- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01798069
Impact of Narrative Medicine (Workshop Reflexive Writing) (INAMERE)
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Paris, France, 75004
- Centre d'Epidemiologie Clinique, Assistance Publique, Hotel Dieu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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)
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It consists of ten questions, denoted by EVGFP scale (excellent = 5, very good = 4, good = 3, fair = 2, poor = 1).
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5 months after randomization (i.e. 1 month after the end of the intervention)
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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)
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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.
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5 months after randomization (i.e. 1 month after the end of the intervention)
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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).
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5 months after randomization (i.e. 1 month after the end of the intervention)
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students' satisfaction
Time Frame: 4 months after randomization (i.e. 1 month after the end of the intervention)
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measure on a numeric scale from 0 (without interest) to 10 (very interesting)
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4 months after randomization (i.e. 1 month after the end of the intervention)
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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)
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5 months after randomization (i.e. 1 month after the end of the intervention)
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Collaborators and Investigators
Investigators
- Principal Investigator: Francois GOUPY, Professeur, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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.
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