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

Impact of a Permanently Maintained Healthcare Multidisciplinary Facility Named Permanece d'Accès Aus Soins de Santé (PASS-MULTI) on Unscheduled Readmissions at 12 Months for Persons in Precarious Situations.

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).

Study Overview

• Status: Unknown
• Conditions: Vulnerable Patients
• Intervention / Treatment: Other: pharmaceutical interview

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1858
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pascal Auquier; Phone Number: +33 4 91 38 47 44; Email: Pascal.AUQUIER@ap-hm.fr

Study Locations

• France
  • Marseille, France, 13354
    • Assistance Publique Hopitaux de Marseille
    • Contact: Pascal Auquier; Phone Number: +33 4 91 38 47 44; Email: Pascal.AUQUIER@ap-hm.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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PASS pharmaceutical interview	Other: pharmaceutical interview; pharmaceutical interview at the end of hospitalization
NO_INTERVENTION: Usual management out of hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of unscheduled hospitalizations	12th month of the study

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 2, 2019
• Primary Completion (ANTICIPATED): September 2, 2020
• Study Completion (ANTICIPATED): September 2, 2021

Study Registration Dates

• First Submitted: June 13, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (ACTUAL): June 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2019
• Last Update Submitted That Met QC Criteria: June 13, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2019-03

Drug and device information, study documents

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