End of LifeDIRFINNCT02892175
Can the Vascular Physician Sensitize Patients to Redaction of Advance Directives on End of Life?
An observational study of End of Life, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
The Leonetti law of 22 April 2005 on the rights of patients at end of life provides the opportunity for "all adults" to write advance directives in case she would one day be "unable to express their will." If this right is enshrined in the hospitalized patient's charter, brought to the attention of any patient… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End of Life
- What is being tested?
- Advance Directives on End of Life
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to Jul 2015
- Phase
- Observational
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: all consecutive patients already followed in the vascular medicine department
Who may be able to join
- All consecutive patients already followed in the vascular medicine department
Who cannot join
- Patients refusing to participate
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
The Leonetti law of 22 April 2005 on the rights of patients at end of life provides the opportunity for "all adults" to write advance directives in case she would one day be "unable to express their will." If this right is enshrined in the hospitalized patient's charter, brought to the attention of any patient entering a hospital, the fact remains that only 2.5% of the deceased have written advance directives (study National Institute of demographic studies published in 2012).
Moreover, according Régis Aubry, a researcher at the observatory on the end of life, the conditions of the end of life are insufficiently discussed with patients and their families and can lead to difficult situations conflicting view. Now, thinking about advance directives should allow an exchange on the conditions of the end of life desired by patients.
Read more
Sicard report of December 2012 concluded that such legislation is known neither patients nor doctors. This is the first obstacle to its use, even if major psychological barriers exist both in patients that their doctors.
It is in this context that Valls government asked MM. Claeys and Leonetti to propose a new bill on the subject. The bill provides that advance directives will no longer be valid for 3 years, but until changed or until the patient's death, and they can be invoked against doctors except emergency or illegality. In addition, to complete the bill, the Ministry of Health commissioned the National Health Authority (HAS) writing a form of advance directives, as well as a doctor's information guide and patient on the subject. The working group is chaired by Professor Sicard. Among the recommendations made to physicians (and by extension health professionals), the investigators accept that talk of advance directives as often as possible and as early as possible, even in the absence of commitment in the short or medium term prognosis .
Read the detailed description
Main objective / secondary:
Feasibility of addressing the topic of advance directives (% of patients agreeing to answer the questionnaire) during vascular medicine clinic in town.
Assessing preferences for editorial context to enable to present the project in optimal circumstances.
Assess felt an evolution of the doctor-patient relationship by patients in the context of advance directives.
Assess the reactions according to the characteristics of the study population to help develop different "profiles" and adapt the introduction of the topic of advance directives.
Methodology :
Design: prospective, single-center, non-interventional kind opinion survey Study duration: 6 months
Acquisition of data:
The characteristics of the population obtained will be studied to try to understand the feelings of patients, to better target patients to talk to about advance directives in vascular medicine and evaluate some extent if the topic of advance directives contributes to "modernize "the doctor-patient relationship.
- List of data gathered: cf. attached questionnaire
- Statistical analysis: local management (GHPSJ) from the patient profile
- Anonymity of data: an identifier for each subject will be awarded (first name and surname - year of birth) and the data will be entered on a computer file which will be sent to the statistician in charge of analyzing the GHPSJ site. There will be no personally identifiable data exchange.
Development of the study:
- Describe how the study: after information transmitted orally by the doctor (Dr P.Priollet) and patient's consent to participate, patients will be interviewed (attached schedule) and data gathered during consultations of office visits to Dr. Priollet city by Dr. Priollet assisted by Hélène Samson (internal medicine), anonymized and handled within the vascular medicine department of Dr. Priollet to GHPSJ.
- Expected duration of patient recruitment: 3 months
- Number of patients to recruit 100 patients, 15 minutes per patient. At all times patients can freely return to the subject in subsequent consultations with Dr. Priollet.
- Conditions
- End of Life
- Being tested
- Advance Directives on End of Life
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance Directives on End of LifeProcedure or surgery
after information transmitted orally by the doctor (Dr P.Priollet) and agreement of the patient to participate, patients will be interviewed (Questionary) and data collected during visits to consultations City office of Dr. Priollet by Dr. Priollet assisted by Mrs. Helena Sanson (internal medicine), anonymized and handled within the vascular medicine department of Dr. Priollet to GHPSJ.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the number of patients agreeing to answer the questionary
Measured: Day 1
Secondary outcomes (1)
Assessment of the felt of the patient on a scale
Assess of felt an evolution of the doctor-patient relationship by patients in the context of advance directives. A scale is used from 0 to 10.
