Elderly Patients in Complex SituationsPROCOPESNCT02348892
Evaluation Program of the Benefit of the Coordination of the Course of the Elderly Patient in Health Establishment - Pilot Study.
An observational study of Elderly Patients in Complex Situations, run by Nantes University Hospital at 1 site in France.
Trial summary
The large share of chronic diseases correlated with an aging population calls to develop necessary coordination between the hospital and non-hospital (professional of the city, home ...) to create new complementarities. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Elderly Patients in Complex Situations
- What is being tested?
- Coordinator and Classic plan
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Feb 2016
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The eligible patients for the study will be the patients of 70 and more years old hospitalized in the Nantes UH in the acute care medical department internal medical departement medical urgency, rehabilitation unit, neurology, gastro-enterology of the CHU of Nantes and which are in complex medical and social situation, whoever is their motive for hospitalization.
Who may be able to join
- Patient of 70 and more years old
- Patient living on Nantes
- Hospitalized in Nantes UH
- Patient whose the hospitalization is not relevant at the time of the request of trajectory case manager
- Patient whose the situation is complex (without solution at the time of the request)
- Patient (or legal representative) having given his assent of participation
Who cannot join
- Patient (or legal representative) refusing to participate in the protocol
- Patient whose follow-up is impossible (ex: programmed move, life expectation)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Nantes UH
Nantes, 44093
Gilles Berrut, gilles.berrut@chu-nantes.fr
Dibon Christelle, christelle.dibon@chu-nantes.fr
About this study
The large share of chronic diseases correlated with an aging population calls to develop necessary coordination between the hospital and non-hospital (professional of the city, home ...) to create new complementarities.
Since July 2013, the Nantes University Hospital experiences the establishment of a coordinator route patient in Gerontology. The evaluation program of the benefit of coordinating the course in elderly patients in health establishment (PROCOPES) must allow to prove the efficiency of the intervention of a coordinator route patient, following elderly patients in complex situations, both within the hospital and outside the hospital (home, nursing home,...). The objective of PROCOPES is to show the added value of an innovative position that can make the link between the hospital and the city on deemed complex situations.The pilot study results present a strong interest for health care settings, nursing home and in the world of research. It will also permit to have preliminary data for bigest studies.
- Conditions
- Elderly Patients in Complex Situations
- Being tested
- Coordinator, Classic plan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoordinatorOther
Patients in complex situation taken care by coordinator
Classic planOther
Patients in complex situation taken care by classic plan
| Study group | Role | What they receive |
|---|---|---|
| With coordinator | Elderly patients, in complex situation, taken care by coordinator Receives: Other: Coordinator | |
| Without coordinator | Elderly patients, in complex situation, taken care by the classic plan Receives: Other: Classic plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-utility analysis (CUA)
A differential cost-utility ratio will be used to compare both interventions. The evaluation of costs will take into account direct health care insurance cost, hospital costs and patient cost (according to the french health care insurance system). The evaluation of utility will be based on the evaluation of patient's quality of life, measured by EuroQol EQ-5D.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly Patients in Complex SituationsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348892
- Sponsor's protocol ID
- RC14_0343
- Acronym
- PROCOPES
- Status last verified
- Jan 2015
- First submitted
- 16 Jan 2015
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Program of the Benefit of the Coordination of the Course of the Elderly Patient in Health Establishment - Pilot Study.
- ClinicalTrials.gov ID
- NCT02348892
- Acronym / sponsor ID
- PROCOPES / RC14_0343
- Conditions
- Elderly Patients in Complex Situations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 28 Jan 2015 (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 large share of chronic diseases correlated with an aging population calls to develop necessary coordination between the hospital and non-hospital (professional of the city, home ...) to create new complementarities.
Since July 2013, the Nantes University Hospital experiences the establishment of a coordinator route patient in Gerontology. The evaluation program of the benefit of coordinating the course in elderly patients in health establishment (PROCOPES) must allow to prove the efficiency of the intervention of a coordinator route patient, following elderly patients in complex situations, both within the hospital and outside the hospital (home, nursing home,...). The objective of PROCOPES is to show the added value of an innovative position that can make the link between the hospital and the city on deemed complex situations.The pilot study results present a strong interest for health care settings, nursing home and in the world of research. It will also permit to have preliminary data for bigest studies.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With coordinator | – | Other: CoordinatorElderly patients, in complex situation, taken care by coordinator |
| Without coordinator | – | Other: Classic planElderly patients, in complex situation, taken care by the classic plan |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The eligible patients for the study will be the patients of 70 and more years old hospitalized in the Nantes UH in the acute care medical department internal medical departement medical urgency, rehabilitation unit, neurology, gastro-enterology of the CHU of Nantes and which are in complex medical and social situation, whoever is their motive for hospitalization.
Key inclusion criteria (6 listed)
- Patient of 70 and more years old
- Patient living on Nantes
- Hospitalized in Nantes UH
- Patient whose the hospitalization is not relevant at the time of the request of trajectory case manager
- Patient whose the situation is complex (without solution at the time of the request)
Key exclusion criteria (2 listed)
- Patient (or legal representative) refusing to participate in the protocol
- Patient whose follow-up is impossible (ex: programmed move, life expectation)
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 |
|---|---|---|
| CoordinatorPatients in complex situation taken care by coordinator | Other | With coordinator |
| Classic planPatients in complex situation taken care by classic plan | Other | Without coordinator |
Primary outcome
Cost-utility analysis (CUA)
Time frame: 6 months
A differential cost-utility ratio will be used to compare both interventions. The evaluation of costs will take into account direct health care insurance cost, hospital costs and patient cost (according to the french health care insurance system). The evaluation of utility will be based on the evaluation of patient's quality of life, measured by EuroQol EQ-5D.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2015.
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.
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 Elderly Patients in Complex Situations, run by Nantes University Hospital 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 6 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: status not confirmed, as of the sponsor's last update on 28 Jan 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-utility analysis (CUA) (time frame: 6 months). 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 28 Jan 2015.