NeoplasmsDICODOMNCT03336489
Evaluation of the Organization of Continuity of Care for Home Hospice Patients by Four Parisian Health Networks
An observational study of Neoplasms and Neurodegenerative Diseases, run by Fondation Ophtalmologique Adolphe de Rothschild at 4 sites in France.
Trial summary
In Paris, France, home hospice care for terminally ill patients is organized by four "palliative care networks". These networks are responsible for information sharing and coordination of all health care professionals working with the patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Neurodegenerative Diseases, Terminal Illness
- How many people
- 200 participants
- Where
- 4 sitesFrance
- Study dates
- 29 Mar 2017to 7 Nov 2018
- 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: All patients newly followed for home hospice care by the four palliative care networks of Paris, France, during the inclusion period (up to the inclusion of 200 patients)
Who may be able to join
- Patient has a disease with fatal prognosis and requires palliative care
- Patient lives in Paris, France
- Patient benefits from home hospice care through one of the four official Paris palliative care networks
Who cannot join
- Pregnant women
- Breastfeeding womed
- Altered cognitive function with a Mini Mental Status below 20
- Patient not able to communicate or not speaking French
- Patient legally not capable of giving informed consent
Trial locations and contacts
4 sites in 1 country.
France4 sites
Reseau QUIETUDE
Paris, 75003
Reseaux ROPE
Paris, 75012
Reseau ENSEMBLE
Paris, 75013
Reseaux ParisOuest
Paris, 75015
About this study
In Paris, France, home hospice care for terminally ill patients is organized by four "palliative care networks". These networks are responsible for information sharing and coordination of all health care professionals working with the patient. Two different systems are in place to ensure continuity of care outside working hours, in such a setting. In the first system, palliative care specialists from the network are reachable over the phone 24/7 by the patient or its caregivers, whenever needed. In the second system, medical information about the patient, regularly updated by the network's medical team, is available to professionals via a secure website, so that in case the patient requires an urgent medical home visit outside working hours, the visiting physician has access to accurate information.
The study's goal is to compare patient's and caregiver's satisfaction between these two systems of continuity of care.
For that purpose, patients will be taken care of as usual by every palliative care network. In every instance where the patient or caregivers have reached out for medical help through the network's continuity of care system, the patient or caregiver will be called 5 days later by the investigation team to go through a satisfaction questionnaire (Likert scales)
- Conditions
- Neoplasms, Neurodegenerative Diseases, Terminal Illness
- Medical subject headings
- Neoplasms, Neurodegenerative Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction about the response given by the network's continuity of care system
Patient's (or caregiver's) satisfaction about the response given by the network's continuity of care system, after the patient or caregiver activated this system at night time or during week-ends or bank holliday, as measured on a 4-level Likert scale (verbal questionnaire by phone call)
Measured: between the first and tenth day after the patient or caregiver activated the network's continuity of care system
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start29 Mar 2017
- Primary completion20 Jun 2018
- Study completion7 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Herve PICARD, MD MSc, Principal investigator, Clinical Research Department, Rothschild Foundation, Paris (France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336489
- Sponsor's protocol ID
- HPD_2016_24
- Acronym
- DICODOM
- Status last verified
- Nov 2017
- First submitted
- 5 Nov 2017
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Organization of Continuity of Care for Home Hospice Patients by Four Parisian Health Networks
- ClinicalTrials.gov ID
- NCT03336489
- Acronym / sponsor ID
- DICODOM / HPD_2016_24
- Conditions
- Neoplasms, Neurodegenerative Diseases, Terminal Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- 7 Nov 2018 (actual)
- First posted
- 8 Nov 2017 (actual)
- 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.
In Paris, France, home hospice care for terminally ill patients is organized by four "palliative care networks". These networks are responsible for information sharing and coordination of all health care professionals working with the patient. Two different systems are in place to ensure continuity of care outside working hours, in such a setting. In the first system, palliative care specialists from the network are reachable over the phone 24/7 by the patient or its caregivers, whenever needed. In the second system, medical information about the patient, regularly updated by the network's medical team, is available to professionals via a secure website, so that in case the patient requires an urgent medical home visit outside working hours, the visiting physician has access to accurate information.
The study's goal is to compare patient's and caregiver's satisfaction between these two systems of continuity of care.
For that purpose, patients will be taken care of as usual by every palliative care network. In every instance where the patient or caregivers have reached out for medical help through the network's continuity of care system, the patient or caregiver will be called 5 days later by the investigation team to go through a satisfaction questionnaire (Likert scales)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients newly followed for home hospice care by the four palliative care networks of Paris, France, during the inclusion period (up to the inclusion of 200 patients)
Key inclusion criteria (3 listed)
- Patient has a disease with fatal prognosis and requires palliative care
- Patient lives in Paris, France
- Patient benefits from home hospice care through one of the four official Paris palliative care networks
Key exclusion criteria (5 listed)
- Pregnant women
- Breastfeeding womed
- Altered cognitive function with a Mini Mental Status below 20
- Patient not able to communicate or not speaking French
- Patient legally not capable of giving informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Satisfaction about the response given by the network's continuity of care system
Time frame: between the first and tenth day after the patient or caregiver activated the network's continuity of care system
Patient's (or caregiver's) satisfaction about the response given by the network's continuity of care system, after the patient or caregiver activated this system at night time or during week-ends or bank holliday, as measured on a 4-level Likert scale (verbal questionnaire by phone call)
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 7 Dec 2018.
Related trials for Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Herve PICARD, MD MSc principal investigator
Clinical Research Department, Rothschild Foundation, Paris (France)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms and Neurodegenerative Diseases, run by Fondation Ophtalmologique Adolphe de Rothschild at 4 sites 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 3 inclusion and 5 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 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 about the response given by the network's continuity of care system (time frame: between the first and tenth day after the patient or caregiver activated the network's continuity of care system). 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 7 Dec 2018.