EmpathyINAMERENCT01798069
Impact of Narrative Medicine (Workshop Reflexive Writing)
A study testing reflective writing and reading medical publication workshops in people with Empathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Empathy
- What is being tested?
- reflective writing and reading medical publication workshops
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- All students refusing to participate in the study.
- All students repeaters.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'Epidémiologie Clinique, Assistance Publique, Hôtel Dieu
Paris, 75004
About this study
Official title: 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.
Read more
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.
- Conditions
- Empathy
- Being tested
- reflective writing, reading medical publication workshops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reflective writingBehavioural
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.
reading medical publication workshopsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: reading medical publication workshops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 months after randomization (i.e. 1 month after the end of the intervention)
Secondary outcomes (1)
The Jefferson Scale of Physician Empathy
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.
Measured: 5 months after randomization (i.e. 1 month after the end of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmpathyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francois GOUPY, Professeur, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798069
- Sponsor's protocol ID
- RAV001
- Acronym
- INAMERE
- Status last verified
- Feb 2013
- First submitted
- 21 Feb 2013
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Educational Program 'Narrative Medicine (Workshop Reflexive Writing) ' Dedicated to Medical Students. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01798069
- Acronym / sponsor ID
- INAMERE / RAV001
- Conditions
- Empathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jul 2013 (actual)
- First posted
- 25 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral intervention | Experimental | Behavioral: reflective writingStudents 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. |
| behavoral intervention | Active comparator | Behavioral: reading medical publication workshopsStudents 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (2 listed)
- All students refusing to participate in the study.
- All students repeaters.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reflective writingStudents 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. | Behavioural | Behavioral intervention |
| reading medical publication workshops | Behavioural | behavoral intervention |
Primary outcome
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).
1 secondary outcome
The Jefferson Scale of Physician Empathy
Time frame: 5 months after randomization (i.e. 1 month after the end of the intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois GOUPY, Professeur principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reflective writing and reading medical publication workshops in people with Empathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2014.