Measured: Hour +1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startMay 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End of LifeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892175
- Sponsor's protocol ID
- DIRFIN
- Acronym
- DIRFIN
- Status last verified
- Sep 2016
- First submitted
- 2 Sep 2016
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Vascular Physician Sensitize Patients to Redaction of Advance Directives on End of Life?
- ClinicalTrials.gov ID
- NCT02892175
- Acronym / sponsor ID
- DIRFIN / DIRFIN
- Conditions
- End of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 8 Sep 2016 (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.
The Leonetti law of 22 April 2005 on the rights of patients at end of life provides the opportunity for "all adults" to write advance directives in case she would one day be "unable to express their will." If this right is enshrined in the hospitalized patient's charter, brought to the attention of any patient entering a hospital, the fact remains that only 2.5% of the deceased have written advance directives (study National Institute of demographic studies published in 2012).
Moreover, according Régis Aubry, a researcher at the observatory on the end of life, the conditions of the end of life are insufficiently discussed with patients and their families and can lead to difficult situations conflicting view. Now, thinking about advance directives should allow an exchange on the conditions of the end of life desired by patients.
Sicard report of December 2012 concluded that such legislation is known neither patients nor doctors. This is the first obstacle to its use, even if major psychological barriers exist both in patients that their doctors.
It is in this context that Valls government asked MM. Claeys and Leonetti to propose a new bill on the subject. The bill provides that advance directives will no longer be valid for 3 years, but until changed or until the patient's death, and they can be invoked against doctors except emergency or illegality. In addition, to complete the bill, the Ministry of Health commissioned the National Health Authority (HAS) writing a form of advance directives, as well as a doctor's information guide and patient on the subject. The working group is chaired by Professor Sicard. Among the recommendations made to physicians (and by extension health professionals), the investigators accept that talk of advance directives as often as possible and as early as possible, even in the absence of commitment in the short or medium term prognosis .
Detailed description
Main objective / secondary:
Feasibility of addressing the topic of advance directives (% of patients agreeing to answer the questionnaire) during vascular medicine clinic in town.
Assessing preferences for editorial context to enable to present the project in optimal circumstances.
Assess felt an evolution of the doctor-patient relationship by patients in the context of advance directives.
Assess the reactions according to the characteristics of the study population to help develop different "profiles" and adapt the introduction of the topic of advance directives.
Methodology :
Design: prospective, single-center, non-interventional kind opinion survey Study duration: 6 months
Acquisition of data:
The characteristics of the population obtained will be studied to try to understand the feelings of patients, to better target patients to talk to about advance directives in vascular medicine and evaluate some extent if the topic of advance directives contributes to "modernize "the doctor-patient relationship.
- List of data gathered: cf. attached questionnaire
- Statistical analysis: local management (GHPSJ) from the patient profile
- Anonymity of data: an identifier for each subject will be awarded (first name and surname - year of birth) and the data will be entered on a computer file which will be sent to the statistician in charge of analyzing the GHPSJ site. There will be no personally identifiable data exchange.
Development of the study:
- Describe how the study: after information transmitted orally by the doctor (Dr P.Priollet) and patient's consent to participate, patients will be interviewed (attached schedule) and data gathered during consultations of office visits to Dr. Priollet city by Dr. Priollet assisted by Hélène Samson (internal medicine), anonymized and handled within the vascular medicine department of Dr. Priollet to GHPSJ.
- Expected duration of patient recruitment: 3 months
- Number of patients to recruit 100 patients, 15 minutes per patient. At all times patients can freely return to the subject in subsequent consultations with Dr. Priollet.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all consecutive patients already followed in the vascular medicine department
Key inclusion criteria (1 listed)
- All consecutive patients already followed in the vascular medicine department
Key exclusion criteria (1 listed)
- Patients refusing to participate
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 |
|---|---|---|
| Advance Directives on End of Lifeafter information transmitted orally by the doctor (Dr P.Priollet) and agreement of the patient to participate, patients will be interviewed (Questionary) and data collected during visits to consultations City office of Dr. Priollet by Dr. Priollet assisted by Mrs. Helena Sanson (internal medicine), anonymized and handled within the vascular medicine department of Dr. Priollet to GHPSJ. | Procedure or surgery | – |
Primary outcome
Assessment of the number of patients agreeing to answer the questionary
Time frame: Day 1
1 secondary outcome
Assessment of the felt of the patient on a scale
Time frame: Hour +1
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 8 Sep 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End of Life, run by Fondation Hôpital Saint-Joseph 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 1 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 8 Sep 2016. 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?
Assessment of the number of patients agreeing to answer the questionary (time frame: Day 1). 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 8 Sep 2016.