Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03660215 |
| Other study ID # |
2018-08 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 6, 2019 |
| Est. completion date |
November 2022 |
Study information
| Verified date |
December 2021 |
| Source |
Assistance Publique Hopitaux De Marseille |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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.
