Vulnerable and Precarious PoupulationEFFIPASSNCT04321824
Effectiveness of an Innovative Program in Primary Care for Vulnerable and Precarious Population With Access Barriers to Healthcare System: PASS de Ville
An observational study of Vulnerable and Precarious Poupulation, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vulnerable and Precarious Poupulation
- How many people
- 488 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2020to 1 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: vulnerable and precarious population with access barriers to healthcare system ( no being coveraged at time of the study)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service Epidémiologie et Economie de la Santé - AP-HM
Marseille, 13354
Pascal AUQUIER, 33(0)4 91 38 47 44, pascal.auquier@univ-amu.fr
About this study
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).
Read more
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.
- Conditions
- Vulnerable and Precarious Poupulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| the innovative programm (PASS de ville) | specific care for precarious people | |
| the standard of care | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of emergency departement visits
Measured: 12 months
Secondary outcomes (1)
Mean change from baseline in Quality of life scores on the WHOQOL
WHOQOL scale
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start1 May 2020 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulnerable and Precarious PoupulationStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 488 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Olivier ARNAUD, Study director, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321824
- Sponsor's protocol ID
- 2019-23
- Acronym
- EFFIPASS
- Status last verified
- Jul 2019
- First submitted
- 10 Jul 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Innovative Program in Primary Care for Vulnerable and Precarious Population With Access Barriers to Healthcare System: PASS de Ville
- ClinicalTrials.gov ID
- NCT04321824
- Acronym / sponsor ID
- EFFIPASS / 2019-23
- Conditions
- Vulnerable and Precarious Poupulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 488 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 25 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the innovative programm (PASS de ville) | – | –specific care for precarious people |
| the standard of care | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- vulnerable and precarious population with access barriers to healthcare system ( no being coveraged at time of the study)
Key inclusion criteria (7 listed)
- at least 18 years old
- without health coverage
- having medical needs
- not presenting a vital emergency
- not requiring hospital technical platform
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
rate of emergency departement visits
Time frame: 12 months
1 secondary outcome
Mean change from baseline in Quality of life scores on the WHOQOL
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Olivier ARNAUD study director
AP-HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vulnerable and Precarious Poupulation, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pascal AUQUIER (33(0)4 91 38 47 44, pascal.auquier@univ-amu.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of emergency departement visits (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.