NCT01798069

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Last Updated

April 21, 2014

Status Verified

February 1, 2013

Enrollment Period

7 months

First QC Date

February 21, 2013

Last Update Submit

April 17, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • The Jefferson Scale of Physician Empathy

    5 months after randomization (i.e. 1 month after the end of the intervention)

Other Outcomes (3)

  • The Interpersonal Reactivity Index

    5 months after randomization (i.e. 1 month after the end of the intervention)

  • students' satisfaction

    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

    5 months after randomization (i.e. 1 month after the end of the intervention)

Study Arms (2)

Behavioral intervention

EXPERIMENTAL

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

behavoral intervention

ACTIVE COMPARATOR

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

Interventions

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 intervention
behavoral intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • All students refusing to participate in the study.
  • All students repeaters.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Epidémiologie Clinique, Assistance Publique, Hôtel Dieu

Paris, 75004, France

Location

Study Officials

  • Francois GOUPY, Professeur

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2013

First Posted

February 25, 2013

Study Start

December 1, 2012

Primary Completion

July 1, 2013

Last Updated

April 21, 2014

Record last verified: 2013-02

Locations