Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03986801 |
| Other study ID # |
2019-03 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2, 2019 |
| Est. completion date |
September 2, 2021 |
Study information
| Verified date |
June 2019 |
| Source |
Assistance Publique Hopitaux De Marseille |
| Contact |
Pascal Auquier |
| Phone |
+33 4 91 38 47 44 |
| Email |
Pascal.AUQUIER[@]ap-hm.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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).
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.
