NCT03986801

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,858

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 14, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

September 2, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2021

Completed
Last Updated

June 14, 2019

Status Verified

June 1, 2019

Enrollment Period

1 year

First QC Date

June 13, 2019

Last Update Submit

June 13, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • The number of unscheduled hospitalizations

    12th month of the study

Study Arms (2)

PASS pharmaceutical interview

EXPERIMENTAL
Other: pharmaceutical interview

Usual management out of hospital

NO INTERVENTION

Interventions

pharmaceutical interview at the end of hospitalization

PASS pharmaceutical interview

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

Study Officials

  • Jean-Olivier ARNAUD

    Assistance Publique des Hôpitaux de Marseille

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2019

First Posted

June 14, 2019

Study Start

September 2, 2019

Primary Completion

September 2, 2020

Study Completion

September 2, 2021

Last Updated

June 14, 2019

Record last verified: 2019-06

Locations