Effectiveness of an Innovative Program in Primary Care for Vulnerable and Precarious Population With Access Barriers to Healthcare System: PASS de Ville (EFFIPASS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vulnerable and Precarious Poupulation

• Study Type: Observational
• Enrollment (Anticipated): 488

Contacts and Locations

• Study Contact: Name: Pascal AUQUIER; Phone Number: 33(0)4 91 38 47 44; Email: pascal.auquier@univ-amu.fr

Study Locations

• France
  • Marseille, France, 13354
    • Service Epidémiologie et Economie de la Santé - AP-HM
    • Contact: Pascal AUQUIER; Phone Number: 33(0)4 91 38 47 44; Email: pascal.auquier@univ-amu.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
the innovative programm (PASS de ville); specific care for precarious people
the standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
rate of emergency departement visits	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline in Quality of life scores on the WHOQOL	WHOQOL scale	18 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2020
• Primary Completion (ANTICIPATED): May 1, 2022
• Study Completion (ANTICIPATED): November 1, 2023

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: March 24, 2020
• First Posted (ACTUAL): March 25, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2019-23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No