Clinical trial NCT04321824: Effectiveness of an Innovative Program in Primary Care for Vulnerable and Precarious Population With Access Barriers to Healthcare System: PASS de Ville
Official title: Effectiveness of an Innovative Program in Primary Care for Vulnerable and Precarious Population With Access Barriers to Healthcare System: PASS de Ville
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vulnerable and Precarious Poupulation
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 488
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: vulnerable and precarious population with access barriers to healthcare system ( no being coveraged at time of the study)

Brief summary: Since the end of 2018, the Care and Orientation Center (CASO)of Marseille corridnated by Medecins du Monde has been investigated an innovative program aimed at direct referrals to primary care for vulnerable and precarious population with access barriers to healthcare system (no being coveraged at time of the study).

Patients consulting at the CASO MDM in Marseille are accompanied and were received, free of charge, by primary care professionals (general practitioners, specialists, pharmacy, analysis laboratory, etc).

This is an observational, comparative study, with two arms: the CASO MDM in Marseille for the intervention site and the CASO MDM in Bordeaux for the control site (where the innovative program does not exist).

A total of 610 patients will be included (305 in the innovative group / 305 in the control group).

The main objective is to evaluate the effectiveness of the innovative programm (PASS de ville) compared to the standard of care by assessing the rate of emergency departement visits at one year in each group.

Duration of inclusion: 12 months; Duration of follow-up: 18 months; Total duration of the study: 36 months.

Both quantitative and qualitative analyses will be conducted to address overall outcomes.

Univariate and multivariate analyzes will be performed on the primary outcome as well as the secondary outcomes in order to highlight significant differences between the two groups and to identify predictive factors for improved effectiveness. The analysis will be conducted in accordance with Good Epidemiological Practices, and the final report will be written according to the CONSORT (Consolidated Standards of Reporting Trials) recommendations. An intention to treat analysis will be conducted.


Eligibility criteria: Inclusion Criteria:

* at least 18 years old
* without health coverage
* having medical needs
* not presenting a vital emergency
* not requiring hospital technical platform
* having declared to want to stay in the area at least 18 months afetr inclusion in the study
* having signed the notice of non opposition to the study

Exclusion Criteria:

* less than 18 years old
* having effective health coverage
* in a life-saving emergency
* needing access to the hospital technical platform
* presenting cognitive impairment that limits comprehension

Primary outcomes:
measure: rate of emergency departement visits
timeFrame: 12 months
Secondary outcomes:
measure: Mean change from baseline in Quality of life scores on the WHOQOL
timeFrame: 18 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Service Epidémiologie et Economie de la Santé - AP-HM
Study officials:
affiliation: AP-HM
name: Jean-Olivier ARNAUD
role: STUDY_DIRECTOR
References: