Impact of a Permanently Maintained Healthcare Multidisciplinary Facility (PASS-MULTI) on Unscheduled Readmissions at 12 Months for Persons in Precarious Situations.

NCT ID: NCT03986801

Last Updated: 2019-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1858 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-02

Study Completion Date

2021-09-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Created in 1998, PASS departments are mostly intrahospital structures providing primary care to vulnerable patients.

The main objective of the project will be to measure the impact of a multidisciplinary PASS benefiting from outpatient pharmaceutical interviews on the rate of unplanned rehospitalization of patients in precarious situations.

The impact of the implementation of such a device will also be measured on other indicators of major interest in the course of care of the precarious patient: average lengths of stay, emergency room, improved continuity of treatment, quality of life of the patient related to his health, medication compliance, effective accessibility to social rights, qualitative improvement in the use of care, medico-economic efficiency of the intervention compared to existing practice.

The study will be multicenter: 6 centers spread throughout France (Marseille, Paris, Nice, Toulouse, Poitiers and Bayonne).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Created in 1998, PASS ( Permanence d'Accès aux Soins de Santé) departments are mostly intrahospital structures providing primary care to vulnerable patients.

This facility allows medico-social care for people in precarious situations, for a return to the common health system. However, the individual difficulties to resort to care, complicated by a system of health sometimes excluding, and the dissociation of the activity of dispensing treatments from the action of the PASS can lead to breaks of treatments, can cause pathological complications, or cause re-hospitalization. More particularly, the methods of dispensing drugs and medical devices for outpatients in precarious situations are very heterogeneous depending on the institutions and the geographical distance of the PASS or the PUI: discharge with orientation towards the PUI and PASS; dispensing via the unitcare by a doctor or social worker; discharge without medication, without orientation and only with a prescription,... Actually, in some cases, it is highlighted the question of the renewal of treatments and the rupture of these and therefore the breakdown of care.

The use of original and innovative practices, including pharmaceutical maintenance and multidisciplinary monitoring (social, medical and pharmaceutical) until the social rights are obtained, is therefore necessary to promote a reliable and effective system for the care of precarious patients, but also to reassure the patient in his care pathway.

The main objective of the project will be to measure the impact of a multidisciplinary PASS facility, integrating pharmaceutical interviews, for outpatient, on the rate of unscheduled rehospitalization of patients in precarious situations.

The impact of the implementation of such a facility will also be measured on other indicators of major interest in the care pathway of the precarious patient: average lengths of stay, emergency room, improved continuity of treatment, quality of life of the patient related to his health, medication compliance, effective accessibility to social rights, qualitative improvement in the use of care, medico-economic efficiency of the intervention compared to existing practice.

Eligible patients will be randomized between a non-interventional group (standard management of patients according to hospital) or interventional group (setting up a PASS pharmaceutical interview on the day of discharge from hospital and multidisciplinary follow-up until social rights are obtained).

The intervention will consist in the overall medico-social care of the patient in precarious situation by the Multidisciplinary PASS facility, at discharge, including a specialized pharmaceutical interview (PI) while dispensing the treatments; then monthly PI, concomitantly with medical consultations and social follow-up until the end of the study or opening of social rights.

In the non-interventional group, the discharge of the precarious patient will be implemented according to the usual methods of each hospital: the unitcare will have the mission of refering the patient towards the medico-social PASS, and of ensure that the patient is in possession of the necessary documents for the dispensing of the treatments; but this one will not benefit from PI.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vulnerable Patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Eligible patients will be randomized between a non-interventional group (standard management of patients according to the institution of origin) or intervention group (setting up a PASS pharmaceutical interview on the day of discharge from hospital and follow-up multidisciplinary until rights are obtained).
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PASS pharmaceutical interview

Group Type EXPERIMENTAL

pharmaceutical interview

Intervention Type OTHER

pharmaceutical interview at the end of hospitalization

Usual management out of hospital

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pharmaceutical interview

pharmaceutical interview at the end of hospitalization

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 Years and older
* Informed consent form signed by the subject
* Inpatient hospitalized for over 24 hours
* Precarious socioeconomic conditions (EPICES Score 30)
* Incomplete social security cover

Exclusion Criteria

* Children
* Refusal of consent
* Outpatients
* No precarious socioeconomic conditions (EPICES Score Under 30)
* Complete social security cover (AMU, CMUc, ACS, ALD)
* Majors in tutorship or guardianship, pregnant women and persons deprived of liberty
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jean-Olivier ARNAUD

Role: STUDY_DIRECTOR

Assistance Publique des Hôpitaux de Marseille

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assistance Publique Hôpitaux de Marseille

Marseille, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Pascal Auquier

Role: CONTACT

+33 4 91 38 47 44

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Pascal Auquier

Role: primary

+33 4 91 38 47 44

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-03

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.