Social IsolationM2PRUSSENCT03660215
Medico-social Mediation on the Prevention of the Return to Emergencies Among People in a Precarious Social Situation
A study testing mediation in people with Social Isolation, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
This research aims to evaluate a new mode of care for precarious public through a medico-social mediation device after emergencies, with the aim of improving their care and to prevent possible complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Isolation
- What is being tested?
- mediation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 724 participants
- Where
- 1 siteFrance
- Study dates
- 6 Feb 2019to 4 Aug 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to emergencies,
- Social precariousness score at the EPICES scale,
- Having made at least one visit to an emergency department during the 90 days prior to inclusion,
- Arriving on their own or being transported to a recumbent position by firefighters or an ambulance,
- Volunteers to participate in the study ,
Who cannot join
- Having a score of social precariousness according to the EPICES scale lower than 30, Transferred from a medico-social institution, Unable to answer a questionnaire, face-to-face with an interviewer, either for medical reasons Coming to emergencies for / with a psychiatric decompensation and / or presenting a serious mental illness and / or under the influence of psychotropes, Residing outside the areas of residence targeted by the research, Refusing to participate in the study , In situations of legal incapacity to fulfill informed consent, in particular persons under guardianship or trusteeship.
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, 13354
About this study
Official title: Interventional Trial in Primary Care of Medico-social Mediation on the Prevention of the Return to Emergencies Among People in a Precarious Social Situation
This research aims to evaluate a new mode of care for precarious public through a medico-social mediation device after emergencies, with the aim of improving their care and to prevent possible complications.
The main objective is to evaluate the effectiveness of management by a medico-social mediation device set up within 48 hours after leaving emergency on the 90-day emergency readmission rate. people living in precarious situations.
Read more
prospective randomized interventional trial with two arms. Patients will complete questionnaires assessing precariousness, quality of life, health literacy, and time perspective. Eligible patients (726 subjects) are randomized : control group (usual management) or experimental group (patient is contacted within 48 hours by a medico-social mediator familiar with the territory), and followed for 90 days by the latter, in order to optimize and secure the care path.
Readmissions are identified from emergency database and Regional Emergency Terminal and documented.
Patients in the experimental group benefit from the support of a local health mediator who carries out a diagnosis of the person's needs in order to follow his or her care path in an optimal way. It implements and ensures with the patient and his entourage the follow-up of the care through his network of professionals of the social sector and the health.
The study will be under the responsibility of a multidisciplinary scientific committee experienced in public health, epidemiology and social psychology of health, in the field of emergencies, precariousness and medico-social mediation, and excellent knowledge. territories concerned.
Read the detailed description
This research aims to evaluate a new mode of care for precarious public through a medico-social mediation device after emergencies, with the aim of improving their care, to prevent possible complications of diseases related to poor / no return home care, to improve the quality of life of the people concerned, and to participate in the decongestion of emergencies.
The main objective is to evaluate the effectiveness of management by a medico-social mediation device set up within 48 hours after leaving emergency on the 90-day emergency readmission rate. people living in precarious situations.
Secondary objectives:
- Evaluate the effectiveness of the studied CEP on the 180-day emergency readmission rate, the hospitalization rate at 30, 90 days and 180 days, the number of readmissions to emergencies within 30, 90 and 180 days of follow-up, duration of hospitalizations occurring within 180 days, subgroups of patients, reasons for readmissions to the emergency department,
- Evaluate the impact of health literacy and temporal awareness levels on the 90 day emergency readmission rate,
- Evaluate the impact of the initial quality of life on the 90-day readmission rate,
- Identify predictive factors for readmission to emergencies at 30, 90 and 180 days.
Methodological approach: prospective randomized interventional trial with two arms.
Patients admitted to one of the four participating UAs meeting the inclusion / exclusion criteria of the trial will complete questionnaires assessing precariousness, quality of life, health literacy, and time perspective. Two emergency centers will be located in dense urban areas that are highly vulnerable (Marseille's northern neighborhoods); two others in less urbanized areas in which there are pockets of neo-rural precariousness. Eligible patients are randomized to emergency in one of the two arms (control: usual management) or (experimental: intervention). In this last arm, the patient is contacted within 48 hours by a medico-social mediator familiar with the territory, and followed for 90 days by the latter, in order to optimize and secure the care path. Patients are recalled at 90 days (number obtained at the signing of the consent). Patients are documented for emergency use, severity (CCMU score), primary and associated conditions, quality of life (WHOQOL-Brief), patterns and patterns of discharge. A health literacy score and a time-domain assessment (short-term PTZ) will be administered only in the experimental arm, using these scales to cover a secondary objective to examine the impact of health literacy and literacy. temporal perspective on the readmission rate. Readmissions are identified from the emergency database and Regional Emergency Terminal and documented (reason for appeal, severity score, mode and reason for leaving the study).
