' diaries" can develop the thinking of the student with respect to his behavior with the patient, and so the relation between student and patient.

Sample size expected: 200 participants.


Condition Intervention
Empathy
 Behavioral: narrative medicine: reading workshop
Behavioral: critical reading

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Impact of an Educational Program 'Narrative Medicine (Workshop Reading Diaries) ' Dedicated to Medical Students. A Randomized Controlled Trial.

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • The Jefferson Scale of Physician Empathy [ Time Frame: 5 months after randomization (i.e. 1 month after the end of the intervention) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The Interpersonal Reactivity Index [ Time Frame: 5 months after randomization (i.e. 1 month after the end of the intervention) ] [ Designated as safety issue: No ]
    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).

  • students' satisfaction [ Time Frame: 4 months after randomization (i.e. 1 month after the end of the intervention) ] [ Designated as safety issue: No ]
    measure on a numeric scale from 0 (without interest) to 10 (very interesting)


Estimated Enrollment: 200
Study Start Date: December 2012
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Behavioral: narrative medicine: reading workshop
Students allocated to the active comparator arm will follow 5 sessions in Class-led instruction of reading patients' diaries or nurses'diaries. 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.
 Behavioral: narrative medicine: reading workshop
Active Comparator: Behavioral: critical reading
Students allocated to the active comparator arm will follow 5 sessions in Class-led instruction of reading literature. 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.
 Behavioral: critical reading

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All students in the fourth year of medical

Exclusion Criteria:

  • refuse to participate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01798290

Contacts
Contact: François Goupy, Pr francois.goupy@htd.aphp.fr
Contact: Isabelle Boutron, Pr isabelle.boutron@htd.aphp.fr

Locations
France
Centre d'épidémiologie clinique, Hôtel Dieu Recruiting
Paris, France
Contact: Isabelle Boutron, Pr         isabelle.boutron@htd.aphp.fr    
Principal Investigator: François Goupy, Pr            
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01798290     History of Changes
Other Study ID Numbers: RAV002 INAMEDI
Study First Received: February 21, 2013
Last Updated: February 21, 2013
Health Authority: France: Ministry of Health

ClinicalTrials.gov processed this record on May 21, 2013