Vulnerable and Precarious Poupulation Clinical Trial
— EFFIPASSOfficial title:
Effectiveness of an Innovative Program in Primary Care for Vulnerable and Precarious Population With Access Barriers to Healthcare System: PASS de Ville
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.
| Status | Not yet recruiting |
| Enrollment | 488 |
| Est. completion date | November 1, 2023 |
| Est. primary completion date | May 1, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Service Epidémiologie et Economie de la Santé - AP-HM | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | rate of emergency departement visits | 12 months | ||
| Secondary | Mean change from baseline in Quality of life scores on the WHOQOL | WHOQOL scale | 18 months |