Patients in the experimental group benefit from the support of a local health mediator who carries out a diagnosis of the person's needs in order to follow his or her care path in an optimal way. It implements and ensures with the patient and his entourage the follow-up of the care through his network of professionals of the social sector and the health.
Patients in the control group do not have the support of the health mediator. They are only initially evaluated. Their eventual readmission is identified from the local emergency database at 30, 90 and 180 days as patients in the experimental group.
The number of subjects needed to carry out the research is 726 subjects, ie 363 subjects per group.
The statistical analyzes are carried out according to an analysis plan validated by the scientific committee of the study, with robust tools , blind (with lifting of the blind at the end of the analyzes). Use of descriptive and then analytical techniques.
The study will be under the responsibility of a multidisciplinary scientific committee experienced in public health, epidemiology and social psychology of health, in the field of emergencies, precariousness and medico-social mediation, and excellent knowledge. territories concerned.
- Conditions
- Social Isolation
- Being tested
- mediation
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mediationOther
support throughout their care journey during the 90 days following an emergency visit. This support will be carried out by a specific staff trained in medico-social mediation
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | usual charge |
| experimental group | Experimental | Mediation:
The mediator will intervene on several levels: planning of care according to the medical prescriptions on a support adapted and comprehensible by the patient according to his level of health literacy and his linguistic capacities, coaching on the management of the chronic diseases, possible orientation towards a workshop of therapeutic education, appointments calendar, clear indication of treatment changes, provision of contact information for allied health professionals , assistance in making appointments, possible accompaniments at a professional health. Receives: Other: mediation |
What is being measured
The primary outcome is the main question the study is designed to answer.
numbers of readmission to hospital emergencies
90-day readmission rate to hospital emergencies
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start6 Feb 2019
- Primary completion4 Aug 2022
- Study completion4 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social IsolationStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 724 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660215
- Sponsor's protocol ID
- 2018-08
- Acronym
- M2PRUSSE
- Status last verified
- Jun 2024
- First submitted
- 4 Sep 2018
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rotily M, Persico N, Lamouroux A, Rojas-Vergara AC, Loundou A, Boucekine M, Apostolidis T, Odena S, Chischportich C, Auquier P. Health mediation does not reduce the readmission rate of frequent users of emergency departments living in precarious conditions: what lessons can be learned from this randomised controlled trial? BMC Emerg Med. 2024 May 15;24(1):83. doi: 10.1186/s12873-024-01000-2.
PubMed 38750416
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Trial in Primary Care of Medico-social Mediation on the Prevention of the Return to Emergencies Among People in a Precarious Social Situation
- ClinicalTrials.gov ID
- NCT03660215
- Acronym / sponsor ID
- M2PRUSSE / 2018-08
- Conditions
- Social Isolation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 724 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 4 Aug 2022 (actual)
- Study completion
- 4 Aug 2022 (actual)
- First posted
- 6 Sep 2018 (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.
This research aims to evaluate a new mode of care for precarious public through a medico-social mediation device after emergencies, with the aim of improving their care and to prevent possible complications.
The main objective is to evaluate the effectiveness of management by a medico-social mediation device set up within 48 hours after leaving emergency on the 90-day emergency readmission rate. people living in precarious situations.
prospective randomized interventional trial with two arms. Patients will complete questionnaires assessing precariousness, quality of life, health literacy, and time perspective. Eligible patients (726 subjects) are randomized : control group (usual management) or experimental group (patient is contacted within 48 hours by a medico-social mediator familiar with the territory), and followed for 90 days by the latter, in order to optimize and secure the care path.
Readmissions are identified from emergency database and Regional Emergency Terminal and documented.
Patients in the experimental group benefit from the support of a local health mediator who carries out a diagnosis of the person's needs in order to follow his or her care path in an optimal way. It implements and ensures with the patient and his entourage the follow-up of the care through his network of professionals of the social sector and the health.
The study will be under the responsibility of a multidisciplinary scientific committee experienced in public health, epidemiology and social psychology of health, in the field of emergencies, precariousness and medico-social mediation, and excellent knowledge. territories concerned.
Detailed description
This research aims to evaluate a new mode of care for precarious public through a medico-social mediation device after emergencies, with the aim of improving their care, to prevent possible complications of diseases related to poor / no return home care, to improve the quality of life of the people concerned, and to participate in the decongestion of emergencies.
The main objective is to evaluate the effectiveness of management by a medico-social mediation device set up within 48 hours after leaving emergency on the 90-day emergency readmission rate. people living in precarious situations.
