NCT03660215

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
724

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

February 6, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2022

Completed
Last Updated

June 20, 2024

Status Verified

June 1, 2024

Enrollment Period

3.5 years

First QC Date

September 4, 2018

Last Update Submit

June 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • numbers of readmission to hospital emergencies

    90-day readmission rate to hospital emergencies

    90 days

Study Arms (2)

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.

Other: mediation

Interventions

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

experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admitted to emergencies,
  • Social precariousness score at the EPICES scale,
  • Arriving on their own or being transported to a recumbent position by firefighters or an ambulance,
  • Volunteers to participate in the study ,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, 13354, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Social Isolation

Interventions

Mediation Analysis

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Intervention Hierarchy (Ancestors)

Factor Analysis, StatisticalStatistics as TopicEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • EMILIE GARRIDO PRADALIE

    APHM

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2018

First Posted

September 6, 2018

Study Start

February 6, 2019

Primary Completion

August 4, 2022

Study Completion

August 4, 2022

Last Updated

June 20, 2024

Record last verified: 2024-06

Locations