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

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ClinicalTrials.gov Identifier: NCT01798069
Recruitment Status : Completed
First Posted : February 25, 2013
Last Update Posted : April 21, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Empathy Behavioral: reflective writing Behavioral: reading medical publication workshops Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Impact of an Educational Program 'Narrative Medicine (Workshop Reflexive Writing) ' Dedicated to Medical Students. A Randomized Controlled Trial.
Study Start Date : December 2012
Actual Primary Completion Date : July 2013
Arms and Interventions
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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.
 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.
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.
 Behavioral: reading medical publication workshops


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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).

  2. 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)

  3. 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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798069


Locations
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France
Centre d'Epidémiologie Clinique, Assistance Publique, Hôtel Dieu
Paris, France, 75004
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Francois GOUPY, Professeur Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01798069    
Other Study ID Numbers: RAV001
First Posted: February 25, 2013    Key Record Dates
Last Update Posted: April 21, 2014
Last Verified: February 2013