Secondary objectives:
- Evaluate the effectiveness of the studied CEP on the 180-day emergency readmission rate, the hospitalization rate at 30, 90 days and 180 days, the number of readmissions to emergencies within 30, 90 and 180 days of follow-up, duration of hospitalizations occurring within 180 days, subgroups of patients, reasons for readmissions to the emergency department,
- Evaluate the impact of health literacy and temporal awareness levels on the 90 day emergency readmission rate,
- Evaluate the impact of the initial quality of life on the 90-day readmission rate,
- Identify predictive factors for readmission to emergencies at 30, 90 and 180 days.
Methodological approach: prospective randomized interventional trial with two arms.
Patients admitted to one of the four participating UAs meeting the inclusion / exclusion criteria of the trial will complete questionnaires assessing precariousness, quality of life, health literacy, and time perspective. Two emergency centers will be located in dense urban areas that are highly vulnerable (Marseille's northern neighborhoods); two others in less urbanized areas in which there are pockets of neo-rural precariousness. Eligible patients are randomized to emergency in one of the two arms (control: usual management) or (experimental: intervention). In this last arm, the patient is contacted within 48 hours by a medico-social mediator familiar with the territory, and followed for 90 days by the latter, in order to optimize and secure the care path. Patients are recalled at 90 days (number obtained at the signing of the consent). Patients are documented for emergency use, severity (CCMU score), primary and associated conditions, quality of life (WHOQOL-Brief), patterns and patterns of discharge. A health literacy score and a time-domain assessment (short-term PTZ) will be administered only in the experimental arm, using these scales to cover a secondary objective to examine the impact of health literacy and literacy. temporal perspective on the readmission rate. Readmissions are identified from the emergency database and Regional Emergency Terminal and documented (reason for appeal, severity score, mode and reason for leaving the study).
Patients in the experimental group benefit from the support of a local health mediator who carries out a diagnosis of the person's needs in order to follow his or her care path in an optimal way. It implements and ensures with the patient and his entourage the follow-up of the care through his network of professionals of the social sector and the health.
Patients in the control group do not have the support of the health mediator. They are only initially evaluated. Their eventual readmission is identified from the local emergency database at 30, 90 and 180 days as patients in the experimental group.
The number of subjects needed to carry out the research is 726 subjects, ie 363 subjects per group.
The statistical analyzes are carried out according to an analysis plan validated by the scientific committee of the study, with robust tools , blind (with lifting of the blind at the end of the analyzes). Use of descriptive and then analytical techniques.
The study will be under the responsibility of a multidisciplinary scientific committee experienced in public health, epidemiology and social psychology of health, in the field of emergencies, precariousness and medico-social mediation, and excellent knowledge. territories concerned.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –usual charge |
| experimental group | Experimental | Other: mediationMediation: The mediator will intervene on several levels: planning of care according to the medical prescriptions on a support adapted and comprehensible by the patient according to his level of health literacy and his linguistic capacities, coaching on the management of the chronic diseases, possible orientation towards a workshop of therapeutic education, appointments calendar, clear indication of treatment changes, provision of contact information for allied health professionals , assistance in making appointments, possible accompaniments at a professional health. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Admitted to emergencies,
- Social precariousness score at the EPICES scale,
- Having made at least one visit to an emergency department during the 90 days prior to inclusion,
- Arriving on their own or being transported to a recumbent position by firefighters or an ambulance,
- Volunteers to participate in the study ,
Key exclusion criteria (1 listed)
- Having a score of social precariousness according to the EPICES scale lower than 30, Transferred from a medico-social institution, Unable to answer a questionnaire, face-to-face with an interviewer, either for medical reasons Coming to emergencies for / with a psychiatric decompensation and / or presenting a serious mental illness and / or under the influence of psychotropes, Residing outside the areas of residence targeted by the research, Refusing to participate in the study , In situations of legal incapacity to fulfill informed consent, in particular persons under guardianship or trusteeship.
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 |
|---|---|---|
| mediationsupport throughout their care journey during the 90 days following an emergency visit. This support will be carried out by a specific staff trained in medico-social mediation | Other | experimental group |
Primary outcome
numbers of readmission to hospital emergencies
Time frame: 90 days
90-day readmission rate to hospital emergencies
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 20 Jun 2024.
- Derived from this study: PubMed 38750416Rotily M, Persico N, Lamouroux A, Rojas-Vergara AC, Loundou A, Boucekine M, Apostolidis T, Odena S, Chischportich C, Auquier P. Health mediation does not reduce the readmission rate of frequent users of emergency departments living in precarious conditions: what lessons can be learned from this randomised controlled trial? BMC Emerg Med. 2024 May 15;24(1):83. doi: 10.1186/s12873-024-01000-2.
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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.
EMILIE GARRIDO PRADALIE study director
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mediation in people with Social Isolation, run by Assistance Publique Hopitaux De Marseille 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 5 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 20 Jun 2024. 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?
numbers of readmission to hospital emergencies (time frame: 90 days). 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 NCT03660215, which also lists 1 linked publication.
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 20 Jun 2024.