End of LifeCACTUSNCT02861469
Reasons of Transfer in Emergency Units of Patients in End of Life Situation.
An observational study of End of Life and Palliative Care, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
This qualitative study aimed to describe and understand the factors leading to the admission in emergency unit of patients coming from their home, in an end of life situation. This study was conducted in the university hospital of Besançon, France. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End of Life, Palliative Care
- What is being tested?
- Semi-structured interviews
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Patients living at their home and admitted in the emergency unit of the university hospital of Besançon, who died within the 3 days following their admission in the emergency unit of a chronic disease in terminal phase. * General practitioners and main carers (family members or friends) of those patients.
Who may be able to join
- FOR PATIENTS :
- aged of 18 yo or more
- Admitted in the emergency unit of the university hospital of Besançon
- who died within the 3 days following their admission in the emergency unit
- who died of a chronic disease in terminal phase
- for whom therapeutic goals were only focused on comfort
Show all 18Show fewer
- living at their home or at their family's home before their transfer in emergency unit
- accompanied by at least one main carer (family member or friend) and one general practitioner during the last weeks before death
- FOR MAIN CARERS :
- Family members or friends of the patient
- who were the main carers of the patient during his/her last weeks
- speaking easily in french
- who agreed for being interviewed and whom psychic and emotional state is compatible with a interview
- living within 80km from Besançon
- FOR GENERAL PRACTITIONERS :
- who were the main medical actor for the patient during his/her last weeks
- who agreed for being interviewed
- working within 80km from Besançon
Who cannot join
- FOR PATIENTS :
- Patients who expressed a wish to not die at home
- Patients who died because of any other medical event than predictable death following the terminal phase of a chronic disease
- minors
- FOR MAIN CARERS AND GENERAL PRACTITIONERS :
- refusal to participate to the interviews
About this study
This qualitative study aimed to describe and understand the factors leading to the admission in emergency unit of patients coming from their home, in an end of life situation.
This study was conducted in the university hospital of Besançon, France. Semi-structured interviews were conducted with general practitioners and family members in order to understand the factors leading, from their points of view, to the admission in emergency unit whereas this hospitalization wasn't necessary.
- Conditions
- End of Life, Palliative Care
- Being tested
- Semi-structured interviews
- Keywords
- qualitative study, end of life, ethics, palliative care
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewsOther
individual semi-structured interviews with general practitioners and family members
| Study group | Role | What they receive |
|---|---|---|
| Main carers | Individual semi-structured interviews Receives: Other: Semi-structured interviews | |
| General practitioners | Individual semi-structured interviews Receives: Other: Semi-structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceptions of general practitioners and family members toward the reasons of admission in emergency unit of patients coming from home in an end of life situation
individual semi-structured interviews
Measured: day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startFeb 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End of LifeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Régis AUBRY, Pr, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861469
- Sponsor's protocol ID
- P/2015/246
- Acronym
- CACTUS
- Status last verified
- Aug 2016
- First submitted
- 5 Aug 2016
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Detering KM, Hancock AD, Reade MC, Silvester W. The impact of advance care planning on end of life care in elderly patients: randomised controlled trial. BMJ. 2010 Mar 23;340:c1345. doi: 10.1136/bmj.c1345.
PubMed 20332506Pennec S, Gaymu J, Monnier A, Riou F, Aubry R, Pontone S, Cases C. [The places of death of people aged 80 and over in France]. Soins Gerontol. 2014 Nov-Dec;(110):12-5. French.
PubMed 25597063
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reasons of Transfer in Emergency Units of Patients in End of Life Situation.
- ClinicalTrials.gov ID
- NCT02861469
- Acronym / sponsor ID
- CACTUS / P/2015/246
- Conditions
- End of Life, Palliative Care
- Keywords
- qualitative study, end of life, ethics, palliative care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Aug 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.
This qualitative study aimed to describe and understand the factors leading to the admission in emergency unit of patients coming from their home, in an end of life situation.
This study was conducted in the university hospital of Besançon, France. Semi-structured interviews were conducted with general practitioners and family members in order to understand the factors leading, from their points of view, to the admission in emergency unit whereas this hospitalization wasn't necessary.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main carers | – | Other: Semi-structured interviewsIndividual semi-structured interviews |
| General practitioners | – | Other: Semi-structured interviewsIndividual semi-structured interviews |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients living at their home and admitted in the emergency unit of the university hospital of Besançon, who died within the 3 days following their admission in the emergency unit of a chronic disease in terminal phase. * General practitioners and main carers (family members or friends) of those patients.
Key inclusion criteria (18 listed)
- FOR PATIENTS :
- aged of 18 yo or more
- Admitted in the emergency unit of the university hospital of Besançon
- who died within the 3 days following their admission in the emergency unit
- who died of a chronic disease in terminal phase
Key exclusion criteria (6 listed)
- FOR PATIENTS :
- Patients who expressed a wish to not die at home
- Patients who died because of any other medical event than predictable death following the terminal phase of a chronic disease
- minors
- FOR MAIN CARERS AND GENERAL PRACTITIONERS :
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 |
|---|---|---|
| Semi-structured interviewsindividual semi-structured interviews with general practitioners and family members | Other | General practitioners, Main carers |
Primary outcome
Perceptions of general practitioners and family members toward the reasons of admission in emergency unit of patients coming from home in an end of life situation
Time frame: day one
individual semi-structured interviews
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 10 Aug 2016.
- Background: PubMed 20332506Detering KM, Hancock AD, Reade MC, Silvester W. The impact of advance care planning on end of life care in elderly patients: randomised controlled trial. BMJ. 2010 Mar 23;340:c1345. doi: 10.1136/bmj.c1345.
- Background: PubMed 25597063Pennec S, Gaymu J, Monnier A, Riou F, Aubry R, Pontone S, Cases C. [The places of death of people aged 80 and over in France]. Soins Gerontol. 2014 Nov-Dec;(110):12-5. French.
- Individual participant dataSharing planned: No
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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.
Régis AUBRY, Pr principal investigator
Centre Hospitalier Universitaire de Besancon
Questions about this trial
What is this clinical trial studying?
An observational study of End of Life and Palliative Care, run by Centre Hospitalier Universitaire de Besancon.
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 18 inclusion and 6 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 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Perceptions of general practitioners and family members toward the reasons of admission in emergency unit of patients coming from home in an end of life situation (time frame: day one). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02861469, which also lists 2 linked publications.
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 10 Aug 2016.