Effectiveness of an Innovative Program in Primary Care for Vulnerable and Precarious Population With Access Barriers to Healthcare System: PASS de Ville
NCT ID: NCT04321824
Last Updated: 2020-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
488 participants
OBSERVATIONAL
2020-05-01
2023-11-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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the innovative programm (PASS de ville)
specific care for precarious people
No interventions assigned to this group
the standard of care
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* having effective health coverage
* in a life-saving emergency
* needing access to the hospital technical platform
* presenting cognitive impairment that limits comprehension
18 Years
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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Jean-Olivier ARNAUD
Role: STUDY_DIRECTOR
AP-HM
Locations
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Service Epidémiologie et Economie de la Santé - AP-HM
Marseille, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019-23
Identifier Type: -
Identifier Source: org_study_id
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